Q. How Does an Insulin Pump Work?

People with type 1 diabetes and some people with type 2 diabetes have to take insulin through injections or insulin pumps to regulate their blood sugar (glucose). Unlike multiple daily insulin injections, an insulin pump continuously delivers small, precise amounts of insulin. Many people also use continuous glucose monitoring (CGM) systems to automatically measure glucose levels. Insulin pumps integrated with CGM were introduced in 2006, and today the most advanced integrated systems, MiniMed 630G and MiniMed 530G, include automation that mimics certain functions of a healthy pancreas.

Insulin Pump Therapy

Q. What is an insulin pump? A. An insulin pump is a device about the size of a deck of cards that continuously delivers small, precise amounts of insulin, much like a healthy pancreas. Insulin pump therapy is an alternative to multiple daily insulin injections. Q. How does an insulin pump work? A. An insulin pump precisely delivers insulin at a constant rate — called a “basal rate” — to keep glucose levels in the desired range. It is worn on the outside of the body and connected via a tiny, plastic tube inserted under the skin, typically in the abdomen. It holds a reservoir with a supply of insulin, and the person with diabetes changes the tubing and reservoir every two to three days. With an insulin pump, syringes are not required to deliver insulin. An insulin pump is easy to program, and people with diabetes can customize a variety of insulin delivery rates to match their individual lifestyle needs. At the touch of a few buttons, people with diabetes can deliver extra insulin — called a “bolus” — for food containing carbohydrates or when their glucose is measured out of target range. Q. What are the proven benefits of insulin pump therapy? A. Insulin pump therapy has been clinically proven for people with type 1 or type 2 diabetes: . Studies have reported that near-normal glucose control, which can be achieved with an insulin pump, can prolong life an average of five years and delay the onset of complications from diabetes, such as blindness, kidney failure, amputation, impotence, coma and heart disease, by an average of 15 years.1 . MiniMed insulin pumps were shown to safely achieve better glucose control than multiple daily injections for people with insulin-dependent type 2 diabetes.2 The American Association of Clinical Endocrinologists (AACE) also supports insulin pump therapy for people with type 1 or type 2 diabetes.3 Q. What are the benefits of insulin pump therapy over multiple daily injections? A. Insulin pumps are associated with greater predictability, individualization, flexibility, quality of life and improved glucose control compared with multiple daily insulin injections.

940M14216-011 20151102 Continuous Glucose Monitoring

Q. What is continuous glucose monitoring (CGM)? A. A CGM system provides people with diabetes continuous, real-time trend information about their glucose levels. It allows for appropriate intervention (after verifying with a blood fingerstick test) to prevent hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar), maximizing the patient’s time in the optimal glucose target range.

Q. How does a CGM system work? A. With a CGM system, the person with diabetes inserts a tiny sensor beneath the skin, typically in the abdomen. The sensor, which measures glucose levels from the fluid under the skin, is attached to a transmitter that sends readings to a wearable monitor or the insulin pump every five minutes. Alerts and alarms can be customized to notify patients up to 30 minutes before they reach personal preset low or high sensor glucose limits. CGM provides a more complete picture because it reveals high and low glucose levels that periodic blood fingerstick testing might miss.

Fingerstick Testing Limits Glucose Variability CGM Reveals the Complete Picture to to Snapshots in Time Optimize Glucose Management Practices

Q. What are the proven benefits of CGM? A. CGM has been clinically proven in several scientific studies: . JDRF-funded landmark CGM trials showed that using CGM can significantly improve diabetes control and decrease the frequency of high and low blood glucose when used regularly.4 . Insulin pump therapy with built-in CGM has been shown to enable people with diabetes to achieve significantly better glucose control compared to multiple daily injections.5

Moreover, AACE recommends CGM particularly for children, adolescents and adults with frequent hypoglycemia or hypoglycemia unawareness, A1C levels (a key measurement used to assess blood glucose control) over their target, large variability in glycemic levels, and the need to lower A1C levels without increasing hypoglycemic events, as well as for those who are pregnant or are planning to become pregnant.6

940M14216-011 20151102 Integrated Insulin Pump and CGM Systems

Q. How does an integrated system with an insulin pump and CGM work? A. An integrated system shows real-time CGM information on the insulin pump and delivers alerts and alarms when the CGM reading detects a low or high threshold for the glucose levels. Medtronic introduced the first integrated insulin pump and CGM system in 2006. The landmark STAR 3 clinical trial proved the system provides better glucose control than multiple daily injections. 5

Q. What advancements have been made in integrated systems? A. Today’s most advanced system can automatically take action based on the CGM reading, mimicking some of the functions of a healthy pancreas. MiniMed 630G and MiniMed 530G includes a feature called SmartGuard that automatically stops insulin delivery if sensor glucose values fall below a predetermined threshold and the patient doesn’t respond to the alarm. It can be harmful if glucose levels go too low, and more insulin would lower glucose levels further. Future Technology

Q. What will future technology look like? A. As part of its commitment to greater freedom and better health for people with diabetes, Medtronic has been advancing research and development for over 30 years with an ultimate goal to develop a closed loop insulin delivery system. Also called an artificial pancreas, it is a system that mimics the biological function of the pancreas for people with type 1 diabetes by fully automating insulin delivery and eliminating the need for attention or interaction from the patient.

Developing and commercializing an artificial pancreas is a step-by-step process. With each step, Medtronic introduces new automation to address key clinical challenges and reduce time and effort, so people with diabetes can spend less time managing their diabetes and more time living their exceptional lives. Future incremental steps include: . Introducing an integrated system in the U.S. that automatically stops insulin delivery before the CGM reading reaches a preset low level and resumes once the CGM readings recover. Called Predictive Low Glucose Management, this feature is commercially available outside the U.S. in the MiniMed 640G. . A system called Hybrid Closed Loop, which is designed to automatically control glucose levels with less input from people with diabetes, who would only need to enter their exercise and mealtime carbohydrates as well as periodically calibrate the sensor in the CGM. This technology is currently in a pivotal trial. . Then, ultimately, a Closed Loop system that fully automates insulin delivery with minimal patient interaction required.

Please visit http://www.medtronicdiabetes.com/important-safety-information for detailed product and important safety information.

940M14216-011 20151102 1 Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA, November 6, 1996; 276: No.17. 2 Reznik Y. Cohen O. Aronson R. et al, Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomized, open-label controlled trial. Lancet 2014; published online July 3, 2014 3 Grunberger, G. AACE/ACE Consensus Statement. Endocrine Practice. 2014; 20: (No. 5). 4 The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008; 359:1464-1476. 5 Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010; 363:311–320. 6 American Association of Clinical Endocrinologists CGM Task Force. Consensus Statement: Continuous Glucose Monitoring. Endocrine Practice. Sept/Oct 2010; Vol 16, No 5, pp 730 – 744. Please note that the MiniMed 530G is approved for patients age 16 and over. MiniMed 530G is not indicated for use in women who are pregnant.