Using American Diabetes Association Standards of Medical Care In the Free Clinic Setting DM-2, By...

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; GNGreenberg@gmail.com

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

Resources

• WWW.OpenDoorDocs.org

• GNGreenberg@gmail.com = GGreenberg@urbanmin.org

• (919) 256-2167