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FDA Clears Artificial Pancreas System for Type 1 Diabetes

MiniMed 670G

MiniMed 670G system (Medtronic Inc.)

28 September 2016. The Food and Drug Administration cleared for sale a system that automatically monitors blood glucose and maintains basic insulin levels in people with type 1 diabetes. The agency’s action will make it possible for medical device maker Medtronic Inc. to market its MiniMed 670G hybrid closed looped system in the U.S.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

The MiniMed 670G is called an artificial pancreas since it can monitor glucose levels and adjust insulin flow with little or no intervention by the wearer. However, people wearing the device still may need to manually increase an insulin dose to account for carbohydrate increases at meal times, and periodically calibrate the sensor. The system monitors glucose levels with the sensor attached to the body, and pumps insulin through an infusion patch and catheter, while an algorithm controls the device, keeping glucose levels in personalized target range.

FDA cleared the device for people with type 1 diabetes age 14 and older. The agency’s approval was based in part on results of a late-stage clinical trial among 123 individuals with type 1 diabetes. Participants in the trial were given the MiniMed 670G for 2 weeks to become familiar with the system, then wore the device with the insulin pump functions fully activated for 3 months. The study looked primarily at reductions in blood glucose levels, measured by glycohemoglobin or A1C, which stayed within target ranges 73 percent of the time, compared to 68 percent without the system.

The trial also tracked occurrences of severe hypoglycemia, or low blood sugar levels, and diabetic ketoacidosis, the build up of ketone acids in the blood from the breakdown of fat into fuel as a result of insulin deficits. FDA says no serious adverse effects from either condition were reported. The agency points out risks from the MiniMed 670G including hyper- and hypoglycemia, as well as redness or skin irritations at the site of the infusion patch. FDA is requiring Medtronic to conduct a post-market study to better understand actual use of the device in day-to-day life.

JDRF, a patient advocacy group for type 1 diabetes, or T1D, says in a statement that the MiniMed 670G “is a life-changing breakthrough that allows people with T1D to stay closer to their target blood sugar levels more consistently.” The organization started the Artificial Pancreas Project in 2006 to support research and development of self-contained systems for glucose monitoring and insulin administration.

The company expects to begin delivering MiniMed 670G system to customers in the U.S. in the spring of 2017. Medtronic is an international medical technology company with operational headquarters in Minneapolis, Minnesota and executive offices in Dublin, Ireland.

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