INSULIN PUMP THERAPY 2012. DIABETES TODAY ► Worldwide 366 million people with DM. ► >80% DM deaths occur in low and middle income countries. ► Leading.

INSULIN PUMP THERAPY INSULIN PUMP THERAPY 20122012

DIABETES TODAYDIABETES TODAY

► Worldwide 366 million people with DM.Worldwide 366 million people with DM.► >80% DM deaths occur in low and middle income >80% DM deaths occur in low and middle income

countries.countries.► Leading cause of renal failure, new cases of Leading cause of renal failure, new cases of

blindness, non-traumatic amputations in adults, and blindness, non-traumatic amputations in adults, and one of the major contributing factors of heart one of the major contributing factors of heart disease and strokes.disease and strokes.

► In 2010 it is estimated that health spending In 2010 it is estimated that health spending associated with diabetes and prediabetes is about associated with diabetes and prediabetes is about 194 billion dollars. The cost is projected to rise to 194 billion dollars. The cost is projected to rise to 500 billion dollars by 2020.500 billion dollars by 2020.

► CDC projects that by 2050, up to 1 in 3 Americans CDC projects that by 2050, up to 1 in 3 Americans may have DM.may have DM.

DIABETES TODAYDIABETES TODAY

► In 2010, there were approximately 5800 board certified In 2010, there were approximately 5800 board certified endocrinologists in the U.S. of which an estimated 2000 endocrinologists in the U.S. of which an estimated 2000 of those were involved in research or academics.of those were involved in research or academics.

► The number of endocrinology fellowships have The number of endocrinology fellowships have decreased from 140 in 1987 to 122 in 2010.decreased from 140 in 1987 to 122 in 2010.

►DIABETES IS TRULY A DIABETES IS TRULY A PRIMARY CARE PRIMARY CARE PROBLEM!!!!PROBLEM!!!!

HISTORY OF INSULIN PUMPSHISTORY OF INSULIN PUMPS

► First introduced in the 1960’s by a Los Angeles Physician by the First introduced in the 1960’s by a Los Angeles Physician by the name of Dr. Arnold Kadish.name of Dr. Arnold Kadish.

19741974

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

19781978

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

19831983

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

INSULIN PUMPS TODAYINSULIN PUMPS TODAY► ACCU-CHEK SPIRIT – ROCHEACCU-CHEK SPIRIT – ROCHE

► AMIGO – NIPRO CORPORATIONAMIGO – NIPRO CORPORATION

► DANA DIABECARE 11S – SOAIL DEVELOPMENTDANA DIABECARE 11S – SOAIL DEVELOPMENT

► MINIMED PARADIGM REVEL – MEDTRONICMINIMED PARADIGM REVEL – MEDTRONIC

► OMNIPOD – INSULET CORPORATIONOMNIPOD – INSULET CORPORATION

► ONE TOUCH PING – ANIMAS CORPORATIONONE TOUCH PING – ANIMAS CORPORATION

INDICATIONS FOR INSULIN PUMP INDICATIONS FOR INSULIN PUMP THERAPYTHERAPY

► INTERMITTENT INSULIN INJECTIONS ARE NOT INTERMITTENT INSULIN INJECTIONS ARE NOT MEETING TREATMENT GOALS AND OUTCOME MEETING TREATMENT GOALS AND OUTCOME MEASURES ARE SUBOPTIMAL, INCLUDING BUT NOT MEASURES ARE SUBOPTIMAL, INCLUDING BUT NOT LIMITED TO:LIMITED TO:

1.1. Frequent and unpredictable fluctuations in blood Frequent and unpredictable fluctuations in blood glucose levels.glucose levels.

2.2. Patient perception that diabetes management Patient perception that diabetes management impedes the pursuit of personal or professional impedes the pursuit of personal or professional goals.goals.

3.3. A1C >7.0-7.5%, accompanied by frequent severe A1C >7.0-7.5%, accompanied by frequent severe hypoglycemia (<55mg/dl).hypoglycemia (<55mg/dl).

4.4. Hypoglycemic events requiring third-party assistance Hypoglycemic events requiring third-party assistance or interfering with work, school, or family obligations.or interfering with work, school, or family obligations.

► 2009 The American Association of Diabetes Educators.2009 The American Association of Diabetes Educators.

INDICATIONS FOR INSULIN PUMP INDICATIONS FOR INSULIN PUMP THERAPYTHERAPY

► RECURRENT HYPOGLYCEMIA, NOCTURNAL RECURRENT HYPOGLYCEMIA, NOCTURNAL HYPOGLYCEMIA, ACTIVITY-INDUCED HYPOGLYCEMIA, ACTIVITY-INDUCED HYPOGLYCEMIA AND HYPOGLYCEMIC HYPOGLYCEMIA AND HYPOGLYCEMIC UNAWARENESS.UNAWARENESS.

► PREGNANCY PREGNANCY ► RECURRENT DIABETIC KETOACIDOSISRECURRENT DIABETIC KETOACIDOSIS► DAWN PHENOMENONDAWN PHENOMENON► GASTROPARESISGASTROPARESIS► PATIENT PREFERENCE, MEAL-TIMING PATIENT PREFERENCE, MEAL-TIMING

FLEXIBILITY AND NORMALIZTION OF FLEXIBILITY AND NORMALIZTION OF LIFESTYLELIFESTYLE

INSULINS USED IN PUMP INSULINS USED IN PUMP THERAPYTHERAPY

►HUMALOGHUMALOG►NOVOLOGNOVOLOG►APIDRAAPIDRA►HUMULIN U-500?HUMULIN U-500?

KEY CONCEPTS KEY CONCEPTS

► BASAL INFUSION – PROVIDES CONTINUOUS INSULIN BASAL INFUSION – PROVIDES CONTINUOUS INSULIN INFUSION TO MIMIC THE PANCREAS IN THE FASTING INFUSION TO MIMIC THE PANCREAS IN THE FASTING STATE.STATE.

► CARBOHYDRATE RATIO OR MEAL BOLUS – THE CARBOHYDRATE RATIO OR MEAL BOLUS – THE NUMBER OF CARBOHYDRATE GRAMS COVERED BY NUMBER OF CARBOHYDRATE GRAMS COVERED BY 1 UNIT OF INSULIN.1 UNIT OF INSULIN.

► INSULIN SENSITIVITY FACTOR – THE BLOOD INSULIN SENSITIVITY FACTOR – THE BLOOD GLUCOSE (mg/dl) THAT IS LOWERED BY ONE UNIT GLUCOSE (mg/dl) THAT IS LOWERED BY ONE UNIT OF INSULIN.OF INSULIN.

STARTING INSULIN PUMP STARTING INSULIN PUMP THERAPYTHERAPY

►CALCULATE THE TOTAL DAILY DOSE CALCULATE THE TOTAL DAILY DOSE (TDD) INSULIN AND REDUCE THIS BY (TDD) INSULIN AND REDUCE THIS BY 10%.10%.

FOR EXAMPLE – 60 KG FEMALE ON 30 UNITS OF FOR EXAMPLE – 60 KG FEMALE ON 30 UNITS OF RAPID ACTING INSULIN (10U TID WITH MEALS) RAPID ACTING INSULIN (10U TID WITH MEALS) AND 30 UNITS OF LONG ACTING INSULIN AT AND 30 UNITS OF LONG ACTING INSULIN AT BEDTIME.BEDTIME.

TOTAL DAILY INSULIN 60 UNITS SUBTRACT 10% TOTAL DAILY INSULIN 60 UNITS SUBTRACT 10% = 54 UNITS TDD= 54 UNITS TDD

BASAL RATEBASAL RATE

1.1. TAKE TDD AND DIVIDE BY 2.TAKE TDD AND DIVIDE BY 2.

54 UNITS/2 = 27 UNITS/DAY54 UNITS/2 = 27 UNITS/DAY

2.2. DIVIDE THE TOTAL BASAL REQUIREMENT BY 24 DIVIDE THE TOTAL BASAL REQUIREMENT BY 24 HOURS.HOURS.

27/24 = ~1.15 UNITS/HR.27/24 = ~1.15 UNITS/HR.

CARBOHYDRATE RATIO – 450 CARBOHYDRATE RATIO – 450 RULERULE

►450 DIVIDE BY THE TDD450 DIVIDE BY THE TDD

450/54 = ~8 THEREFORE 1 UNIT 450/54 = ~8 THEREFORE 1 UNIT INSULIN FOR EVERY 8 GRAMS INSULIN FOR EVERY 8 GRAMS CARBS.CARBS.

INSULIN SENSITIVITY FACTOR – INSULIN SENSITIVITY FACTOR – 1700 RULE1700 RULE

►1700 DIVIDE BY THE TDD1700 DIVIDE BY THE TDD

1700/54 = ~30 THEREFORE ONE UNIT 1700/54 = ~30 THEREFORE ONE UNIT OF INSULIN LOWERS THE BLOOD OF INSULIN LOWERS THE BLOOD GLUCOSE BY GLUCOSE BY

30mg/dl.30mg/dl.

INSULIN PUMP SETTINGSINSULIN PUMP SETTINGS

► BASAL INSULINBASAL INSULIN 0000 AT 1.15 UNITS/HR.0000 AT 1.15 UNITS/HR.► CARB RATIOCARB RATIO 0000 AT 8.0000 AT 8.► INSULIN SENSITIVITYINSULIN SENSITIVITY 0000 AT 30.0000 AT 30.► BLOOD GLUCOSE TARGETBLOOD GLUCOSE TARGET 90-120mg/dl.90-120mg/dl.► ACTIVE INSULIN TIMEACTIVE INSULIN TIME 3HRS.3HRS.

INFUSION SETSINFUSION SETS

INFUSION SITESINFUSION SITES

PumpPump Size andSize and

weightweightBatteryBattery ReservoirReservoir Infusion setInfusion set Basal rangeBasal range Bolus rangeBolus range Food Food

databasedatabaseInteracts Interacts with meter?with meter?

Interacts Interacts with CGMS?with CGMS?

DetailsDetails

ACCU-CHEKACCU-CHEK

SPIRIT -SPIRIT -RocheRoche

3.2X2.2X0.83.2X2.2X0.8

inchesinches

4oz with 4oz with battery, full battery, full reservoir, reservoir, and infusionand infusion

setset

(1) AA(1) AA 315 unit 315 unit cartridgecartridge

Compatible Compatible with all with all standard standard Luer-lock Luer-lock connectorsconnectors

From 0.1 to From 0.1 to 25 units per 25 units per hour in 0.1 hour in 0.1 unit unit incrementsincrements

0.1 to 25 0.1 to 25 units in units in increments increments of 0.1, 0.2, of 0.1, 0.2, 0.5, 1, and 0.5, 1, and 2 units. 2 units. Extended or Extended or multiwave multiwave 0.10.1

Yes. Yes. Database Database includes includes over 900 over 900 preloaded preloaded common common foods and foods and stores 1200 stores 1200

NoNo NoNo Display can Display can flip 180 flip 180 degrees for degrees for easy easy reading. reading. Package Package includes a includes a backup backup pumppump

AMIGO – AMIGO – Nipro Corp.Nipro Corp.

3.28x2.18x3.28x2.18x

0.93 inches0.93 inches

4oz with 4oz with battery and battery and full full reservoirreservoir

(1) CR2 3 (1) CR2 3 volt lithiumvolt lithium

200 unit 200 unit reservoirreservoir

Unomedical Unomedical comfort comfort onlyonly

0-30 0-30 units/hr in units/hr in 0.05 unit 0.05 unit incrementsincrements

Bolus Bolus increments increments of .05units of .05units to 30 unitsto 30 units

NoNo NoNo NoNo Pump Pump casing is casing is shatter and shatter and waterproof. waterproof. 6 colors 6 colors availableavailable

DANADANA

DIABECAREDIABECARE

IIS – Sooil IIS – Sooil DevelopmeDevelopment.nt.

2.95x1.77x2.95x1.77x0.75 inches0.75 inches

1.8 oz 1.8 oz without without batterybattery

(1) 3.6 volt (1) 3.6 volt DC lithiumDC lithium

300 unit 300 unit cartridgecartridge

Compatible Compatible with Sooll with Sooll infusion infusion sets onlysets only

From 0.01 From 0.01 to 16 units to 16 units per hour in per hour in 0.1 unit 0.1 unit incrementsincrements

0.1 to 10 0.1 to 10 units in 0.1 units in 0.1 unit unit increments. increments. From 10 to From 10 to 87 units in 1 87 units in 1 unit unit incrementsincrements

NoNo NoNo NoNo Menu uses Menu uses icons icons instead of instead of words. words. Available in Available in 5 colors5 colors

MINIMEDMINIMED

REVEL – REVEL – Medtronic Medtronic DiabetesDiabetes

Model 523:Model 523:

2x3x0.8 in.2x3x0.8 in.

3.53 oz3.53 oz

Model 723:Model 723:

2x3.6x0.8 2x3.6x0.8 inchesinches

3.81 oz3.81 oz

with battery with battery and full and full reservoirreservoir

(1) AAA(1) AAA Model 523:Model 523:

176 unit 176 unit reservoirreservoir

Model 723:Model 723:

176 or 300 176 or 300 unit unit reservoirreservoir

Compatible Compatible with with Medtronic Medtronic infusion infusion sets as well sets as well as sets from as sets from select select brandsbrands

From 0.025 From 0.025 to 35 units to 35 units per hour in per hour in 0.025 unit 0.025 unit incrementsincrements

0.025 to 25 0.025 to 25 units. units. Increments Increments of 0.025 of 0.025 units up to units up to 0.975 units. 0.975 units. Increments Increments of 0.05 of 0.05 units for units for amounts amounts larger than larger than 0.975 units0.975 units

NoNo Yes. The Yes. The One Touch One Touch Ultralink Ultralink meter meter wirelessly wirelessly sends test sends test results to results to the pumpthe pump

Yes. The Yes. The Real Time Real Time Revel is a Revel is a combination combination pump and pump and CGMCGM

The Real The Real Time Revel Time Revel uses a uses a sensor to sensor to wirelessly wirelessly transmit transmit continuous continuous glucose glucose readings to readings to the pumpthe pump

OMNIPOD – OMNIPOD – Insulet Insulet Corp.Corp.

Pod: Pod: 1.6x2.4x0.7 1.6x2.4x0.7 inchesinches

1.2oz with 1.2oz with full full reservoirreservoir

PDM: PDM: 2.5x4.5x1 2.5x4.5x1 inch and inch and 4.4oz 4.4oz

Pod: Battery Pod: Battery integratedintegrated

PDM: (2) PDM: (2) AAAAAA

Pod Pod includes includes built in built in reservoir reservoir that holds that holds 200 units200 units

Does not Does not use tubing. use tubing. Pod comes Pod comes with a built with a built in infusion in infusion set, set, cannula, cannula, and and automated automated inserterinserter

From 0.05 From 0.05 to 30 units to 30 units per hour in per hour in 0.05 unit 0.05 unit incrementsincrements

0.05 to 30 0.05 to 30 units in units in increments increments of 0.05, 0.1, of 0.05, 0.1, 0.5, or 1 0.5, or 1 unitunit

Yes. PDM Yes. PDM contains contains more than more than 1,000 1,000 common common foods and foods and their their nutrition nutrition informationinformation

Yes. A Yes. A FreeStyle FreeStyle blood blood glucose glucose meter is meter is built into built into the PDMthe PDM

NoNo No tubing No tubing required. required. Pod is used Pod is used for 72 hours for 72 hours than than discarded. discarded. Waterproof Waterproof up to 8 feet up to 8 feet deep.deep.

ONE TOUCHONE TOUCH

PING – PING – Animas Animas Corp.Corp.

Pump: Pump: 2x3.25x0.82x3.25x0.85 inches. 5 inches. 3.9oz 3.9oz

Meter: Meter: 3.8x2.46x1.3.8x2.46x1.12 inches 12 inches andand

3.88oz3.88oz

Pump (1) Pump (1) 1.5 volt 1.5 volt lithium AA lithium AA or (1) AAor (1) AA

Meter: (2) Meter: (2) AAAAAA

200 unit 200 unit cartridgecartridge

Compatible Compatible with all with all standard, standard, Luer-lock Luer-lock connectorsconnectors

From 0.025 From 0.025 to 25 units to 25 units per hour in per hour in 0.025 unit 0.025 unit incrementsincrements

0.05 to 35 0.05 to 35 units in 0.05 units in 0.05 unit unit incrementsincrements

Yes. Meter Yes. Meter remote remote stores up to stores up to 500 foods 500 foods and their and their nutrition nutrition informationinformation

Yes. Meter Yes. Meter remote remote sends sends results results wirelessly wirelessly to pumpto pump

NoNo Both meter Both meter remote and remote and pump are pump are fully fully functional. functional. Waterproof Waterproof up to 12 up to 12 feetfeet

ReferencesReferences1.1. Centers for Disease Control – 2011 National Diabetes Fact Sheet.Centers for Disease Control – 2011 National Diabetes Fact Sheet.2.2. American Diabetes Association. Standards of Medical Care in Diabetes – 2011. Diabetes Care, Volume 34, Supplement 1, January 2011.American Diabetes Association. Standards of Medical Care in Diabetes – 2011. Diabetes Care, Volume 34, Supplement 1, January 2011.3.3. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. 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.Copyright AACE 2011. Endocrine Practice Volume 17, Supplement 2, March/April 2011.4.4. American Association of Diabetes Educators Position Statement – Continuous Subcutaneous Insulin Therapy Using a Pump. AADE 2011.American Association of Diabetes Educators Position Statement – Continuous Subcutaneous Insulin Therapy Using a Pump. AADE 2011.5.5. American Association of Diabetes Educators – The Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes American Association of Diabetes Educators – The Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes

Educators. AADE 2011.Educators. AADE 2011.6.6. Diabetes Control and Complications Trial Research Group. The effectiveness of intensive treatment of diabetes on the development and progression of 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.long term complications in insulin dependent diabetes mellitus. New England Journal of Medicine. 1993;329:977-986.7.7. 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 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.patients. Diabetes Medicine. 2005;22:1037-1046.8.8. Pickup JC, Sutton AJ. Severe hypoglycemia and glycaemic control in type 1 diabetes: Meta-analysis of multiple daily insulin injections compared with 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.continuous subcutaneous insulin infusion. Diabetes Medicine. 2008;25:765-774.9.9. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of Sensor-Augmented Insulin Pump Therapy in Type 1 Diabetes. New England Journal 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.of Medicine. 2010;363:311-320.10.10. Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes 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. 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.New England Journal of Medicine. 2005;22:2643-2653.

11.11. Hoogma RP, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion and NPH-based multiple daily insulin 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.injections on glycaemic control and quality of life: results of the 5 – nations trial. Diabetes Medicine. 2006;23:141-147.

12.12. Philip M, Batelino T, Rodriguez H, Danne T, Kaufman F, Consensus Forum Participants. Use of insulin pump therapy in pediatric age group. Diabetes 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.Care. 2007:30:1653-1662.

13.13. United Healthcare Medical Policy. Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes. Copyright 2011.United Healthcare Medical Policy. Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes. Copyright 2011.14.14. United Health – Center for health reform and modernization. November 2010.United Health – Center for health reform and modernization. November 2010.15.15. Diabetes Forecast January 2011.Diabetes Forecast January 2011.16.16. American Association of Diabetes Educators 2008 Consensus Summit. Insulin Pump Therapy.American Association of Diabetes Educators 2008 Consensus Summit. Insulin Pump Therapy.17.17. Pumping Protocol by Bruce Bode M.D. 2008 Medtronic Minimed, Inc.Pumping Protocol by Bruce Bode M.D. 2008 Medtronic Minimed, Inc.18.18. Animas Corporation.Animas Corporation.19.19. Insulet Corporation.Insulet Corporation.20.20. Sooil Development.Sooil Development.21.21. Roche Insulin Delivery Systems.Roche Insulin Delivery Systems.22.22. Nipro Corporation.Nipro Corporation.23.23. Consultant. Diabetes and Prediabetes. Edward J. Shahady M.D. August 2011. Volume 51. Number 8.Consultant. Diabetes and Prediabetes. Edward J. Shahady M.D. August 2011. Volume 51. Number 8.24.24. Rizza RA, et al. Diabetes Care. 2003:26(5): 1545-1552.Rizza RA, et al. Diabetes Care. 2003:26(5): 1545-1552.25.25. Stewart AF. Journal of Clinical Endocrinology and Metabolism. 2008:93: 1164-1166.Stewart AF. Journal of Clinical Endocrinology and Metabolism. 2008:93: 1164-1166.