1. INSULIN PUMP THERAPY 2011

2. HISTORY OF DIABETES ► 1550 BC first described in an Egyptian manuscript as “the passing of too much urine”. ► 2 nd Century Greek Physician Aretaeus first used the word Diabetes derived from the Greek meaning “siphon” or “to go through” referring to urinary frequency. ► 17 th Century English Anatomist and Physician first used the word Mellitus from the Latin meaning “honey”. ► 1921-1923 insulin was discovered by Fredrick Banting and Charles Best (Macleod and Collip).

3. DIABETES TODAY ► Worldwide 346 million people with DM. ► >80% DM deaths occur in low and middle income countries. ► Diabetes affects ~27million people in the U.S. or 8.7% of the population. ► Leading cause of renal failure, new cases of blindness, non-traumatic amputations in adults, and one of the major contributing factors of heart disease and strokes. ► In 2010 it is estimated that health spending associated with diabetes and prediabetes is about 194 billion dollars. The cost is projected to rise to 500 billion dollars by 2020. ► CDC projects that by 2050, up to 1 in 3 Americans may have DM.

4. DIABETES TODAY ► In 2010, there were approximately 5800 board certified endocrinologists in the U.S. of which an estimated 2000 of those were involved in research or academics. ► The number of endocrinology fellowships have decreased from 140 in 1987 to 122 in 2010. ► DIABETES IS TRULY A PRIMARY CARE PROBLEM!!!!

5. Diagnosed and undiagnosed diabetes among people aged 20 years or older in the U.S. in 2010 Group Number and percentage Age 20 or greater 25.6 million or 11.3% Age 65 or greater 10.9 million or 26.9% Men age 20 or greater 13 million or 11.8% Women age 20 or greater 12.6 million or 10.8% Non-Hispanic Whites 15.7 million or 10.2% Non-Hispanic Blacks 4.9 million or 18.7%

6. Estimated percentage of people age 20 or older with diagnosed and undiagnosed diabetes by age group in the U.S. 2005-2008 ► 2011 National Diabetes Fact Sheet. CDC.

7. Estimated number of new cases of diagnosed diabetes among people aged 20 or older in the U.S. 2010 ► 2011 National Diabetes Fact Sheet. CDC.

8. Rate of new cases of type 1 and type 2 diabetes among youth aged < 20 years, by race/ethnicity U.S. 2002-2005 NHW = non-Hispanic whites; NHB = non-Hispanic blacks; H = Hispanics; API = Asians/Pacific Islanders; AI = American Indians ► 2011 National Diabetes Fact Sheet. CDC.

9. Treatment of diabetes in the U.S. 2007-2009 ► 2011 National Diabetes Fact Sheet. CDC.

10. HISTORY OF INSULIN PUMPS ► First introduced in the 1960’s by a Los Angeles Physician by the name of Dr. Arnold Kadish.

11. 1974 ► First non-portable computer controlled insulin pump.

12. 1978 ► First commercially available portable insulin pump called the Autosyringe “Big Blue Brick”.

13. 1983 ► Medtronic releases the first small programmable insulin pump into the market.

14. INSULIN PUMPS TODAY ► ACCU-CHEK SPIRIT – ROCHE ► AMIGO – NIPRO CORPORATION ► DANA DIABECARE 11S – SOAIL DEVELOPMENT ► MINIMED PARADIGM REVEL – MEDTRONIC ► OMNIPOD – INSULET CORPORATION ► ONE TOUCH PING – ANIMAS CORPORATION

15. INDICATIONS FOR INSULIN PUMP THERAPY ► INTERMITTENT INSULIN INJECTIONS ARE NOT MEETING TREATMENT GOALS AND OUTCOME MEASURES ARE SUBOPTIMAL, INCLUDING BUT NOT LIMITED TO: 1. Frequent and unpredictable fluctuations in blood glucose levels. 2. Patient perception that diabetes management impedes the pursuit of personal or professional goals. 3. A1C >7.0-7.5%, accompanied by frequent severe hypoglycemia ( 7.0-7.5%, accompanied by frequent severe hypoglycemia (<55mg/dl). 4. Hypoglycemic events requiring third-party assistance or interfering with work, school, or family obligations. ► 2009 The American Association of Diabetes Educators.

16. INDICATIONS FOR INSULIN PUMP THERAPY ► RECURRENT HYPOGLYCEMIA, NOCTURNAL HYPOGLYCEMIA, ACTIVITY-INDUCED HYPOGLYCEMIA AND HYPOGLYCEMIC UNAWARENESS. ► PREGNANCY ► RECURRENT DIABETIC KETOACIDOSIS ► DAWN PHENOMENON ► GASTROPARESIS ► PATIENT PREFERENCE, MEAL-TIMING FLEXIBILITY AND NORMALIZTION OF LIFESTYLE

17. INSULINS USED IN PUMP THERAPY ► HUMALOG ► NOVOLOG ► APIDRA ► HUMULIN U-500?

18. KEY CONCEPTS ► BASAL INFUSION – PROVIDES CONTINUOUS INSULIN INFUSION TO MIMIC THE PANCREAS IN THE FASTING STATE. ► CARBOHYDRATE RATIO OR MEAL BOLUS – THE NUMBER OF CARBOHYDRATE GRAMS COVERED BY 1 UNIT OF INSULIN. ► INSULIN SENSITIVITY FACTOR – THE BLOOD GLUCOSE (mg/dl) THAT IS LOWERED BY ONE UNIT OF INSULIN.

19. STARTING INSULIN PUMP THERAPY ► CALCULATE THE TOTAL DAILY DOSE (TDD) INSULIN AND REDUCE THIS BY 10%. FOR EXAMPLE – 60 KG FEMALE ON 30 UNITS OF RAPID ACTING INSULIN (10U TID WITH MEALS) AND 30 UNITS OF LONG ACTING INSULIN AT BEDTIME. FOR EXAMPLE – 60 KG FEMALE ON 30 UNITS OF RAPID ACTING INSULIN (10U TID WITH MEALS) AND 30 UNITS OF LONG ACTING INSULIN AT BEDTIME. TOTAL DAILY INSULIN 60 UNITS SUBTRACT 10% = 54 UNITS TDD TOTAL DAILY INSULIN 60 UNITS SUBTRACT 10% = 54 UNITS TDD

20. BASAL RATE 1. TAKE TDD AND DIVIDE BY 2. 54 UNITS/2 = 27 UNITS/DAY 54 UNITS/2 = 27 UNITS/DAY 2. DIVIDE THE TOTAL BASAL REQUIREMENT BY 24 HOURS. 27/24 = ~1.15 UNITS/HR. 27/24 = ~1.15 UNITS/HR.

21. CARBOHYDRATE RATIO – 450 RULE ► 450 DIVIDE BY THE TDD 450/54 = ~8 THEREFORE 1 UNIT INSULIN FOR EVERY 8 GRAMS CARBS. 450/54 = ~8 THEREFORE 1 UNIT INSULIN FOR EVERY 8 GRAMS CARBS.

22. INSULIN SENSITIVITY FACTOR – 1700 RULE ► 1700 DIVIDE BY THE TDD 1700/54 = ~30 THEREFORE ONE UNIT OF INSULIN LOWERS THE BLOOD GLUCOSE BY 1700/54 = ~30 THEREFORE ONE UNIT OF INSULIN LOWERS THE BLOOD GLUCOSE BY 30mg/dl. 30mg/dl.

23. INSULIN PUMP SETTINGS ► BASAL INSULIN 0000 AT 1.15 UNITS/HR. 0000 AT 1.15 UNITS/HR. ► CARB RATIO 0000 AT 8. 0000 AT 8. ► INSULIN SENSITIVITY 0000 AT 30. 0000 AT 30. ► BLOOD GLUCOSE TARGET 90-120mg/dl. 90-120mg/dl. ► ACTIVE INSULIN TIME 3HRS. 3HRS.

24. INFUSION SETS

25. INFUSION SITES

26. Pump Size and weightBatteryReservoir Infusion set Basal range Bolus range Food database Interacts with meter? Interacts with CGMS? Details ACCU-CHEK SPIRIT - Roche 3.2X2.2X0.8inches 4oz with battery, full reservoir, and infusion set (1) AA 315 unit cartridge Compatible with all standard Luer-lock connectors From 0.1 to 25 units per hour in 0.1 unit increments 0.1 to 25 units in increments of 0.1, 0.2, 0.5, 1, and 2 units. Extended or multiwave 0.1 Yes. Database includes over 900 preloaded common foods and stores 1200 NoNo Display can flip 180 degrees for easy reading. Package includes a backup pump AMIGO – Nipro Corp. 3.28x2.18x 0.93 inches 4oz with battery and full reservoir (1) CR2 3 volt lithium 200 unit reservoir Unomedical comfort only 0-30 units/hr in 0.05 unit increments Bolus increments of.05units to 30 units NoNoNo Pump casing is shatter and waterproof. 6 colors available DANADIABECARE IIS – Sooil Development. 2.95x1.77x0. 75 inches 1.8 oz without battery (1) 3.6 volt DC lithium 300 unit cartridge Compatible with Sooll infusion sets only From 0.01 to 16 units per hour in 0.1 unit increments 0.1 to 10 units in 0.1 unit increments. From 10 to 87 units in 1 unit increments NoNoNo Menu uses icons instead of words. Available in 5 colors MINIMED REVEL – Medtronic Diabetes Model 523: 2x3x0.8 in. 3.53 oz Model 723: 2x3.6x0.8 inches 3.81 oz with battery and full reservoir (1) AAA Model 523: 176 unit reservoir Model 723: 176 or 300 unit reservoir Compatible with Medtronic infusion sets as well as sets from select brands From 0.025 to 35 units per hour in 0.025 unit increments 0.025 to 25 units. Increments of 0.025 units up to 0.975 units. Increments of 0.05 units for amounts larger than 0.975 units No Yes. The One Touch Ultralink meter wirelessly sends test results to the pump Yes. The Real Time Revel is a combination pump and CGM The Real Time Revel uses a sensor to wirelessly transmit continuous glucose readings to the pump OMNIPOD – Insulet Corp. Pod: 1.6x2.4x0.7 inches 1.2oz with full reservoir PDM: 2.5x4.5x1 inch and 4.4oz Pod: Battery integrated PDM: (2) AAA Pod includes built in reservoir that holds 200 units Does not use tubing. Pod comes with a built in infusion set, cannula, and automated inserter From 0.05 to 30 units per hour in 0.05 unit increments 0.05 to 30 units in increments of 0.05, 0.1, 0.5, or 1 unit Yes. PDM contains more than 1,000 common foods and their nutrition information Yes. A FreeStyle blood glucose meter is built into the PDM No No tubing required. Pod is used for 72 hours than discarded. Waterproof up to 8 feet deep. ONE TOUCH PING – Animas Corp. Pump: 2x3.25x0.85 inches. 3.9oz Meter: 3.8x2.46x1.1 2 inches and 3.88oz Pump (1) 1.5 volt lithium AA or (1) AA Meter: (2) AAA 200 unit cartridge Compatible with all standard, Luer-lock connectors From 0.025 to 25 units per hour in 0.025 unit increments 0.05 to 35 units in 0.05 unit increments Yes. Meter remote stores up to 500 foods and their nutrition information Yes. Meter remote sends results wirelessly to pump No Both meter remote and pump are fully functional. Waterproof up to 12 feet

27. References 1. Centers for Disease Control – 2011 National Diabetes Fact Sheet. 2. American Diabetes Association. Standards of Medical Care in Diabetes – 2011. Diabetes Care, Volume 34, Supplement 1, January 2011. 3. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Copyright AACE 2011. Endocrine Practice Volume 17, Supplement 2, March/April 2011. 4. American Association of Diabetes Educators Position Statement – Continuous Subcutaneous Insulin Therapy Using a Pump. AADE 2011. 5. American Association of Diabetes Educators – The Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes Educators. AADE 2011. 6. Diabetes Control and Complications Trial Research Group. The effectiveness of intensive treatment of diabetes on the development and progression of long term complications in insulin dependent diabetes mellitus. New England Journal of Medicine. 1993;329:977-986. 7. Wainstein J, Metzger M, Boaz M, Minuchin O, Cohen Y, Yaffe A, et al. Insulin pump therapy versus multiple daily injections in obese type 2 diabetic patients. Diabetes Medicine. 2005;22:1037-1046. 8. Pickup JC, Sutton AJ. Severe hypoglycemia and glycaemic control in type 1 diabetes: Meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabetes Medicine. 2008;25:765-774. 9. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of Sensor-Augmented Insulin Pump Therapy in Type 1 Diabetes. New England Journal of Medicine. 2010;363:311-320. 10. Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. New England Journal of Medicine. 2005;22:2643-2653. 11. Hoogma RP, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion and NPH-based multiple daily insulin injections on glycaemic control and quality of life: results of the 5 – nations trial. Diabetes Medicine. 2006;23:141-147. 12. Philip M, Batelino T, Rodriguez H, Danne T, Kaufman F, Consensus Forum Participants. Use of insulin pump therapy in pediatric age group. Diabetes Care. 2007:30:1653- 1662. 13. United Healthcare Medical Policy. Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes. Copyright 2011. 14. United Health – Center for health reform and modernization. November 2010. 15. Diabetes Forecast January 2011. 16. American Association of Diabetes Educators 2008 Consensus Summit. Insulin Pump Therapy. 17. Pumping Protocol by Bruce Bode M.D. 2008 Medtronic Minimed, Inc. 18. Animas Corporation. 19. Insulet Corporation. 20. Sooil Development. 21. Roche Insulin Delivery Systems. 22. Nipro Corporation. 23. Consultant. Diabetes and Prediabetes. Edward J. Shahady M.D. August 2011. Volume 51. Number 8. 24. Rizza RA, et al. Diabetes Care. 2003:26(5): 1545-1552. 25. Stewart AF. Journal of Clinical Endocrinology and Metabolism. 2008:93: 1164-1166.