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) 256-2167; GNGreenberg@gmail.com
April, 2010
Whose Rules?
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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 lifelong, 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 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
HgbA1C
It still takes TWO, but:
• HemoglobinA1C > 6.5%
Advantages:
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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:
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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
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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 Diabetes
Every 3 years:
Annual: high-risk + overweight
• All overweight adults •
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45 & older (BMI ≥ 25
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2
kg/m )
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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 efforts
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
Major Classes of
Medications
1. Insulin Sensitizers
sensitize the body to
insulin and/or control
hepatic glucose
production
Thiazolidinediones
– Avandia (rosiglitazone), gone
– Actos (pioglitazone)
Biguanides
– Metformin
Sulfonylureas
2. Secretagogues
stimulate the pancreas to
make more insulin
– 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:
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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
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)
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, allday basal effect, $112 for 1,000 units
– Humalog (aspart), Apidra (glulisine): immediate onset,
life-style responsive, flexible, $119 for 1,000 units
Insulin
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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 Snack or
Sugar
Breakfast
Lunch or small
supper
Dinner
<100
0
2
4
100-200
2
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6
200-300
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>300
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10
Insulin Sensitizers
Metformin
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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
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
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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:
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HgbA1C
Creatinine
LDL cholesterol
LFT’s (if on statin)
Urine Microalbumin
• Vaccines
– Pneumovax
– Fluvax
• Exams
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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
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Pharmacist
Nursing
DM educator
Nutritionist, Dietician
Exercise coach/therapist
Podiatrist
Eye specialist
Family
Important & New Changes
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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