1. Using American Diabetes Association Standards of Medical Care In the Free Clinic Setting DM-2, By the Rules
Gary Greenberg, MD
Medical Director, Open Door Clinic
Urban Ministries of Wake County
(919) ;
April, 2010

2. 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)

3. How do you FIND the Rules?
Finding Guidelines
All the world’s guidelines
Free access narrative, with links
(mine)
Bulletted links to accepted standards, including this presentation

4. How do you FIND the Rules?

5. 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 ?

6. Diagnosis of Diabetes Previously: 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

7. HgbA1C It still takes TWO, but: Advantages: HemoglobinA1C > 6.5%
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”

8. 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

9. 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

10. Pre-Diabetes or “Increased risk of Diabetes”
A serious diagnosis, with legitimate therapies, including medications
Impaired Fasting Glucose (IFG) : Fasting glucose mg/dl
Impaired Glucose Tolerance (IGT): 2-hr post-challenge mg/dl
New: HgbA1C between 5.7 – 6.4

11. Screening for Diabetes
Every 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

12. Diabetes Prevention Lifestyle efforts Medications
Documented 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

13. Major Classes of Medications
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)
There are five major classes of oral diabetes medications: thiazolidinediones, biguanides, sulfonylureas, meglitinides, and alpha-glucosidase inhibitors. These five classes of medication operate in essentially three different ways.
Thiazolidinediones and biguanides decrease glucose production in the liver and increase insulin sensitivity in peripheral body tissues.
Sulfonylureas and meglitinides stimulate the pancreatic beta cells to make more insulin.
Finally, alpha-glucosidase inhibitors slow the absorption of starches in the gut, reducing the amount of glucose that enters the bloodstream.

14. 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
There are five major classes of oral diabetes medications: thiazolidinediones, biguanides, sulfonylureas, meglitinides, and alpha-glucosidase inhibitors. These five classes of medication operate in essentially three different ways.
Thiazolidinediones and biguanides decrease glucose production in the liver and increase insulin sensitivity in peripheral body tissues.
Sulfonylureas and meglitinides stimulate the pancreatic beta cells to make more insulin.
Finally, alpha-glucosidase inhibitors slow the absorption of starches in the gut, reducing the amount of glucose that enters the bloodstream.
Exenatide (Byetta)
Liraglutide (Victoza)
Sitagliptin (Januvia)

15. Other Medications 5. Carbohydrate digestion interference
6. Amylin mimic
-Glucosidase inhibitor
Acarbose (Precose)
Miglitol (Glyset)
Pramlintide (Symlin)
There are five major classes of oral diabetes medications: thiazolidinediones, biguanides, sulfonylureas, meglitinides, and alpha-glucosidase inhibitors. These five classes of medication operate in essentially three different ways.
Thiazolidinediones and biguanides decrease glucose production in the liver and increase insulin sensitivity in peripheral body tissues.
Sulfonylureas and meglitinides stimulate the pancreatic beta cells to make more insulin.
Finally, alpha-glucosidase inhibitors slow the absorption of starches in the gut, reducing the amount of glucose that enters the bloodstream.

16. Previous Charted Algorithm

17. Meds for Glucose Control
Consensus Statement from ADA’s Diabetes Care 32:193–203, 2009
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)

18. Insulin Older forms: Newer synthetic 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

19. 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
Meal
Sugar
Snack or
Breakfast
Lunch or small supper
Dinner
<100 2 4 6 8
>300 10

20. Insulin Sensitizers Metformin “Glitazones” or TZD’s
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’s
Pioglitazone (Actos) or Rosiglitazone (Avandia)
Cardiac risk controversies
Delayed onset
Fluid / sodium retention
No generic
Improve lipid parameters

21. 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

22. 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.

23. Cardiac Risk Factors Lipids BP < 130/80
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

24. 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)

25. Infection Concerns Pneumonia Influenza Skin, foot infections
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

26. 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

27. 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’ ?

28. 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)

29. 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

30. 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

31. Tactics for Organized Care
Full utilization of a Diabetic Team, including
Pharmacist
Nursing
DM educator
Nutritionist, Dietician
Exercise coach/therapist
Podiatrist
Eye specialist
Family

32. Important & New Changes
HgbA1C as diagnostic tool, DM & pre-DM
Glyburide dismissed
Metformin limitations
Treating diabetics with HgbA1C < 7.0

33. Resources WWW.OpenDoorDocs.org=
(919)