Presentation on theme: "Using American Diabetes Association Standards of Medical Care In the Free Clinic Setting DM-2, By the Rules Gary Greenberg, MD Medical Director, Open."— Presentation transcript:
1Using American Diabetes Association Standards of Medical Care In the Free Clinic Setting DM-2, By the RulesGary Greenberg, MDMedical Director, Open Door ClinicUrban Ministries of Wake County(919) ;April, 2010
2Whose Rules? American Diabetes Association (ADA) 01/10 European Assoc. for the Study of Diabetes (now = ADA’s)American College of Clinical Endocrinology 05/07US Preventive Services Task Force (USPSTF) 06/08Health Plan Employer Data & Information Set (HEDIS)National Committee for Quality Assurance (NCQA), 2009Centers for Medicare & Medicaid Services (CMS)(previous HealthCare Finance Admin, HCFA)Community Care of N. Carolina (based on ADA, 01/05)
3How do you FIND the Rules? Finding GuidelinesAll the world’s guidelinesFree access narrative, with links(mine)Bulletted links to accepted standards, including this presentation
5General PrinciplesDiagnosis is categorical, leading to automatic risks & clinical interventionsManaged as a chronic disease, with life-long, multi-dimensional concernsRx is far-reaching, in tools, goals, tacticsDM-2 isn’t “DM-II” any more, but when did it become T2DM ?
6Diagnosis 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 lossSingle random (incl. post-prandial) ≥200 mg/dl
7HgbA1C It still takes TWO, but: Advantages: HemoglobinA1C > 6.5% Non-fastingEasier transport, sample preservationNon-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 controlSoon reported in interpolated units of glucose, “mg/dl”
8HgbA1C Circulating hemoglobin is seen as the perfect passive witness Disadvantages:Cost: $14-$18Short RBC survivalHemolysisBleeding or donorAbnormal hemoglobin phenotypeRecent Transfusion
9Hemoglobin A1c More generically: Glycohemoglobin “Average” glucose, cumulative over the age of the RBC witnessing plasma levelsLegitimate use of extrapolation, eg:Baseline: A1C = 12.0, began metforminOne month later: A1C = 10.0Rate of fall: 2 points/moExpected / eventual A1C seems on-targetConsider: other serum glycosylated proteinsfructosamine = 3 week avgHbA1c Avg Glucose6% 126 mg/dL6.5% 140 mg/dL7% 154 mg/dL7.5% 169 mg/dL8% 183 mg/dL8.5% 197 mg/dL9% 212 mg/dL9.5% 226 mg/dL10% 240 mg/dL11% 269 mg/dL12% 298 mg/dL
10Pre-Diabetes or “Increased risk of Diabetes” A serious diagnosis, with legitimate therapies, including medicationsImpaired Fasting Glucose (IFG) : Fasting glucose mg/dlImpaired Glucose Tolerance (IGT): 2-hr post-challenge mg/dlNew: HgbA1C between 5.7 – 6.4
12Diabetes Prevention Lifestyle efforts Medications Documented success (up to ~58% reduction in 3 years)Weight loss, even modestExercise, even mild “increased activity”Clinical monitoringMedicationsMetformin (especially with both pre-diabetes criteria)Acarbose, Orlistat, Rosiglitazone
13Major Classes of Medications Insulin Sensitizerssensitize the body to insulin and/or control hepatic glucose production2. Secretagoguesstimulate the pancreas to make more insulinThiazolidinedionesAvandia (rosiglitazone), goneActos (pioglitazone)BiguanidesMetforminSulfonylureasGlimepiride (Amaryl)Glipizide (Glucotrol)Glyburide (Diabeta, Glynase, Micronase) no longer recommendedMeglitinidesNateglinide (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.
14Newer Classes of Medications Incretin: short-lived gut hormones, multiple actions:Release insulinSuppress glucagonReduce gastric emptyingTrigger satiety3. Injected drugs that mimic Incretin (but longer t1/2)4. Drugs that delay Incretin degradationThere 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)
15Other Medications 5. Carbohydrate digestion interference 6. Amylin mimic-Glucosidase inhibitorAcarbose (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.
17Meds for Glucose Control Consensus Statement from ADA’s Diabetes Care 32:193–203, 2009Tier 1: well-validated coreStep 1, initial therapy (estimated HgbA1c improvement)Lifestyle to decrease weight and increase activity (1 - 2)Metformin (1 - 2)Step 2, additional therapyInsulin (1.5 – 3.5)Sulfonylurea (1 - 2)Tier 2: less well validatedTZD’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)
18Insulin Older forms: Newer synthetic forms NPH: 8 hr peak, 12 hr duration, $62 for 1,000 unitsRegular: 2-4 hr peak, 8 hr duration, $62 for 1,000 unitsNewer synthetic formsLantus (glargine), Levemir (detemir): Flat kinetics, all-day basal effect, $112 for 1,000 unitsHumalog (aspart), Apidra (glulisine): immediate onset, life-style responsive, flexible, $119 for 1,000 units
19Insulin Initial Dosing: Lantus 10 units, adjust at least weekly Auto-titration (not “sliding scale”) for the well informedPhone management is criticalFor immediate insulin, we use a “2-dimensional” table, NOT a calculation or sugar-only look-upMealSugarSnack orBreakfastLunch or small supperDinner<1002468>30010
20Insulin Sensitizers Metformin “Glitazones” or TZD’s Direct approach to physiological problem (insulin receptor resistance)Usually mild weight loss (?from GI distress)Cheap as genericUse-able in conjunction with insulinRenal concerns (maximum serum creatinine, I2-dye risks)“Glitazones” or TZD’sPioglitazone (Actos) or Rosiglitazone (Avandia)Cardiac risk controversiesDelayed onsetFluid / sodium retentionNo genericImprove lipid parameters
21Insulin Secretory Stimulators Sulfonylureas and meglitinidesHistoric tales of increased mortality (UGDP), missing evidence for health benefit (as opposed to intermediate goal of glucose control) is hard to findModern generational drugs without [Na+] shiftsHypoglycemia remains a concernGenerics are available
22The rest of the patientPrescribed 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 atherosclerosisCoronary disease remains the main cause for mortality. Arterial insufficiency leads to amputation.
23Cardiac Risk Factors Lipids BP < 130/80 LDL < 100 (even lower, to <70 if uncontrolled other risks, eg smoking)BP < 130/80HCTZ OK even though glucose elevationACE or ARB shown beneficial for renal protectionAspirin, based on overall CAD risk factorsMen: 40 y/o if additional risks, 50 y/o even if noneWomen: 50 y/o if additional risks, 60 y/o if none
24Lipid “screening” Rx actions are based on overall CV risk: General patient populationRx 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)
25Infection Concerns Pneumonia Influenza Skin, foot infections Despite antibiotic Rx, high-mortality group warrants pneumococcal vaccine, once at diagnosis, then at 65 y/oInfluenzaMortality is huge, with additional coronary, metabolic complications, so annual “regular” flu-shotSkin, foot infectionsUlcers, cellulitis, merit closer monitoring, earlier and more aggressive therapy. Polymicrobial flora
26Renal 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 RxFirst choice for BP RxACE’s even just for (+) urinary microalbuminARB’s more costly, similar effectRenin inhibitor: Tekturna
27Direct End-Organ DM Effects OcularRetinal exam by specialist, annually (unless told otherwise)Cataract monitoringDelay refraction until BS controlledNeuropathyLong axonal function, standardized monofilament testingIs vibration sense more ‘sensitive’ ?
28Tactics for Organized Care Consensus approach for standards of clinical managementDisplay of standard of care is effective for providers & patientsSigns for patient to remind clinician for flu shot, foot exam, labsPre-visit labs for HgbA1c, lipids, renal monitoring (proteinuria and creatinine)
29Tactics for Organized Care Checklist on entering room:Last labs:HgbA1CCreatinineLDL cholesterolLFT’s (if on statin)Urine MicroalbuminVaccinesPneumovaxFluvaxExamsEye (date)FeetDentalGyn
30Tactics for Organized Care Low threshold for performing clinical tasks:Flow-sheets for reminders, results, logging prior interventionsFlags on charts for missing interventionsStickers / stamps for check-listsStanding orders to decompress physician demands
31Tactics for Organized Care Full utilization of a Diabetic Team, includingPharmacistNursingDM educatorNutritionist, DieticianExercise coach/therapistPodiatristEye specialistFamily
32Important & New Changes HgbA1C as diagnostic tool, DM & pre-DMGlyburide dismissedMetformin limitationsTreating diabetics with HgbA1C < 7.0