Infographic of the Medtronic Star 3 Clinical Trial

The Improvements in Diabetes Therapy Treating diabeteš with technology 1983 • First Medtronic insulin pump 1985 ......... Medtronic insulin pump now has meal bolus and Diabetes-Related Complications intensive diabetes management can help reduce the risk of long term complications 1993 daily insulin totals рсст The Diabetes Control and Complications Trial (DCCT) found that intensive Stroke Eye disease Kidney disease therapy helps reduce A1C and Heart long term complications'123 |Nerve damage Blood flow 1994 disease EDIC The Epidemiology of Diabetes Interventions and Complications (EDIC) found that Intensive 1996 ....... • First clinical trial for CGM 1999 • CGMS, world's first ambulatory physician use therapy reduces cardiovascular disease and non-fatal heart attack, stroke, or A1C and relative risk of diabetes complications12,3,4 Relative risk of complications (number times more likely) death from cardiovascular causes 2002 • MiniMed Paradigm pump introduced 15 13 2004 11 • CareLink therapy management software for patients introduced • Guardian, stand-alone CGM system for patients 6. 10 11 12 2006 MiniMed Paradigm REAL-Time, world's first insulin pump with integrated ČGM A1C 2008 JDRF Using CGM can lower A1C and achieve a reduction in hypo events • Kidney disease • Eye disease • Nerve damage Every % point decrease in A1C can mean up to a 40% reduction in 2010 STAR 3 Insulin pump therapy with CGM can provide better glucose control without an increase in hypoglycemia compared to multiple daily injections (MDI). risk of microvascular complications MDI group placed on Insulin Pump Therapy with Integrated CGM showed dramatic results In STAR 3, a large, multicenter, randomized clinical trial, adults, children and teens achieved better glucose control without an increase in hypoglycemia (low blood sugar) by using an insulin pump with integrated continuous glucose monitoring (CGM) compared to multiple daily injections (MDI). After 12 months, the 244 patients using an insulin pump integrated with CGM had a reduction in mean A1C levels that was four times greater than the 241 MDI patients. (-0.8% vs.-0.2) • MDI • Insulin Pump with Integrated CGM MDI to Insulin Pump with Integrated CGM Transition A1C (%) 8.5- 8.1 8.0 7.6 The benefit of using an insulin pump integrated with CGM was seen within 3 months and 7.5 was sustained for the full 18 months of the study. After 12 months of the study, patients using MDI switched to insulin pump therapy integrated with CGM, and mean A1C dropped from 8.1% to 7.6%. The more often patients wore the sensor with the insulin pump, the more effectively they managed their disease. Insulin pump therapy integrated with CGM can provide better glucose control so that people with diabetes can improve their A1C without increase in hypoglycemia and ultimately reduce the long-term complications of diabetes. 7.5 7.3 (A 7.0 Study Phase Continuation Phase 6.5 3 6. 12 15 18 Month Insulin Pump with CGM lowered A1C more than MDI Insulin Pump with Integrated CGM had a reduction in A1C that was 4 times greater than MDI group (-0.8 vs. -0.2) Mean 1-Year Change in Alc MDI (-0.2 Insulin Pump with Integrated CGM reduced A1Ç Insulin Pump with Integrated CGM without increase in ALL PATIENTS Hypoglycemia Insulin Pump MDI Insulin Pump with Integrated CGM with Integrated CGM MDI -0.4 (-0.8 (+0.2 -0.4 -1.0 ADULTS >19 years PEDIATRICS 7-18 years More people reach ADA targets using an Insulin Pump with Integrated CGM than with MDI • Insulin Pump with Integrated CGM American Diabetes Association glycated hemoglobin targets (A1C): CHILDREN (6 to 12 years of age, target <8%) ADOLESCENTS (13 to 19 years of age, target of <7.5%) • MDI ADULTS 57% ADULTS (>19 years) PEDIATRICS (7-18 years) .... ..... www 2X as many 19% 16% 3X as many 57% 38% Adults Kids and Teens Increased sensor use associated with greater reduction in A1C Decrease A1Ç without increasing Hypoglycemia 41-60% 61-80% of time 81-100% of time of time -0.64% -0.79% -1.21% IMPORTANT SAFETY INFORMATION • Insulin Infusion System Safety Information: Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. • Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day. Insulin pump users should have sufficient visual and audio acuity to recognize the alerts and alarms provided by the pump. • Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. • Replace the infusion set every 48-72 hours, or more frequently per your healthcare professional's instructions. Please visit www.medtronicdiabetes.com/about/safety.html for complete details. • CGM Systems Safety Information: Continuous glucose monitoring systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with risks associated with the use of these systems. • The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using glucose meter. A'confirmatory fingerstick is required prior to making adjustments to diabetes therapy. • insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. • A version of the CGM product specially designed for children Please visit www.medtronicdiabetes.com/about/safety.html for complete details. • Carelink Therapy Management Software for Diabetes Safety Information: This system is intended to be used together with advice from a healthcare professional familiar with the diagnosis and treatment of diabetes. Do not make any changes to treatment without talking to a healthcare professional first. home blood indicated for patients age 7-17. Please visit www.medtronicdiabetes.com/about/safety.html for complete safety information. 1. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes melitus. N Engl J Med 1993; 329. 977-086. 2. Diabetes Control and Complications Trial Research Group. Ettect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes melitus: Diabetes Control and Complications Trial. JPediatr 1994:125:177-88. 3. The Diabetes Control and Complications Trial Research Group. Implementation of treatment protocols in the diabetes control and complications trial. Diabetes Care 1996; 18361-376. 4. Skyler JS. Diabetic complications: the importance of glucose cortrol. Endocrinol Metab Clin North Am, 199625243-254. 5. Diabetes Control and Complications TrialEpidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group, Intensive diabetes treatment and cardiovascular disease in patients with type 1 dabetes. NEngl J Med 2005,353:2643-2653 6. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of Type 1 diabetes. NEngl Jed 2008. Ana b Coun Etectivoess of sensoraugmented insulin-pump therapy 8. Bergenstal FRM. Tamborlane wV, Ahmann A et al, Sensor-augmented pump therapy for A1C reduction (STAR 3 study: results from the G-month continuation phase Dabetos. 2011:60S1407-PP Medtronic c2011 Medtronic MiniMed, Inc, All rights reserved. www.MedtronicDiabetes.com