FDA Approves Artificial Pancreas

The US Food and Drug Administration has approved Medtronic’s MiniMed 670G hybrid closed looped system, intended to automatically monitor glucose and administer basal insulin doses in individuals aged 14 and older with type 1 diabetes.

The device, also referred to as an “artificial pancreas,” adjusts insulin levels with little-to-no input from the user. It works by measuring glucose levels once every 5 minutes and administering or withholding insulin dependent upon these readings. It includes an insulin-measuring sensor, an insulin pump, and an infusion patch with a catheter for insulin delivery.

The approval is based upon data from a study of 123 participants with type 1 diabetes, including an initial 2-week period in which the system was not used, followed by a 3-month period in which the system was used by the participants as frequently as possible. The study diabetes. No adverse events were reported.

Risks associated with use of the device include hypoglycemia, hyperglycemia, and skin irritation.

The FDA has required a post-market study to better understand the performance of the device in real-world settings. Studies are also underway evaluating the safety and efficacy of the device in individuals 7 to 13 years old.

—Michael Potts

Reference:

FDA. FDA approves first automated insulin delivery device for type 1 diabetes [press release]. September 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htm.