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.
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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.
Reference
FDA Approves First Automated Insulin Delivery Device for Type 1 Diabetes [press release]. Silver Spring, MD: Food and Drug Administration; September 28, 2016.
