Disease Management for Diabetes

Disease Managementfor Diabetes

DISCLAIMER: The information contained in this annotated bibliography was obtained from the publications listed. The NationalPharmaceutical Council (NPC) has worked to ensure that the annotations accurately reflect the information contained in the publications, but cannot guarantee the accuracy of the annotations or the publications. There are articles available on the treatment of diabetes that are not included in this bibliography, which may include relevant information not covered herein. Theinclusion of any publication in this bibliography does not constitute an endorsement of that publication by NPC or an endorsementof the services, programs, treatments, or other information contained in such publication.

This bibliography is designed for informational purposes only, and should not be construed as professional advice on any specificset of facts and circumstances. This bibliography is not intended to be a comprehensive source of disease management servicesor programs in the treatment of diabetes, or a substitute for informed medical advice. If medical advice or other expert assistanceis required, readers are urged to consult a qualified health care provider or other professional. NPC is not responsible for anyclaims or losses that may arise from any errors or omissions in the information contained in this bibliography or in the listed publi-cations, whether caused by NPC or originating in any of the listed publications, or any reliance thereon, whether in a clinical orother setting.

© February 2004 National Pharmaceutical Council, Inc.

IntroductionFaced with rising health care costs and limited resources,

health care providers continually seek new ways to providehigh-quality, cost-efficient care.1,2 Years ago, diseasemanagement emerged as a strategy with the potential toachieve this goal.3 The Boston Consulting Group first usedthe phrase “disease management” in its current sense in a1993 report. Since that time, disease managementprograms, techniques, and models have been designed bythe pharmaceutical industry, managed care, pharmacybenefit management (PBM) plans, and most recently by stateMedicaid programs.1,4–8

The Centers for Medicare and Medicaid Services and theDisease Management Association of America define diseasemanagement as a system of coordinated health careinterventions and communications for populations withconditions in which patient self-care efforts are significant.9,10

Disease management supports the clinician-patientrelationship and plan of care, and emphasizes prevention ofdisease-related exacerbations and complications usingevidence-based practice guidelines and patientempowerment tools.9,10 Disease management also evaluatesclinical, humanistic, and economic outcomes on an ongoingbasis with the goal of improving overall health.9–11 The goalsof disease management include:9–11

• Improving patient self-care through patient education,monitoring, and communication with members of thehealth care team.

• Improving physician performance through feedbackand/or reports on patient progress in compliance withprotocols.

• Improving communication and coordination of servicesbetween patient, physician, disease managementorganization, and other providers.

• Improving access to services, including preventionservices and prescription drugs as needed.

The following functions are the main components ofdisease management:9–11

• Identification of patient populations.• Use of evidence-based practice guidelines.• Support of adherence to evidence-based medical

practice guidelines by providing practice guidelines tophysicians and other providers, reporting on thepatient's progress in compliance with protocols, and

providing support services to assist the physician inmonitoring the patient.

• Provision of services designed to enhance patient self-management and adherence to the patient’s treatmentplan.

• Routine reporting and feedback to the health careproviders and to the patient.

• Communication and collaboration among providers andbetween the patient and the patient’s providers.

• Collection and analysis of process and outcomesmeasures along with a system to make necessarychanges based on the findings of the process andoutcomes measures.

Disease management programs are used widely for manychronic diseases, but the most common diseases includeasthma, congestive heart failure, diabetes mellitus, andhypertension. Considerations in selecting a disease fordisease management often include:11,12

• Availability of treatment guidelines with consensusabout what constitutes appropriate and effective care.

• Presence of generally recognized problems in therapythat are well documented in the medical literature.

• Large practice variation and a range of drug treatmentmodalities.

• Large number of patients with the disease whosetherapy could be improved.

• Preventable acute events that often are associated withthe chronic disease (e.g., emergency department orurgent care visits).

• Outcomes that can be defined and measured instandardized and objective ways and that can bemodified by application of appropriate therapy (e.g.,decreased number of emergency department visits orhospitalizations).

• The potential for costs savings within a short period(e.g., less than 3 years).

Three major not-for-profit organizations whose mission isto promote quality health care have recognized thecontribution of disease management activities to qualityhealth care by establishing disease management certificationor accreditation programs. The Joint Commission onAccreditation of Healthcare Organizations, an independent,not-for-profit organization and the nation’s predominantstandards-setting and accrediting body in health care, offers

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Disease Management for Diabetes

disease-specific care program certification. Programcertification is based on an assessment of compliance withconsensus-based national standards, effective use ofestablished clinical practice guidelines to manage andoptimize care, and activities for performance measurementand improvement.13

The National Committee for Quality Assurance recentlybegan accrediting disease management programs on thebasis of standards that are patient oriented, practitioneroriented, or both. It also offers organizations certification forprogram design (i.e., content development), systems (i.e.,clinical information and other support systems), or patientcontact (e.g., for nurse call centers and other organizationswithout comprehensive activities).14 Many diseasemanagement organizations were so eager to undergo theaccreditation or certification process that they volunteered todo so before the standards were finalized.15

The Utilization Review Accreditation Commission (URAC),also known as the American Accreditation HealthCareCommission, establishes standards for the health care andinsurance industries. By establishing standards, educationand communication programs, and a process ofaccreditation, URAC motivates purchasers, providers, andpatients to achieve excellence, thus promoting continuousimprovement in the quality and efficiency of health caredelivery. URAC has accreditation programs for diseasemanagement as well as case management, claimsprocessing, core accreditation, credential verification, healthcall centers, health networks, health plans, health providercredentialing, health utilization management, health Websites, Health Insurance Portability and Accountability Actprivacy and security, independent review organizations,vendor certification, and workers’ compensation utilizationmanagement. URAC also has goals for disease managementaccreditation and case management.16

Penetration and TrendsThe ultimate goal of disease management is to produce

optimal health outcomes for patients. Therefore, virtually allstakeholders in health care want to be involved. Diseasemanagement is of interest to providers, patients, managedcare organizations, insurance companies, governmentagencies, PBM firms, and employer purchasing coalitions.7,11

Most disease management programs are implementedthrough health maintenance organizations (HMOs), PBMfirms, or Medicaid agencies.9–12 Some organizations chooseto hire a vendor and contract out disease management

services, whereas others choose to develop their ownprograms. Each method has advantages and disadvantages;success often depends on the organization and its level ofresources and commitment.

Managed Care Organizations andPharmacy Benefit Management Firms

Managed care organizations and PBM firms were the firstto implement disease management programs. PBM firmsoffer disease management programs and services toemployers and managed care clients as part of their overallbenefit management services.17 The 1998 Novartis Pharmacy

Benefit Report indicated that 75% of PBM pharmacydirectors were expending resources to develop diseasemanagement programs for conditions that respond to ordepend on pharmaceutical products and services.17 HMOsreported that 16% of their disease management programswere provided through a PBM firm.17 Most employersreported using PBM firms to manage costs, and manyemployers used PBM firms to provide disease managementservices.

The American Association of Health Plans (AAHP)represents more than 1,000 HMOs, preferred providerorganizations, and other network-based plans. Members ofthe association provide health care to more than 200 millionAmericans nationwide. The AAHP 2002 annual survey ofhealth plans found that 99.5% of health plans offer a diseasemanagement program.18

State Medicaid ProgramsIn the rapidly changing environment of Medicaid managed

care, it is essential for Medicaid directors and their topmanaged care staff to remain abreast of innovations inorganization and payment that are occurring to serve thespecial needs of the Medicaid population. Traditionally, stateMedicaid programs either have retained insurance risk andpaid on a fee-for-service basis or have outsourced risk andcontracted with Medicaid HMOs. Disease managementrepresents a method of managed care in the middle betweentraditional fee-for-service and HMOs. Four types of modelsare emerging:19

1. Medicaid health outcomes partnerships are usuallyapplied to an existing fee-for-service primary care casemanagement program. Medicaid programs focus onhigh-priority diseases, offering a number of supportsystems to help existing Medicaid providers better servethe patients assigned to them.20

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2. Disease management organizations are outsidecontractors who are retained by the state to addressparticular diseases, either by supplementing existingMedicaid providers and their case managementactivities or by taking over responsibility for targetedpatients.

3. Pay-for-performance approaches establish new rules forscope of practice or referrals and involve nontraditionalproviders in the care of patients with specific diseases.The nontraditional providers are paid a special feecontingent on improving health outcomes or loweringcosts.

4. Centers of excellence focus on particular diseaseepisodes for high-cost, high-volume diseases and selecta network of hospitals, physicians, and other providerswho are already organized to receive a prospective,bundled payment per episode of care. To meet criteriafor designation as a center of excellence, anorganization must provide written documentation of thequality and outcomes of care for a selected disease.

Most states are actively involved in the diseasemanagement process. By far, the diseases most oftenfocused on in these programs are asthma and diabetes.Other diseases and conditions included in state diseasemanagement programs are arthritis, congestive heart failure,depression, gastrointestinal disease, hemophilia, HIVinfection/AIDS, hyperkinetic activity, dyslipidemia, mentalhealth, otitis media, pregnancy, smoking, ulcer, and upperrespiratory infections.19 Current information about statedisease/case management activities is available on the Webat http://www.dmnow.org/state_activities/.

Concerns have been raised about inadequate monitoringof clinical outcomes in patients with diabetes by stateMedicaid agencies when implementing cost-containmentstrategies for the Medicaid pharmaceutical benefit.21

Additional research is needed to determine whether cost-containment strategies adversely affect patient outcomes.

Why Focus on Diabetes?In the 1990s, managed care organizations began an

intense utilization review process to identify areas in whichcost control measures would be appropriate. Diabetes wasone of the first diseases selected because there is greatopportunity to treat this disease more effectively and todevelop programs that will help payers and plans managethe high costs associated with it (see “Economic Impact”).

Diabetes disease management programs continue to gainin popularity as providers try to contain health care costs.Diabetes affects roughly 1 in 20 Americans, but the diseaseaccounts for 1 of every 10 health care dollars spent in theUnited States.22 Diabetes is among the leading healthindicators identified in Healthy People 2010, a set of healthobjectives for the nation to achieve in the first decade of thenew century.23

Diabetes often is selected as a disease for intervention forthe following reasons:

• High-cost patients can be identified easily based on thepatterns of drug use (e.g., chronic refills of insulin orantidiabetic agents).

• Consistent clinical practice guidelines are available withcore recommendations that apply to both children andadults.

• Validated outcome measures (e.g., hospital admissions,emergency department admissions) that can helpmeasure the effectiveness of the interventions areavailable.

• Communication programs are available and have beenshown to work in the treatment of diabetes.

• Patient education materials are plentiful.• Feedback and information necessary for behavior

modification in health care practitioners can begenerated easily.

Economic ImpactIn 2002, the total cost of diabetes was approximately

$132 billion, of which $92 billion was for direct medical costsand $40 billion was for indirect costs associated with lostproductivity due to disability and death.24 Inpatient hospitalcare and nursing home care accounted for approximately$40 billion and $14 billion, respectively, of the direct medicalcosts.24 Nearly 17 million days of hospitalization and morethan 82 million nursing home days were attributed todiabetes in 2002.24

The total per capita health care expenditure for patientswith diabetes (including health care costs not associated withdiabetes) amounted to more than $13,000 in 2002.24 Incontrast, the total per capita health care expenditure forpeople without diabetes was only about $2,500.24

EpidemiologyApproximately 6.2% of the U.S. population—an estimated

17 million Americans—have diabetes mellitus.22 However,only about two in three of these patients are aware that theyhave the disease. Diabetes is the sixth leading cause of

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death and the leading cause of both treated end-stage renal

disease and new cases of blindness in the United States.

Diabetes increases the risk for heart disease and stroke two-

to fourfold. Diabetes also causes nerve damage and

increases the risk for lower-limb amputation.22

Certain racial and ethnic groups (e.g., African Americans,

Hispanics/Latinos, Asian Americans, Pacific Islanders, Native

Americans) are at increased risk for diabetes.22 Other risk

factors for diabetes mellitus include a family history of the

disease, age greater than 45 years, obesity, lack of regular

exercise, dyslipidemia (high triglyceride or low high-density

lipoprotein cholesterol levels), a history of gestational

diabetes, and delivery of a baby weighing nine pounds or

more at birth.

What Is Diabetes?Diabetes mellitus is a heterogeneous group of chronic

metabolic disorders that result in hyperglycemia—excess

blood levels of glucose, which provides energy to cells. The

various forms of the disease are caused by defects in insulin

secretion, insulin action, or both.25,26 The hormone insulin,

which is produced by the pancreas, is vital for the transport

of glucose to body cells. When glucose levels in the blood

are too high, the body’s cells become starved for energy.

Over time, blood vessels may be damaged, leading to eye

problems (retinopathy), kidney problems (nephropathy), nerve

problems (neuropathy), and cardiovascular, cerebrovascular,

and peripheral vascular disease.25 Hyperglycemia also

causes excessive urination (polyuria) and excessive thirst

(polydipsia).25,26

Approximately 10% of patients with diabetes have type 1,

or insulin-dependent, diabetes, which is characterized by an

absolute lack of insulin. Type 1 disease is caused by an

autoimmune process that destroys the pancreatic beta cells

that produce insulin.25,26 Because type 1 diabetes usually

develops in childhood or early adulthood, it was once

referred to as juvenile diabetes, although it also occurs in

adults.25,26

The great majority—about 90%—of patients with diabetes

mellitus have type 2, or non–insulin-dependent, diabetes.

Type 2 diabetes is characterized by insulin resistance

(reduced sensitivity of cells to insulin), a relative insulin

deficiency, or both.25 In people with type 2 diabetes, the

pancreas may not produce enough insulin, the body’s cells

may be unable to utilize the insulin that is produced, or both.

Type 2 diabetes usually develops in adulthood, and most

patients with type 2 disease are obese.25,26

Diabetes Health GoalsThe basic goals of diabetes therapy remained largely

unchanged for many years. Many clinicians assumed that

strict management of blood glucose levels was beneficial to

the patient’s welfare, although few clinical data supported

this idea. The report of the Diabetes Control and

Complications Trial (DCCT) was made available in 1993.27

This long-term study evaluated (1) whether intensive

management of blood glucose levels prevents the

development of diabetes complications (primary prevention)

and (2) whether intensive management prevents or limits the

progression of diabetes complications (secondary

prevention).27 The 1,441 patients in the trial had type 1

diabetes and were randomly assigned to intensive and

conventional treatment groups (Table 1).27 The study results

are shown in Table 2.

The dramatic findings of the DCCT changed goals for the

treatment of type 1 diabetes.27 The findings from the DCCT

have led to plans to apply similar principles to managing type

2 diabetes because the cellular changes causing

complications in both type 1 and type 2 disease are very

similar.27

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Treatment Parameter Conventional IntensiveInsulin 1 or 2 daily injections 3 daily injections or insulin pumpTesting Daily monitoring, urine or blood Blood monitoring several times a dayDiet and exercise instruction Quarterly MonthlyFollow-up exam Quarterly MonthlyCare contact As needed by patient Weekly by nurse

Source: Reference 27.

Table 1. Treatment Plan in Diabetes Control and Complications Trial

Table 3 lists commonly used authoritative guidelines formanaging diabetes. Up-to-date information on treatmentguidelines from various sources also is available online fromthe National Guideline Clearinghouse(http://www.guideline.gov/). The management of diabetes,based on information in the guidelines, is discussed inAppendix A. Table 4 is a list of organizations with informationabout diabetes for patients.

Review of the Diabetes DiseaseManagement Literature

A comprehensive search of the diabetes diseasemanagement literature was conducted to identify reports onthe impact of educational interventions to improve diabetestreatment and management. These reports discuss theimpact of specific educational interventions or programs ondiabetes treatment and management. These may not becomprehensive disease management programs.

The database searched was MEDLINE, the NationalLibrary of Medicine’s premier database of more than 12million bibliographic citations and abstracts from more than4,600 journals in the fields of medicine, nursing, dentistry,veterinary medicine, health care systems, and preclinicalsciences. The decision to index a journal in MEDLINE isbased on scientific policy and quality considerations.

The MEDLINE database was searched from January 1990to October 2003, using the terms “disease management”

AND “diabetes.” Because disease management is a relativelynew concept, articles were manually culled from journals thatare known to publish reports about disease managementprograms but that had not been indexed by MEDLINE (e.g.,Disease Management and Health Outcomes).

The primary criteria for inclusion of a study report in theanalysis were (1) an educational intervention to improvetreatment and management of diabetes and (2) meas-urement of the impact of that intervention.

MethodologiesReports on 67 diabetes disease management programs

(Appendix B and Appendix C) met the inclusion criteria (otherprograms that did not meet the criteria are described inAppendix D). Various methods were used to identify patientsto participate in the disease management programs. Nineprograms were developed exclusively for children, an agegroup in whom diabetes must be carefully monitored toprevent future complications. Children were included withadults in another six programs. The size of the patientpopulation in these studies ranged from 17 to 4,400.

Most of the interventions were educational programs forpatients. Sixteen were educational programs directed athealth care providers (usually nurses or physicians). Twenty-five programs were based on guidelines widely accepted bythe medical community (e.g., the American DiabetesAssociation). Most of the educational programs that weretargeted to patients were administered by specially trainednurses or health educators (i.e., non-physicians). In some ofthe studies, educational programs were administered by ateam of providers such as physicians, physician assistants,nurses, diabetes nurse educators, nutritionists, pharmacists,social workers, and podiatrists.

Various formats and settings were used for the educationalprograms. Individualized and small-group sessionssupplemented by audiovisual and printed information werecommon. Program content typically included diabetes self-management principles, concepts about the disease, andinformation about diet, exercise, and weight loss. Newsletters,written in easy-to-understand language, often were used.Most programs were conducted in an outpatient clinic setting,although a few programs were provided in hospitals (i.e., toinpatients), physicians’ offices, and pharmacies.

Thirty-five of the studies that evaluated diseasemanagement programs were randomized, controlled trials. In eight studies, patients served as their own controls. In 14studies, outcomes were assessed over a 1-year period afterthe intervention.

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Complication Reduction (%)Sustained retinopathy 63Macular edema 26Severe nonproliferative or

proliferative retinopathy 47Laser treatment 51Urinary albumin excretion (>40 mg/24 hrs) 39Urinary albumin excretion (>300 mg/24 hrs) 54Clinical neuropathy at 5 yrs 60

aIncludes both primary prevention and secondary prevention.

Source: Reference 27.

Table 2. Results of DiabetesControl andComplications Trial:Risk Reductions inIntensive Cohorta

OutcomesClinical values (e.g., glycosylated hemoglobin, fasting

blood glucose levels, medication requirements, body weight,

blood pressure, serum cholesterol, triglyceride levels) were

used as outcome measures in most of the studies. Foot

examinations also were used as an outcome measure in

many of the studies. The number of emergency department

visits or hospital admissions was used as an outcome

measure in six studies. In three of these six studies, the

intervention significantly reduced the number of emergency

department visits or hospital admissions. Three studies found

a significant reduction in physician office visits as a result of

the intervention.

Diabetes knowledge increased significantly as a result of

the intervention in all 20 of the studies in which cognitive

outcomes were measured. Nine studies demonstrated

improved understanding and self-management practices as a

result of the intervention. All nine of the studies in which

patient adherence to the drug regimen or education program

was evaluated demonstrated a positive influence of the

intervention on adherence.

The use of medications was an outcome measure in 14

studies. The intervention led to improved medication use or

understanding in eight of these studies. The dispensing of

drugs recommended for the treatment of diabetes was not

measured in any of the studies.

Cost-effectiveness was measured in 10 of the 65 studies,

and 2 studies determined that the cost savings were

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1. American Association of ClinicalEndocrinologists/American College of EndocrinologyMedical guidelines for the management of diabetes mellitus.Available in print (Endocr Pract. 2002;8[suppl 1]:41–82) andonline at: http://www.aace.com/clin/guidelines/diabetes_2002.pdf.

Position statement on insulin resistance syndrome. Available inprint (Endocr Pract. 2003;9:240–252) and online at:http://www.aace.com/clin/guidelines/ACEIRSPositionStatement.pdf.

2. American College of PhysiciansThe evidence base for tight blood pressure control in the man-agement of type 2 diabetes mellitus. Available in print (AnnIntern Med. 2003;138:587–592) and online at:http://www.annals.org/cgi/reprint/138/7/587.pdf.

Treatment of hypertension in type 2 diabetes mellitus: bloodpressure goals, choice of agents, and setting priorities in dia-betes care. Available in print (Ann Intern Med.2003;138:593–602) and online at:http://www.annals.org/cgi/content/full/138/7/593

3. American Diabetes AssociationClinical practice recommendations, including position state-ments, technical reviews, and consensus statements. Availablein print annually in a supplement to the January issue ofDiabetes Care, which is published by the American DiabetesAssociation, and online at: http://care.diabetesjournals.org/

4. American Dietetic AssociationNutrition practice guidelines for type 1 and type 2 diabetesmellitus (December 2001). Available in print and on CD-ROMat www.eatright.org and 120 South Riverside Plaza, Suite2000, Chicago, IL 60606-6995 (1-800-877-1600, extension5000).

5. American Society of Health-System PharmacistsTherapeutic position statement on strict glycemic control inpatients with diabetes. Available in print (Am J Health SystPharm. 2003;60:2357–2362) and online at:http://www.ashp.org/bestpractices/tps/Therapeutic%20Position%20Statement%20Strict%20Glycemic%20Control%20in%20Patients%20with%20Diabetes.pdf.

6. Centers for Disease Control and PreventionRecommendations for health care system and self-management education interventions to reduce morbidity andmortality from diabetes. Available in print (Am J Prev Med.2002;22[suppl 4]:10–4) and online at: http://www.thecommunityguide.org/diabetes/dm-AJPM-recs.pdf.

7. U.S. Preventive Services Task ForceScreening for type 2 diabetes mellitus in adults: recommenda-tions and rationale. Available in print (Ann Intern Med.2003;138:212–214) and online at: http://www.ahrq.gov/clinic/3rduspstf/diabscr/diabetrr.htm.

Table 3. Authoritative Guidelines for Managing Diabetesa

aClinical practice is subject to constant change, and the guidelines in this list may become outdated or be superceded by newer ones. The reader is encour-aged to consult the National Guideline Clearinghouse (http://www.guideline.gov/), a public resource for evidence-based clinical practice guidelines sponsoredby the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research) in partnership with the American MedicalAssociation and the American Association of Health Plans, for the most current guidelines.

attributable to the intervention (e.g., a reduced number ofphysician office visits). The studies that measured cost-effectiveness portend that the cost-benefit ratio of providinga diabetes disease management program will decrease (i.e.,become more favorable) as the intervention is applied to alarger patient population. Over time, the fixed costsassociated with developing a disease management programwill be spread over larger numbers of patients.

The Future of Disease Management Disease management can improve patient outcomes and

quality of life while potentially reducing overall costs. It is animportant approach to integrated care.

As health care payers incorporate disease managementprinciples into the delivery of care, they need to becomemore sophisticated in contracting with outside vendors forthese services. The Disease Management Association ofAmerica works with potential customers to address issuesassociated with contracting, such as data contracting andrisk sharing. Currently, the Disease Management Associationof America has more than 100 members that provide diseasemanagement services.

Disease management vendors have begun using theInternet to reach out to target populations. The Internetallows two-way communication between clinicians andpatients, as well as immediate and free access toeducational materials. Compared with traditional office visitsand postal mailings, the Internet may save time and money.Initially the Internet may be used to educate Medicaidphysicians, nurses, pharmacists, and other providers aboutdisease management. As more people gain access topersonal computers and enter the “informationsuperhighway,” the Internet will become an increasinglypowerful tool.

Disease management is a useful, efficient approach tohealth care. It will continue to gain widespread acceptanceamong health plans that provide care for patients withchronic disease.

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American Association of Diabetes Educators100 West Monroe, Suite 400Chicago, IL 606031-800-338-3633http://www.aadenet.org

American Diabetes AssociationAttn: National Call Center1701 North Beauregard StreetAlexandria, VA 223111-800-DIABETES (1-800-342-2383)E-mail: [email protected]://www.diabetes.org

Centers for Disease Control and PreventionNational Center for Chronic Disease Prevention and HealthPromotionDiabetes Public Health ResourceP.O. Box 8728Silver Spring, MD 209101-877-CDC-DIABhttp://www.cdc.gov/diabetes

National Diabetes Education Program (a partnership of the National Institutes of Health, the Centersfor Disease Control and Prevention, and more than 200 pub-lic and private organizations)http://ndep.nih.gov

National Diabetes Information Clearinghouse (a service of the National Institute of Diabetes & Digestive &Kidney Diseases)1 Information WayBethesda, MD 20892-35601-800-860-8747 or 301-654-3327Fax: 301-907-8906E-mail: [email protected]://diabetes.niddk.nih.gov

Table 4. Organizations withInformation AboutDiabetes forPatients

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The goals of treatment for diabetes are to reduce and control bloodglucose levels, relieve the symptoms of the disease, and preventcomplications.28 Numerous studies have demonstrated that inten-sive treatment and careful control of blood glucose levels canreduce the risk of complications from diabetes.27,29–32 The AmericanDiabetes Association recommends the formulation of an individual-ized diabetes management plan in collaboration with the patient.28

A high degree of patient involvement in self-management should bepart of this plan, including frequent self-monitoring of blood glu-cose.28 Long-term control of blood glucose levels can be assessedby measuring the extent to which glucose is bound to the A1c com-ponent of hemoglobin. This glycosylated hemoglobin value isexpressed as a percentage and should be less than 7% in patientswith diabetes.28

A proven method to curb the escalating costs of diabetes-relatedmorbidity and mortality is through education and disease manage-ment.27–29 The successful management of diabetes requires lifestylechanges for the patient (e.g., diet, exercise, self-monitoring of bloodand possibly urine). The patient must be involved in the decision-making process and must learn as much as possible about dia-betes, including why the symptoms of diabetes occur and howthey can be alleviated through control of blood glucose levels.Education is essential for motivating patients to manage their dis-ease, encouraging changes in lifestyle, and improving patient out-comes. Disease management programs provide an excellent wayto integrate education into the management of the disease.

Nonpharmacologic InterventionsMedical nutrition therapy (i.e., diet) and exercise are importantaspects of nonpharmacologic treatment for diabetes.33,34 Weightloss is a vital part of treatment for type 2 diabetes because it canhelp improve the sensitivity of cells to insulin and the uptake of glucose by cells.

A goal of medical nutrition therapy is to attain and maintain bloodglucose levels in the normal range or as close to normal as possi-ble.33 Patients with type 2 diabetes typically have dyslipidemia, andanother goal for these patients is to improve the lipid profile.33

Blood pressure levels that reduce the risk for vascular disease areanother goal for patients with type 2 disease.33 Caloric restrictionand weight loss are recommended for patients who are overweight,because weight loss may help normalize blood glucose levels.33

Physical activity can improve insulin sensitivity (i.e., help cells takein more glucose), which can lower elevated blood glucose levels.34

Exercise also provides many other health benefits, includingimproved energy levels and increased self-esteem.

Pharmacologic InterventionsAll patients with type 1 diabetes require insulin injections. Patientswith type 2 disease who have multiple symptoms, are severelyhyperglycemic, are pregnant, or have ketosis (increased ketoneproduction due to the breakdown of fat for energy) also should use

insulin injections.35 Other patients with type 2 diabetes may attemptto control their diabetes through diet and exercise for a 3-monthtrial period.35 However, only 10% of patients with type 2 diseasecan control their blood glucose levels with diet and exercisealone.35 Various oral antidiabetic agents (or insulin) may be used inconjunction with diet and exercise to control blood glucose levels in these patients.

Insulin. Injections of insulin help cells take in glucose, therebyreducing blood glucose levels. Insulin is usually given as an intermediate-acting insulin or a mixture of an intermediate-actinginsulin plus a short-acting or rapid-acting insulin. Injections shouldbe administered at least twice daily.35 Some patients may requirethree or more daily insulin injections or continuous subcutaneousinfusions with an insulin pump.35

Oral Antidiabetic Agents. Classes of oral antidiabetic agents includesulfonylureas, biguanides, alpha-glucosidase inhibitors, meglitinides,and thiazolidinediones. Each class has a unique mechanism ofaction, pharmacologic effects, and adverse-effect profile. Ifmonotherapy with an oral antidiabetic agent (plus diet and exercise)is ineffective in controlling blood glucose levels, adding a secondantidiabetic agent (preferably with a different mechanism of action) orinsulin is recommended.35 Using two or more oral antidiabetic agentswith different mechanisms of action may provide an additive bloodglucose–lowering effect and minimize adverse effects.35 If combina-tion therapy is not effective, insulin monotherapy is recommended.35

Sulfonylureas. Sulfonylureas are the best-established oral antidia-betic agents and are a rational choice for initial drug therapy.35 Theyact primarily to increase insulin secretion by pancreatic beta cellsand can cause hypoglycemia.25 Weight gain also can occur withsulfonylurea therapy.25

Biguanide. Currently, metformin is the only drug in the biguanideclass. Metformin reduces blood glucose concentrations by increas-ing glucose uptake in the peripheral muscles and decreasing theamount of glucose produced and released in the liver.25 It alsoimproves the lipid profile.35 The most common adverse effects frommetformin are diarrhea and other gastrointestinal disorders.25

Metformin is contraindicated in patients with renal impairmentbecause of the risk of lactic acidosis, a potentially serious compli-cation.25

Alpha-Glucosidase Inhibitors. The alpha-glucosidase inhibitorsacarbose and miglitol inhibit the action of intestinal enzymes thatbreak down carbohydrates.25 These oral antidiabetic agents delayglucose absorption and are particularly useful for patients withpostprandial hyperglycemia (high blood sugar levels after eating).However, they are not as effective as sulfonylureas and biguanidesin providing long-term control of blood glucose levels.35 Alpha-glucosidase inhibitors do not cause hypoglycemia or weight gain.However, they can cause flatulence, diarrhea, and abdominalcramps.25,36

Appendix A. Management of Diabetes

Repaglinide. Repaglinide is a meglitinide that stimulates insulinrelease by pancreatic beta cells, although it is not a sulfonylurea.Repaglinide is indicated as monotherapy or, if blood glucose con-trol cannot be achieved with repaglinide or metformin alone, incombination with metformin.36 Repaglinide and metformin togetheract synergistically to reduce glucose levels to lower levels than canbe achieved with either drug alone.36

Repaglinide usually is taken two to four times a day, within 30 min-utes before meals.36 Adverse effects include hypoglycemia andweight gain. Patients who are elderly, debilitated, or malnourishedor who have adrenal, pituitary, or hepatic insufficiency are particu-larly susceptible to hypoglycemic reactions.36

Nateglinide. Nateglinide is a non-sulfonylurea with a mechanism ofaction that is similar to that of repaglinide; it stimulates the releaseof insulin by pancreatic beta cells.36 Like repaglinide, nateglinide isindicated for use as monotherapy or in combination with met-formin.36 Nateglinide and metformin have a synergistic blood glucose–lowering effect.36

Nateglinide is taken three times daily, within 30 minutes beforemeals.36 Hypoglycemia and weight gain can occur during nateglin-ide therapy.36

Thiazolidinediones. Thiazolidinediones are the newest class ofantidiabetic agents. They increase insulin sensitivity and action inliver, muscle, and fatty tissues. Thiazolidinediones reduce bloodglucose concentrations and improve the lipid profile.36 Theseagents do not stimulate insulin secretion or cause hypoglycemia.36

However, they can cause weight gain.36

Troglitazone, the first thiazolidinedione to become available, hasbeen withdrawn from the market because of reports of severe livertoxicity resulting in death or requiring transplantation.37 The risk ofsevere liver toxicity appears to be lower with the newer thiazolidine-diones rosiglitazone and pioglitazone.36 Nevertheless, periodicmonitoring of liver enzymes is recommended during treatment withthese agents.36

Appendix A. Management of Diabetes (continued)

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The impact of a diabetes nurse educator on nurses’ knowl-edge of diabetes and nursing interventions in a home caresetting.Adams CE, Cook DL.The Diabetes Educator. 1994;20:49–53.

The impact of a diabetes nurse educator on the diabetes knowl-edge of and patient care provided by registered nurses at homehealth care agencies was assessed by comparing a home healthcare agency that had a diabetes nurse educator with an agencywithout a diabetes nurse educator. The responsibilities of the dia-betes nurse educator included completing needs assessments forboth patients and staff; developing nursing standards of care, staffeducation programs, and specific methods for implementing andevaluating care; designing diabetes self-care content that is userfriendly; and providing ongoing support for staff nurses.

The average score on a test of basic diabetes knowledge was77.3% at the agency with a diabetes nurse educator (N=45 regis-tered nurses) and 70.0% at the agency without the educator (N=17registered nurses), a difference that is significant. Patient care wasassessed using a retrospective chart review of 31 patient charts ateach agency and a list of 33 items addressing patient admission,care plan, ongoing care (assessment, patient education, nursingcare treatments, and evaluation), and discharge. This list wasbased on guidelines of the American Diabetes Association andAmerican Association of Diabetes Educators and federal and stateregulations governing home health care. Patient care scores weresignificantly higher at the agency with the diabetes nurse educatorthan at the agency without the educator. Patient care outcomes(e.g., glycosylated hemoglobin) were not studied. The investigatorsconcluded that the role of the diabetes nurse educator shouldinclude educating staff nurses and setting up standards of patientcare as well as educating patients.

A national diabetes care and education programme: theGhana model.Amoah AG, Owusu SK, Acheampong JW, Agyenim-Boateng K,Asare HR, Owusu AA, Mensah-Poku MF, Adamu FC, AmegashieRA, Saunders JT, Fang WL, Pastors JG, Sanborn C, Barrett EJ,Woode MK.Diabetes Res Clin Pract. 2000 Aug;49(2-3):149–57.

A national diabetes care and education program was created in adeveloping country (Ghana) through international collaborationbetween medical schools, industry, and governmental health careinstitutions. Ghana’s population of 18 million (85% of whom areless than 45 years old) is served by 2 teaching hospitals, 9 regionalhospitals, and 100 subregional hospitals. Two core teams com-prising a physician, a nurse, and a dietitian underwent intensivetraining in a multidisciplinary approach to diabetes care and educa-tion. The core teams subsequently developed a patient educationbooklet and a professional diabetes education curriculum for train-ing health care providers at regional and subregional hospitals and

health care facilities. Culturally appropriate illustrations were devel-oped for teaching illiterate patients. After 3 years, trained diabeteshealth care teams were in place and diabetes services were provid-ed in all regional and 63% of subregional facilities. The number ofpatients with diabetes registered before the program was 4,719,and after the program, the number was 13,643. Prohibitively highprices of antidiabetic medications and supplies were a problem.The experience implementing this program can serve as a modelfor other developing countries.

Evaluation of an activated patient diabetes educationnewsletter.Anderson RM, Fitzgerald JT, Funnell MM, Barr PA, Stepien CJ, HissRG, Armbruster BA.The Diabetes Educator. 1994;20:29–34.

In a nonrandomized study, 1,863 patients with type 1 or 2 diabeteswere recruited from physician offices, pharmacies, clinic waitingrooms, and diabetes patient education programs in nine Michigancommunities. The patients were asked to return a postage-paidpostcard if they wished to receive a free monthly newsletter aboutdiabetes. The newsletter was approximately one page long andprovided readable, concise, and action-oriented information aboutdiabetes care. The newsletter also encouraged patients to becomeassertive consumers of diabetes care who are prepared to interactwith physicians, nurses, and dietitians during diabetes care visits.Each of the 21 newsletters mailed during the 2-year study periodaddressed a specific topic (e.g., diabetic retinopathy) and conclud-ed with a specific recommended action for patients to take (e.g.,ask the physician for a referral for an eye examination). The costof providing the newsletters was about 25 cents per person permonth.

Among 720 patients who received and read most or all of thenewsletters, the newsletters were rated “Helpful” or “Very Helpful”by 77% of patients with type 2 diabetes who were not usinginsulin, 70% of patients with type 2 diabetes who were usinginsulin, and 57% of patients with type 1 diabetes. Patients whofound the newsletters “Helpful” or “Very Helpful” were older and inpoorer overall health and had more complications, lower incomes,and a lesser understanding of diabetes than patients who rated thenewsletters “Not Helpful” or “Somewhat Helpful.” Patients weremore likely to discuss newsletter topics with family or friends thanwith physicians, nurses, or dietitians and were least likely to discusstopics with nurses and dietitians. The topic most frequently dis-cussed with physicians was the importance of annual eye examina-tions. Few of the newsletters resulted in changes in diabetes care;on average, 7.8% of patients made changes in response to anewsletter. The topic resulting in change in the largest percentageof patients (13.1%) was the importance of daily self-testing of bloodglucose levels. Patients who found the newsletters “Helpful” or“Very Helpful” were significantly more likely to make changes in dia-betes care than patients who rated the newsletters “Not Helpful” or“Somewhat Helpful.”

Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Diabetes

Learning to empower patients: results of professional edu-cation program for diabetes educators.Anderson RM, Funnell MM, Barr PA, Dedrick RF, David WK.Diabetes Care. 1991;14:584–9.

A counseling and educational skills training program was conduct-ed for 23 diabetes educators (including 20 nurses and 2 dietitians)who responded to a flyer mailed to diabetes educators in Michigan.The program was designed to equip the educators to use a patientempowerment approach to diabetes patient education, whichrequires health care providers to help patients increase their self-awareness of their values, needs, and goals for diabetes care;assume greater autonomy; and make informed decisions abouttheir own care. The program for diabetes educators involved a 3-day simulated diabetes care regimen (two daily saline injections,self-monitoring of blood glucose four times daily, a 1,200-kcal/daydiet, daily foot care and aerobic exercise, and extensive recordkeeping) to give the educators a greater sense of the challengesfaced by patients. The simulated diabetes care regimen was fol-lowed by a 3-day intensive skills-based workshop, using a four-phase learning sequence with information (lectures, handouts, andreprints) on educational and counseling skills, demonstration ofcounseling skills, videotaped small-group practice in counseling,and review of videotaped counseling sessions. Values clarification,the impact of communication style on approach to diabetes educa-tion, and effective and ineffective teaching also were addressed inthe program.

Counseling skills in simulated and actual patient encountersimproved significantly as a result of the program. A questionnairecompleted before and after the program revealed that the attitudesof the diabetes educators toward patient autonomy also improvedsignificantly. Attitudes toward the need for special training for dia-betes educators did not change significantly. Participants consid-ered the 3-day simulated diabetes care regimen a valuable learningexperience that increased their appreciation of patients’ concerns.

Boost glycemic control in teen diabetics through “family-focused teamwork.”Anon.Dis Manag Advis. 2003;9:120–2.

Family-focused teamwork is an approach to improving glycemiccontrol in teenagers with type 1 diabetes that was developed byresearchers at Joslin Diabetes Center in Boston, Massachusetts.Sharing of responsibility by the teenager and his or her parents is akey element in the approach. A series of educational modules wasdeveloped and used over the course of a year at routine visits. Tomake the program cost-effective, college graduates without ahealth care background administered the modules instead of morecostly health care professionals. A randomized controlled studywas conducted of 105 children 8–17 years of age to compare theintervention with usual care. After 1 year, glycemic control was sig-nificantly better in the intervention group (8.2%) than in the usual

care group (8.7%), although there was room for improvement toreach the goal of 7% in both groups. Participants in the interven-tion group were twice as likely as participants in the usual caregroup to maintain or increase family involvement with diabetes-related tasks.

Diabetes QI program cuts complications by 60%.Anon.Hosp Case Manag. 2003;11(7):103–4.

A quality improvement initiative was undertaken to improve the pro-vision of diabetes disease management in an Iowa health systemthat provided care to 58,000 patients with diabetes. The healthsystem had 11 hospitals, each of which had a diabetic teachingcenter (clinic). The initiative involved developing a strategic planand standardizing care. A standardized patient education curricu-lum was adopted, and staff training was provided in patient educa-tion and data collection. Group patient education sessions wereused instead of individual sessions to improve clinic operational effi-ciency. Reminder calls to patients for return appointments alsowere used.

The average glycosylated hemoglobin decreased from 9.2% to7.0% (i.e., glycemic control improved) over a 6-month period.Hourly clinic operational costs decreased by 20% as a result of theswitch from individual to group patient education sessions.

A comparison of learning activity packages and classroominstruction for diet management of patients with non–insulin-dependent diabetes mellitus.Arsenau DL, Mason AC, Wood OB, Schwab E, Green D. The Diabetes Educator. 1994;20:509–14.

Forty patients attending a diabetes education program at a hospital-based diabetes center volunteered to participate in a ran-domized 5-month study comparing the effectiveness of diabeteseducation using an individualized method of learning with that offormal classroom sessions. The individualized learning programwas based on goals of the American Diabetes Association andAmerican Dietetic Association. It comprised pretest and posttestmaterials, goals and learning objectives, factual information (usinginexpensive existing materials), and activities. Program contentwas reviewed by two registered dietitians, a nutrition specialist, andan education specialist. Follow-up visits were conducted 2 and 5months after randomization.

There were no significant differences between the two groups infasting plasma glucose, glycosylated hemoglobin, knowledge,behavior (a measure of compliance), or body weight at the 2-monthfollow-up visit. The behavior score in the individualized group wassignificantly increased (indicating improved compliance) and bodyweight was significantly decreased at the 2-month follow-up visitcompared with baseline. However, behavior scores decreased andfasting plasma glucose concentrations increased significantly in the

Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Diabetes (continued)

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subsequent 3 months. Knowledge and body weight improved overthe course of the 5-month study in the individualized group.

At the time of the 2-month follow-up in the classroom group, therewere significant decreases in fasting plasma glucose and glycosy-lated hemoglobin levels and an increase in behavior scores com-pared with baseline. Behavior correlated with glycemic control.Glycosylated hemoglobin and behavior scores improved over thecourse of the 5-month study.

Change in knowledge was the only variable that differed significant-ly between the two groups. Increases in knowledge did not corre-late with improved glycemic control or body weight. The results ofthe study suggest that an individualized method of education is aseffective as traditional classroom instruction in educating patientswith diabetes. The individualized method may be more cost-effective, particularly for patients who live a long distance from theclassroom site or for whom the classroom schedule is inconvenient(e.g., employed patients with inflexible work schedules). Choice ofan education method for patients with diabetes might take intoconsideration various patient factors.

Nurse case management to improve glycemic control in dia-betic patients in a health maintenance organization.Aubert RE, Herman WH, Waters J, Moore W, Sutton D, PetersonBL, Bailey CM, Koplan JP. Ann Intern Med. 1998;129:605–12.

A 12-month randomized, controlled trial was conducted to com-pare diabetes control in patients receiving nurse case managementwith that in patients receiving usual care at primary care clinics in agroup-model health maintenance organization. Patients were iden-tified from pharmacy records and a database of patients who hadvisited a physician for diabetes care, been hospitalized for diabetes,been seen by a utilization management nurse, or been referred toan ophthalmologist for a diabetic retinal examination. Seventeenpatients with type 1 diabetes and 121 patients with type 2 diseasewere randomized to the nurse case management group or theusual care group. The nurse case manager (a registered nurse andcertified diabetes educator) was trained to follow detailed manage-ment algorithms under the direction of a board-certified family med-icine physician and an endocrinologist. The algorithms weredesigned to improve glycemic control by adjusting drug therapy,planning meals, and reinforcing exercise recommendations.Patients assigned to the nurse case management group wereinstructed about blood glucose monitoring at an initial visit with thenurse case manager and returned for a follow-up visit 2 weeks laterfor reevaluation and adjustment of the treatment plan. Patientsalso were referred to a 5-week, 12-hour diabetes education pro-gram that addressed diet and exercise among other topics.Patients received weekly or biweekly follow-up telephone calls todiscuss blood glucose values, adjust drug therapy, and reinforcedietary and exercise recommendations. Patients in the usual caregroup received diabetes care from their primary care physicians.

They were provided with blood glucose monitoring equipment andencouraged to participate in the 5-week diabetes education pro-gram attended by the nurse case management group.

The nurse case management group had a greater decrease in gly-cosylated hemoglobin values than did the usual care group (1.7%versus 0.6%, respectively) over the course of the 12-month study.The difference between the two groups was evident after 6 monthsand was maintained for the subsequent 6 months. The reductionin glycosylated hemoglobin was greater with nurse case manage-ment than with usual care in the subset of patients with type 1 dia-betes and in the subset of patients with type 2 disease. There wasno significant difference between the two groups in blood pressure,serum cholesterol and triglyceride levels, body weight, insulinrequirements, hospital admissions, emergency department visits, orfrequency of severe hypoglycemic episodes. Self-reported healthstatus improved significantly in the nurse case management group.

A diabetes control program in a public health care setting.Baker SB, Vallbona C, Pavlik V, Fasser CE, Armbruster M, McCrayR, Baker RL. Public Health Rep. 1993;108(5):595–604.

Protocols for the prevention and care of diabetes-related complica-tions of the eyes, lower extremities, and cardiovascular systemwere developed and implemented in nine community health cen-ters. These facilities were located in urban low-income neighbor-hoods in Houston, Texas, and served approximately 4,300 patients.A culturally sensitive patient education curriculum was provided infour 2-hour sessions by a diabetes nurse educator and a nutrition-ist. Health care professionals received continuing medical educa-tion, and there was financial incentive for nurses to become certi-fied diabetes educators. These efforts are part of a program that isongoing, although some results are available after 5 years of expe-rience.

There was an increase in eye examinations from 8% to 26% of thepatient population. A reduction in the incidence of legal blindnessfrom 9.5 to 2.7 per 1,000 patients was observed after 4 years. Acost-benefit analysis of providing 12 months of screening and pre-ventive treatment for diabetic eye disease suggests a benefit-to-cost ratio of at least 2.77 for such a program.

The percentage of the population with annual foot examinationsincreased from 18% to 44%. Control of blood pressure wasachieved in 77% of patients. However, there were no significantimprovements in body weight or blood glucose control.

The average percentage of correct responses to test questionsabout diabetes increased from 65% to 85% in patients. The rate atwhich proliferative retinopathy and nonproliferative retinopathy (orfundus abnormalities) were correctly identified by physicians inslides or photographs was 79% and 77%, respectively, in 1990and 95% and 86%, respectively, in 1991. In retrospective chart


reviews, 83% of patients with hypertension and 92% of patientswith ischemic heart disease received appropriate medications anddosages.

Intensive education improves knowledge, compliance, andfoot problems in type 2 diabetes.Barth R, Campbell LV, Allen S, Jupp JJ, Chisholm DJ. Diabetic Med. 1991;8:111–17.

The effectiveness of an intensive foot care intervention program anda conventional one were compared in 62 patients with type 2 dia-betes. Patients were recruited through an extensive radio andnewspaper campaign, from referrals by general practitioners andfrom people attending the Diabetes Center, St. Vincent’s Hospitaland other diabetes centers in Sydney, Australia.

There were two types of programs (conventional and intensive).The conventional program included information on diabetes educa-tion (what is diabetes, diet and exercise), complications of diabetes,and a 1 hour lecture on foot care (washing, drying, and inspectingthe feet; cutting toenails, treating minor foot problems, appropriatefootwear, and dealing with extreme temperatures). The intensiveprogram also had comprehensive diabetes education and foot careinformation but patients were encouraged to perform daily foot careprocedures so as to avoid foot problems and reduce the risk ofdiabetic complications. Detailed foot care recommendations anddemonstrations were given. Practice sessions on foot care wereperformed during the study.

The intensive group showed significantly greater improvement thanthe conventional group in foot care knowledge (p<0.001), compli-ance with the recommended foot care routine (p=0.012), and compliance with the initial advice to consult a podiatrist (other thanthe project podiatrist) for further treatment (p=0.008). At the firstfollow-up visit, the intensive group also showed a significantlygreater reduction in the number of foot problems requiring treat-ment than the conventional group. It is not possible to investigatewhether the intensive group’s significant improvement in knowl-edge, compliance, and foot problems will reduce the number ofamputations.

Effectiveness of a diabetes education program adapted forpeople with vision impairment.Bernbaum M, Wittry S, Stich T, Brusca S, Albert SG.Diabetes Care. 2000 Sep;23(9):1430–2.

The use of adaptive self-care skills (e.g., the use of adaptive equip-ment such as syringe magnifiers, syringe loading devices, and glu-cose monitoring systems with speech capability and tactile aids forproper blood sample placement) was studied in 163 visually-impaired patients with type 1 or type 2 diabetes over a 10-yearperiod at a university-based hospital clinic. The mean age was 56years. Diabetes educators specializing in adaptive diabetes tech-

niques assessed visual function and diabetes knowledge, providedinstruction in basic diabetes knowledge and self-care, and assistedin the selection of self-management devices. Demonstration ofproficient self-care technique was considered a successful out-come.

Success was achieved in 72% of participants. The adaptive dia-betes education program was more successful in restoring inde-pendent diabetes self-care practices in patients who were young orhad early visual impairment (legal blindness with some residualfunctional vision) than in patients who were older or had late visualimpairment (light perception only or total blindness). The successrate was 57% in patients with late visual impairment compared with81% in patients with early visual impairment, possibly becauseresidual vision may facilitate the acquisition of self-care skills.

The impact of a staged management approach to diabetesfoot care in the Louisiana public hospital system.Birke JA, Horswell R, Patout CA Jr, Chen SL.J La State Med Soc. 2003;155(1):37–42.

The impact of a statewide (Louisiana), public hospital-based, dis-ease management initiative (DMI) for diabetes and a citywide(Baton Rouge) staged-management diabetes foot program (DFP)on (1) diabetes foot-related hospitalizations and (2) lower extremityamputations was assessed in a retrospective, nonrandomizedstudy of a low-income patient population. The DMI included goalsfor the medical management of diabetes consistent with AmericanDiabetes Association frequencies for performing various tests andexaminations and for counseling patients on nutrition and self-management. The Lower Extremity Amputation PreventionProgram, which includes annual foot screening, patient educationabout foot care, assistance in selection of proper footwear, dailyfoot self-inspection, and management of simple foot problems, was implemented as part of the DMI.

The staged management DFP was established to provide referralcare for high-risk foot problems so that patients receive prompttreatment. Patients with diabetes were stratified by risk for footinjury based on various factors (e.g., loss of protective sensation,foot deformities, poor circulation, history of ulceration), and inter-ventions and follow-up were provided in accordance with thedegree of risk.

The diabetes foot-related hospitalization rate during the year afterprogram implementation was significantly lower than during theyear before implementation both in the five facilities outside BatonRouge where only the DMI was used and in the three facilities inBaton Rouge where the DMI and DFP programs were used. Thereduction in hospitalization rate over time was greater with DMI plusDFP (44%) than with DMI alone (15%).

The lower extremity amputation rate during the year after programimplementation was significantly lower than during the year before


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implementation both in facilities outside Baton Rouge where onlythe DMI was used and in facilities in Baton Rouge where the DMIand DFP programs were used. There was no difference betweengroups in the reduction in lower extremity amputation rate overtime (29% with DMI alone and 33% with DMI plus DFP).

Randomized, controlled trial of diabetic patient education:improved knowledge without improved metabolic status.Bloomgarden ZT, Karmally W, Metzger MJ, Brothers M,Nechemias C, Bookman J, Faierman D, Ginsberg-Fellner F, RayfiledE, Brown WV. Diabetes Care. 1987;10(3):263–72.

In a randomized, controlled trial, the effect of a traditional diabetespatient education program on metabolic control (HbA1c) and othervariables was assessed in 266 patients at a large, hospital-baseddiabetes clinic. All 749 insulin-treated, “predominantly type II” dia-betic patients on the clinic roster were randomly assigned to aneducation group or a control group. Of these patients, 345 agreedto participate in the program and 266 (education group=127; con-trol group=139) completed the study. Patients in both groups hadcontact at each clinic visit with their physician and nurse, whoreviewed medications and specific problems. Patients in the educa-tion group were also offered nine monthly education sessions,which included sessions and audiovisual materials in Spanish forHispanic patients. Material reviewed in these sessions includedbasic physiology; foot, skin, and dental care; insulin administrationand emergencies; complications and risk factors, and nutritionalinformation, which was presented via card games, films, filmstrips,and slides. Sixty-two percent (N=79) of the patients in the educa-tion group attended seven or more sessions and were considered“graduates.”

During the 1.5-year observation period, HbA1c fell from 6.8% to6.1% in the education group and 6.6% to 6.3% in the controlgroup, representing an insignificant difference (p=0.1995). Post-intervention comparison of fasting blood glucose, triglycerides, cho-lesterol, insulin dosages, blood pressure, and foot lesion scoresalso failed to show significant intergroup variation. Whereas womenin the education group gained less weight than those in the controlgroup, this effect was not attributed to the intervention. However,post-intervention comparison of the groups did reveal a significantincrease in cognitive scores in the education group, but not thecontrol group, that was attributed to the program (p=0.0073).Subgroup analysis also revealed that program graduates showedsignificantly greater improvement in behavior scores than eithernongraduates or controls. The authors noted that, as the grouppopulation sizes were sufficient to detect a significant difference inthe primary outcome measure—mean HbA1c, between the educa-tion and control groups, patient education may not be an effica-cious therapeutic intervention in most adults with type 2 diabetes.

Evaluation of a holistic treatment and teaching programmefor patients with type 1 diabetes who failed to achieve theirtherapeutic goals under intensified insulin therapy.Bott U, Bott S, Hemmann D, Berger M.Diabet Med. 2000 Sep;17(9):635–43.

The impact of a specialized educational program was studied in 83experienced patients with type 1 diabetes who failed to achievetheir treatment goals for glycemic control or quality of life despitethe use of intensified insulin therapy and participation in standardeducational programs. Patients were referred to the programbecause of frequent hypoglycemic events, motivational problems, aneed to refresh their diabetes knowledge, or a need for greaterflexibility in the insulin treatment regimen. The specialized programwas provided for small groups (4–6 patients) over a 5-day period(20 hours of education) on an inpatient basis. Insulin therapy,hypoglycemia, diet, and patient-specific concerns were addressed.Psychosocial problems (especially lack of motivation) and copingstrategies were the focus of intensive group discussions.

Face-to-face or telephone interviews were conducted an averageof 17.5 months (range 9–31 months) after the specialized program.Compared with baseline values, there was no change in the meanglycosylated hemoglobin A1c at follow-up. However, there was asignificant decrease in the incidence of severe hypoglycemia (needfor glucose i.v. or glucagon injection) from 0.62 episodes perpatient/year at baseline to 0.16 episodes per patient/year at follow-up. Hospital admission decreased from 9.3 days per patient/yearto 6.2 days per patient/year, a difference that is not significant. Thenumber of sick leave days per patient/year decreased significantlyfrom 17.0 at baseline to 7.7 at follow-up. Thus, the specializededucational program exploring motivation and other psychosocialaspects of self-management improved outcomes in experiencedpatients with poor glycemic control.

A community-based, culturally sensitive education andgroup-support intervention for Mexican Americans withNIDDM: a pilot study of efficacy.Brown SA, Hanis CL.The Diabetes Educator. 1995;21:203–10.

A 9-week pilot study was conducted to determine the feasibility ofproviding culturally sensitive diabetes patient education and groupsupport to Mexican Americans in a rural community setting. Sevensubjects were randomly selected from a cohort of 353 patients withtype 2 diabetes who had been followed in another study for 12years. Eight weekly 2-hour diabetes education sessions (culturallyrelevant videotape presentations, discussions, demonstrations, anda visit to a grocery store to learn to read and interpret food labels)and one 2-hour support group session were conducted in theSpanish language. A family member or friend participated in allsessions to provide support for the patient. Sessions were con-ducted by a clinical nurse specialist, registered dietitian, and com-munity lay worker, all of whom were Mexican American. Program


content was based on a curriculum guide from the AmericanAssociation of Diabetes Educators and included nutrition (especiallyreduction in fat, sodium, and calorie intake), exercise, self-monitoring of blood glucose, drug therapy, and disease complica-tions. The sessions reflected cultural preferences (e.g., food prepa-ration methods) and addressed religious influences (e.g., diabetesas punishment for wrongdoing, conflict from thinking that assumingresponsibility for health interferes with God’s will). The sessionswere conducted in the context of social activities (e.g., cookingdemonstrations) at a county agricultural extension office (i.e., anonthreatening site with an informal, social atmosphere). The useof medical terminology was minimized, and tools for assessingknowledge of diabetes were designed to obviate the need for ahigh reading level.

Two subjects were dropped from the analysis because of seriousfamily illness and coronary artery bypass surgery, respectively.Three months after the intervention, glycosylated hemoglobin andfasting blood glucose levels and knowledge of diabetes self-management were significantly improved compared with baseline inthe remaining five subjects. The subjects found the presence offamily members or other support persons helpful. The group sizewas judged appropriate. The subjects needed additional time tolearn the nutritional content of foods. An additional four weeklyeducational sessions were requested by the subjects. Subjectsparticularly appreciated the grocery store visit, use of culturally rele-vant videotapes, and sharing of healthy recipes.

Effects of behavior-modifying education in the metabolicprofile of the type 2 diabetes mellitus patient.Cabrera-Pivaral CE, Gonzalez-Perez G, Vega-Lopez G, Gonzalez-Hita M, Centeno-Lopez M, Gonzalez-Ortiz M, Martinez-Abundis E,Gonzalez Ojeda A.J Diabetes Complications. 2000 Nov-Dec;14(6):322–6.

The effects of a behavior-modifying educational program on themetabolic profile (serum glucose, total cholesterol, and triglyceridelevels) were assessed in a randomized, controlled trial of 49patients with type 2 diabetes who were not using insulin. Both theexperimental group and control group attended classes once aweek for 9 months. The behavior-modifying educational programwas designed to improve nutritional habits. Classes addressedbasic and applied nutrition concepts and involved workshops,teamwork, and discussions. A traditional educational intervention(i.e., didactic instruction in anatomy and physiology and memoriza-tion of nutritional facts) was used for the control group.

The average serum glucose level decreased significantly from 210mg/dL at baseline to 147 mg/dL at the end of the study in theexperimental group. Total cholesterol and triglyceride levels alsodecreased significantly from baseline. There were no significantchanges in metabolic profile in the control group. Thus, behavior-modifying education was more effective for providing metaboliccontrol than traditional education.

Intervention study for smoking cessation in diabeticpatients: a randomized controlled trial in both clinical andprimary care settings.Canga N, De Irala J, Vara E, Duaso MJ, Ferrer A, Martinez-Gonzalez MA.Diabetes Care. 2000 Oct;23(10):1455–60.

The impact of a nurse-led, face-to-face, individually structuredintervention to help smokers quit smoking was assessed in a 6-month, randomized, controlled trial of 280 patients with type 1 or 2diabetes at two urban hospitals and 15 urban primary care centers.The intervention involved a 40-minute interview, optional transder-mal nicotine replacement therapy, and a follow-up support pro-gram. In the interview, the advantages of smoking cessation wereemphasized, a cessation date was negotiated with the patient, andself-help materials were provided. The intervention was based onthe protocols established in How to Help Your Patients StopSmoking: A National Cancer Institute Manual for Physicians.Subjects assigned to the control group received routine care,including advice to quit smoking.

After 6 months, the incidence of smoking cessation (validated byurine cotinine concentrations) was 7.5 times higher in the interven-tion group (17.0%) than in the control group (2.3%). In patientswho failed to quit smoking, the mean number of cigarettes smokeddaily decreased significantly from baseline in both groups but thereduction was greater in the intervention group (4.6 cigarettes/day)than in the control group (1.6 cigarettes/day). Thus, the nurse-ledintervention was effective in modifying smoking behavior in patientswith diabetes.

Diabetes care organization, process, and patient outcomes:effects of a diabetes control program.Carlson A, Rosenqvist U.The Diabetes Educator. 1991;17:42–8.

The effects of a diabetes control program with continuing medicaleducation for health care providers and organizational change onseveral organization, process, and outcome measures in patientswith diabetes were evaluated in an 18-month, randomized, con-trolled study. Thirty-four primary health care centers in Swedenwere randomized to the intervention (the diabetes control program)group or a control group. A random sample of 20% of the patientsin a registry of patients with diabetes at each center was selectedfor study.

Routine measurement of glycosylated hemoglobin and perform-ance of eye examinations were significantly higher in the interven-tion group than in the control group. There were no significant dif-ferences between the two groups in access to or continuity of care,patient education, or dietary knowledge. Self-monitoring of bloodglucose was significantly more common in the intervention groupthan in the control group, although the degree of metabolic controlwas similar in the two groups. Multivariate analysis by multiple


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regression revealed that routine diabetes care and patient-ratedquality of care were related to patient education, which in turn wasrelated to dietary knowledge, self-care practices, and metaboliccontrol. The link between metabolic control and organization andprocess variables was weak.

Group visits in medically and economically disadvantagedpatients with type 2 diabetes and their relationships to clini-cal outcomes.Clancy DE, Brown SB, Magruder KM, Huang P.Top Health Inf Manage. 2003;24(1):8–14.

The use of group visits (the intervention) was compared with usualcare in a randomized controlled study of 120 adults with poorlycontrolled type 2 diabetes (glycosylated hemoglobin >8.5%) at auniversity-based clinic. Most patients were female and AfricanAmerican, with a mean self-reported educational level of 10.6 yearsand an average health literacy level of grade 7.5. Most patientslacked insurance (30%) or were covered by Medicaid (44%) orMedicare (19%).

In the intervention group, groups of 19 or 20 patients met monthlyfor 6 months. Each 2-hour group visit included a presentation on ahealth-related topic (e.g., nutrition, exercise, sick day management,stress management), a question-and-answer session, and individ-ual attention to patient needs (e.g., immunizations). A controlgroup received usual care.

After 6 months, glycemic control and lipid profiles had improved inboth groups, with no significant differences between groups.Patients in the intervention group had significantly higher scores inthe Trust in Physician Scale, a measure of patients’ sense of trustin their health care providers, than patients in the control group.The use of the Patient Care Assessment Tool (a validated measureof patient satisfaction with various aspects of primary care) revealedtrends toward improved coordination of care, community orienta-tion, and cultural competence in the intervention group, althoughthe differences between the two groups were not significant.Significantly greater compliance with American DiabetesAssociation standards of medical care process indicators (e.g.,annual performance of eye examinations) was observed in theintervention group than in the control group at the end of the study.

Management of patients with type 2 diabetes by pharmacistsin primary care clinics.Coast-Senior EA, Kroner BA, Kelley CL, Trilli LE. Ann Pharmacother. 1998;32:636–41.

The impact of clinical pharmacists working as part of a multidiscipli-nary team on glycemic control in patients with type 2 diabetes whorequire insulin was evaluated. The study was conducted at twoprimary care clinics at a university-affiliated Veterans Affairs medicalcenter. Primary care providers referred 23 patients with inadequateglycemic control to the pharmacists, who provided patient educa-

tion, medication counseling, monitoring, and insulin initiation oradjustment. Goals for glycemic control were in accordance withAmerican Diabetes Association standards. Patients met with apharmacist for an initial 30- to 60-minute visit during which thepatient’s knowledge of diabetes, eating patterns, and glycemiccontrol were assessed and the patient’s medical history and med-ications were reviewed. Follow-up visits were scheduled on anindividualized basis at approximately 1-month intervals. Glycemiccontrol and symptoms were assessed and insulin was adjusted asneeded at these visits. Patients also were monitored by telephoneat 1- to 4-week intervals, depending on glycemic control.Appointments were scheduled with the primary care provider atleast every 6 months. Pharmacists also arranged for visits withphysicians, dietitians, social workers, and psychologists as needed.

Patients were followed for up to 45 weeks (27.1 weeks on aver-age). The average glycosylated hemoglobin decreased from 11.1%at baseline to 8.9% at the last follow-up visit, a change that is sig-nificant. Six (26%) patients achieved a value in the target range(less than 8%). Average fasting blood glucose concentrations andaverage random blood glucose concentrations also decreased sig-nificantly from baseline. Ten (43%) patients achieved a fastingblood glucose value in the target range (140 mg/dL or less), and 19(83%) patients achieved a random blood glucose value in the targetrange (180 mg/dL or less). Eight (35%) patients experienced 85episodes of symptomatic hypoglycemia (one patient who failed toadhere to recommendations for diet, alcohol use, and exerciseaccounted for 48 of these episodes). None of the patients wasseen at the emergency department or hospitalized. Thus,improved glycemic control was associated with pharmacists’ effortsas part of a multidisciplinary team.

The effect of intensive treatment of diabetes on the develop-ment and progression of long-term complications in insulin-dependent diabetes mellitus.The Diabetes Control and Complications Trial Research Group.N Engl J Med. 1993;329:977–86.

In what was a landmark study, 1,441 patients with type 1 diabeteswere followed for an average of 6.5 years to compare the impact ofintensive therapy (an external insulin pump or three or more dailyinsulin injections and frequent blood glucose monitoring) with thatof conventional therapy (one or two daily insulin injections) onmicrovascular complications (retinopathy and nephropathy) andneuropathy. Glycosylated hemoglobin and blood glucose levelswere significantly lower in the intensive therapy group than in theconventional therapy group. Intensive therapy reduced the risk fordeveloping retinopathy by 76% (compared with conventional thera-py) in the 726 patients with no retinopathy at baseline. Intensivetherapy slowed the progression of retinopathy by 54% and reducedthe development of proliferative or severe nonproliferative retinopa-thy by 47% in the 715 patients with mild retinopathy at baseline.Intensive therapy also reduced the occurrence of microalbuminuriaand albuminuria (two measures of nephropathy) by 39% and 54%,


respectively, and reduced the occurrence of clinical neuropathy by60%. The development of hypercholesterolemia (elevated serumconcentrations of low-density lipoprotein cholesterol) was signifi-cantly lower in the intensive therapy group compared with the con-ventional therapy group. The risk of macrovascular disease (i.e.,major cardiovascular and peripheral vascular events) was reducedby 41% by intensive therapy, although the difference between theintensive therapy group and the conventional therapy group wasnot significant. The risk of severe hypoglycemia was increasedapproximately three-fold by intensive therapy compared with con-ventional therapy, a difference that is significant.

Diabetes managed care and clinical outcomes: the HarborCity, California, Kaiser Permanente Diabetes Care System.Domurat ES. Am J Manag Care. 1999;5:1299–1307.

The impact of Diabetes Care System (DCS), a computer-supporteddiabetes care management program, on clinical outcomes in aCalifornia health maintenance organization (HMO) was assessedusing data from a 3-year period. Approximately 30% of HMOmembers with diabetes were targeted by DCS because of factorsthat placed them at high risk for disease complications or prob-lems. Care for these patients was provided by a team of healthcare professionals, and data from individual visits, group encoun-ters, and telephone contacts were tracked in a computer database.The other 70% of patients with diabetes received usual care.Goals for blood glucose and blood pressure control were estab-lished in accordance with American Diabetes Association clinicalpractice recommendations.

Screening rates for glycosylated hemoglobin (a measure of long-term glycemic control), urinary protein, and serum lipids were signif-icantly higher in the 2,617 patients managed by DCS comparedwith the 5,993 patients receiving usual care. Similarly, the rate offollow-up testing in patients with an elevated glycosylated hemoglo-bin was significantly higher in the DCS patients than in the usualcare patients (77% versus 44%, respectively). Significant reduc-tions in glycosylated hemoglobin levels were observed in patients inboth groups with initial elevations. There was a significant reduc-tion in blood pressure in the DCS patients with an elevated bloodpressure but no change in blood pressure in usual care patientswith elevated blood pressure. Inpatient utilization decreased signifi-cantly between 1995 and 1997 in a subset of 386 patients man-aged through the DCS program during that period and in 1997was significantly lower than in 287 patients who were discontinuedfrom the DCS program because of patient factors and resourcelimitations. Screening rates for glycosylated hemoglobin, urinaryprotein, and serum lipids in patients who were no longer managedthrough DCS were significantly lower than rates in patients man-aged through DCS on a long-term basis. Thus, computerizedtracking of patient care improved clinical outcomes.

Disease management proves itself at Geisinger.Edlin M.Healthplan. 2003;44(4):55–8.

The impact of implementation of a diabetes disease managementprogram at a rural not-for-profit health plan was evaluated by per-forming a chart review. A subset of 3,118 of 6,799 health planenrollees with diabetes participated in the disease managementprogram; participants were referred by a physician or self-referred.The program involved one to four annual visits with a nurse in theprimary care setting (depending on the presence of diabetes com-plications) and patient education by nurse educators about self-management techniques and preventive care. Treatment guidelineswere developed by physicians using Health Plan Employer Dataand Information Set (HEDIS) measures that establish frequenciesfor various tests (e.g., glycosylated hemoglobin, lipids, kidney func-tion, eye exams). Nurse educators promoted guideline use in thecourse of providing patient care.

Participants in the disease management program had higher ratesof testing (i.e., higher HEDIS scores); better glycemic control (afteronly 3 months); and fewer emergency department visits and inpa-tient days than nonparticipants. An annual cost savings of $4 mil-lion (nearly $1,300 per participant) was realized, which more thanoffsets the program cost of $1.8 million.

A project to reduce the burden of diabetes in the African-American Community: Project DIRECT.Engelgau MM, Narayan KMV, Geiss LS, et al. J Natl Med Assoc. 1998;90:605–13.

Project DIRECT (Diabetes Interventions Reaching and EducatingCommunities Together) is a 5-year community-based demonstra-tion project that targets African Americans because of the highprevalence of diabetes and risk for complications from the diseasein this patient population. It will be a collaborative effort involvingcommunity leaders, health care providers, and the Centers forDisease Control and Prevention. The project comprises (1) healthpromotion initiatives to improve diet and physical activity in patientswith diabetes; (2) outreach efforts to increase community aware-ness of diabetes risk factors, screening for patients with undiag-nosed diabetes, and integration of previously diagnosed patientsinto the health care system; and (3) efforts to improve diabetes self-care practices, increase access to care, and quality of care provid-ed by primary care providers. The interventions are not based onspecific practice guidelines. Approximately 4,400 households willbe contacted in each of two communities in North Carolina with alarge population of African Americans and similar socioeconomicprofiles and health care resources. One community (Raleigh) willparticipate in the project, and the other community (Greensboro)will serve as a control. Participation in programs, screening rates,changes in diabetes practice, glycosylated hemoglobin concentra-tion (i.e., long-term blood glucose control), and patient knowledgeand skills are among the process and outcome measures that will


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be evaluated. Many of the data will be collected by questionnaire.

In a 1993 pilot study, 45% of 902 participating individuals wereAfrican American. Half of these African Americans were physicallyinactive (light or no physical activity during most weeks) and halfwere overweight. The prevalence of diagnosed and undiagnoseddiabetes was higher in African Americans than in members of otherraces. African Americans also were more likely to smoke and haveuncontrolled hypertension and less likely to have a primary healthcare provider. In patients of all races with diabetes, the level of pre-ventive care was low; only 42% had undergone a diabetes eyeexamination and 50% had their feet examined by a health careprovider within the previous year.

Diabetes support groups improve health care of older diabetic patients. Gilden JL, Hendryx MS, Clar S, Casia C, Singh SP. J Am Geriatr Soc. 1992;40:147–50.

A study of 32 elderly (68 years of age on average) male patientswith diabetes was conducted to determine whether diabetesknowledge, quality of life, and glycemic control are affected by pro-viding support group sessions in conjunction with a diabetes edu-cation program. The diabetes education program comprised sixweekly sessions on the disease, nutrition, drug management, psy-chosocial adjustment, stress management skills, and self-care (e.g.,self-monitoring of blood glucose, foot care). The 11 patients inGroup A participated in the diabetes education program followedby an 18-month support group program with monthly sessionsconsisting of continuing education, coping skills training, group dis-cussions, and structured social activities. Support group sessionswere self-directed by patients and supervised by a social worker,with continuing education provided by members of the diabetescare team (a diabetologist, nurse educator, dietitian, social worker,psychologist, podiatrist, and pharmacist) as appropriate. The 13patients in Group B participated only in the diabetes education pro-gram (they were on a waiting list for the support group program).Eight patients in Group C participated in neither the diabetes edu-cation program nor the support group program.

Patients who received both the support group intervention and dia-betes education program (Group A) had significantly better scoresin measures of diabetes knowledge, quality of life, and depressionthan patients in the other two groups at the end of the study.Glycemic control (fasting blood glucose and glycosylated hemoglo-bin) was significantly worse in Group C (patients who did not par-ticipate in either program) than in patients in the other two groupsbut there was no significant difference between Group A andGroup B. At the 2-year follow-up, the patients who participated inthe support group program (Group A) were more successful inmaintaining diabetes knowledge and had a better quality of life thanpatients in Group B who received diabetes education withoutgroup support.

A community-based case management model for hyperten-sion and diabetes.Ginn M, Frate DA, Keys L. J Miss State Med Assc. 1999 July; 40(7):226–8.

The effect of a community-based case management approach ondisease knowledge, self-perceived health status, and actual healthstatus in 754 patients with diabetes, hypertension, or both wasassessed in a 24-month uncontrolled study. A case managementprogram involving client assessment, care plan development,implementation, client service monitoring, and periodic assessmentwas used at 12 ambulatory clinics and one hospital. These facili-ties were located in five rural Mississippi counties with barriers tohealth care, including a lack of financial resources and insurance,inadequate distribution of primary care providers, transportationlimitations, and low educational levels. Case managers were hiredfrom the local community and trained in methods for educating andmanaging patients.

Knowledge about diabetes and hypertension and self-reportedhealth status improved significantly over the course of the study.The percentage of patients with good blood pressure control (sys-tolic blood pressure <140 mm Hg and diastolic blood pressure <90mm Hg) increased from 33.5% at baseline to 47% after 24 months,a difference that is significant. The percentage of patients withgood blood glucose control (60–120 mg/dL) also increased (from13.9% to 18.9%) over this period, although the change from base-line was not significant.

Brief, computer-assisted diabetes dietary self-managementcounseling: effects on behavior, physiologic outcomes, andquality of life.Glasgow RE, Toobert DJ.Med Care. 2000 Nov;38(11):1062–73.

The reach (percentage of eligible patients participating), adoption(willingness of primary care physicians to participate), and effective-ness of a behavioral dietary intervention with or without diabetesself-management support were assessed in 320 patients with type2 diabetes in a 6-month study. The behavior intervention involvedassessment and analysis of dietary habits and barriers to dietaryself-management and establishment of goals for reducing dietaryfat intake using a multimedia touch-screen computer. Diabetesself-management support involved follow-up telephone calls andcommunity resources enhancement (e.g., newsletters, informationon dining out and shopping).

Seventy-six percent of eligible patients and 40 of 42 primary carephysicians agreed to participate. On average there was a 50%reduction in dietary fat intake. However, there were small reduc-tions in glycosylated hemoglobin A1c and the ratio of total choles-terol to high-density lipoprotein cholesterol (a predictor of heart dis-ease) that were not significant. There was relatively little change inillness-related quality of life. Follow-up phone calls and community


resources enhancement did not add to efficacy of the behavioralintervention.

A brief office-based intervention to facilitate diabetes dietaryself-management.Glasgow RE, Toobert DJ, Hampson SE. Diabetes Care. 1996 Aug; 19(8):833–42.

There is a pressing need for brief practical interventions thataddress diabetes management. Using a randomized design, amedical office-based intervention focused on behavioral issues rele-vant to dietary self-management was evaluated. There were 206adult diabetes patients randomized to usual care or brief interven-tion, which consisted of touch-screen computer-assisted assess-ment to provide immediate feedback on key barriers to dietary self-management, and goal-setting and problem-solving counseling forpatients. Follow-up components to the single session interventionincluded phone calls and interactive video or videotape instructionas needed.

Results using multivariate analyses of covariance revealed that thebrief intervention produced greater improvements than usual careon a number of measures of dietary behavior (e.g., fewer caloriesfrom saturated fat, fewer high-fat eating habits and behaviors) atthe 3-month follow-up. There were also significant differencesfavoring intervention on changes in serum cholesterol levels andpatient satisfaction but not on glycosylated hemoglobin. The inter-vention effects were relatively robust across a variety of characteris-tics, the two participating physicians, and intervention staff mem-bers.

If the results of this study were to be generalized to other settings,this intervention could provide a prototype for a feasible cost-effec-tive way to integrate patient views and behavioral management intooffice-based care for diabetes.

A brief office-based intervention to facilitate diabetes dietaryself-management. Glasgow RE, Toobert DJ, Hampson SE, Noell JW. Health Educ Res. 1995;10:467–78.

An office-based intervention to prompt both patients and providersto focus on behavioral issues relevant to dietary self-managementwas developed for approximately 200 adult patients with type 1 or2 diabetes who are at least 40 years of age (data for the initial 95are presented in this article). Patients were identified via letterabout the study, with informed consent statements sent to patientswho have diabetes and a scheduled appointment at an office-based practice, followed by a phone call from an investigator.

The intervention used computer-assisted and interactive video pro-cedures that assess patient views and behaviors related to dia-betes care and self-management; assistance for patients in settingdietary goals and problem-solving strategies; and follow-up phone

contact and office visits for support. Diet was chosen as a focusbecause it is an objective of Healthy People 2010. An endocrinolo-gist and internist who specialize in diabetes were the managers ofthe intervention.

Follow-up components include phone calls and videotape or inter-active video instruction as needed. Initial process results suggestsuccess in producing modest, targeted behavior changes among abroad cross section of patients. If long-term results are equallypositive, this intervention could provide a prototype for a feasible,cost-effective way to integrate patient views and behavioral man-agement into office-based care for diabetes. Outcomes measuredinclude weight, eating patterns (fat content), serum cholesterol, andglycemic control (glycosylated hemoglobin) and will be measuredbut are not yet available.

Coping skills training for youths with diabetes on intensivetherapy. Grey M, Boland EA, Davidson M, Yu C, Tamborlane WV. Applied Nursing Research. 1999;12:3–12.

A 6-month randomized, controlled study was conducted to evalu-ate the impact of coping and skills training (CST) on metabolic con-trol in adolescents with type 1 diabetes who were initiating intensiveinsulin therapy. Seventy-seven patients selected from a university-based pediatric diabetes service were randomized to the interven-tion group, which received CST and intensive insulin therapy, or thecontrol group, which received intensive insulin therapy alone.Patients were admitted for 1 day to a research center to obtainbaseline data and review treatment goals and methods. The healthcare providers were blinded to the study group assignment ofpatients. Intensive insulin therapy involved three or more dailyinsulin injections or the use of an external insulin pump and self-monitoring of blood glucose at least four times daily. CST wasdesigned to teach problem-solving skills and communications.Four to eight 1- to 1.5-hour weekly small-group sessions followedby monthly sessions were led by a master’s-prepared nurse practi-tioner with experience in pediatric psychiatry and diabetes. Role-playing in various social situations (e.g., making food choices withfriends and decisions about drugs and alcohol) was used in thesesessions.

Both the intervention group (intensive insulin therapy plus CST) andthe control group (intensive insulin therapy alone) had a significantreduction in glycosylated hemoglobin after 6 months, although thereduction was faster and greater in the intervention group. CSTneither reduced nor increased the rate of acute complications ofintensive therapy (i.e., severe hypoglycemic episodes). Patients inthe intervention group had significantly better general self-efficacy(personal competence, power, resourcefulness) and diabetes-related quality of life, reported that diabetes had less of a negativeimpact on quality of life, and had fewer worries about diabetes inrelation to quality of life than patients in the control group.


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Effect of multiple patient reminders in improving diabeticretinopathy screening. Halbert RJ, Leung KM, Nichol JM, Legorreta AP.Diabetes Care. 1992 May;22(5):752–5.

The impact of multiple patient reminders on improving the rate ofdiabetic retinopathy screening was evaluated in 19,523 diabeticmembers of a large, network-based, health maintenance organiza-tion (HMO). Claims and pharmacy databases were used to identifyall HMO members ≥18 years with diabetes and their diabetic retinalexamination (DRE) status. Patients were then randomized to single(N=9614) or multiple (N=9909) reminder intervention groups. Bothgroups received mailed educational materials and a reminder forDRE. Their treating physician groups also received a letter explain-ing the program, current American Diabetes Association (ADA)guidelines for retinal examinations, and a list of their diabeticpatients, indicating DRE status. The single intervention group (thecontrol group) received no additional reminders, while the multipleintervention group (the study group) received additional reminders3, 6, and 9 months after baseline if the claims database indicatedno record of DRE. Monthly DRE rates were determined for the 7months preceding the first intervention (patient reminder) and sub-sequent 12 months.

There was a short-lived (~ 2-month) increase in monthly DRE ratesin both intervention groups following the initial intervention (firstreminder). After a second reminder was sent to the multiple inter-vention group, the percentage of patients who underwent DRE washigher than that in the single intervention group. However, DRErates between groups did not significantly differ after the thirdreminder, nor did monthly differences in rates exist. There was asignificant difference in overall annual DRE rates between groups(p=0.023). Analysis of direct costs of reminders (only printing andpostage) in the multiple reminders group suggested an incrementalcost of $80 per additional eye examination.

Multiple patient reminders are more effective than single remindersin improving rates of diabetic retinopathy screening in a managedcare setting. However, incremental improvement is small and doesnot extend beyond a second reminder. Future research shouldexplore other avenues of improving DRE rates (e.g., telephone follow-up of nonresponders, increased provider involvement,provider reminders). Given the costs of multiple reminders, financialresources may be better utilized on other approaches for reducingdiabetic complications.

Evaluation of a clinical pharmacist in caring for hypertensiveand diabetic patients.Hawkins DW, Fiedler FP, Douglas HL, Eschbach RC. Am J Hosp Pharm. 1979;36:1321–5.

A 29-month randomized, controlled study of 1,722 patients withdiabetes, hypertension, or both was conducted to determinewhether the outcomes of care provided by a clinical pharmacist (an

individual with a doctor of pharmacy degree and 2 years of clinicaltraining in general medicine) differ from the outcomes of care pro-vided by a physician. The pharmacist-managed care was closelymonitored by a physician to ensure that care would be adequate,although care plans written by the pharmacist were rarely altered.The attrition rate was significantly lower and the kept-clinic-appoint-ment rate was significantly higher in the experimental group (phar-macist-managed care) than in the control group (physician-man-aged care). These differences may reflect greater patient satisfac-tion with pharmacist-managed care. There was no significant dif-ference between the two groups in compliance with drug therapy,emergency department visits, hospital admissions, fasting bloodglucose level, or diastolic blood pressure. Systolic blood pressurewas significantly lower in the control group compared with theexperimental group, possibly in part because the control group hada larger percentage of patients with both diabetes and hyperten-sion than the experimental group (diabetes contributes to vascularchanges and hypertension). Care provided by the clinical pharma-cist was safe and effective.

Is the quality of diabetes care better in a diabetes clinic or ina general medicine clinic? Ho M, Marger J, Beart J, Yip I, Shekelle P. Diabetes Care. 1997;20:472–5.

A retrospective chart review was conducted to compare the qualityof ambulatory diabetes care delivered by specialists (faculty dia-betologists, endocrine fellows, medical residents, a diabetic nurseeducator, a podiatrist, and an optometrist) at a diabetes mellitusclinic (DMC) with that provided by generalists (faculty internists,medical fellows, medical residents, and nurse practitioners) at ageneral medicine clinic (GMC) in 1993 and 1994. Computerizedmedication profiles and clinic enrollment lists were used to identify112 patient medical records, half of which documented care pro-vided in the DMC and half of which reflected care delivered at theGMC. Process criteria for “good” quality of diabetes care weredeveloped using American Diabetes Association guidelines. A sub-set of minimally acceptable criteria was chosen because of astrong link with good patient outcomes in clinical trials (e.g., bloodpressure and glycosylated hemoglobin measurements, urinalysis) orbecause of their importance for continuity of care. Compliancewith criteria for self-monitoring of blood glucose levels, foot exami-nation, comprehensive eye examination, and referral for diabeteseducation when glycemic control was poor was significantly greaterin the DMC patient medical records than in the GMC records.Compliance with the criterion for inquiry about cardiac symptomswas significantly higher in the GMC than in the DMC. None of themedical records from either clinic met all the criteria for “good”quality of care. Significantly more DMC patient medical recordsthan GMC records met the minimally acceptable criteria (73% ver-sus 52%, respectively). The most common shortcoming for bothclinics was failure to perform a comprehensive eye examination.Differences between specialists and generalists in knowledge aboutdiabetes management could explain these results.


Empowering diabetes out-patients with structured educa-tion: short-term and long-term effects of functional insulintreatment on perceived control over diabetes.Howorka K, Pumprla J, Wagner-Nosiska D, Grillmayr H, SchluscheC, Schabmann A.J Psychosom Res. 2000 Jan;48(1):37–44.

The short- and long-term effects of structured education aboutfunctional insulin treatment (insulin dosing according to self-moni-toring of blood glucose levels and food intake, thereby avoiding theneed for adherence to a prescribed schedule of doses and meals)were studied in outpatients with type 1 diabetes. Study 1 was a 4-week randomized, controlled study of 32 patients. Both the inter-vention group and the control group received general diabetes edu-cation but only the intervention group received training in functionalinsulin treatment (FIT). Patients undergoing FIT training learned cri-teria for adapting insulin dosing before meals and for the correctionof hyperglycemia. Study 2 was a 3-year uncontrolled pilot study of68 patients. The effect of training in FIT on perceived control overdiabetes and diabetes-related health beliefs was assessed in bothstudies using questionnaires.

In study 1, FIT training induced feelings of independence from situ-ational control while self-managing diabetes. There was no changein the control group over the 4-week period. After 3 years, FITtraining improved perceived self-efficacy, treatment satisfaction, andglycemic control, resulting in a feeling of empowerment. Patientsfelt greater freedom from the control of physicians and treatmentrestrictions. Perceived treatment cost-effectiveness (the differencebetween measures of benefits from treatment and barriers to treat-ment) improved significantly due to decreases in barriers to treat-ment.

Pharmacist-managed diabetes education service. Huff PS, Ives TJ, Almond SN, Griffin NW. Am J Hosp Pharm. 1983;40:991–4.

Ten years of experience with a diabetes education service providedby pharmacists to ambulatory patients was described in 1983.Funding was provided by the U.S. Public Health Service of theDepartment of Health and Human Services, and pharmacists werereimbursed for the service. The education program was developedin accordance with American Diabetes Association patient educa-tion guidelines. Patients were referred to the service by a primarycare provider after diagnosis. A diabetes questionnaire was admin-istered to assess the patient’s knowledge of diabetes. The ques-tionnaire was used to establish a teaching plan and short- andlong-term treatment goals. An initial 1-hour counseling sessionwas conducted to address the pathophysiology of the disease,complications, importance of patient compliance, role of diet anddrug therapy, administration technique, adverse effects, and self-monitoring. Patient progress in the educational process was docu-mented. Additional 15-minute sessions at follow-up visits wereprovided as needed. Patients were assessed a fee of $15.00 for

the initial 1-hour session and $7.50 for additional sessions.Approximately 10 new patients joined the service each month.

Pharmacists were able to provide more instructional time than typi-cally is provided by physicians, thereby improving patient under-standing. Patients were grateful to have ready access to pharma-cists for information or help solving problems. Physicians had moretime available to spend with other patients once pharmacistsassumed the patient education responsibility. Communicationbetween pharmacists and physicians improved.

Impact of community-based diabetes education on programattenders and nonattenders. Irvine AA, Mitchell CM. The Diabetes Educator. 1992;18:29–33.

The impact of community-based diabetes education on patientswith diabetes who dropped out of the program was compared withthat on patients who continued in the program. In threeAppalachian communities that were comparable in size and char-acter, adults with diabetes were referred by physicians and sent aletter inviting them to participate in the study. Sixty-one patientsattended three initial evening meetings at a local church over thecourse of 1 week. The diabetes education program was designedto increase knowledge, self-care, and metabolic control and wasconducted by a nurse educator, nutritionist, psychologist, andphysical therapist. Classes were held on alternate Thursdays overa 3-month period on various topics, including the disease, diet,stress, medication, blood glucose testing, complications, and exer-cise. The 24 subjects who attended fewer than half (two or fewer)of the education classes were considered the Attrition group. Theother 19 subjects, who attended three or more of the educationsessions, were considered the Education group. A control groupof 18 patients received no special education. This control groupwas further divided on the basis of whether subjects attended allthree testing sessions. Data for members of the control group whodid not attend all three testing sessions (pretest, posttest, and 3-month follow-up) were combined with data for the Attrition group tocreate a Nonattenders group, and data for members of the controlgroup who attended all three testing sessions were combined withdata for the Education group to form an Attenders group.

Diabetes knowledge increased significantly over the course of thestudy in the Attenders group but not in the Nonattenders group.There was no significant difference between the two groups inchange in attitude toward living with diabetes (self-esteem, denial,locus of control, degree to which regimen intrudes on lifestyle, atti-tude toward physician). Attitudes improved over the course of thestudy in both groups. There was no significant change over time inany group in self-reported adherence to the treatment regimen fordiet, exercise, medication use, glucose testing, or number ofpounds overweight. Foot care improved significantly in Attendersbut not in Nonattenders. Glycosylated hemoglobin improved signif-icantly in the Education group but not in the Control group.


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Nonattenders tended to be less educated, have a lower income,be younger, have had diabetes for twice as long, report more barri-ers to self-care, and have poorer health than Attenders. Theresults of this study suggest that Attenders may have characteris-tics that allow them to benefit from minimal intervention and thatNonattenders may require special efforts to overcome barriers toparticipating in programs.

Evaluation of pharmaceutical care model on diabetes man-agement. Jaber LA, Halapy H, Fernet M, Tummalapalli S, Diwakaran H. Ann Pharmacother. 1996;30:238–43.

This study assessed the effectiveness of a comprehensive pharma-ceutical care model in improving management of type 2 diabetes in39 African American patients in a clinic setting. Potential subjectsconsisted of urban African American patients with type 2 diabeteswho were currently attending a university-affiliated, internal medi-cine outpatient clinic. Medical chart review was used to excludepatients with certain medical conditions or a recent history of clinicvisit noncompliance; the remaining 156 (eligible) patients were con-tacted by letter followed by a telephone call. The 45 patients whoagreed to participate were assigned to an intervention group orcontrol group in a random, parallel design fashion. These patientswere followed up over a period of 4 months, and 39 patients (17intervention-group patients; 22 controls) completed the study.

Patients in the intervention group received pharmaceutical care consistent with, but broader than, that described by Helper andStrand’s disease-specific model of pharmaceutical care. This pharmacist-administered care consisted of (1) disease-specific pharmacotherapeutic evaluation and dosage adjustments, (2) com-prehensive, individualized patient education about diabetes and itscomplications, (3) training in the recognition and treatment of hypo-glycemia and hyperglycemia, (4) medication counseling, (5) specificinstructions about diet and exercise, and (6) training in the self-moni-toring of blood glucose (SMBG). Follow-up visits were conductedweekly until targeted glycemic control was reached and then every 2to 4 weeks for the study duration. Patients in the control groupattended an initial assessment at the clinic and an exit interview atthe study’s conclusion; they were instructed to continue with stan-dard care, which usually involved clinic visits every 3 to 4 months.

Clinical, laboratory, and quality of life assessments were performedat baseline and at the end of the study (i.e., at 4 months). Primaryoutcome measures consisted of fasting plasma glucose (FPG) andglycosylated hemoglobin (GHb). Secondary outcome endpointsincluded blood pressure, lipid levels, and measures of renal functionas well as quality of life. Information about compliance with medica-tions, diet, and exercise, as well as the frequency of hypo- andhyperglycemic episodes, was obtained at each clinic visit. In addi-tion, SMBG records were reviewed and FBG, weight, and bloodpressure were measured.

Post-intervention evaluation revealed that glycemic control signifi-cantly improved in the intervention group and remained unchangedin the control subjects. Final GHb and FPG concentrations in theintervention group were significantly decreased compared withbaseline, and significant intergroup differences existed for finalGHb, FPG, and the mean absolute change in GHb. No significantchanges in blood pressure control, lipid profiles, renal functionparameters, body weight, or quality-of-life measures were docu-mented within or between groups, except for a decrease in the finalserum creatinine in controls. There were 17 reported hypoglycemicevents in the intervention group versus two in the control group; allwere mild to moderate, accompanied by classic symptoms, andrecognized and successfully treated by patients.

These results suggest that this disease-specific model of pharma-ceutical care effectively improved glycemic control in a clinic-basedpopulation of urban African American, diabetic patients. Given thelack of change in other parameters (e.g., body weight, lipids, bloodpressure), this improvement was primarily attributed to optimizationof glycemic control and enhancement of patient knowledge versusinstruction about diet and exercise. Cost analysis of this programwas not performed.

Effects of diet and exercise interventions on control andquality of life in non–insulin-dependent diabetes mellitus. Kaplan RM, Hartwell SL, Wilson DK, Wallace JP. J Gen Intern Med. 1987;2:220–7.

An 18-month randomized trial evaluated the effects of diet, exer-cise, diet plus exercise, or education on glycosylated hemoglobin,weight, and quality of life in 70 diabetic patients. Following recruit-ment by radio announcements, newspaper notices, and physicians,adult volunteers with a confirmed diagnosis of type 2 diabetes anda fasting plasma glucose of > 3.62 mmol/L were randomlyassigned to one of four 10-week programs: (1) diet, (2) exercise, (3)diet plus exercise, or (4) education (control). Participants in allgroups were given both the American Diabetes Association-recom-mended exchange diet (approximately 1,200 calories/day) and antest-based exercise prescription and asked to attend weekly 2-hourmeetings for 10 consecutive weeks. Volunteers in the educationgroup, designed to be a control group, attended lectures by healthcare specialists that provided information about diabetes care butnot specific instructions for behavioral changes. Subjects in thediet, exercise, and diet-plus-exercise intervention groups attendedweekly sessions that incorporated behavioral modification methods(e.g., diaries to monitor eating/exercise; identification of reinforcersand contingencies; use of distractors) and other strategies (e.g.,instruction in stretching and foot care) to increase compliance withdiet and/or exercise plans.

Baseline parameters were similar among groups. Compared withcontrols, the diet group demonstrated weight loss at 3 and 6months, but had regained this weight by the 18-month evaluation.The greatest reduction in mean glycosylated hemoglobin at 18


months was found in the diet-plus-exercise group (p<0.05), whosemean weight remained essentially unchanged throughout the study.Significant differences in quality of life were noted between the diet-plus-exercise and control groups (p<0.01) and the diet and controlgroups (p<0.05), but not the exercise and control groups, at 18months. The estimated cost of the diet and exercise program was$1,000 per patient. Quality of life-based cost/utility analysis sug-gested the cost of a single “well year” produced by this programwould be $10,870.

Effects of a formalized diabetes education. Karlander SG, Kindstedt K. Acta Med Scand. 1983;213:41–3.

The effects of a formalized diabetes education program on dia-betes and nutrition knowledge and metabolic control wereassessed in a 1-year controlled study of ambulatory patients withdiabetes. All patients attending a diabetes clinic were invited toparticipate, although another 32 patients matched for age were notasked to participate and served as controls. Two daily lessonsabout the disease and nutrition, respectively, were conducted oneach day of the 5-day program. Oral presentations were supple-mented with color slides, and patients were encouraged to askquestions and participate in discussions. An illustrated text thatsummarized each lesson was provided.

Eighty-three patients with diabetes participated in the formal edu-cation program. Their scores on tests of knowledge of diabetesand nutrition increased significantly immediately after the formalprogram and 1 year after the program compared with baseline.Patients in the control group tended to have lower scores thanpatients in the intervention group. Scores for the control group atthe second visit (usually 2 months after the initial visit) wereunchanged compared with the first visit. The only significantchanges in metabolic control in the intervention group 1 year afterthe formal education program were a reduction in relative bodyweight from 133% to 126% in the subset of patients managed withdiet alone and a decrease in serum cholesterol from 6.3 mmol/L to5.8 mmol/L in the subset of patients receiving oral antidiabetic drugtherapy. There were no significant changes in blood glucose level,urinary glucose excretion, glycosylated hemoglobin, or serum cho-lesterol or triglycerides. The investigators concluded that efforts toimprove diabetes control must address patient attitudes toward thedisease and not be limited to imparting facts.

Effect of a comprehensive nurse-managed diabetes pro-gram: an HMO prospective study. Legorreta AP, Peters AL, Ossorio RC, Lopez RJ, Jatulis D,Davidson MB. Am J Manag Care. 1996;2:1024–30.

This 18-month prospective, nonrandomized, control trial assessedwhether a diabetes management program involving special proto-cols linked to a computer system could provide cost-effective out-

patient diabetes care. Patients for this study were recruited fromtwo large medical groups contracted to provide health care toHMO members. One of the groups (site A) was a typical participat-ing medical group (PMG); the other site (site B) was an IPA. A sin-gle separate site was selected as a control for site A, and 13 non-experimental physician office sites served as the control for site B.ICD codes were used to generate a list of patients with diabetes ateach control and experimental site. Approximately 15 patients permonth were randomly selected from this list to enter the programover the course of 6 months at experimental sites. Due to insuffi-cient enrollment, physicians at each experimental facility were sub-sequently permitted to assign patients for inclusion. Patients in thecontrol group were selected a few months after enrollment hadbegun at the experimental sites on the basis of an available gly-cosolated hemoglobin level.

A provider team at each experimental site, consisting of a nurse orphysician assistant (PA), an endocrinologist, and a staff assistant,received a training manual, specially designed protocols and forms,and a computer information system. Protocols were designed toimprove diabetes and lipid management as well as compliance withreferrals and laboratory studies. The computer system wasdesigned to (1) track patient clinical and laboratory data, (2) trackpatient appointments and generate reminders, and (3) provide algo-rithms to adjust insulin dosages based on results of blood glucoseself-monitoring. Training in the application of the program lasted 2weeks for nurses/PAs and one day for physicians. These experi-mental teams also attended quarterly meetings with diabetologiststo discuss program progress. Providers at control sites were notinformed that a study was being carried out.

As part of the program, all patients treated at experimental sitesunderwent an initial evaluation and were then seen at least quarter-ly. Telephone calls and weekly visits were used for patients requiringmore frequent monitoring. The computer ordered baseline laborato-ry values (glycosolated hemoglobin, fasting plasma glucose, fulllipid panel, serum creatinine, urinalysis); follow-up glycosolatedhemoglobin and fasting plasma glucose were obtained every 2months, and the remaining laboratory studies were repeated yearly.Data collection from controls was less complete to avoid alertingproviders and patients that a study was being conducted. Onlypatients whose charts provided a glycosolated hemoglobin levelwithin a one-year interval were selected as controls, and a singlefollow-up level was obtained at the end of the study.

Provider team adherence to protocols was assessed by follow-updata obtained from 117 experimental patients at site A, 123 experi-mental patients at site B, 88 control patients for site A, and 62 con-trol patients for site B (N=390). At site A, 12-month and baseline-to-endpoint decreases in glycosolated hemoglobin were significant-ly greater in the experimental group than the control group. Low-density lipoprotein cholesterol levels also improved in the former,but were not measured in controls. Referral for yearly ophthalmo-logic examination was 100%. The same staff was employed for the


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duration of the study, and nurse adherence to protocols wasjudged to be close. At site B, baseline-to-endpoint analysis, but not12-month data, showed a significantly greater decrease in glycoso-lated hemoglobin levels in experimental group patients than con-trols. However, these levels remained above desirable levels.Improvement in low-density lipoprotein cholesterol levels was alsofound in the experimental group, but only 52% of patients at site Bwere referred for ophthalmologic examination. Considerable staffturnover was also found at site B, which was thought to have con-tributed to disruption of the program and the level of care provided.This disruption was associated with lower levels of protocol adher-ence and reduced proficiency with the computer systems com-pared with that for the staff at site A. Comparison of glycosolatedhemoglobin data from experimental groups A and B also demon-strated a stronger treatment effect at site A.

These results suggest that physician-supervised nurses who followprotocols linked to a computer system can provide high-qualityoutpatient diabetes care associated with improved glycemic con-trol, lipid levels, and patient compliance with referrals. Differences inpatient improvements between experimental groups as sites A andB were attributed to higher staff turnover at site B, resulting in pro-gram and care disruption.

Impact of endocrine and diabetes team consultation on hos-pital length of stay for patients with diabetes.Levetan CS, Salas JR, Wilets IF, Zumoff B.Am J Med. 1995;99:22–8.

The length of hospital stay of consecutive patients with diabeteswas compared when (1) consultation by a diabetes team (nurseeducator, registered dietitian, and endocrinologist) was obtained, (2)a traditional consultation by an endocrinologist was obtained, and(3) no consultation was obtained. The average length of stay ofpatients in the diabetes team consultation group (3.6 days) wassignificantly shorter than values for the endocrinologist-consultationgroup (5.5 days) and the no-consultation group (8.2 days). Eachday delay in consultation resulted in an increase of 1 day in lengthof stay.

Management of chronic pediatric diseases with interactivehealth games: theory and research findings.Lieberman DA.J Ambulatory Care Manage. 2001 Jan;24(1):26–38.

A 6-month randomized controlled trial evaluated the effects of adiabetes self-management video game in 59 children and adoles-cents with diabetes. The diabetes video game had two main char-acters who were presented with challenges modeled after the chal-lenges faced by patients with diabetes. Players were called uponto help their character monitor blood glucose, take appropriateinsulin doses, and eat appropriate foods. Winning the gamerequired success in performing these tasks. Multiple-choice ques-tions posed by a video character were used to teach diabetes self-

care principles. Subjects were randomized to take home the dia-betes video game or an entertainment pinball video game (subjectsusing the pinball game served as controls).

Over the 6-month study period, the average total playing time forthe diabetes video game was 34 hours, which was not significantlydifferent from the playing time in the control group. There was a77% decrease from baseline in urgent care and emergency medicalvisits in the diabetes video game group but there was no change inthe control group (an average of 2.4 visits per year in the controlgroup). There were improvements in diabetes-related self-efficacy(ability to affect outcomes), communication with parents about dia-betes, and daily diabetes self-care in the diabetes video gamegroup but not in the control group.

Pharmacists’ interventions using an electronic medication-event monitoring device’s adherence data versus pill counts. Matsuyama JR, Mason BJ, Jue SG.Ann Pharmacother. 1993;27:851–5.

A randomized, double-blind study was conducted to compare theusefulness of adherence data from an electronic medication-eventmonitoring system (MEMS) with that of pill counts in assisting phar-macists in making recommendations for diabetes therapy (patienteducation or change in drug, dosage, or schedule). MEMS is amedication vial cap with a microprocessor that records each dateand time that the vial is opened. Computer medication profiles andlaboratory data for all patients with scheduled medicine clinicappointments at Veterans Affairs medical center ambulatory clinicsin Boise, Idaho, were screened for patients receiving a sulfonylureafor 3 months or longer with a consistent dosage and poor to fairmetabolic control between July 1990 and May 1991. Patientswere randomized to the MEMS group or a control (pill count)group. Patients in both groups received a 35-day supply of med-ication in a vial with the MEMS cap and returned to the pharmacyfor a refill after 30 and 60 days, at which time pill counts were per-formed. Initially, the data from the microprocessor were retrievedonly for patients in the MEMS group, and pill count data were ana-lyzed only for patients in the control group. There was no signifi-cant difference between the two groups in measured non-adher-ence rates (60% in the MEMS group and 35% in the controlgroup). Seven (47%) of 15 pharmacist recommendations based onadherence data in the MEMS group and two (12%) of 17 recom-mendations in the control group were for patient education, a dif-ference that is significant. To determine how consistent the twoadherence measurement methods (MEMS and pill counts) were,MEMS data were later retrieved for the control group and com-pared with the pill count data, and pill count data were later ana-lyzed for the MEMS group. The pill count data were inconsistentwith the MEMS data for seven (47%) of the 15 patients in theMEMS group. The MEMS data were inconsistent with the pillcount data for nine (53%) of the 17 patients in the control group. Ifthe pharmacists had had access to the MEMS data for four of thepatients in the control group, they would have recommended


patient education. For two of these patients, this recommendationwould have been made instead of a dosage increase because apattern of inconsistent medication-taking behavior was evident withMEMS. These results demonstrate that MEMS allows pharmaciststo individualize recommendations to a greater extent than the pillcount method.

Demonstrating the added value of community health nursingfor clients with insulin-dependent diabetes. Mazzuca KB, Farris NA, Mendenhall J, Stoupa RA. J Community Health Nurs. 1997;14:211–24.

A randomized, controlled study was performed to determinewhether community health nursing (weekly or biweekly home visitsto provide health teaching and guidance, health referrals, coordina-tion of care, and client advocacy) improves the self-care competen-cy and health status of adults with insulin-treated diabetes andpoor glycemic control. Teaching addressed nutrition, exercise, footcare, and blood glucose monitoring. Patients who had receivedcare at a university-based internal medicine clinic were contactedby telephone by investigators and invited to participate in the study.Community health nursing students who were in their senior yearprovided community health nursing to the experimental group overa 32-week period. The students were supervised by a nursing fac-ulty investigator.

Twenty-two of 29 subjects completed the study. Self-care behav-iors improved significantly over the course of the study in the 11subjects in the intervention group; managing complications (hypo-glycemia and hyperglycemia), adhering to a meal and snack regi-men, testing and recording blood glucose levels, and calling thephysician about foot changes are aspects of self-care thatimproved most. Self-care behaviors decreased slightly over thecourse of the study in the control group. There was no significantdifference between the two groups in outcomes for dietary adher-ence (nutritional content), foot care, blood glucose levels, overalldiabetes knowledge, or functional health status and well-being.These results may reflect the limitations of the instruments used tomeasure outcomes, the small sample size, the use of novice nurs-es instead of experienced nurses, and the complexity of outcomesresearch.

A population-based approach to diabetes management in aprimary care setting: early results and lessons learned.McCulloch DK, Price MJ, Hindmarsh M, Wagner EH.Effective Clinical Practice. 1998;1:12–22.

The effect of a program of support for primary care providers whocare for patients with diabetes on provider satisfaction and healthoutcomes was assessed over a 3-year period beginning in 1994 ata not-for-profit staff-model health maintenance organization inWashington state. The support program comprised an onlinepatient registry and the use of evidence-based clinical guidelines foreye and foot examinations, screening for microalbuminuria, and

glycemic control. The registry served as a reminder of the recom-mended elements of care (e.g., foot examinations). Delivery of carewas redesigned to provide for patient group visits as well as individ-ual patient visits and to establish a decentralized team of diabetesexperts that sees patients jointly with primary care providers. Thedecentralized team traveled to each clinic several times a year and,along with the primary care team, saw each patient for approxi-mately 30–40 minutes.

The prevalence of testing for glycosylated hemoglobin and eyeexaminations both increased over the 3-year period after imple-mentation of the program. Nearly two-thirds of patients with dia-betes received annual eye examinations by the end of the 3-yearperiod. In the first year of the program, half of all patients with dia-betes had a foot examination compared with fewer than 20%before program implementation. Microalbuminuria screening alsoincreased markedly after program implementation. The prevalenceof smoking decreased from 14% in 1994 to 10% in 1996.

Thirty randomly selected practices that collaborated with thedecentralized diabetes expert team (group A) were compared with30 randomly selected practices that did not work with this team(group B). The rates of eye examination and glycosylated hemo-globin testing increased in group A but did not change in group Bbetween 1994 and 1996. In 1996, both rates were significantlyhigher in group A than in group B. However, the average glycosy-lated hemoglobin level in 1996 in group A was not significantly dif-ferent from that in group B (7.7% and 7.8%, respectively). Therates of foot examination and microalbuminuria screening weremore than threefold higher in group A compared with group B. The percentage of randomly selected primary care physicians whorated diabetes resources (e.g., access to certified diabetes educa-tors) as good or excellent increased between 1992 and 1996.

A controlled trial of Web-based diabetes disease manage-ment: the MGH diabetes primary care improvement project.Meigs JB, Cagliero E, Dubey A, Murphy-Sheehy P, Gildesgame C,Chueh H, Barry MJ, Singer DE, Nathan DM.Diabetes Care. 2003;26(3):750–7.

The impact of a Web-based information management/decisionsupport tool was evaluated in a randomized controlled trial of 598adults with diabetes who attended a hospital-based internal medi-cine clinic. The intervention involved the use of the Web-basedtool, which linked patient-specific information with evidence-basedtreatment recommendations.

The 1-year period after the intervention was compared with the 1-year period before the intervention. Testing of glycosylatedhemoglobin and low-density lipoprotein cholesterol and footscreening increased significantly in the intervention group com-pared with the control group. Values of glycosylated hemoglobin(i.e., glycemic control) improved in the intervention group but not inthe control group. Lipid and blood pressure control improved and


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eye examination rates increased in both groups. The investigatorsconcluded that the Web-based patient-specific decision supporttool has the potential to improve evidence-based parameters ofdiabetes care.

A computer-generated reminder system improves physiciancompliance with diabetes preventive care guidelines. Nilasena DS, Lincoln MJ. Proc Annu Symp Comput Appl Med Care. 1995;640–5.

A 6-month, randomized, controlled study was conducted to evalu-ate the impact of a computer-generated reminder system on physi-cian compliance with guidelines for diabetes preventive care.Internal medicine resident physicians in their second or third year atthe University of Utah who were providing care to patients with dia-betes at outpatient general internal medicine clinics were random-ized to an intervention group or control group. Residents in theintervention group were provided with a patient-specific report list-ing patient health data and upcoming or overdue preventive healthactivities (e.g., physical examinations, laboratory tests, referrals,patient education). Diabetes preventive care guidelines publishedby the American Diabetes Association addressing renal care, footcare, eye care, glycemic control, macrovascular care, and neuro-logic care were the basis for the computerized-reminder system.Residents in the control group received a generic patient reportwithout specific recommendations. All patients with diabetes type1 or 2 who were treated by the residents were included in thestudy; these patients were identified by reviewing clinic, pharmacy,and laboratory records. Encounter forms with patient clinical datawere completed by residents in both groups after patient visits.

A score for compliance of the resident physician with diabetes pre-ventive care guidelines was calculated for each patient visit. Theaverage compliance score 1 month after implementation of thereminder system was significantly higher compared with baseline inthe intervention group (54.9% after 1 month versus 38.0% at base-line). The average compliance score in the control group alsoincreased significantly over the same period (51.0% after 1 monthversus 34.6% at baseline); there was no significant differencebetween the two groups in the change in compliance. Possibleexplanations for these unexpected findings include the short dura-tion of the study (many aspects of patient care are recommendedannually), the Hawthorne effect (i.e., the altered behavior in thecontrol group could have been the result of the fact that the sub-jects were under observation), or other factors. The highest com-pliance scores were for laboratory tests and referrals, and the low-est scores were for patient education. The use of encounter formsfacilitated documentation of clinical data and compliance withguidelines for diabetes preventive care.

Community-based chronic disease management program forAfrican Americans.Nine SL, Lakies CL, Jarrett HK, Davis BA.Outcomes Manag. 2003;7(3):106–12.

The impact of a chronic disease management program for AfricanAmerican persons with diabetes, hypertension, or both was evalu-ated over a 1-year period in a community setting in West Virginia.The chronic disease management program comprised exercise,medical nutrition therapy (dietary counseling and meal planning),support groups, cooking schools, and service coordination (goalsetting and phone calls from and home visits by a service coordina-tor). Seventy-five patients, most of whom were African American,volunteered to participate.

Significant reductions from baseline in systolic and diastolic bloodpressure were observed after 1 year. Reductions in glycosylatedhemoglobin also were observed but the reductions were significantonly in the 12 patients with elevated baseline values (>7%). Qualityof life improved but the change from baseline was not significant.

The impact of an educational program on improving dia-betes knowledge and changing behaviors of nurses in long-term care facilities. Parker MT, Keggett-Frazier N, Vincent PA, Swanson MS.The Diabetes Educator. 1995;21:541–5.

The impact of a diabetes education program on knowledge anddiabetes care practices of the nursing staff was ascertained in twolong-term-care facilities (LTCFs) in eastern North Carolina. Thenursing staff at another LTCF served as a control group. The edu-cation program comprised seven biweekly sessions conducted bydiabetes educators over a 12-week period. A lecture format withslides and a question-and-answer period was used. Topics includ-ed medications, patient monitoring (blood glucose and ketones),managing hyperglycemia and hypoglycemia, diet, foot care, illnesscare, and exercise and patient-family education. Each educationalsession was 20 minutes long to facilitate nursing staff participation.A diabetes knowledge test was developed using guidelines of theAmerican Association of Diabetes Educators and the AmericanDiabetes Association. This test was administered at the start of thestudy (before the education program in the intervention group) andat the end of the study. Patient charts from before and after theintervention were reviewed to determine whether carbohydrateswere provided to patients with hypoglycemia, ketones were testedand a physician was contacted when a patient exhibited hyper-glycemia, insulin was administered in the abdomen (a preferred sitebecause of the rapid rate of absorption), and toenails were cut by apodiatrist.

Thirty-five registered nurses and licensed practical nurses partici-pated in the study. They had 8 years of nursing experience onaverage. Only one nurse had diabetes, and another 14 had a fami-ly member with the disease. The intervention and control groups


did not differ significantly in nursing education, nursing experience,experience with patients with diabetes, or participation in diabetescontinuing education programs. The average pretest diabetesknowledge score was 67% for both groups. The average posttestscore was significantly higher in the intervention group (73%) thanin the control group (69%). The difference between the averagepretest and posttest scores in the control group was not significant.The retrospective chart review revealed that the frequency of givingcarbohydrates to patients with hypoglycemia, administering insulinin the abdomen, and having toenails cut by a podiatrist increasedover the course of the study in the intervention group. However,the change was not significant. Thus, additional training as well aseducation is needed to improve diabetes care practices in the nurs-ing staff at LTCFs.

Do automated calls with nurse follow-up improve self-careand glycemic control among vulnerable patients with dia-betes?Piette JD, Weinberger M, McPhee SJ, Mah CA, Kraemer FB,Crapo LM.Am J Med. 2000 Jan;108(1):20–7.

The effects of automated telephone assessment and nurse follow-up on self-care (self-monitoring of blood glucose, foot inspection,weight monitoring, and medication adherence) and glycemic con-trol were assessed in a 12-month randomized, controlled study of248 English- or Spanish-speaking adult patients with diabetesmanaged by medication. The intervention involved biweekly, auto-mated telephone assessment (patient use of the touch-tone tele-phone keypad to enter blood glucose readings and other data forreview by a nurse) and self-care education calls with nurse follow-up. The self-care education component of the automated tele-phone assessment was a 3- to 5-minute interactive module on dietand weight control. The nurse follow-up involved telephone calls topatients to address problems identified in a review of data enteredin the automated telephone assessment. The control groupreceived usual care.

Self-monitoring of blood glucose, foot inspection, and weight moni-toring were more frequent and problems with medication adher-ence were less common in the intervention group than in the usualcare group. The differences were significant. Mean glycosylatedhemoglobin A1c values after 12 months were slightly lower in theintervention group than in the usual care group but the differencewas not significant. More than twice as many patients in the inter-vention group as in the usual care group (17% versus 8%, respec-tively) had glycosylated hemoglobin A1c values in the normal range.Mean serum glucose levels were 41 mg/dL lower in the interventiongroup than in the usual care group, a difference that is significant.Symptoms of hyperglycemia and hypoglycemia were less commonin the intervention group than in the usual care group. Similar per-centages of subjects in the two groups were hospitalized or seen inthe emergency department.

The effect of automated calls with telephone nurse follow-upon patient-centered outcomes of diabetes care: a random-ized, controlled trial.Piette JD, Weinberger M, McPhee SJ.Med Care. 2000 Feb;38(2):218–30.

Patient-centered outcomes, including depression, anxiety, self-effi-cacy (patients’ confidence in participating in their own care), days inbed because of illness, days cut down on activities because of ill-ness, diabetes-specific health-related quality of life, satisfaction withcare, and general quality of life were assessed in the study of auto-mated telephone assessment and nurse follow-up that is describedabove (Piette JD, Weinberger M, et al. Am J Med. 2000Jan;108(1):20–7). Patients in the intervention group (i.e., participat-ing in automated telephone assessment) had significantly fewersymptoms of depression and days in bed because of illness andsignificantly greater self-efficacy to perform self-care activities thanpatients in the control (usual care) group. Anxiety levels, diabetes-specific health-related quality of life, and general health-relatedquality of life were similar in the two groups.

Impact of automated calls with nurse follow-up on diabetestreatment outcomes in a Department of Veterans AffairsHealth Care System: a randomized controlled trial.Piette JD, Weinberger M, Kraemer FB, McPhee SJ.Diabetes Care. 2001 Feb;24(2):202–8.

The effects of automated telephone assessment and nurse follow-up (see the summaries of the two reports by Piette JD, WeinbergerM, et al., above) on patients’ self-care, symptoms, satisfaction withcare, and glycemic control were assessed in 272 patients with dia-betes at a Veterans Affairs clinic in a 12-month randomized con-trolled study. Only 44% of patients had a baseline glycosylatedhemoglobin A1c level of 8% or higher, which is the level at whichintervention is recommended (i.e., more than half of patients hadgood glycemic control). After 12 months, patients in the interven-tion group reported significantly more frequent self-monitoring ofblood glucose and foot inspections and were more likely to beseen in podiatry clinics and diabetes specialty clinics than patientsin the control (usual care) group. Among patients with a baselineglycosylated hemoglobin A1c of 8% or higher, the mean value after12 months was significantly lower in the intervention group than inthe control group (8.7% versus 9.2%, respectively). Significantlyfewer symptoms of poor glycemic control and greater satisfactionwith care were reported by patients in the intervention group thanby patients in the control group.

Adherence to protein restriction in patients with type 2 dia-betes mellitus: a randomized trial.Pijls LT, de Vries H, van Eijk JT, Donker AJ.Eur J Clin Nutr. 2000 Apr;54(4):347–52.

The effect of a dietary counseling on protein restriction wasassessed in a 12-month randomized, controlled study of 125


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patients with type 2 diabetes and microalbuminuria, relatively highalbuminuria, or diabetes for at least 5 years and a high dietary pro-tein intake. The experimental and control groups both receivedcounseling on restricting dietary intake of saturated fats. Theexperimental group also received counseling on reducing dietaryprotein intake, with partial replacement of proteins by unsaturatedfats and carbohydrates.

Dietary protein intake (measured indirectly using urinary urea excre-tion) was significantly lower in the experimental group than in thecontrol group after 6 months but the difference was smaller andnot significant after 12 months. Factors predicting reduction indietary protein intake included satisfaction with preexisting diet, lowbody mass index, and living alone. Dietary counseling resulted inonly modest protein restriction.

A randomized controlled trial of an intervention designed toimprove the care given in general practice to type II diabeticpatients: patient outcomes and professional ability tochange behaviour.Pill R, Stott NCH, Rollnick SR, Rees M. Family Practice. 1998;15:229–35.

A 3-year randomized, controlled study was conducted to evaluatethe effect of training for clinicians (general practitioners and practicenurses) on outcomes for patients with type 2 diabetes. The trainingaddressed a patient-centered intervention, which was designed to (1)encourage clinicians to negotiate individual patient care plans basedon patients’ perceptions of their disease and readiness to changetheir lifestyles and (2) to work toward realistic targets for behaviorchange. Thirty-three general practices with 252 patients with type 2diabetes were randomized to the experimental group or the controlgroup. Clinicians in the experimental group received at least 3 hours(divided into two sessions) of training in the patient-centered intervention. This training involved discussions, demonstra-tions, and role-playing. A research nurse provided continuing sup-port, visited the practice sites, sent newsletters every 3 to 4 months,and held two group meetings during the course of the study.

There were no significant differences between the experimental andcontrol groups in glycosylated hemoglobin level or the number ofcomplications. Patient satisfaction with recent consultations andtreatment improved significantly over the course of the study in thecontrol group but not in the experimental group, although the lattergroup had little room for improvement. Physical functioning alsoimproved in the control group. Most of this improvement was infemale subjects (the control group had a larger percentage ofwomen than did the experimental group).

Analysis of audiotapes of patient consultation sessions revealedthat nurses covered more topics and addressed diet, alcohol use,smoking, and body weight more often than did physicians. Thedifferences were more marked in the experimental group than inthe control group. Experimental group patients were more likely

than control group patients to initiate a discussion of behavioralchange. Twenty-two (69%) of 32 clinicians were judged to have amoderate to good understanding of the methods and principlesunderlying the intervention. However, only six (19%) clinicians rou-tinely applied these principles in practice.

Improve control of type 2 diabetes mellitus: a practical education/behavior modification program in a primary careclinic. Ridgeway NA, Harvill DR, Harvill LM, et al. South Med J. 1999 Jul;92(7):667–72.

This study evaluated the efficacy and ease of administration of edu-cation/behavior modification classes in improving disease control in38 diabetic patients in a primary care clinic population. A comput-erized audit identified diabetic patients who visited the clinic in thepreceding year, and physicians recommended participation topatients who met the following inclusion criteria: (1) a diagnosis oftype 2 diabetes, (2) poor glycemic control, (3) ≥ 20% over idealbody weight, and (4) able to attend monthly clinic visits and com-prehend presented material. Patients were randomized to an inter-vention group or control group, and metabolic parameters, bodyweight, health-related quality of life, and cognitive knowledge ofdiabetes were assessed at baseline and regular intervals.

The intervention group attended 90-minute classes taught by aregistered nurse and registered dietitian monthly for 6 months, witha follow-up session at 12 months. Didactic portions of the classeswere based on the Life Skills program, featuring lectures, teachingslides, and handouts about diabetes, its treatment, and conse-quences. Diet and exercise were emphasized as important meansof controlling diabetes. Behavior modification involved (1) individualsessions with instructors to individualize diets, prescribe exercise,and set goals; (2) use of worksheets and contracts to emphasizeneed for patient responsibility; (3) class participation, encourage-ment, and praise; and (4) brief classroom appearances by physi-cians.

Statistically significant reductions in mean fasting blood glucose(FBG), glycosylated hemoglobin (GHb), total cholesterol, and low-density lipoprotein cholesterol (LDL-C) values were observed at theend of the intervention in the intervention group (N=18; p< 0.05).These values remained decreased, but not significantly differentfrom baseline, at the 12-month follow-up, when a significantdecrease in mean body weight was noted (p=0.0166).Improvement in the control group (N=20) was limited to smalldecreases in GHb and body weight at 6 months (P<0.02), whichdid not persist at significant levels at 12 months. The DiabetesEducation Society’s Life Skills test revealed that patients in theintervention group improved and had significantly greater knowl-edge about diabetes than those in the control group post-interven-tion. Results from quality life assessments (i.e., Medical OutcomesStudy 36-item, short-form survey; diabetes-related problems ques-tionnaire) showed no significant intergroup differences.


The short-lived clinical improvements in the intervention group wereconsistent with those seen with different techniques, as was thelack of difference in quality of life between groups. The cost of theprogram was estimated to be $95 per patient for educational mate-rials and teaching salaries only. Thus, the class was consideredinexpensive as well as easy to administer, well suited to primarycare clinics, and clinically worthwhile.

Pharmacist-led, primary care-based disease managementimproves hemoglobin A1c in high-risk patients with diabetes.Rothman R, Malone R, Bryant B, Horlen C, Pignone M.Am J Med Qual. 2003;18(2):51–8.

The impact of a pharmacist-based diabetes care program wasevaluated retrospectively in 138 patients with type 2 diabetes andpoor glycemic control (glycosylated hemoglobin 8% or higher). Theintervention involved diabetes education, limited physical examina-tion (e.g., foot exams), initial treatment recommendations, the useof medication algorithms, and frequent patient follow-up with thesupport of a computer database. Patient education addressed glu-cose control and monitoring, management of hypoglycemia, nutri-tion and exercise, proper foot and eye care, and medication man-agement.

After 6 months, a significant reduction in mean glycosylated hemo-globin was observed. A recent diagnosis of diabetes (within theprevious 4 months) and a high baseline glycosylated hemoglobinvalue were associated with improvement in glycosylated hemoglo-bin. Age, race, gender, and educational status did not predict out-come.

Evaluation of a quality improvement intervention for diabetesmanagement.Schmidt SO, Burns C, Feller DB, Chang KL, Hernandez B,McCarthy J, Burg MA.J Healthc Qual. 2003;25(3):26–32.

The impact of two quality improvement interventions on physicians’diabetes management behaviors was assessed in six outpatientclinics associated with a university-affiliated family practice depart-ment. One intervention was the use of a diabetes managementflow sheet to be inserted in the patient chart where it would serveas a prompt for the health care provider as well as a tool to edu-cate the provider on American Diabetes Association (ADA) guide-lines for treating patients with diabetes (ADA recommended fre-quencies for various tests and examinations). The second interven-tion involved the use of the diabetes management flow sheet plusquarterly provider feedback on the results of chart audits of per-formance in treating patients (i.e., compliance with ADA recommen-dations). One clinic served as the “flow sheet-only” site, anotherclinic served as the “flow sheet-plus-provider-feedback” site, andthe other four clinics served as control sites.

Compared with baseline, both interventions significantly improved

the performance of foot examinations over a 12-month period, witha greater improvement in the flow sheet-plus-provider-feedbackclinic than in the flow sheet-only clinic. There was little change inthis variable in the control groups. The percentages of patientsreceiving annual testing for glycosylated hemoglobin, eye examina-tion, and assessment for diabetic nephropathy did not improve sig-nificantly in either intervention group. These percentagesdecreased in the control groups.

In the flow sheet-only clinic, the percentage of patients with poorglycemic control (glycosylated hemoglobin >9.5%) decreased sig-nificantly, and ADA targets for this variable were met. No other sig-nificant changes in patient outcomes (lipid profile and blood pres-sure) were observed in either intervention group or in the controlgroups.

Although the impact of the diabetes management flow sheet onprovider compliance with ADA standards and patient outcomeswas minimal, providers participating in the study believed that useof the flow sheet plus feedback increased their awareness of dia-betes management guidelines.

Motivational interviewing to improve adherence to a behav-ioral weight-control program for older obese women withNIDDM. Smith DE, Heckemeyer CM, Kraty PP, Mason DA. Diabetes Care. 1997;20:52–4.

The impact of adding motivational interviewing strategies to abehavioral obesity program on treatment adherence, glycemic con-trol, and weight loss was explored in a randomized pilot study.Twenty-two obese women who were 50 years of age or older andhad type 2 diabetes were recruited by advertisements and a patientletter. All patients participated in a 16-session group behavioralweight-control program with moderate calorie restriction(1,200–1,500 kcal/day), fat intake restriction (30–40 g/day),increased physical activity, and home monitoring of blood glucose.Weekly group meetings provided nutritional information and trainingin how to modify eating and exercise behavior. Patients maintainedand periodically submitted diaries in which calorie consumption andphysical activity were noted daily and fasting blood glucose levelswere recorded three times weekly. Patients randomized to themotivational group also participated in three motivational interview-ing sessions (one at the beginning of the study and two during thestudy) conducted by a psychologist experienced in the technique.Motivational interviews assessed the patient’s ambivalence aboutbehavior change, elicited and formulated personal goals, andsolved problems that presented barriers to change. Objective dataon health and behavior were reviewed with the patient to delineatediscrepancies between current status and goals. The interviewerused open-ended questions and a reflective listening approach,avoiding confrontation. Realistic and objective goals were devel-oped collaboratively with the patient.


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The motivational group demonstrated significantly better adherenceto the behavioral obesity program than did the standard (control)group. The group session attendance, number of diaries submit-ted, and blood glucose monitoring frequency were greater in themotivational group. Blood glucose control also was better in themotivational group than in the standard group; the glycosylatedhemoglobin at the end of the 16-week study was 9.8% in the moti-vational group and 10.8% in the standard group. Both groups losta significant amount of weight over the course of the study (onaverage, 5.5 kg in the motivational group and 4.5 kg in the stan-dard group). However, there was no significant difference betweenthe two groups in weight loss, possibly because of the small sam-ple size (16 patients due to attrition).

Telecommunication support for rural women with diabetes.Smith L, Weinert C.Diabetes Educ. 2000 Jul-Aug;26:645–55.

Thirty women with diabetes who lived in rural areas far from theclosest source of health care participated in a 10-month random-ized, controlled trial of the use of computer-based telecommunica-tions technology to provide support, information, and education. Acontrol group received usual modes of support and communica-tion. Subjects in the computer group were not required to be com-puter literate to participate. The computer software had four com-ponents, including conversation among patients (i.e., a supportgroup function), private dialogue between a patient and a nurse orbetween two patients, a “health chat” guided by a certified dia-betes educator with diabetes information, and a bulletin board withpostings of pertinent information by the investigators. The comput-er software compiled data on computer access frequency andduration. Telephone interviews and mail questionnaires were usedto assess social support, quality of life, psychosocial adaptation toillness (i.e., well-being), and attitudes about the impact of the com-puter intervention.

The average time spent on the computer each month was highestthe first month (129 minutes) and decreased in subsequentmonths, possibly because of the novelty or the need to learn to usethe software during the first month. Quality of life scores werehigher for women in both groups who had more education andimproving health. The computer group had slightly better psy-chosocial adjustment to illness scores than the control group.Attitudes toward the use of telecommunications technology werepositive and 77% of subjects in the computer group recommendedits use “very highly.” Conversation among patients (i.e., the supportgroup function) was the most frequently used software component.The program provided a great deal of support to 77% of women inthe computer group.

Professional responses to innovative in clinical method: dia-betes care and negotiating skills. Stott NC, Rees M, Rollnick S, Pill RM, Hackett P. Patient Educ Couns. 1996 Oct;29(1):67–73.

This randomized controlled trial evaluated the responses of familydoctors and nurses to application of an innovative clinical technique(visual agenda-setting technology) designed to facilitate patient-clinician interaction in routine diabetes care and promote patientlifestyle changes. Doctors and nurses at 30 family practices identi-fied as being “interested and active in diabetes care” (i.e., recentprofessional participation in continuing education sessions) wereinvited to participate. Twenty-nine practices agreed to participate,and doctors and nurses in these practices were randomly assignedto an experimental group (doctors=16, nurses=18) or a controlgroup (doctors=14, nurses=15). Over the 3-year course of thestudy, these professionals provided care to 200 patients with type2 diabetes within their practices.

The intervention began with a visit to each practice to explore howthe doctor(s) and nurse(s) felt about care of patients with diabetesand their intra-practice organization of such care. The contents ofan “Agenda Setting Pack” were then discussed and demonstratedin various ways, including role-playing, to members of the interven-tion group. This Pack consisted of a visual agenda-setting chart, areadiness-to-change ruler, a diary, and a balance chart (to weighpros and cons of a given change). The former chart appeared as aseries of pictures (e.g., food, exercise, cigarettes, medication) withthe words “To Change or Not To Change” at the top.

Next, each intervention, family practice-based team was encour-aged to negotiate the number of formal training sessions based onperceived need. All opted for a least two 1.5-hour sessions inwhich application of the visual materials to patients, using negotia-tion and motivational interviewing techniques, was reviewed.Continuing contact with the members of the experimental groupwas achieved with bimonthly newsletters, personal contacts, andgroup meetings. In addition, invitations for audio recordings of clini-cal consultations were accepted by more than 90% of nurses and56% of doctors.

Evaluation via questionnaire halfway through the study (i.e., at 18months) revealed that 71% of the clinicians frequently used theAgenda Setting Chart and 22% occasionally used the chart; 6%reported rare use and one group failed to return the questionnaire.Many participants also made selective use of the remaining materi-als designed for “the more selective or ambivalent patient.” Forexample, the diary was used “sometimes” by 55% of the doctorsand nurses in the experimental group and “most of the time” by19%. The readiness-to-change ruler was used sometimes by 42%and most of the time by 35%. The balance chart was used some-times by 45% and most of the time by 22%.

Additional evaluation and sharing of experiences occurred at group


meetings designed for the experimental group. The first meeting,attended by 83% of participating nurses and 56% of participatingdoctors, was run as a workshop intended to explore use of themethod, identify problems, and share successes. The secondmeeting (7 months later) was a workshop based on a series oftape-recorded role-plays between a clinician and patient.Evaluations following both meetings confirmed that doctors andnurses found sharing of experiences in a group useful, and 90% ofthese professionals agreed or strongly agreed that a style of con-sultation with patients with type 2 diabetes that uses negotiation ishelpful. While tape-recorded encounters were used in a number ofcases, a detailed analysis of these events was not included in thisreport. Neither evaluation of the control group nor comparison ofparameters between the intervention and control groups wasaddressed.

Patient education in the management of diabetes mellitus. Tan ASL, Yong LS, Wan S, Wong ML. Singapore Med J. 1997;38:156–60.

The effects of a diabetes education program on diabetes knowl-edge, dietary practices, medication compliance, self-monitoring ofblood or urine glucose, and glycosylated hemoglobin were assessedin a controlled study of 278 patients with diabetes who attended aprimary health care clinic in Singapore. The first 100 patients wereassigned to the control group (five patients eventually dropped out),which received usual treatment and advice on managing diabetesfrom their physician. Subsequent patients were assigned to theintervention group, which participated in a diabetes education pro-gram. The program consisted of at least six individual or small-group counseling sessions at which patient booklets on the disease,treatment, handling of emergencies, self-monitoring of blood glu-cose, meal planning, and general health care were reviewed. Thesesessions were conducted by a nurse trained in counseling tech-niques. Four larger group sessions also were held, with lectures,videotaped presentations, group discussions, and food displays.Family members were encouraged to attend these sessions.

Compared with baseline, scores on tests of diabetes knowledge(disease, complications, management, and self-care) were signifi-cantly higher 1 year after the completion of the education programin both the intervention and control groups. The magnitude of theincrease was greater in the intervention group than in the controlgroup. Dietary practices (recommendations to increase fiber intakeand decrease intake of calories and fats) improved significantly frombaseline in the intervention group. There were no significantchanges in the control group. Medication compliance increasedsignificantly in both groups and was higher in the intervention groupthan in the control group. There was no significant change in thepercentage of patients in either group who self-monitored blood orurine glucose. Glycosylated hemoglobin decreased significantlyfrom baseline in the intervention group. However, the change frombaseline in the glycosylated hemoglobin was not significant in thecontrol group.

Development of a primary prevention program: insightgained in the Zuni diabetes prevention program.Teufel NI, Ritenbaugh CK.Clin Pediatr. 1998;37:131–42.

Diabetes prevention programs are essential in Native Americancommunities that are experiencing high rates of non–insulin-dependent diabetes. The Zuni Diabetes Prevention program is acommunity-based primary prevention project designed to reducethe prevalence of diabetes risk factors among high-school-ageyouths. The size of the population is not specified (it is unclearhow many patients participated for the first 2 years of this 4-yearstudy and provided longitudinal data for that period).

The program strives to enhance knowledge of diabetes and to sup-port increased physical activity, increased fruit and vegetableintake, and reduced soft drink consumption. The primary mecha-nisms of intervention are diabetes education, school-based well-ness center supportive social networks, and modification of thefood supply to reduce fat content and consumption of sugary bev-erages and increase fiber content.

There was collaboration between the public school district and uni-versity department of family and community medicine. Mid-projectresults indicate a significant reduction in soft drink consumptionand an increase in glucose/insulin rations, suggesting a decline inthe incidence of hyperinsulinemia. Outcomes measured includebody mass index, dietary intake of fiber and sugary beverages,heart rate, and fasting and postprandial glucose and insulin levels.

Within 2 years after the intervention, the consumption of sugarybeverages, body mass index, and heart rate had decreased (adecreased heart rate suggests improved cardiovascular fitness) anddietary fiber intake and glucose-to-insulin ratios had increased (anincrease in the glucose-to-insulin ratio suggests a reduced preva-lence of hyperinsulinemia and risk for type 2 diabetes). Only thechanges in sugary beverage consumption and insulin levels weresignificant but the other changes suggest the adoption of healthybehaviors that might reduce the prevalence of risk factors for type2 disease as the study continues.

Early lifestyle intervention in patients with non–insulin-dependent diabetes mellitus and impaired glucose tolerance. Uusitupa MIJ.Ann Med. 1996;28:445–9.

A controlled study was conducted in 86 obese Finnish patientsrecently diagnosed with type 2 diabetes to determine the impact ofnonpharmacologic interventions (i.e., diet, exercise) on glycemiccontrol and cardiovascular risk factors (e.g., serum lipids, bloodpressure). After a 3-month period during which all patientsreceived basic education about the disease and dietary adviceabout losing weight and reducing the intake of saturated fat andcholesterol, patients were randomized to an intervention group or a


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conventional treatment group. The intervention group made six vis-its to an outpatient clinic at 2-month intervals for intensive therapywith (1) a restricted dietary intake of calories, total fat (<30%), satu-rated fats (<10%), and cholesterol (<300 mg/day), which was moni-tored by examining food records and measuring serum lipids and(2) exercise training (30–60 minutes three to four times per week),which was monitored by analyzing daily exercise records. Theintervention was not based on specific treatment guidelines.

The intervention led to a reduction in intake of saturated fats andcalories. Dietary changes in the conventional treatment group weresmaller than in the intervention group. The total weight loss fromthe time of diagnosis until the end of the 12-month interventionperiod was greater in the intervention group than in the convention-al treatment group (6.9 kg versus 3.8 kg, respectively). Weight lossand beneficial changes in metabolic control (fasting blood glucose)and lipid profile (e.g., high-density lipoprotein cholesterol, triglyc-erides) were observed during the intervention period only in theintervention group. There was a trend toward reduced blood pres-sure in both groups.

Follow-up assessment 1 year after the completion of the interven-tion period revealed that glycemic control was maintained by a sig-nificantly larger percentage of patients in the intervention groupthan in the conventional treatment group, although deterioration incontrol was found in both groups. Significantly fewer patients inthe intervention group were receiving oral antidiabetic agents thanpatients in the conventional treatment group (34.8% versus 12.5%,respectively).

A randomized, controlled study to assess the impact of nonphar-macologic interventions (weight reduction, dietary saturated fatrestriction, and increased physical activity) on the development oftype 2 diabetes in patients with impaired glucose tolerance (a con-dition that often leads to diabetes) is under way at five centers inFinland. Preliminary results after 1 year of data collection in the 5- or 6-year study suggest a weight loss and improvement in glu-cose tolerance in only the intervention group.

Education integrated into structured general practice carefor type 2 diabetic patients results in sustained improvementof disease knowledge and self-care.van den Arend IJ, Stolk RP, Rutten GE, Schrijvers GJ.Diabet Med. 2000 Mar;17(3):190–7.

The effects of four structured programs for diabetes care with andwithout integrated education on disease knowledge, self-carebehavior (dietary adherence, self-monitoring of blood glucose,physical exercise, and foot inspection), and disease perceptionwere assessed in 243 patients with type 2 diabetes after 6 months(i.e., after the program) and after 12 months (i.e., at follow-up toascertain whether effects were lasting). The programs included (1) care guided by protocol, with oral and written patient informa-tion, (2) care with computerized support and a diabetes nurse avail-

able to answer patient questions, (3) a special educational programfocusing on blood glucose monitoring for a subset of patients withpoor glycemic control, and (4) an integrated care program, includ-ing an educational program with didactic elements and interactivegroup discussion on basic self-care skills and diabetes pathophysi-ology and complications.

Disease knowledge increased in all four programs and was main-tained at follow-up. The increase in disease knowledge was signifi-cantly greater in programs with an educational component (pro-grams 3 and 4) than in those without an educational component(programs 1 and 2). Similarly, self-care behavior (dietary adher-ence, self-monitoring of blood glucose, physical exercise, and footinspection) was increased in all four programs after 6 months andwas maintained after 12 months. The increases in self-care behav-ior were significantly greater in the programs with an educationalcomponent than in those without an educational component.There was no change in disease perception in any of the programs.Disease knowledge and self-care behavior were positively related(i.e., disease knowledge correlated with self-care behavior).

A nurse-coordinated intervention for primary care patientswith non–insulin-dependent diabetes mellitus: impact onglycemic control and health-related quality of life. Weinberger M, Kirkman MS, Samsa GP, et al. J Gen Intern Med. 1995;10:59–66.

The impact of nurse-initiated telephone contacts between officevisits to primary care physicians was evaluated in 275 patients withtype 2 diabetes at a Veteran Affairs general medical clinic (GMC). Acomputerized audit identified patients who had ever filled a pre-scription for insulin or an oral hypoglycemic at the medical centerpharmacy and had visited the GMC in the preceding year. Patientswho met the inclusion criteria (i.e., diagnosis of type 2 diabetes,current use of insulin or oral hypoglycemic agent, receiving regularcare at GMC, telephone access) were invited to participate via let-ter, phone, or clinic visit. Following baseline data collection,patients were randomly assigned to three intervention groups (fol-lowed by three study nurses) or a control group.

Patients in the intervention group received monthly (or more fre-quent) phone calls from the study nurses intended to provide edu-cation, facilitate and reinforce compliance, monitor health status,facilitate resolution of identified problems, and facilitate access toprimary care; patients were also encouraged to contact study nurses should questions arise. Patients in the control groupreceived usual care (i.e., physician visit every 3–4 months), with nosystematic provider-initiated education, monitoring of health status,or telephone reminders between clinic visits.

Baseline sociodemographic, clinical, and health-related quality oflife (HRQOL) data were similar between groups. During the study,2,399 nurse-patient telephone contacts were made, with only 162(6.8%) initiated by the patients. The mean number of contacts per


intervention patient was 13, and advice was provided to the patientin 57% of phone contacts. One-year follow-up data, available for151 of the 275 randomized patients, revealed significant intergroupdifferences with respect to both fasting blood sugar (FBS) and gly-cosylated hemoglobin (GHb)(p<0.05), which favored the interven-tion group. However, no statistically significant intergroup differ-ences existed for scores on the Medical Outcomes Study 36-item,short-form survey (used to assess HRQOL) or patient-reported diabetes-related signs and symptoms. Thus, between-office nurse-initiated telephone contacts, designed to serve as pragmatic, low-intensity adjuncts to physician-administered care, modestlyimproved glycemic control, but not HRQOL or diabetes-relatedsigns and symptoms, in patients with type 2 diabetes.

Telemedicine improved diabetic management.Whitlock WL, Brown A, Moore K, Pavliscsak H, Dingbaum A,Lacefield D, Buker K, Xenakis S.Mil Med. 2000 Aug;165(8):579–84.

The effects of weekly home telemedicine visits by a nurse casemanager to review blood glucose levels, body weight, blood pres-sure, hypoglycemic episodes, exercise and nutrition goals, andwell-being were assessed in a 3-month randomized, controlledstudy of 28 adult patients with type 2 diabetes. A glycosylatedhemoglobin A1c level greater than 8% was an eligibility criterion.The nurse case manager maintained frequent contact with thepatients’ physician by electronic mail, and the physician mademonthly home telemedicine visits to evaluate the patients. A con-trol group received routine diabetes care. Both the telemedicinegroup and the control group were encouraged to participate in mul-tidisciplinary diabetes education classes held at a medical center.

After 3 months, there was a significant reduction in glycosylatedhemoglobin A1c in the telemedicine group (from a mean of 9.5% to8.2%) but not in the control group. Similarly, a significant reductionin total body weight was observed over the course of the study inthe telemedicine group (from a mean of 214 to 207 pounds) butnot in the control group. Triglyceride levels decreased in thetelemedicine group and low-density lipoprotein levels increased inthe control group but other lipid values did not change significantly.There was no change in quality of life in either group. The nursecase manager’s and physician’s subjective impression of the useful-ness of telemedicine was favorable but the use of the technologywas hampered by technical difficulties.

Lifestyle intervention in overweight individuals with a familyhistory of diabetes.Wing RR, Venditti E, Jakicic JM, Polley BA, Lang W. Diabetes Care. 1998;21:350–9.

The effect of diet, exercise, or a combination of diet and exerciseon body weight, risk factors for cardiovascular disease (lipid profile,blood pressure), and the development of type 2 diabetes wasassessed in a 2-year controlled study of 154 non-diabetic individu-als at risk for the disease because of overweight and a parent withdiabetes. Subjects were recruited through newspaper advertise-ments. Subjects randomized to the control group received a self-help manual with information about healthy eating, exercise, andbehavioral strategies for weight control. Subjects randomized tothe diet, exercise, and diet plus exercise groups attended weeklygroup sessions for the first 6 months of the study, biweekly ses-sions for the next 6 months, and two 6-week refresher coursesduring the second year of the study. These sessions were con-ducted by a multidisciplinary team of health care providers, includ-ing registered dietitians, exercise physiologists, and behavior thera-pists. In the diet group, calorie intake was severely restricted(800–1,000 kcal/day with 20% of calories as fat) for the first 8weeks of the study and relaxed thereafter (1,200–1,500 kcal/day).Meal plans and shopping lists were provided. The exercise groupwas encouraged to gradually increase physical activity to 1,500kcal/week. Supervised exercise was performed at weekly sessionsfor 10 weeks.

Weight loss and improvement in fasting glucose and insulin, lipidparameters, and blood pressure over the first 6 months of thestudy were significantly greater in the diet group and diet plus exer-cise group than in the exercise group and control group. However,attendance at group sessions decreased during the second 6months of the study and some of the weight loss was regained inall groups. After 1 year, the diet group and diet plus exercise grouphad maintained 60% and 72% of the weight loss, respectively.These two groups had significantly greater weight loss than theexercise group and control group. By the end of the 2-year study,the lipid profile and blood pressure had returned to baseline levelsand glycemic control had worsened in all groups. Type 2 diabeteshad developed in 17% of subjects. Weight loss over the 2-yearstudy period and impaired glucose tolerance at baseline were pre-dictors of type 2 diabetes. A modest weight loss (4.5 kg) reducedthe risk of type 2 diabetes by 30% (compared with no weight loss),even in subjects with impaired glucose tolerance at baseline.


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Appendix C.

Adams CE, Two home Home health care Completing American Registered Diabetes nurse Cook DL, 1994 health care agencies were needs Diabetes nurses (45 at educator

agencies, one selected at the assessments Association, the agency with with a diabetes convenience of for both patients American a diabetes nurse educator the researcher. and staff; Association of nurse educator and the other developing Diabetes and 17 at the without a nursing Educators, and agency without diabetes nurse standards federal and state an educator)educator of care, staff regulations

education governing home programs, and health carespecific methods for implementing and evaluating care; designing diabetes self-care content that is user friendly;and providing ongoing support for staff nurses

Amoah AG, Patients with Not specified Intensive training No established Health care Core teamOwusu SK, diabetes in a of two core teams guidelines were providers at et al., 2000 developing comprising a available. regional and

country with a physician, a nurse, subregional population of and a dietitian in hospitals and 18 million, a multidisciplinary facilities and 85% of whom approach to patients with are less than diabetes care diabetes45 years old, and education, served by 2 who subsequently teaching developed a hospitals, 9 patient education regional booklet and a hospitals, and professional 100 sub- diabetes regional education hospitals and curriculum for health care training health facilities care providers at

regional and sub-regional facilities

Method of Identifying Population for

Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention

RCT=randomized controlled trial

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Patient’s basic Not applicable Correlational None Home health Registered nurses at a knowledge and (outcomes research design care agencies home health care agencypatient care provided a (nonexperimental with a diabetes nurse score on a snapshot of the design) educator scored list of 33 items status of the two significantly higher on aaddressing home health care test of basic diabetespatient admission, agencies, and the knowledge than nurses care plan, ongoing length of time that at a home health care care (assessment, the diabetes nurse agency without a patient education, educator was diabetes nurse educator.nursing care present at the one The standard of patient treatments, and home health care provided by the evaluation), and care agency home health care discharge was not specified) agency with the

diabetes nurse educator was significantly higher than that provided by the other agency.

Training of health 3 years Not randomized None Hospital-based After 3 years, trained care providers or controlled clinics diabetes health care teamsand provision of were in place and diabetesdiabetes services services were provided in

all regional and about 63% of subregional hospitals. The number of patients with diabetes registered before the program was 4,719 and after the program, it was 13,643.

Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results

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Appendix C. (continued)



Anderson RM, 1,863 patients Recruited from Newsletter with Not specified Patients with Not specifiedFitzgerald JT, with type 1 or physician offices, readable, concise, type 1 or 2 et al., 1994 2 diabetes in pharmacies, clinic action-oriented diabetes

Michigan waiting rooms, and information about diabetes patient diabetes and education encouragement to programs; patients become assertive were asked to consumers of return a postage- diabetes care paid postcard who are preparedif they wished to to interact with receive a free physicians, monthly newsletter nurses, and about diabetes dietitians

Anderson RM, 23 diabetes Volunteers 3-day simulated Not specified Diabetes Not specifiedFunnell MM, et al., educators (20 responding to diabetes care educators1991 nurses, 2 mailed flyer regimen (two daily

dietitians, 1 saline injections, “other”) self-monitoring

of blood glucose four times daily, 1,200 kcal diet, daily foot care and aerobic exercise, and extensive record keeping) followed by a 3-day intensive skills-based workshop, using a four-phase learning sequence with information on educational and counseling skills, demonstration of counseling skills, videotaped small-group practice in counseling, and review of videotapes

Anon, 2003 105 patients Not specified Family-focused Not specified Teenagers College graduates (Dis Manag Advis. 8–17 years teamwork without health 2003;9:120–122) of age care background


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Overall response to 2 years (21 Nonrandomized None Community The newsletters were most newsletters (patient newsletters) (patients were helpful to patients with ratings of whether at home) type 2 diabetes who were the newsletters elderly or in poor overall were helpful) and health or who had specific reactions complications, low incomes, to individual or a poor understanding of issues (i.e., topics) diabetes. The likelihood of of newsletter change in diabetes care in (whether and with response to newsletters whom issue was was low in all patients.discussed and whether change was made)

Diabetes educators’ 6 days Not randomized None Not applicable Counseling skills andcounseling skills, or controlled attitudes toward patient attitudes toward autonomy improved patient autonomy, significantly as a result of and need for the intervention.special training for diabetes educators

Glycemic control 1 year RCT None Home Glycemic control was significantly better in the intervention group than theusual care group.

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Anon, 2003 (Hosp 58,000 patients Not specified Care Not specified Patients, staff Lead diabetic educator Case Manag. with diabetes standardization, or coordinator2003;11(7):103–104) patient and

staff education

Arsenau DL, 40 patients Patients attending An individualized American Diabetes Patients with Registered dietitians, Mason AC, et al., with diabetes a diabetes method of learning Association and diabetes nutrition specialist, 1994 education program instead of American Dietetic and education

were asked to classroom Association specialist reviewed participate. instruction content and design

of individualized learning programs from existing sources.

Aubert RE, 17 patients Group-model Nurse case Not specified Patients with Registered nurse Herman WH, with type 1 HMO pharmacy management diabetes who was a certified et al., 1998 diabetes and records and a using written diabetes educator

121 patients database of algorithms under with type 2 patients who had the direction of a disease visited a physician family physician

for diabetes care, and been hospitalized endocrinologist for diabetes, been (close patient seen by a utilization monitoring, management nurse, continuous or been referred to reinforcement ofan ophthalmologist dietary and for a diabetic retinal exercise examination recommendations,

and systematic drug therapy adjustments by a nurse case manager)


[39]

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Glycosylated 6 months Non-randomized Hourly clinic Health system The average glycosylated hemoglobin operational costs (clinic) hemoglobin decreased from

decreased by 20%. 9.2% to 7.0%.

Fasting plasma 5 months RCT Individualized Hospital-based The individualized method glucose, glycosylated learning was judged diabetes center of education was as hemoglobin, cost-effective. (presumably effective as traditional percentage of ideal clinic) classroom instruction in body weight, educating patients with knowledge, and diabetes and may be morebehavior scores cost-effective but the

individualized method didnot improve glycemic control.

Glycosylated 12 months RCT None Primary care Glycemic control improvedhemoglobin, clinics in a to a significantly greaterfasting blood group-model extent with nurse caseglucose levels, HMO management than with medication usual care.requirements, body weight, blood pressure, serum cholesterol and triglyceride levels, self-rated health status, episodes of severe hypoglycemia, emergency department visits, and hospital admissions

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Baker SB, 4,300 patients Not specified Development and American Diabetes Patients with Physicians, physician Vallbona C, with diabetes implementation Association, diabetes and assistants, nurses, et al., 1993 of protocols for National health care diabetes nurse

prevention and Cholesterol professionals educator, nutritionists, care of diabetes- Education social workers, related Program podiatristscomplications, general management of diabetes, education of patients and professionals

Barth R, 62 participants Patients were Conventional Programs were Patients with Not specifiedCampbell LV, recruited through program: Diabetes designed by the type 2 diabetic et al., 1990 an extensive radio education, current standards patients, (age

and newspaper lectures on foot of practice in >30 years, campaign, from care, footwear, Australia overweight) referrals by general and dealing with (unclear if there practitioners and extreme were actual from people temperatures. guidelines).attending the Diabetes Center, Intensive program:St. Vincent’s In addition to Hospital, and other diabetes education, diabetes centers in foot care Sydney, Australia information and

demonstrations were given.

Bernbaum M, 163 visually Participants were Adaptive diabetes Not specified Patients with Diabetes educatorsWittry S, et al., impaired referred but method education program type 1 or 2000 patients with not specified. with adaptive 2 diabetes

type 1 or equipment (e.g., type 2 diabetes syringe magnifiers,

syringe loading devices, glucose monitoring systems with speech capability, and tactile aids for proper blood sample placement)


[41]

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Blood glucose level, 5+ years (study Retrospective chart Costs of 12 months Community health Preliminary results suggestbody weight, is ongoing) reviews (not of treatment for centers in urban that screening and prevalence of randomized or diabetic eye low-income preventive treatment for uncontrolled controlled) disease (benefits neighborhoods diabetic eye disease is hypertension, number and benefit-to-cost cost-effective. The of patients receiving ratio were percentage of patients with eye examinations, projected) eye examinations incidence of legal increased and the blindness, number of incidence of legal blindnesspatients receiving foot decreased. Foot examinations, patient examinations and blood knowledge, pressure control both appropriateness of improved, although body prescribing, physician weight and blood glucoseproficiency in control have not improved.assessing visual Patient knowledge and impairment physician accuracy in eye

examinations both increased.

Routine follow-up 6 months Experimental design Implementation of Diabetes Center The intensive group visits to the podiatrist with 2 samples the intensive and Garvan showed greater (other than project program is more Institute of Medical improvements than the podiatrist), foot care costly than the Research, St. conventional group in knowledge, and conventional Vincent’s Hospital, foot care knowledge, routine foot care program because Sydney, Australia compliance with the compliance the intensive group recommended foot care

requires more routine, and compliance manpower per with the initial advice to person. consult a podiatrist for

further treatment. The intensive group also showed a significant reduction in the number of foot problems that required treatment compared to the conventional group.

Demonstration of 10 years Not randomized or None University-based The success rate in proficient self-care controlled hospital clinic restoring diabetes self-caretechnique practices was 72% overall,

including 81% in patients with early visual impairment (legal blindness with some residual functional vision) and 57% in patients with late visual impairment (legal blindness with some residual functional vision).

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Birke JA, >14,000 Not specified Disease American Diabetes Patients Not specified Horswell R, et al., patients management Association (multidisciplinary)2003 initiative (DMI) with

or without staged management diabetes foot program (DFP)

Bloomgarden ZT, 266 diabetic Clinic roster was Nine monthly Not specified Patients Not specifiedKarmally W, patients used to identify all education sessions et al., 1987 insulin-treated (audiovisual

clinic patients who materials, card were contacted by games) reviewing telephone to diabetes establish an physiology; foot, appointment skin, and dental for interview hygiene; insulin

administration andemergencies;complications andrisk factors; and nutrition. Separatesessions and audiovisual materials in Spanish were available for Hispanic participants.

Bott U, Bott S, 83 patients with Patients were 5-day inpatient Not specified Patients with Educators and et al., 2000 type 1 diabetes referred because small-group type 1 diabetes others not specified

of inability to educational achieve therapeutic sessions (20 goals for glycemic hours) on insulin control or quality of therapy, life on an outpatient hypoglycemia, diet, basis (e.g., frequent psychosocial hypoglycemic problems, and events, other patient-motivational specific concernsproblems, need for diabetes knowledge refresher, need for greater flexibility in insulin treatment regimen)


[43]

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Diabetes foot-related 2 years Retrospective, None Hospital The hospitalization rate was hospitalizations and nonrandomized reduced by both the DMI lower extremity alone and DMI + DFP but amputations the reduction was greater

with the combination. DMI alone and DMI + DFP both reduced amputation rates;there was no difference in the reduction between the two groups.

Glycosolated 1.6 years in RCT None Large diabetes A traditional diabetes hemoglobin levels, education group; clinic in a patient education program fasting blood 1.5 years in metropolitan failed to significantly glucose, weight, control group teaching hospital change glycosolated lipid levels, hemoglobin levels, fasting development of foot blood glucose levels, lipid lesions, control of levels, body weight, foot hypertension, use of lesion scores, and use of medical care, medical care in a clinic knowledge of diabetes population of insulin-treated and behavior diabetics. While knowledge

of diabetes and behavior was improved in program graduates, the authors concluded that patient education may not be an efficacious therapeutic intervention in most adults with type 2 diabetes.

Glycosylated Follow-up after a Not randomized or Days of Hospital There was no change from hemoglobin levels, mean of 17.5 controlled hospitalization and baseline in the mean incidence of severe months (range sick leave glycosylated hemoglobin at hypoglycemia (need 9–31 months) follow-up but there was a for glucose i.v. or significant decrease in the glucagon injection), incidence of severe days of hospitalization hypoglycemia. The number and sick leave of sick leave days per

patient/year decreased significantly from 17.0 at baseline to 7.7 at follow-up.

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Brown SA, 353 Mexican Random selection Eight weekly Curriculum Mexican American Clinical nurse specialist,Hanis CL, 1995 American of seven Mexican 2-hour guide from patients with registered dietitian,

patients with American subjects culturally sensitive American diabetes and a and communitytype 2 diabetes with diabetes from diabetes education Association of family member or lay worker, all of

a cohort of 353 sessions Diabetes Educators friend for support whom were patients who had (videotape Mexican Americanbeen followed in presentations, another study for discussions, 12 years demonstrations,

visit to a grocery store) and one 2-hour support group session conducted in Spanish language

Cabrera-Pivaral CE, 49 patients with Not specified Behavior-modifying Not specified Patients with Not specifiedGonzalez-Perez G, type 2 diabetes intervention (basic type 2 diabetes et al., 2000 not using insulin and applied not using insulin

nutrition concepts with workshops, teamwork, and discussions)

Canga N, 280 patients Review of clinical A nurse-led, face- Protocols Patients with type A nurse trained De Irala J, with type 1 or records and to-face, individually established in 1 or 2 diabetes in smoking et al., 2000 2 diabetes contact by structured How to Help Your cessation

registered at telephone or intervention to Patients Stop counseling2 urban written help smokers quit Smoking: A hospitals and correspondence smoking, optional National Cancer 15 urban transdermal Institute Manual primary care nicotine for Physicianscenters replacement

therapy, and follow-up support program


[45]

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Knowledge of 9 weeks in 1992 Pilot study of randomly None County agricultural Glycosylated hemoglobin diabetes, health or 1993 with selected subjects extension office and fasting blood glucose behaviors, body follow-up (no control group) in a rural levels and knowledge of weight, metabolic 3 months later community diabetes self-management control were significantly improved

3 months after the intervention.

Serum glucose, 9 months RCT None Not specified Significant reductions intotal cholesterol, and serum glucose, total triglyceride levels cholesterol, and

triglyceride levels occurred in the experimental group over the course of the study. No significant changes occurred in the control group.

Success in smoking 6 months RCT None Hospitals and The incidence of smoking cessation (with primary care cessation was 17.0% in the biochemical validation centers intervention group and of urine cotinine 2.3% in the control group.concentrations) or In subjects who failed to reduction in quit, the mean number of number of cigarettes smoked daily cigarettes smoked decreased significantly in daily both groups but the

reduction was greater in the intervention group than inthe control group.

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Carlson A, A 20% sample Diabetic patient Continuing Not specified Health care Health care Rosenqvist U, (N=806 patients) registry at each medical education providers and 1991 selected center courses for health patients with

randomly from care providers diabetes4,492 patients and organizational with diabetes changewho visited 34 primary health care centers in the past year in Sweden

Clancy DE, 120 patients Electronic medical Group visits with American Diabetes Patients Primary care Brown SB, with poorly records search and presentations, Association (ADA) internal medicine et al., 2003 controlled telephone or on-site questions and physician and

type 2 diabetes solicitation answers, and diabetes nurse individual care educator

Coast-Senior EA, 23 patients with Referral by primary Patient education, Goals for glycemic Patients with PharmacistsKroner BA, type 2 diabetes care providers medication control were in type 2 diabetes et al., 1998 who require because of counseling, accordance with referred to a

insulin therapy inadequate monitoring, insulin American Diabetes pharmacist by glycemic control initiation or Association primary care

adjustment standards providers to improve glycemic control


[47]

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Organization 18 months RCT (centers, not None Not specified The intervention improvedproviders variables (nurse individual patients, quality of care and involvement, were randomized) with self-monitoring of blood resources, multivariate analysis glucose but it did not competence), by multiple regression improve metabolic performance of to identify factors control.routine measurements contributing to (glycosylated variance in selected hemoglobin, eye organization, process, examination), patient and outcome variablesaccess to and continuity of care, patient education, dietary knowledge, self-monitoring of blood glucose, metabolic control, patient-rated quality of care

Glycemic control, 6 months RCT None Clinic Glycemic control and lipidslipid profiles, trust in improved in both groups.physician, patient Trust in physician, patient satisfaction with care, satisfaction, and compliance with ADA compliance with process process of care indicators were greater in indicators the intervention group than

in the control group.

Glycemic control Up to 45 weeks Not randomized None Two primary care Pharmacists’ efforts as part (glycosylated or controlled clinics at a of a multidisciplinary team hemoglobin, fasting university-affiliated improved glycemic control blood glucose and Veterans Affairs significantly in patients with random blood medical center type 2 diabetes who require glucose levels), insulin.symptomatic hypoglycemic episodes, emergency department visits, hospitalizations

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Diabetes Control 1,441 patients Not specified Intensive therapy Not specified Patients with Physiciansand Complications with type 1 with an external type 1 diabetesTrial Research Group. diabetes insulin pump or The effect of intensive three or more treatment of diabetes daily insulin on the development injections and and progression of frequent blood long-term glucose monitoring complications in (versus insulin-dependent conventional diabetes mellitus, therapy with one 1993 or two daily insulin

injections)

Domurat ES, 1999 30% of HMO HMO members Use of Diabetes American Diabetes Patients with Team of health members with Care System Association diabetes care professionalsdiabetes (DCS), a (2,617 patients) computer-

supported diabetes care management program

Edlin M, 2003 3,118 of 6,799 Patient self-referral Promotion of Health Plan Physicians and Nurse educatorshealth plan or physician referral guideline use by Employer Data and patientsenrollees with physicians, 1–4 Information Set diabetes annual patient measures

visits, and patient education on self-management techniques and preventive care


[49]

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Glycosylated 6.5 years (average) Multicenter, RCT None Not specified Intensive therapy delays hemoglobin and blood (presumably at the onset and slows the glucose levels, eye home with progression of retinopathy, examinations for intermittent clinic nephropathy, and retinopathy, urinary visits) neuropathy in patients with albumin excretion for type 1 diabetes.nephropathy, clinical neurologic examination for neuropathy; low-density lipoprotein cholesterol, cardiovascular and peripheral vascular events

Glycosylated 3 years Pre-post comparison None California HMO Screening rates for hemoglobin, blood glycosylated hemoglobin, pressure, urinary urinary protein, and serum protein, and lipids were significantly serum lipids higher in the 2,617 patients

managed by DCS compared with the 5,993 patients receiving usual care. The rate of follow-up testing in patients with an elevated glycosylated hemoglobin was significantly higher in the DCS patients than in the usual care patients.

Glycosylated 24 months Chart review $1,300 per member Home, clinic, and Participants had higher hemoglobin testing, or total of $4 million hospital rates of testing, screening, lipid screening, eye saved annually, and eye exams; better exams, kidney which more than glycemic control; and fewer screening; glycemic offsets program cost emergency department control, health care of $1.8 million visits and inpatient days utilization than nonparticipants.

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Engelgau MM, 4,400 Not specified Health promotion Not specified Community in Not specified Narayan KM, households in initiatives (e.g., southeast section (collaborative effort et al., 1998 each of two walking programs, of Raleigh, N.C., involving community

communities publication of with large African leaders, health care (one with large articles on low-fat American providers, Centers population of diets); outreach population for Disease African efforts to increase Control and Americans at awareness of Prevention)high risk and diabetes risk the other as factors, screening a control) for undiagnosed

diabetes, and tracking of previously diagnosed patients; self-management workshops and medical record reviews and other efforts involving primary care providers to improve quality of diabetes care

Gilden JL, 32 elderly Not specified 18 monthly Not specified Patients Social workersHendryx MS, (average age support group et al., 1992 68 yrs) male sessions with

patients with continuing diabetes at a education, coping Veterans skills training, Affairs group discussions, medical center and structured

social activities

Ginn M, 754 patients Not specified Community-based Not specified Patients with Case managers Frate DA, with diabetes, case management diabetes, hired from the et al., 1999 hypertension, (client assessment, hypertension, or local community

or both care plan both and trained in development, methods for implementation, educating and client service managing patientsmonitoring, and periodic assessment)


[51]

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Patient participation Pilot study was Process and outcome None Community Provided only for in programs, conducted in 1993 measures assessed (presumably clinic) pilot study in which 902 screening rates, (duration primarily by individuals participated changes in diabetes unspecified); questionnaire (45% African American);practice, glycosylated Project DIRECT half of African Americans hemoglobin will take 5 years. were physically inactive and concentration (i.e., half were overweight;long-term blood African Americans had a glucose control), higher prevalence of patient knowledge diagnosed and and skills undiagnosed diabetes and

were more likely to smoke and have uncontrolledhypertension and less likely to have single health care providers than members of other races;all diabetic patients had alow level of preventive care(eye and foot exams).

Diabetes knowledge, 2 years Partially None Clinic Diabetes psychosocial factors randomized knowledge and (self-care-related and controlled quality of life quality of life, were better in stress, family patients who involvement in care, attended support and social group sessions involvement), than in patients depression, and who did not.glycemic control

Knowledge of 24 months Uncontrolled None 12 ambulatory Knowledge about diabetes hypertension and longitudinal study clinics and one and hypertension, diabetes, self- hospital in rural self-reported health status,reported health Mississippi and blood pressure control status, blood increased significantly.pressure control Blood glucose control alsostatus, diabetes increased, although the control status difference from baseline

was not significant.

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Glasgow RE, Approximately Letter about study Computer-assisted Not specified Patients with An endocrinologist Toobert DJ, 200 adult with informed and interactive diabetes and internist who et al., 1995 patients with consent video procedures specializes in

type 1 or 2 statement sent that assess diabetesdiabetes who to patients who patient views and are at least have diabetes behaviors related 40 years of and a scheduled to diabetes age (data for appointment at care and self-the initial 95 an office-based management;are presented practice, followed assistance for in this article) by a phone call patients in

from investigator setting dietary goals and problem-solving strategies;follow-up phone contact and office visits for support

Glasgow RE, 206 adult Letter about study Computer-assisted Diet chosen as Patients with An endocrinologist Toobert DJ, et al., diabetic with informed and interactive focus because is diabetes and internist who 1996 patients consent statement video procedures an objective of specializes in

sent to patients that assess Healthy People diabeteswho have diabetes patient views and 2010and a scheduled behaviors related appointment at to diabetes care an office-based and self-practice, followed management;by a phone call assistance for from investigator patients in setting

dietary goals and problem-solving strategies;follow-up phone contact and office visits for support


[53]

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Weight, eating Not specified RCT None Physicians’ Baseline data from only patterns (fat content), offices initial visit and 1- and serum cholesterol, 3-week follow-up phone and glycemic calls for 51 of initial 95 control patients reveal that 90% of (glycosylated those randomized to hemoglobin) intervention achieved

dietary goals at 1-week follow-up and 96% did so at 3-week follow-up.

Weight, eating 12 months RCT None Physicians’ The intervention produced patterns (fat content), offices greater improvement than serum cholesterol, usual care in a number of and glycemic control measures of dietary (glycosylated behavior (e.g., fewer hemoglobin) calories from saturated fat,

fewer high-fat eating habits and behaviors) at the 3-month follow-up. There were also significant differences favoring intervention in changes in serum cholesterol levels and patient satisfaction but not in glycosolated hemoglobin. The intervention effects were relatively robust across a variety of patient characteristics, the two participating physicians, and intervention staff members.

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Glasgow RE, 320 adult Letter about Behavioral dietary Not specified Patients with type A nurse/certified Toobert DJ, 2000 patients with project sent by intervention 2 diabetes diabetes educator,

type 2 diabetes primary care (dietary goal registered dietitian, providers to setting) with or doctoral-level patients, followed without diabetes psychologist, and by a phone call self-management an education from investigator support: major

(1) follow-up telephone calls and (2) community resources enhancement (e.g., newsletters, information on dining out and shopping)

Grey M, 77 adolescents Not specified Coping (problem Not Patients with A master’s prepared Boland EA, with type 1 (selected from a solving) and skills guideline-based diabetes nurse practitioner et al., 1999 diabetes who university-based training (four to with experience

were beginning pediatric diabetes eight 1- to in pediatric intensive service) 1.5-hour weekly psychiatry and insulin therapy small-group diabetes

sessions followed by monthly sessions using role-playing in various social situations)

Halbert RJ, 19,523 diabetic Reviewed claims Mailed patient Current ADA Physicians were PhysiciansNichol JM, members of and pharmacy reminders for guidelines sent a letter et al.,1999 an HMO databases to screening sent to explaining the

identify all examinations; also physicians program that diabetic members provided reports included current of HMO ≥18 years of patient DRE guidelinesas well as their status to patients diabetic retinal and treating examination physicians, (DRE) status educational

materials to patients, and current American Diabetes Association retinal examination guidelines to treating physicians


[55]

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Reach (percentage 6 months RCT None Clinic Seventy-six percent of eligible patients of eligible patients and participating), 40 of 42 primary care adoption (willingness physicians agreed to of primary care participate. On average, physicians to there was a 50% reduction participate), patient in dietary fat intake.behavior (e.g., fat However, there were small intake), physiologic reductions in glycosylated measures hemoglobin and the ratio of (glycosylated total cholesterol to hemoglobin, lipids), high-density lipoprotein illness-related cholesterol that were not quality of life significant. There was

relatively little change in illness-related quality of life.Follow-up phone calls and community resources enhancement did not add to efficacy of the behavioral intervention.

Metabolic control, 6 months RCT (health care None Admitted for After 6 months, coping andself-efficacy providers blinded to 1 day to skills training (CST)(personal study group university-based improved metabolic competence, assignment) research center control and quality of life power, to obtain baseline in adolescents with type 1 resourcefulness), data and review diabetes who were impact of diabetes treatment goals initiating intensive insulin on quality of life, and methods therapy. CST did not worries about affect the rate of severe diabetes, rate of hypoglycemic episodes.severe hypoglycemic episodes

Diabetic retinal 7 months pre- and RCT (no Analysis of direct HMO Rates of DRE were higher examination (DRE) 1 year post- nonintervention control costs of reminders in the multiple intervention

intervention group, but single (only printing and group than the single intervention treated postage) in multiple intervention group after a as control group) reminders group second patient reminder,

showed incremental but significant intergroup cost of $80 per differences did not exist additional eye following subsequent examination. reminders. Financial

resources for multiple patient reminders for DRE may be better spent on alternative approaches for reducing complications ofdiabetes.

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Hawkins DW, 1,722 patients Not specified, Management of Not guideline Patients Clinical pharmacist Fiedler FP, with diabetes, but included all patients by based (PharmD with et al., 1979 hypertension, patients enrolled pharmacists (with 2 years of clinical

or both in a hospital-based physician training in medical follow-up supervision) general medicine)clinic compared with

physician management

Ho M, 112 medical Randomly selected Comparison is American Patients with Specialists (faculty Marger J, records for from computerized between a Diabetes diabetes diabetologists, et al., 1997 diabetes medication profiles general medicine Association endocrine fellows,

patients and clinic clinic staffed by guidelines medical residents, is the sample enrollment list generalists diabetic nurse size in a (faculty educator, podiatrist,population of internists, and optometrist) 35,000 patients, medical fellows, at diabetes not necessarily medical residents, mellitus clinicwith diabetes and nurse

practitioners) and a diabetes mellitus clinic staffed by specialists (faculty diabetologists, endocrine fellows, medical residents, diabetic nurse educator, podiatrist, and optometrist)


[57]

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Kept-clinic- 29 months RCT None Clinic Care provided by the appointment rate, clinical pharmacist and medication care provided by the compliance rate, physician were equivalentemergency in controlling blood glucose department visits, and diastolic blood hospital admissions, pressure. The kept-clinic-blood pressure and appointment rate was fasting blood glucose higher and the clinic measurements dropout rate was lower in

the experimental group (pharmacist-managed care)compared with the control group (physician-managed care), suggesting greater patient satisfaction with care provided by the clinical pharmacist.

Compliance with 2 years Retrospective chart None University- Quality of care at a process-of-care review affiliated Veterans diabetes specialty cliniccriteria and a subset Affairs was better than at a of minimally medical center, general medicine clinic.acceptable criteria general medical chosen because of clinic, and a strong link with diabetes mellitus good patient outcomes clinicin clinical trials or importance for continuity of care

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Howorka K, 32 and 68 Patients were Structured Not specified Patients with Not specifiedPumprla J, et al., adult patients recruited from a education about type 1 diabetes2000 with type 1 population of functional insulin

diabetes for about 400 treatment (insulinstudy 1 and according to dosing accordingstudy 2, eligibility criteria to blood glucoserespectively (e.g., duration of levels and food

diabetes at least intake, thereby 1 year) avoiding the need

for adherence to a prescribed schedule of doses and meals)

Huff PS, Ives TJ, Not specified Referral by primary Diabetes American Patients Pharmacists and et al., 1983 care provider questionnaire Diabetes physicians

assessed Association patientknowledgeof diabetesand was used to establish a teaching plan and treatment goals.An initial 1-hour counseling session was conducted to address diseasepathophysiology,complications, importance of patient compliance, role of diet and drug therapy, administration technique, adverse effects, and self-monitoring.Patient progress in the educational process was documented.Additional 15-minute sessions at follow-up visits were provided as needed.




[59]

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Perceived control 4 weeks for study RCT for study 1, Perceived treatment Not specified On a short-term basis,over diabetes and 1 and 3 years for uncontrolled pilot cost-effectiveness functional-insulin-treatment diabetes-related study 2 study for study 2 as the difference (FIT) training induced health beliefs between measures feelings of independence

of benefits from because of situational treatment and control. After 3 years, FIT barriers to training improved treatment perceived self-efficacy,

treatment satisfaction, and glycemic control, resulting in a feeling of empowerment. Perceived treatment cost-effectiveness improved significantly due to decreases in barriers to treatment.

None specified Not specified Survey None Ambulatory care Pharmacists were able to clinic provide more instructional

time than typically is provided by physicians, thereby improving patient understanding. Patients were grateful to have readyaccess to pharmacists for information or help solving problems.Physicians had more time available to spend with other patients once pharmacists assumed the patient education responsibility.Communication between pharmacists and physicians improved.


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Irvine AA, 61 adults with 250 patients Diabetes Not specified Patients with Nurse educator, Mitchell CM, diabetes referred by education program diabetes nutritionist, et al., 1992 physicians were to increase psychologist, and

sent a letter inviting knowledge, self- physical therapistthem to participate care, and and attend initial metabolic controlmeetings in a local church three evenings during 1 week.


[61]

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Self-reported 3 months Controlled, but None Community (three Subjects who did not dropadherence to not randomized Appalachian out of the educationtreatment regimen communities that program and subjects in (diet and weight, were comparable the control group who exercise, self- in size and attended all three testing monitoring of character) sessions (Attenders) hadglucose levels, significant increases in medication use, diabetes knowledge andand foot care), foot care over the coursemetabolic control of the study (however, (glycosylated these Attenders may havehemoglobin), attitudes characteristics thattoward living with allow for improvement diabetes (self-esteem, regardless of whether denial, locus of education is provided).control, degree to Subjects who dropped outwhich regimen of the education programintrudes on lifestyle, and subjects in the attitude toward control group who did physician), knowledge not attend all three of diabetes, barriers testing sessions to self-care (Nonattenders) had no

improvement in diabetesknowledge or foot care.These Nonattenders tendedto be less educated, have a lower income, be younger, have had diabetesfor twice as long, report more barriers to self-care, and have poorer health than Attenders. Special efforts may be required to promote program attendance in patients with these characteristics.

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Jaber LA, 39 adults Diabetic patients Comprehensive Not specified Urban African PharmacistsHalapy H, currently attending pharmaceutical American clinic et al., 1996 a clinic who met care model, patients

the inclusion including criteria and education, responded to medication contact via mail counseling, and telephone instruction about

diet, exercise, and home blood glucose monitoring,and evaluation/adjustment of hypoglycemic regimen

Kaplan RM, 70 adults Invitations to Four types of Not specified Patients Not specifiedHartwell SL, participate via intervention et al., 1987 public radio strategies—diet

announcements, alone, exercise newspaper notices, alone, diet plusand physicians exercise, or

education alone(control)

Karlander SG, 83 patients with All patients attending 5-day formal Not specified Patients with Not specifiedKindstedt K, diabetes (and a diabetes diabetes education diabeteset al., 1983 another 32 clinic were invited program with

patients with to participate (32 two daily diabetes as patients with lessons about controls) diabetes matched the disease and

for age were not nutrition, asked to participate respectively, usingand served as lecture, slides, controls; how these questions-and-patients were answers, and identified was not printed textexplained in the article).


[63]

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Primary outcome 4 months RCT None A university- A comprehensive model of measures: fasting affiliated internal pharmaceutical care plasma glucose medicine effectively improved and glycosylated outpatient clinic glycemic control, but not hemoglobin; blood pressure, lipid levels, secondary outcome body weight, or measured endpoints: blood quality-of-life parameters, in pressure, lipid levels, a clinic-based population of renal function, and urban African American quality of life patients with type 2

diabetes. Changes in glycemic control were attributed to improved patient understanding of diabetes and optimization of oral hypoglycemic regimens.

Glycosylated 18 months Randomized trial (no Estimated cost of Not specified A combination hemoglobin, body non-intervention diet and exercise diet-plus-exercise programweight, quality of life control group, but program was produced the greatest

education group $1,000 per patient; reduction in glycosylated as control group) estimated cost of hemoglobin, as well as

a single “well year” significant improvement in produced by this quality of life, compared with program was interventions consisting of$10,870. diet, exercise, or education

alone. These improvementswere largely uncorrelatedwith body weight changes.

Knowledge about 1 year Nonrandomized, None Ambulatory clinic Knowledge of diabetes anddiabetes and but controlled nutrition were significantly nutrition, metabolic improved immediately andcontrol (blood 1 year after the glucose, urinary intervention. Knowledgeglucose excretion, did not change betweenrelative body the initial visit and weight, serum second visit 2 months latercholesterol and in the control group.triglycerides, and, Metabolic control was not in some patients, affected by the intervention.glycosylated hemoglobin)

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Legorreta AP, 390 patients Use of ICD-9 codes Provider teams Not specified Health care Not specified who Peters AL, with type 1 or to generate list of (nurses, physician providers (nurses, assessed et al., 1996 type 2 diabetes diabetic patients at assistants, physician assistants, adherence to

study sites endocrinologists) endocrinologists) protocols by were trained in received training health professionalapplication of in program teams; nurses diabetes administration; managed management patients were application of program that uses recipients of program to protocols linked program. patientsto a computer system to improve disease management and compliance with referrals and laboratory tests.

Levetan CS, 104 patients Consecutive Consultation Not specified Patients Diabetes team Salas JR, with diabetes patients provided by a (nurse educator,et al., 1995 diabetes team registered dietitian,

and endocrinologist)

Lieberman DA, 59 children and Not specified Diabetes self- Not specified Children and Not specified2001 adolescents management adolescents with

with diabetes video game diabetes


[65]

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Provider 18 months Prospective, non- None Large medical A nurse-administered adherence to randomized, groups contracted diabetes management protocols by controlled trial to provided health program, employingmeasurement of care to HMO special protocols linked patient laboratory members, to a computer system, values (glycosolated including a effectively improved hemoglobin, fasting typical glycemic control, lipid plasma glucose, full participating levels, and referral rates inlipid panel, serum medical group diabetic patients treated increatinine, urinalysis) and IPA an outpatient setting.

Length of stay Not specified Not specified None Hospital Length of stay in thediabetes team consultationgroup (3.6 days) was significantly shorter than in the endocrinologist consultation group (5.5 days) and the no-consultation group (8.2 days).

Amount of video 6 months RCT None Home There was a 77% decreasegame playing time, from baseline in urgent diabetes-related care and emergency urgent care and medical visits in the emergency medical diabetes video game groupvisits, diabetes-related but no change in the self-efficacy (ability to control group. There wereaffect outcomes), improvements in communication with diabetes-related parents about diabetes, self-efficacy, daily diabetes communication with self-care parents about diabetes, and

daily diabetes self-care in the diabetes video game group but not in the control group.

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Matsuyama JR, 47 patients with Screening of Use of an American Patients with PharmacistsMason BJ, et al., poor to fair computer electronic Diabetes diabetes 1993 metabolic medication medication- Association receiving oral

control of profiles and event guidelines for antidiabetic drugdiabetes laboratory values monitoring metabolic control therapymellitus of all patients system (MEMS), (metabolic

receiving a a medication control was notsulfonylurea vial cap with a a primary for 3 months or microprocessor outcome longer with a that records measure)consistent dosage each date and and poor to fair time that the metabolic control vial is opened

Mazzuca KB, 22 adults with Patients who had Community Not specified Adults with Community healthFarris NA, et al., diabetes who received care at a health nursing diabetes who nursing students 1997 were receiving university-based intervention were receiving in their senior year

insulin therapy internal medicine (weekly or insulin therapy who were under and had poor clinic were biweekly home and had poor the supervision of glycemic contacted by visits to provide glycemic control a nursing facultycontrol telephone by health teaching investigator

investigators. and guidance,health referrals,coordination of care, and client advocacy;teaching addressed nutrition, exercise, foot care, and blood glucose monitoring)


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Dates and times 2 months Double-blind RCT None Veterans The MEMS data allowedmedication vial Affairs pharmacists to individualizewas opened medical center recommendations to aand pill counts ambulatory greater extent than the pill after 30 and clinics count method60 days

Self-reported 32 weeks RCT None Community Community health nursingself-care behaviors (patient homes) produced a significant (managing improvement in self-care complications, blood competency in adults with glucose monitoring, insulin-treated diabetes,diet, reporting foot although it did not improvechanges, exercise), health status.dietary adherence(3-day dietary recall), foot care (ulcer formation),blood glucose levels, diabetes knowledge,functional healthstatus and well-being

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McCulloch DK, 30 practices Not specified Support program American Patients PhysiciansPrice MJ, et al., (unclear as to comprised an Diabetes1998 the number of online patient Association

patients) registry and use of guidelines for eye and foot examinations, screening for microalbuminuria, and glycemic control; registry served as a reminder of the recommended elements of care;delivery of care redesigned to provide for patient group visits as well as individual visits and to establish a decentralized team of diabetes experts that sees patients jointly with primary care providers; team traveled to each clinic several times a year and, along with the primary care team, saw each patient for approximately 30–40 minutes

Meigs JB, 598 patients ICD-9 codes, with Web-based American Physicians and Data collection byCagliero E, with diabetes randomization by patient-specific Diabetes patients nurseset al., 2003 coin toss information Association,

management/ National decision support Cholesterol tool Education

Program, and Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureRCT=randomized controlled trial

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Glycosylated 3 years RCT None Not-for-profit The prevalence ofhemoglobin and staff-model health testing for eye examinations maintenance glycosylated

organization hemoglobin and eyeexaminations both increased over the 3-year period after implementation of theprogram. Nearly two-thirds of patientswith diabetes received annual eyeexaminations by the end of the 3-year period. In the first year of the program, half of all patients with diabetes had afoot examinationcompared with fewer than 20%before programimplementation.Microalbuminuriascreening alsoincreased markedlyafter program implementation. The prevalence of smokingdecreased from 14% in1994 to 10% in 1996.

Testing rates and 12 months RCT (1 yr before and None Hospital-based Testing of glycosylatedvalues for after intervention) clinic hemoglobin and LDL glycosylated cholesterol and foot hemoglobin, low- examinations increased anddensity lipoprotein glycemic control improved(LDL) cholesterol, in the intervention group.and blood pressure;eye and foot examination rates

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Nilasena DS, 31 Physicians Internal medicine Impact of a American Internal medicine Not specifiedLincoln MJ, resident physicians computer- Diabetes resident et al., 1995 in their 3rd or 4th generated Association physicians

year reminder system in their 3rd or on physician 4th yearcompliance with guidelines for diabetes preventive care;residents in intervention group were provided with a patient-specific report listing patient health data and upcoming or overdue preventive health activities (e.g., physical examinations, laboratory tests, referrals, patient education)

Nine SL, 75 African Patients Exercise, medical Not specified Patients Registered nurseLakies CL, Americans with volunteered to nutrition therapy, or dietitianet al., 2003 diabetes, participate support groups,

hypertension, cooking schools,or both and service

coordination


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Compliance with 6 months RCT None Hospital The average complianceguidelines for score 1 month afterpreventive implementation of thecare reminder system was

significantly higher compared with baseline inthe intervention group(54.9% after 1 month versus 38.0% at baseline). The averagecompliance score in thecontrol group also increased significantly over the same period(51.0% after 1 monthversus 34.6% at baseline);there was no significant difference between thetwo groups in the changein compliance. The highest compliance scoreswere for laboratory testsand referrals, and the lowest scores were for patient education. The useof encounter formsfacilitated documentation of clinical data and compliance with guidelines for diabetes preventive care.

Blood pressure, 1 year Quasi-experimental None Community Glycosylated hemoglobin glycosylated decreased significantlyhemoglobin, and in patients with elevated quality of life initial values. Quality of life

improved but the change was not significant.

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Parker MT, Three long- A letter was sent Education American Registered Diabetes educatorsKeggett-Frazier N, term-care to administrators program Association of nurses andet al., 1995 facilities of 40 long-term- (7 biweekly Diabetes licensed practical

(LTCFs); two care facilities (the 20-minute Educators and nurses at long-received method for sessions using American term care intervention identifying these a lecture format Diabetes facilitiesand one served facilities was not with slides and Association as a control specified) in a question-and- guidelines weregroup eastern North answer period on used to develop

Carolina that met medications, the diabetescertain criteria for patient monitoring, knowledge testnumber of beds managing and number of hyperglycemia patients with and hypoglycemia,diabetes. diet, foot care,

illness care, and exercise and patient-family education)

Piette JD, 248 English- Culled from Biweekly Self-care Patients Diabetes nurseWeinberger M, or Spanish- medical automated education recorded educatoret al., 2000 speaking adult records of patients telephone messages were

patients with with scheduled assessment based on diabetes appointments at (patient use of literature managed by one of two general the touch-tone- published by the medication medicine clinics of telephone keypad Centers for

a county health to enter blood Disease Controlcare system glucose readings and Prevention

and other data and Americanfor review by a Diabetes nurse) and Associationself-care education calls with nurse follow-up


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Diabetes knowledge 3 months LTCFs were None Long-term-care The intervention and diabetes care randomized to the facilities significantly improved practices (providing intervention or control diabetes knowledge butcarbohydrates for group; pretests and did not affect diabetes carepatients with posttests were used practices.hypoglycemia, to test diabetes testing for knowledge and a ketones and retrospective chart contacting a review (randomly physician for selected charts for patients with LTCFs with more hyperglycemia, than 20 residentsadministering with diabetes andinsulin in the the entire abdomen, and population of having a podiatrist patients with cut toenails) diabetes for LTCFs

with fewer residents with diabetes) was used to evaluate diabetes care.

Self-monitoring of 12 months RCT None Home Self-monitoring of blood blood glucose, glucose, foot inspection, foot inspection, and weight monitoring wereand weight more frequent; problems monitoring, with medication adherencemedication were less common; and adherence, glycemic control was glycemic control better in the intervention(glycosylated group than in the control hemoglobin, group, which received serum glucose) usual care.

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Piette JD, 248 English- or Culled from Biweekly Self-care Patients Diabetes nurse Weinberger M, Spanish- medical automated education recorded educatoret al., 2000 speaking adult records of patients telephone messages

patients with with scheduled assessment were based ondiabetes appointments at (patient use of literature managed by one of two the touch-tone- published by themedication general medicine telephone Centers for

clinics of a county keypad to enter Disease Controlhealth care blood glucose and Preventionsystem readings and and American

other data for Diabetes review by a nurse) Association.and self-care education calls with nurse follow-up

Piette JD, 272 patients Recruited from Biweekly Not specified Patients NurseWeinberger M, with diabetes at three general automated 2001 a Veterans medicine clinics telephone

Affairs and one diabetes assessment clinic specialty clinic (patient use of

within a the touch-tone-university-affiliated telephone keypadVeterans to enter bloodAdministration glucose readingshealth care system, and other datausing patient for review by amedical records nurse) and

self-care education calls with nurse follow-up

Pijls LT, 125 patients Not specified Dietary European Patients Dietitiansde Vries H, et al., with type 2 (described counseling Association for the 2000 diabetes elsewhere in Study of Diabetes

and micro- published and American albuminuria, literature) Diabetes relatively high Associationalbuminuria, or diabetes for at least 5 years and high dietaryprotein intake


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Depression, anxiety, 12 months RCT None Home Significantly fewer self-efficacy symptoms of depression(patients’ and days in bed because confidence in of illness and significantly participating in greater self-efficacy to their own care), perform self-care activities days in bed were associated with the because of illness, intervention (automated diabetes-specific telephone assessment andhealth-related nurse follow-up) than with quality of life, usual care (the control general quality group). Anxiety and of life quality of life were similar

in the two groups.

Self-care (self- 12 months RCT None Clinic Patients in the interventionmonitoring of blood group reported significantlyglucose, foot more frequent self-inspections), monitoring of blood symptoms, glucose and footsatisfaction with inspections, fewer care, and glycemic symptoms of poor control glycemic control, and

greater satisfaction with care. Among patients with an elevated baselineglycosylated hemoglobin,the mean value after 12 months was significantly lower in the intervention group than in the control group.

Protein intake 12 months RCT None Not specified Dietary protein intake wasestimated from significantly lower in the urinary urea experimental group than in excretion the control group after

6 months but the differencewas smaller and not significant after 12 months.Dietary counseling resulted in only modest protein restriction.

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Pill R, 33 general Not specified Training (at least Not specified General A general Stott NCH, practices with 3 hours divided practitioners and practitioner, et al., 1998 252 patients into two sessions practice nurses research nurse,

with type 2 using discussions, and clinical diabetes demonstrations, psychologist

and role-play) of general practitioners and practice nurses about an unspecified patient-centered intervention (“described elsewhere”) designed to encourage clinicians to negotiate individual care plans based on patients’perceptions of their disease and readiness to change their lifestyles and to work towardrealistic targets for behavior change

Ridgeway NA, 28 adults Computerized Six 90-minute Not specified Patients Registered Harvill DR, et al., audit identified education/behavior dietitians and 1999 diabetic patients modification registered nurses

who visited clinic sessions offered who were certifiedin preceding year monthly, with a diabetes educatorsand physicians follow-up sessionrecommended at 12 monthsparticipation to those patients who met the inclusion criteria (i.e., diagnosis of type 2 diabetes,≥20% over ideal weight, able to participate in monthly visits and comprehend presented material, inadequate glycemic control).RCT=randomized controlled trial

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Change in 3 years RCT None General practice Although most cliniciansglycosylated had a moderate to good hemoglobin, understanding of the complications, underlying principles of thepatient satisfaction intervention, few routinelywith care, functional applied the principles inhealth status, ability practice. An impact onof health care patient outcomes andprofessionals to health status was not apply the intervention demonstrated.

Glycemic control During and RCT Cost of Primary care Significant but transient (fasting blood 12 months educational clinic improvements in metabolicglucose and after 6-month materials parameters as well asglycosylated intervention and salaries body weight occurred in hemoglobin), lipid for the program patients with type 2 profiles, body diabetes who participated weight, knowledge in education/behavior about diabetes, modification classes.health-related Patients who took the quality of life classes also improved (HRQOL), their knowledge of medication diabetes and requirements demonstrated significantly

more knowledge than controls post-intervention.

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Rothman R, 138 adults General internal Diabetes American Patients PharmacistsMalone R, with poorly medicine practice education, Diabetes et al., 2003 controlled limited physical Association

type 2 diabetes examination, initial treatment recommendations, the use of medication algorithms, and frequent patient follow-up

Schmidt SO, 231 patients Random selection Use of a diabetes American Diabetes Physicians Not specifiedBurns C, et al., with diabetes of charts management Association (ADA)2003 at six clinics flow sheet, with or

without provider feedback on performance

Smith DE, 22 older obese Advertisements Three Not specified Patients Psychologists Heckemeyer CM, women with and a patient individualized experienced in theet al., 1997 type 2 diabetes letter motivational intervention

interviewing techniquesessions (to assess attitude toward change, solve problems,assess objective data on health and behavior, delineate discrepancies between current status and goals, and develop realistic and objective goals)


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Glycosylated 6 months Retrospective, not None University-based Glycosylated hemoglobin hemoglobin controlled clinic decreased significantly,

especially in patients withhigh baseline levels or arecent diagnosis.

Compliance with 2 months Quasi-experimental None Clinic Both interventions ADA recommended significantly improved the frequencies for performance of foot examsvarious tests and but had little impact onexams and patient other tests and patient outcomes outcomes.

Body weight, 16 weeks RCT None Home with Treatment adherence glycosylated intermittent and blood glucose control hemoglobin, meetings in were significantly better intreatment unspecified the motivational adherence (group setting (intervention) group than inmeeting attendance, the standard (control) maintaining and group. Both groups lost asubmitting diaries significant amount of of eating, exercise, weight but the two groupsand home blood did not differ in the glucose monitoring) amount of weight loss.

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Smith L, 30 women with Letters were Program using None Female patients Certified diabetesWeinert C, 2000 type 1 or 2 sent to certified computer-based with diabetes educator

diabetes living diabetes educators, telecommunicationsin rural areas and flyers about technology to

the program for provide support, distribution to information, andpatients were educationenclosed; the mailing list for the state chapter of the American Diabetes Association was also used to identify potential participants who then received flyers.

Stott NC, 30 primary Identified family Introduction of Not specified Doctors and Not specified who Rees M, care doctors, practices with visual agenda- nurses; patients managed et al., 1996 33 nurses, and doctors and nurses setting technology secondarily intervention for

200 patients who are (charts, diaries, involved as doctors and “interested and readiness-to- recipients of nurses; nurses active in diabetes change ruler), as technique and doctors care” (e.g., attend well as applied techniquescontinuing techniques in to patientseducation sessions) negotiation and

motivational interviewing that health professionals can use to facilitate clinician-patient interactions, patient lifestyle changes, and compliance


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Measures of 10 months RCT None Patient homes, Quality of life scores were social support, many of which higher for women in bothquality of life, were far from the groups who had more psychosocial nearest source of education and improvingadaptation to health care health. Attitudes towardillness, attitudes the use of about the telecommunications impact of the technology were positive, computer and 77% of subjects intervention recommended its use “very

highly.” The program provided a great deal ofsupport to 77% of womenin the computer group.

Uptake of training, 3 years RCT None 29 family A high percentage of family use of the method, practices in practice-based cliniciansattendance/ Wales reported frequent (71%) orparticipation in occasional (22%) use of group discussions, agenda-setting technology willingness to in their interactions with have consultations type 2 diabetics following tape-recorded an intervention directed at

introducing and promoting this technique.While levels of engagementwere higher among nurses, doctors alsoreported benefits of using visual charts andtechniques, negotiation, and motivational interviewing to encourage patient compliance and lifestyle changes.

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Tan ASL, Yong LS, 278 patients Recruited as they Diabetes Not specified Patients Nurse trained in et al., 1997 with diabetes came to the clinic education program counseling

(183 for the for treatment (at least six techniquesintervention) out (first 100 individual or of a total assigned to small-grouppopulation of control group, counseling about 2,500 subsequent sessions usingwith diabetes patients to the patient booklets served by the intervention group) and four groupclinic sessions, with

lectures, videotaped presentations, group discussions, and food displays)

Teufel NI, Not specified Not specified Establishment of Not specified Zuni high school Collaboration Ritenbaugh (it is unclear supportive social students in New between public CK, 1998 how many networks, Mexico, a school district

patients development of a population with and university participated for wellness (exercise) a high prevalence department of the first facility, incorporation of type 2 diabetes family and 2 years of of diabetes and an early community this 4-year education into the age at diagnosis medicinestudy and high school provided curriculum, and longitudinal modification of the data for that food supply to period) reduce fat content

and consumption of sugary beverages and increase fiber content


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Diabetes 1.5 years Controlled, but not None Government The intervention (diabetes knowledge (disease, randomized primary education program) complications, health care clinic significantly improved management, and diabetes knowledge, dietary self-care), dietary practices, medication practices, medication compliance, and glycemiccompliance, self- control in patients with monitoring of blood diabetes.or urine glucose,glycosylated hemoglobin

Body mass index, 4 years (results Not controlled None Two high schools Within 2 years after thedietary intake of available only for (community) intervention, the fiber and sugary first 2 years) consumption of sugarybeverages, heart beverages, body massrate, fasting and index, and heart rate hadpostprandial decreased (a decreasedglucose and heart rate suggests insulin levels improved cardiovascular

fitness), and dietary fiberintake and glucose-to-insulin ratios had increased (an increase in the glucose-to-insulin ratiosuggests a reduced prevalence of hyperinsulinemia and riskfor type 2 diabetes). Onlythe changes in sugarybeverage consumption and insulin levels weresignificant, but the other changes suggest the adoption of healthy behaviors that might reduce the prevalence of risk factors for type 2 disease as the study continues.

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Uusitupa MIJ, 1996 86 obese Not specified Intervention group Not specified Patients Not specifiedFinnish patients made six visits to

an outpatient clinic at 2-month intervals for intensive therapy with (1) a restricted dietary intake of calories, total fat (<30%), saturated fats (<10%), and cholesterol (<300 mg/day), which was monitored by examining food records and measuring serum lipids, and (2) exercise training (30–60 minutes three to four times per week), which was monitored by analyzing daily exercise records.


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Dietary intake of 1 year and RCT None Outpatient clinic The intervention led to acalories via food 3 months reduction in intake of records, serum saturated fats and calories.lipids, and Weight loss and beneficial exercise training changes in metabolic

control (fasting blood glucose) and lipid profile (e.g., high-density lipoprotein cholesterol,triglycerides) were observed during theintervention period only inthe intervention group.Follow-up assessment 1 year after the completion of the intervention periodrevealed that glycemiccontrol was maintained by a significantly largerpercentage of patients in the intervention group than in the conventionaltreatment group.

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van den Arend IJ, 243 patients All eligible Four structured Guidelines on Patients General Stolk RP, et al., with type 2 patients were programs for type 2 diabetes practitioners,2000 diabetes included or some patient care, of the Dutch dietitians,

were selected including (1) care College of diabetes nurses,randomly or based guided by General ophthalmologists,on poor glycemic protocol, with oral Practitioners podiatristscontrol (depending and written on the program) patient information,

(2) care with computerized support and a diabetes nurse available to answer patient questions, (3) a special educational program focusing on blood glucose monitoring for a subset of patients with poor glycemic control, and (4) an integrated care program with an educational program with didactic elements and interactive group discussion on basic self-care skills and diabetes pathophysiology and complications


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Disease knowledge, 12 months Randomized, but None Primary care Disease knowledgeself-care behavior not controlled setting and self-care behavior(dietary adherence, increased in all four self-monitoring of programs and was blood glucose, maintained at follow-up.physical exercise, The increases were and foot inspection), significantly greaterand disease in programs with anperception educational component

(programs 3 and 4) than in those without an educational component (programs 1 and 2).

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Weinberger M, 275 adults Computerized Nurse-initiated Not specified Patients NursesKirkman S, receiving care audit identified telephone contactset al., 1995 at Veterans patients who between clinic

Affairs medical had ever filled visits to primary clinic a prescription for care physicians to

insulin or an oral provide education,hypoglycemic reinforce agent at the compliance, pharmacy and had monitor health visited the clinic in status, solve the preceding year. problems, and Patients who met facilitate accessthe inclusion criteria to primary care(i.e., diagnosis of type 2 diabetes,currently using insulin or oral hypoglycemic agent, receiving regular care at clinic, access to phone) were invited to participate by letter, phone, or clinic visit.

Whitlock WL, 28 adult Recruited based Weekly home American Patients Nurse case Brown A, et al., patients with on glycosylated telemedicine Diabetes manager under2000 type 2 diabetes hemoglobin value (voice and video Association direction of

and from internal interaction) visits primary care glycosylated medicine, family with patient by physicianhemoglobin practice, and nurse case >8% primary care manager to review

clinics using blood glucosehospital levels, body information weight, blood systems at an pressure,Army medical hypoglycemic center episodes,

exercise and nutrition goals, and well-being, and monthly physician telemedicine visits

Wing RR, 154 non-diabetic Newspaper Group meetings Not specified Non-diabetic Behavior therapist,Venditti E, et al., individuals at advertisement for about diet, individuals registered dietitian,1998 risk for diabetes overweight exercise, or both; exercise

because of individuals restricted diet with physiologistoverweight and with a parent who structured meal a parental has diabetes plans; grouphistory of the exercise sessionsdisease plus individual

exercise


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Glycosolated 1 year RCT None Veterans Affairs The intervention modestly hemoglobin, general medical improved glycemic controlfasting blood sugar clinic but not HRQOL or health-related diabetes-related quality of symptoms.life (HRQOL),and symptoms

Laboratory tests 3 months RCT None Home There were significant (glycosylated reductions in glycosylated hemoglobin, hemoglobin and total lipid values), body weight in the total body weight, telemedicine group but notquality of life in the control group.

Body weight, oral 2 years RCT None Not specified Diet and diet plus exerciseglucose tolerance produced significant weighttest, fasting glucose loss and improvement in and insulin, cardiovascular risk factors glycosylated (lipid profile, blood hemoglobin, lipid pressure) initially but theseprofile, blood improvements were not pressure maintained on a long-term

basis. The risk for type 2diabetes was significantly reduced by even a modest weight loss.

Group Health Cooperative of Puget SoundSeattle, Washington

Group Health Cooperative of Puget Sound, a Seattle-based HMO,is developing a “clinical road map” for members with diabetes thatincludes a sophisticated, individualized method of patient educationand empowerment and a restructuring of clinic operations. A ran-domized, controlled trial is under way to compare outcomes inthree groups: one using a new educational model in conjunctionwith a diabetes clinic, another incorporating the model into primarycare practices, and a control group receiving usual care with noeducational intervention. The educational model is based on thetranstheoretical model of behavior change. Intervention guidelineshave been developed for each of five stages of behavior change(precontemplation, contemplation, preparation, action, mainte-nance).

Baylor College of MedicineHouston, Texas

Improving the health of Mexican Americans, who have high rates ofobesity and are at high risk for type 2 diabetes, was the objectiveof Unidos en Salud (United in Health), a 5-year research projectconducted by Baylor College of Medicine. The researchersfocused on a population of 40,000 people who were primarily(97%) Hispanic and poor in Starr County, which borders northernMexico. The project was built on the results of Cuidando elCorazon (Caring for Your Heart), an earlier research project thatinvolved culturally sensitive approaches to reducing dietary fatintake and other dietary modifications.

A randomized, controlled study was undertaken to determinewhether 6 months of professional nutrition, lifestyle management,and exercise interventions followed by 6 months of social supportand peer support as maintenance would result in an individualweight loss of at least 10 pounds in 300 women. Other outcomemeasures include body mass index, serum glucose, insulin, glyco-sylated hemoglobin, lipids, and blood pressure. Women were ran-domized to the intervention or a wait-listed group (the latter servedas a control group).

Many women did not reach the goal of losing at least 10 poundsduring the intervention period, although some women achievedsuccess during the maintenance period. Peer support providedsignificant benefits. Women with the least education and incomeappeared to benefit most from the social support.

U.S. Public Health ServiceCarville, Louisiana

Reducing lower-extremity amputations in patients with diabetes by40% is an objective of a project called the Lower ExtremityAmputation Prevention (LEAP) Program, which is headquartered atthe Gill W. Long Hansen’s Disease Center in Carville, Louisiana.Annual foot screenings, patient education, proper footwear selec-tion, daily self-inspection of the feet, and management of simplefoot problems are components of the LEAP program. A 25%reduction in lower-extremity amputations has already been report-ed, although additional progress is sought. A study of a patientempowerment program in which patients self-screen for loss ofsensation in the feet is under way at 40 sites in 18 states.

Texas A&M School of Rural Public HealthBryan, Texas

A 3-year study by researchers at Texas A&M’s School of RuralPublic Health is under way to explore cost-effective strategies forbringing disease management to rural populations. A model devel-oped at Mahomet, Illinois–based Carle Health Systems ResearchCenter was used. This model involves branch clinics to improvepatient access to health care in rural areas, a care team made upof a registered nurse partnered with 5–10 primary care providers,and the use of authoritative clinical guidelines. Another model ofcare under study by the Texas A&M researchers is the St. Elizabethof Hungary Clinic in Tucson, Arizona, which takes care of manyuninsured patients with diabetes. A diabetes clinical flow sheet isused to track clinical assessments, laboratory test results, interven-tions, physician exams, and self-care activities for each patient.Diabetes day group visits are used to make care more accessibleor convenient for patients and to improve compliance (patients canobtain all needed services in a single visit instead of multiple visits).The average glycosylated hemoglobin measurement decreasedfrom 8.9% to 8.2% over a 2-year period as a result of the interven-tion. Glycemic control improved over the course of 1 year in nearlyhalf of patients with diabetes who were considered at high risk.Plans are under way to use telemedicine for patients with diabetesin rural areas and to implement preventive initiatives (e.g., nutritioncounseling) for patients at risk for developing diabetes (i.e., patientswith prediabetes). See: The new frontier: delivering cost-effectiveDM to rural populations. Dis Manag Advis. 2003;9:122–26.

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Appendix D. Diabetes Disease Management Programs

Gottleib Memorial HospitalMelrose Park, Illinois

Gottlieb Memorial Hospital offers a subcapitated disease manage-ment program for diabetes to the 200 physician members of itsphysician/hospital organization. The program uses a multidiscipli-nary approach to manage diabetes and reduce the incidence ofcomplications. About 100 patients have been enrolled. Dramaticimprovements in glycemic control have been observed with theprogram. There were no hospital admissions because of uncon-trolled diabetes in the first 6 months of the program. Annual costsavings of $750,000 are projected, based on 50% reductions inboth hospital admissions and hospital days for diabetes.

UnitedHealthcare Diabetes Management ProgramMinneapolis, Minnesota

Visions for Diabetes was a UnitedHealthcare program designed tohelp members with diabetes take better care of themselves andprevent serious complications. It sought to promote physician com-pliance with guidelines established by the American DiabetesAssociation, improve quality of care and clinical outcomes, andmodify member and physician behaviors. The company delivered acomprehensive diabetes health management program in collabora-tion with Merck-Medco Managed Care, LLC. The InternationalDiabetes Center, a world leader in the development of educationand treatment models to improve the health and lives of peoplewith diabetes, provided continuing medical education credits forprovider “rollout” and case management training. UnitedHealthcarealso has a disease management program for asthma and a well-ness program for pregnancy. (For additional information, go tohttp://www.unitedhealthcare.com.)

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Appendix D. Diabetes Disease Management Programs (continued)

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Disease Management for Diabetes