FDA Approves First Automated Insulin System for Young Pediatric Patients

The FDA has approved the MiniMed 770G System, the first automated insulin delivery and monitoring system intended for use by individuals aged 2 to 6 years with type 1 diabetes.

The device, an updated version of the previously-approved MiniMed 670G System, is a Bluetooth-enabled hybrid closed loop system that takes measurements of the body’s glucose levels every 5 minutes. The device then withholds or administers insulin as needed. The only interaction necessary by the user or the caretaker is to manually request insulin doses to counter carbohydrate consumption.

The approval was based on the evaluation of data from a clinical trial including 46 participants, aged 2 to 6 years, with type 1 diabetes. While data from this study has been used to support the expanded indication of this device, the FDA is also requiring the device manufacturer to conduct a post-market study as part of their approval.

The most common side effects include hypoglycemia, hyperglycemia, and skin irritation or redness where the device is attached. The MiniMed 770G system is not intended for patients younger than 2 years of age or for individuals who need less than 8 units of insulin daily.

—Leigh Precopio

Reference:

FDA pproves first-of-its-kind automated insulin delivery and monitoring system for use in young pediatric patients. News release. US Food and Drug Administration. August 31, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-automated-insulin-delivery-and-monitoring-system-use-young-pediatric