HealthDay News — The US Food and Drug Administration has approved the first automated insulin delivery device for type 1 diabetes in patients aged 14 and older.
Often called an “artificial pancreas,” the MiniMed 670G hybrid closed loop system automatically monitors glucose levels every 5 minutes and delivers insulin when needed with little or no input from the user, the FDA said in a news release.
Clinical testing of the device involved 123 patients with type 1 diabetes. No serious adverse reactions were reported. But risks associated with the device include hyperglycemia, hypoglycemia and skin irritation near where the device’s sensor attaches to the body, the FDA said.
The product should be considered unsafe for use by children aged 6 or younger and for patients who require fewer than 8 units of insulin daily.
As a condition of approval, manufacturer Medtronic is required to conduct a post-market study to evaluate “how the device performs in real-world settings,” the FDA said. In addition, Medtronic, based in Dublin, is studying the device’s safety and effectiveness in children aged 7 to 13.
FDA Approves First Automated Insulin Delivery Device for Type 1 Diabetes [press release]. Silver Spring, MD: Food and Drug Administration; September 28, 2016.