FDA Green-lights First 'Artificial Pancreas' for Type 1 Diabetes
FDA approves first closed-loop system.
Officials with the US Food and Drug Administration (FDA) have approved the first device that automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes aged 14 years and older.
Medtronic's MiniMed 670G hybrid closed-loop system adjusts insulin levels with little or no input from the user, according to a press release.1 The system measures glucose levels every 5 minutes and either dispenses or withholds insulin, depending upon readings.
The approval was based on a clinical trial that included 123 people with type 1 diabetes who used the MiniMed 670G hybrid closed-loop system for 3 months, following an initial 2-week period of no use. The researchers in that trial noted that there were no adverse events, and that the device was safe to use in people aged 14 and older.
Risks associated with use of the system may include skin irritation, or hypoglycemia and hyperglycemia. FDA officials are requiring postmarket data, and company officials note that they are conducting studies in children aged 7 to 13 to evaluate the system's efficacy and safety in pediatric populations.
“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases — especially those that require day-to-day maintenance and ongoing attention,” Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health said in the release. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.”
- FDA approves first automated insulin delivery device for type 1 diabetes [press release]. Silver Spring, MD: US Food and Drug Administration; September 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htm. Accessed September 28, 2016.