2008 Age-Adjusted Estimates of the % Obese Adults in PA

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1 Outline The Sugar Fix : Practical Approaches to Blood Glucose Management in Diabetes Monica DiNardo, RN, APNP, BC, CDE VA Pittsburgh Health Care System, University of Pittsburgh School of Nursing PhD Program Overview and goals Pharmacologic therapies Oral medications Insulin Incretins Insulin Delivery System Technologies Case discussions 2008 Age-Adjusted Estimates of %Adults with Diagnosed Diabetes in Pennsylvania % Source: National Health and Nutrition Examination Survey. Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: Retrieved 7/31/ Age-Adjusted Estimates of the % Obese Adults in PA The State of Diabetes 2011 Positives Scientific advances Better understanding of disease state New therapies Improved monitoring devices/technology Evidence that Diabetes Education is effective BMI>30 kg/m 2 Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: Retrieved 7/31/

2 State of Diabetes 2011 Goals Negatives Increased prevalence/ mortality Increased costs Sub-optimal quality of care Insufficient diabetes education/ nutrition programs Poor access to specialists Lack of attention to psychological needs Limited time with providers Prevention of Diabetes Lifestyle and nutrition counseling Weight control Identification of new cases through screening Prevention of Complications Blood glucose control Blood pressure control Lipid control Preconception Counseling and peri-natal screening Glucose Priorities of Care for Adults with Diabetes Lipids Diagnosis -Prevention Dx Fasting glucose > 126 Casual > Symptoms Prevent (IFG -IGT) & Metabolic Syndrome Diabetes Self-Management Skills Lifestyle Behavioral Health Patient Education BG Monitoring Medical Nutrition Physical Activity History and Physical Exam Hypertension Emotional assessment distress, depression, complications Support needs family, peers, medical Microvascular Complications Other Essentials of Care Classifications of Diabetes Mellitus Type 1 diabetes: 5% to 10% of cases Immune-mediated beta-cell destruction leading to absolute insulin deficiency Emphasis on hypoglycemia prevention Prevention of DKA Ongoing education and support/skill building Endocrinologist Care Hemoglobin A1C Target < % SMBG Pre mg/dl Post <160 mg/dl (~ 50% of readings) Macrovascular Complications ASA, Tobacco, ACEI/ARB, Statin Annual Lipid Profile LDL < 100 HDL > 40 Trigs < 150 DM + CVD LDL < 70 Blood Pressure (every visit) Dx and Rx = 130/80 Annual Screening Nephropathy Microalbumin Screening Calculated GFR Retinopathy Dilated retinal exam Neuropathy Neuro and Foot exam Sexual Heath Hospital Care Gestational DM Foot Care Dental Care Immunizations Type 2 diabetes: 90% to 95% of cases Insulin resistance Insulin deficiency Hallmark is central obesity 2004 International Diabetes Center. All rights reserved. Other Classifications Principles of Metabolic Control Gestational diabetes mellitus (GDM) ~4% of pregnant women Impaired glucose homeostasis Impaired fasting glucose (IFG): FPG >100 and <126 mg/dl Impaired glucose tolerance (IGT): 2 hr OGT PG >140 and <200 mg/dl 79 million people in US > age 20yrs Defined target goals Medical nutrition therapy/physical activity Blood glucose monitoring Diabetes education Physiologic basal bolus insulin replacement (Type 1) Stepwise and combined pharmacologic therapies (Type 2) Oral medications and other Insulin 2

3 Diagnostic Criteria for Diabetes Guidelines for Glycemic Control Stage of Glycemia FPG (mg/dl) OGTT (mg/dl) Normal <100 <140 IFG or IGT >100 and <126 >140 and <200 Casual PG (mg/dl) Diabetes >126 >200 >200 plus symptoms Non-pregnant adults A1C (%) Preprandial plasma glucose (mg/dl) Peak postprandial plasma glucose (mg/dl) GOALS SHOULD BE INDIVIDUALIZED Goal < <180 Diabetes Care 1. ADA. Diabetes Care. 2004;26(suppl 1):S33-S European Diabetes Policy Group. Diabet Med. 1999;16: American College of Endocrinology/AACE. Endocr Pract. 2002;8(suppl 1): DCCT: Diabetic Complication Event Rates dence (%) Cumulative Incid % Risk Reduction % Risk Reduction % Risk Reduction % Risk Reduction 5.1 Retinopathy Laser Rx 1 Microalbuminuria Albuminuria 2 Progression % Risk Reduction Conventional Intensive Clinical Neuropathy 3 1. DCCT Research Group. Ophthalmology. 1995;102: DCCT Research Group. Kidney Int. 1995;47: DCCT Research Group. Ann Intern Med. 1995;122: Microvascular Complications: Risk Reduction per 1% Decrease in A1C Stages of Type 2 Diabetes 100 Study Retinopathy Nephropathy Neuropathy DCCT 27-38% 22-28% 29-35% Kumamoto 28% 50% NCV UKPDS 19% 26% 18% NCV = Nerve Conduction Velocity Davidson JA. Endocr Pract. 2002;8(suppl 1): Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993;329: Ohkubo Y, et al. Diabetes Res Clin Pract. 1995;28: UK Prospective Diabetes Study Group. Lancet. 1998;352: Type 2 Diabetes 25 Phase III Type 2 Type 2 Postprandial IGT Diabetes Diabetes Hyperglycemia Phase I Phase II Years From Diagnosis Reprinted with permission from Lebovitz H. Diabetes Reviews. 1999;7:

4 Natural History of Type 2 Diabetes Progressive Insulin Deficiency Glycated Hemoglobin or HbA1c Glucose (mg/dl) Relative Function (%) Obesity IFG Diabetes Postmeal Glucose Uncontrolled Hyperglycemia Fasting Glucose Insulin Resistance β-cell Function HbA1c % Average Blood Glucose mg/dl Years of Diabetes 2000 International Diabetes Center, Minneapolis, Minnesota. PACE Diabetes Nathan D: N Engl J Med 310: , 1984 Why Are Patients Not Meeting Targets? Type 2 diabetes has a progressive decline in β-cell function Most patients will need insulin to reach glucose targets Long lapse between treatment failure and therapy advancement Insulin initiated at mean A1C of 10.4% 1 True for both specialists and primary care physicians Reluctance on the part of patients and healthcare providers to advance to injectable medications 2 1. Bergenstal RM et al. In: DeGroot LJ, Jameson JL, eds. Endocrinology. 4th ed. Philadelphia: WB Saunders; 2001: Buse JB. Diabetes Care. 1999;22(suppl 3):C65-C Korytkowski M. Int J Obes. 2002;26(suppl 3):S18-S Shah BR et al. Diabetes Care. 2005;28: Source: National Health Interview Survey. Post-prandial Glucose Contributes to Nearly 50% of Overall A1C When A1C Is 8.4 or Below bution % Contrib A1C Goal: Increasing Contribution of PPG as A1C Improves A1C Range (%) Adapted from Monnier L, et al. Diabetes Care. 2003;26: Correcting Fasting Hyperglycemia Is Usually the First Task when A1C is > 8.5% g/dl) PG (m Uncontrolled A1C ~9% Normal A1C 5% 6% Controlled A1C <7% Time of Day A1C ~6% then, Tackle Postprandial Hyperglycemia if A1C still >7%! Adapted with permission from Cefalu WT. In: Leahy JL, Cefalu WT, eds. Insulin Therapy. New York: Marcel Dekker; 2002:

5 Combination Therapy Combination therapies for the treatment of T2DM have been proven in many instances to be more effective than treatment with a single agent The combination of insulin plus metformin and insulin plus a TZD are particularly effective means of lowering glycemia. 1 Dipeptidyl peptidase IV inhibitors and sulfonylurea is more beneficial than sulfonylureas alone 2 1. Nathan DM, et al. Diabetes Care. 2006;29: Takasaki K, et al. J Pharmacol Sci. 2004;95: Pancreas Causes of Hyperglycemia in Type 2 Diabetes Beta-cell Function Islet Beta-cell Degranulation; Insulin Released in Response to Elevated Plasma Glucose Physiologic Plasma Insulin Glucose Output Hyperglycemia Liver Insulin Sensitivity Glucose Production Plasma FFA Glucose Uptake Muscle Glucose Transport Lipolysis Adipose Tissue Pancreatic Islets Established Antihyperglycemic Agents Major Sites of Action ß cell Insulin / Amylin Glucagon Somatostatin Delta Agent Insulin Glitazones Metformin Site of Action Major Mode of Action Peripheral tissue Allow uptake and utilization of glucose Peripheral tissue Improve insulin sensitivity Liver Decrease hepatic glucose output Primary Glucose Lowering Effect Fasting or postprandial Fasting Fasting Pancreatic polypeptide Sulfonylureas Pancreas Stimulate insulin release from β-cells Fasting Meglitinides Pancreas Stimulate insulin release from β-cells Postprandial α-glucosidase inhibitors GI tract Delay absorption of carbohydrates Postprandial Oral Antihyperglycemic Monotherapy Maximum Therapeutic Effect on A1C A word about metformin Nateglinide Acarbose Repaglinide Rosiglitazone Pioglitazone Glimepiride Glipizide GITS Metformin Reduction in A1C (%) Food and Drug Administration prescribing guidelines for metformin contraindicate its use in men and women with serum creatinine concentrations >1.5 and >1.4 mg/dl, respectively. Most healthcare providers in the USA do not use metformin if egfr < 60 ml/min. Diabetes Care. 2000;23: ; Precose (acarbose) package insert; Drugs. 1995;50: ; J Clin Endocrinol Metab. 2001;86: ; Diabetes Care. 2000;23: ; Diabetes Care. 1996; 19: ; Diabetes Care. 1997;20: ; Am J Med. 1997;102:

6 Recommendations for use of metformin based on egfr Adverse Effects and Limitations of Current Agents for Type 2 Diabetes Based on recommendations from National Institute for Health and Clinical Excellence Guidelines United Kingdom, Canadian Diabetes Association and Australian Diabetes Society Lipska et all. Diabetes Care 34: 1431, 2011 Hypoglycemia CV GI Lactic Acidosis Weight Gain Edema Safety (special pops*) Poor responder rates Lack of durability of effect Sulfonylureas Repaglinide Nateglinide Metformin inhibitors α-glucosidase TZDs Insulin GLP-1 agonists Pramlintide * Special populations= elderly, renal-impaired and CHF patients Efficacy of Oral Antihyperglycemics Declines With Time GLP-1 Modes of Action in Humans A1C rises at ~0.2% to 0.3% yearly on stable therapy This rate is the same as for diet alone, sulfonylureas, and metformin β-cell function declines at the same rate with all these treatments Combination treatments are routinely needed Future direction: β-cell preservation therapies UKPDS Group. Diabetes. 1995;44: ; Turner RC et al. JAMA. 1999;281: Upon ingestion of food GLP-1 is secreted from the L-cells in the intestine Long term effects observed in animals Improves β-cell efficiency and increases β-cell mass This in turn Stimulates glucose-dependent insulin secretion Suppresses glucagon secretion Slows gastric emptying Reduces food intake Drucker DJ. Curr Pharm Des. 2001; 7: Drucker DJ. Mol Endocrinol. 2003; 17: GLP-1 Secretion and Metabolism DPP-IV Inhibitors Mixed meal Intestinal GLP-1 release GLP-1 1(736) (7-36) active Plasma DPP-IV GLP-1 actions X Rapid inactivation (>80% of pool) GLP-1 (9-36) inactive Renal clearance The Potential for GLP-1 Agonists and Other Gut Hormones Limitations of native or mimetic GLP-1 as therapy Rapidly degraded by DPP-IV in minutes Requires continuous subcutaneous injection Alternative approaches Modification of molecule to prolong time of action- GLP-1 Agonists Agents to limit DPP-IV activity-dpp IV Inhibitors For Whom? A patient whose diabetes is not controlled by oral therapy with metformin, a sulfonylurea, or combination of the two Initial therapy when weight loss is desired and use of metformin is not appropriate Kieffer TJ, Habener JF. Endocr Rev. 1999;20: Deacon CF et al. Diabetes. 1995;44: Kieffer TJ, Habener JF. Endocr Rev. 1999;20:

7 Difference in GLP-1 Activation vs DPP-IV Inhibition Summary of Incretin Therapies Enhance insulin secretion GLP-1 DPP-IV Inhibition Reduce glucagons Agent Exenatide Administration A1C Reduction Weight Change Incretin Mimetics: GLP-1 Agonists Twice daily Up to -0.86% injection Main Adverse Effect Nausea Nausea/Vomiting +++ No Liraglutide Once daily injection Up to -0.75% Nausea Weight loss ++ No Administration Injectable Oral Inflammation, allergic reactions No? Vildagliptin Sitagliptin Saxagliptin Incretin Enhancers: DPP-IV Inhibitors Oral Oral Oral Up to 0.6% Up to 0.8% Up to 0.8% GLP-1: glucagon-like peptide-1 n (pol/l) Amylin the Hormone: Deficient in Diabetes Co-located and co-secreted with insulin from pancreatic β-cells Plasma Amylin Normal Type 2 Diabetes Type 1 Diabetes 10 Meal Type 1 (n=190). Healthy subjects (n=27). Type 2 taking insulin (n=12). Kruger DF et al. Diabetes Educ. 1999;25: Time After Sustacal Meal (min) Pramlintide Is a synthetic analogue of human amylin Use in Type 1 and Type 2 Improves glucose control in postprandial period Is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia y (particularly in patients with type 1 diabetes) Reduces weight independently of nausea (increased satiety 50% reduction of mealtime insulin Frequent blood glucose monitoring Pramlintide Doses/Vial Physiologic Insulin Profile Type 2 1 vial = 25 doses of 120 µg 500 units/vial 20 units = µg 2 times/day = 3 vials/month 120 µg 3 times/day = 4 vials/month Type 1 1 vial = 50 doses of 60 µg 500 units/vial 10 units = µg 3 times/day = 2 vials/month 30 µg 3 times/day = 1 vial/month Dose (µg) Units Plasma insulin (mg/dl) Breakfast Lunch Dinner :00 8:00 12:00 16:00 20:00 24:00 4:00 Time 8:00 Symlin [package insert]. San Diego, Calif: Amylin Pharmaceuticals Inc.;

8 Basal-Bolus Insulin Therapy Insulin Effec ct Breakfast Lunch Dinner Bedtime Indications for Insulin Type 1 diabetes Type 2 - disease progression May use insulin as initial treatment any time; especially if symptomatic or FPG > 200 mg/dl and HbA 1c > 10% May use insulin alone or in combination if OAD s do not achieve target Gestational diabetes Acute illness, surgery, hospitalization, DKA, hyperosmolar state Aspart (NovoLOG) Glargine (Lantus) Medical Management of Type 2 Diabetes. American Diabetes Association, Fourth Edition, 1998, pp Leahy JL. Insulin Therapy. Marcel Dekker Inc; 2002: Class Human insulins Insulin analogues Insulin Preparations Agents Regular, NPH, U-500 Regular Aspart, lispro, apidra, glargine, detemir Premixed insulins Human 70/30, 50/50 Humalog mix 75/25 Novolog mix 70/30 Plasma insulin levels Insulin Action Profiles Aspart, lispro 4 6 hours Regular 6 8 hours NPH hours Detemir hours Glargine 24 hours Hours Human Insulins and Analogues Typical Times of Action Insulin Therapy Regimens Insulin Onset of Duration of Preparations Action Peak Action Lispro/aspart/apidra ~15 minutes 1 2 hours 4 6 hours Human regular minutes 2 4 hours 6 8 hours Human NPH 2 4 hours 4 10 hours hours Determir 2-4 hours nearly flat hours dose dependent Glargine 2 4 hours Flat ~24 hours No typical dose! Dosing schedules vary from once daily to Multiple Daily Injections (MDI) Insulin Pen or Insulin Pump AADE Core Curriculum, Third Edition, 1998, pp

9 Intensive Insulin Therapy Education should include Assessment of management skills and level of knowledge Intensive training on hypoglycemia awareness, prevention and treatment SMBG testing and pattern management Advanced insulin dosage adjustment training Professional help for emotional and motivational counseling Insulin Adjustment Considerations Insulin variables Type, dose Insulin action peak, duration Timing Delivery method Food intake Type, composition, quantity, timing Physical activity Proactive insulin or food adjustment Typical Multiple-Injection Regimens Three SMBG-adjusted pre-meal injections of a rapid acting insulin analog (aspart, humalog or apidra) insulin plus glargine taken at bedtime Three injection regimen: pre-breakfast N and R, presupper R and bedtime N 70/30 insulin with meals bid and bedtime N Timing of insulin with meals is crucial! Starting Insulin: Calculating total dialy dose (TDD) To Calculate: TDD= 0.2 to 0.5 units per pound of body weight 0.4 units/kg/day with poorly controlled or new T2D 0.2 units/kg/day for T1D ½ TDD given as basal; ½ TDD divided between 3 meals for basal-bolus regime 2/3 TDD given in AM and ½ TDD in PM for premixed insulin (if using N and R- 2/3 of AM and PM dosse is given as N and ½ as R) David M. Nathan, M.D. N Engl J Med 2002; 347: October 24, 2002 Start-up Insulin Dosing Examples in T2D Body weight TDD 200 lbs (90 kg) 45 units Examples: Glargine 23 units at HS and 7 unit aspart TID AC OR 70/30 30 units q AM and 15 units q PM AC Bk and Supper OR NPH 20 units plus 10 units R in AM and 10 units N plus 5 units R AC supper Treat to Target with basal insulin analogue plus OAD Add 10 units at HS Increase by 2-3 units every 3 days until FBS is at goal May need to add pre-meal insulin at largest meal Yki-Järvinen, Diabetes Care June : ; published ahead of print March 23, 2007, doi: /dc

10 Correctional insulin: When sliding scale isn t really sliding scale SMBG Short acting Insulin Injection < 50 decrease 2-3 units after treating with 15gm CHO decrease 1-2 Units base dose increase 1 Units Increase 2 Units Increase 3 Units Insulin Storage and Disposal Avoid heat, light and freezing Store unopened products in the refrigerator Insulin in use can be kept at room temperature; store back-up in refrigerator Discard vial after 28 days Check product for expiration date and appearance Follow local EPA guidelines Drugs That Alter Diabetes Control Drug-Induced Hypoglycemia: Alcohol inhibits gluconeogenesis Beta-adrenergic receptor antagonists (Beta-blockers) inhibit the effects of catecholamines on gluconeogenesis and glycogenolysis Quinalone antibiotics Drug Induced Hyperglycemia: Epinephrine Glucocorticoids Oral contraceptives Phenytoin and clonidine Thiazides Insulin pens Faster and easier than syringes Improve patient attitude and adherence Have accurate dosing mechanisms Visual impairments Tremor Cost effective in lower doses: contains 300 units Education and pen needles Insulin Injection Devices Insulin Pumps Continuous subcutaneous insulin infusion (CSII) External, programmable pump connected to an indwelling subcutaneous catheter to deliver rapid-acting insulin Smart pump features Appropriate patient selection Continuous Subcutaneous Insulin Infusion (CSII) Therapy Initiated and monitored by specialist trained in pump therapy on an outpatient basis SMBG > 4 times a day Catheter change infusion set q 2-3 days Pre-programmed Continuous flow of rapid acting insulin provides basal insulin Sample dosage: TDD based on weight basal 50% premeal 16% 12% 16% prebedtime snack bolus 6% 10

11 Continuous Glucose Monitoring Systems (CGMS) Conference Evaluation Alerts uncontrolled hyper or hypoglycemia (hypoglycemia unawareness) Improves BG control even for people with A1c below 7% Used to tweak insulin pump settings Future implications Online evaluations at: 11

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