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Using American Diabetes Association Standards of Medical Care In the Free
Clinic Setting
DM-2, By the RulesGary Greenberg, MD
Medical Director, Open Door Clinic
Urban Ministries of Wake County
(919) 256-2167; [email protected]
April, 2010
Whose Rules?
• American Diabetes Association (ADA) 01/10
• European Assoc. for the Study of Diabetes (now = ADA’s)
• American College of Clinical Endocrinology 05/07
• US Preventive Services Task Force (USPSTF) 06/08
• Health Plan Employer Data & Information Set (HEDIS)– National Committee for Quality Assurance (NCQA), 2009
• Centers for Medicare & Medicaid Services (CMS)– (previous HealthCare Finance Admin, HCFA)
• Community Care of N. Carolina (based on ADA, 01/05)
How do you FIND the Rules?
Finding Guidelines
• WWW.Guidelines.gov– All the world’s guidelines
• WWW.eMedicine.com– Free access narrative, with links
• WWW.OpenDoorDocs.org (mine)– Bulletted links to accepted standards, including this
presentation
How do you FIND the Rules?
General Principles
• Diagnosis is categorical, leading to automatic risks & clinical interventions
• Managed as a chronic disease, with life-long, multi-dimensional concerns
• Rx is far-reaching, in tools, goals, tactics
• DM-2 isn’t “DM-II” any more, but when did it become T2DM ?
Diagnosis of DiabetesPreviously:It took TWO of either of these: • Fasting glucose ≥ 126 mg/dl (8 hours)• 2-hour post-challenge ≥200 mg/dl (75 g)Or in a symptomatic patient with:• Polyuria, polydipsia, and unexplained weight
loss• Single random (incl. post-prandial) ≥200 mg/dl
HgbA1C
It still takes TWO, but: • HemoglobinA1C > 6.5%
Advantages:• Non-fasting• Easier transport, sample preservation• Non-momentary (eg during steroids or acute illness)• More standardized than glucose from lab-to-lab (not as true
for point-of-care tests)• Leads directly to measures of control• Soon reported in interpolated units of glucose, “mg/dl”
HgbA1C
Circulating hemoglobin is seen as the perfect passive witness
Disadvantages: • Cost: $14-$18• Short RBC survival
– Hemolysis– Bleeding or donor
• Abnormal hemoglobin phenotype• Recent Transfusion
Hemoglobin A1c
• More generically: Glycohemoglobin• “Average” glucose, cumulative over the
age of the RBC witnessing plasma levels• Legitimate use of extrapolation, eg:
– Baseline: A1C = 12.0, began metformin– One month later: A1C = 10.0– Rate of fall: 2 points/mo– Expected / eventual A1C seems on-target
• Consider: other serum glycosylated proteins– fructosamine = 3 week avg
HbA1c Avg Glucose
• 6% 126 mg/dL
• 6.5% 140 mg/dL
• 7% 154 mg/dL
• 7.5% 169 mg/dL
• 8% 183 mg/dL
• 8.5% 197 mg/dL
• 9% 212 mg/dL
• 9.5% 226 mg/dL
• 10% 240 mg/dL
• 11% 269 mg/dL
• 12% 298 mg/dL
Pre-Diabetes or “Increased risk of Diabetes”A serious diagnosis, with legitimate therapies,
including medications
• Impaired Fasting Glucose (IFG) : Fasting glucose 100-125 mg/dl
• Impaired Glucose Tolerance (IGT): 2-hr post-challenge 140-199 mg/dl
• New: HgbA1C between 5.7 – 6.4
Screening for DiabetesEvery 3 years:• All overweight adults
45 & older (BMI ≥ 25 kg/m2)
Annual: high-risk + overweight• Sedentary• Family History (1o relative)• Ethnic risks (AA, Latino, Native Amer.)• Prior gestational (or baby ≥ 9 lbs)• Hypertensive• Metabolic Syndrome (Low HDL or
hypertriglyceridemia)• Polycystic Ovaries Syndrome• Known Pre-diabetes• Acanthosis Nigracans• Known vascular disease
Diabetes Prevention
• Lifestyle effortsDocumented success (up to ~58% reduction in 3 years)
– Weight loss, even modest
– Exercise, even mild “increased activity”
– Clinical monitoring
• Medications– Metformin (especially with both pre-diabetes criteria)
– Acarbose, Orlistat, Rosiglitazone
Major Classes of Medications
1. Insulin Sensitizers
sensitize the body to insulin and/or control hepatic glucose production
2. Secretagogues
stimulate the pancreas to make more insulin
Thiazolidinediones– Avandia (rosiglitazone), gone– Actos (pioglitazone)
Biguanides– Metformin
Sulfonylureas– Glimepiride (Amaryl)– Glipizide (Glucotrol)– Glyburide (Diabeta, Glynase,
Micronase) no longer recommended
Meglitinides– Nateglinide (Starlix)– Repaglinide (Prandin)
Newer Classes of Medications
Incretin: short-lived gut hormones, multiple actions:• Release insulin
• Suppress glucagon
• Reduce gastric emptying
• Trigger satiety
3. Injected drugs that mimic Incretin (but longer t1/2)
4. Drugs that delay Incretin degradation
Exenatide (Byetta)Liraglutide (Victoza)
Sitagliptin (Januvia)
Other Medications
5. Carbohydrate digestion interference
6. Amylin mimic
-Glucosidase inhibitor – Acarbose (Precose)– Miglitol (Glyset)
Pramlintide (Symlin)
Previous Charted Algorithm
Meds for Glucose Control
Tier 1: well-validated core
• Step 1, initial therapy (estimated HgbA1c improvement)– Lifestyle to decrease weight and increase activity (1 - 2)
– Metformin (1 - 2)
• Step 2, additional therapy– Insulin (1.5 – 3.5)
– Sulfonylurea (1 - 2)
Tier 2: less well validated– TZD’s (0.5 – 1.4)
– GLP-1 agonist (0.5 – 1)
“Other therapy” - -Glucosidase inhibitor (0.5–0.8) - Pramlintide (0.5 – 1.0) - DPP-4 inhibitor (0.5 – 0.8)
Consensus Statement from ADA’s Diabetes Care 32:193–203, 2009
Insulin
• Older forms:– NPH: 8 hr peak, 12 hr duration, $62 for 1,000 units
– Regular: 2-4 hr peak, 8 hr duration, $62 for 1,000 units
• Newer synthetic forms– Lantus (glargine), Levemir (detemir): Flat kinetics, all-
day basal effect, $112 for 1,000 units
– Humalog (aspart), Apidra (glulisine): immediate onset, life-style responsive, flexible, $119 for 1,000 units
Insulin
• Initial Dosing: Lantus 10 units, adjust at least weekly
• Auto-titration (not “sliding scale”) for the well informed
• Phone management is critical
• For immediate insulin, we use a “2-dimensional” table, NOT a calculation or sugar-only look-up
MealSugar
Snack orBreakfast
Lunch or small supper
Dinner
<100 0 2 4
100-200 2 4 6
200-300 4 6 8
>300 6 8 10
Insulin Sensitizers Metformin• Direct approach to physiological problem (insulin receptor resistance)• Usually mild weight loss (?from GI distress)• Cheap as generic• Use-able in conjunction with insulin• Renal concerns (maximum serum creatinine, I2-dye risks)
“Glitazones” or TZD’sPioglitazone (Actos) or Rosiglitazone (Avandia)• Cardiac risk controversies• Delayed onset• Fluid / sodium retention• No generic• Improve lipid parameters
Insulin Secretory Stimulators
Sulfonylureas and meglitinides• Historic tales of increased mortality (UGDP),
missing evidence for health benefit (as opposed to intermediate goal of glucose control) is hard to find
• Modern generational drugs without [Na+] shifts• Hypoglycemia remains a concern• Generics are available
The rest of the patient
Prescribed comprehensive management of many clinical parameters, often remote to the metabolic disorder.
Risks are no longer from hyperglycemia and D.K.A., but from cumulative damage and atherosclerosis
Coronary disease remains the main cause for mortality. Arterial insufficiency leads to amputation.
Cardiac Risk Factors• Lipids
LDL < 100 (even lower, to <70 if uncontrolled other risks, eg smoking)
• BP < 130/80• HCTZ OK even though glucose elevation
• ACE or ARB shown beneficial for renal protection
• Aspirin, based on overall CAD risk factors– Men: 40 y/o if additional risks, 50 y/o even if none
– Women: 50 y/o if additional risks, 60 y/o if none
Lipid “screening”
Rx actions are based on overall CV risk:
• General patient population– Rx treatment threshold is high (LDL-C>160 mg/dl)
– Screening with simple Cholesterol is enough ($6-$8)
• Diabetic population (or with known CVD)– Rx treatment threshold is low (LDL-C>100 mg/dl)
– Screening with directly measured LDL ($13-$18)
Infection Concerns
Pneumonia• Despite antibiotic Rx, high-mortality group warrants
pneumococcal vaccine, once at diagnosis, then at 65 y/o
Influenza• Mortality is huge, with additional coronary, metabolic
complications, so annual “regular” flu-shot
Skin, foot infections• Ulcers, cellulitis, merit closer monitoring, earlier and more
aggressive therapy. Polymicrobial flora
Renal Dangers
• BP control is for glomerular protection: <130/80• Annual monitoring:
– Serum Creatinine (excretory capacity)
– Urinary microalbumin excretion (resorptive, tubular capacity), corrected for hydration with ratio to urinary creatinine excretion)
• Renin Angiotensin System priority for Rx– First choice for BP Rx
– ACE’s even just for (+) urinary microalbumin
– ARB’s more costly, similar effect
– Renin inhibitor: Tekturna
Direct End-Organ DM Effects
Ocular• Retinal exam by specialist, annually (unless told
otherwise)
• Cataract monitoring
• Delay refraction until BS controlled
Neuropathy• Long axonal function, standardized monofilament testing
• Is vibration sense more ‘sensitive’ ?
Tactics for Organized Care
• Consensus approach for standards of clinical management– Display of standard of care is effective for
providers & patients– Signs for patient to remind clinician for flu
shot, foot exam, labs
• Pre-visit labs for HgbA1c, lipids, renal monitoring (proteinuria and creatinine)
Tactics for Organized Care
Checklist on entering room:
• Last labs:– HgbA1C
– Creatinine
– LDL cholesterol
– LFT’s (if on statin)
– Urine Microalbumin
• Vaccines– Pneumovax
– Fluvax
• Exams– Eye (date)
– Feet
– Dental
– Gyn
Tactics for Organized Care
Low threshold for performing clinical tasks:
– Flow-sheets for reminders, results, logging prior interventions
– Flags on charts for missing interventions– Stickers / stamps for check-lists– Standing orders to decompress physician
demands
Tactics for Organized Care
Full utilization of a Diabetic Team, including• Pharmacist• Nursing• DM educator• Nutritionist, Dietician• Exercise coach/therapist• Podiatrist• Eye specialist• Family
Important & New Changes
• HgbA1C as diagnostic tool, DM & pre-DM
• Glyburide dismissed
• Metformin limitations
• Treating diabetics with HgbA1C < 7.0
