On August 31, 2020, the U.S. Food and Drug Administration (FDA) approved the Medtronic plc MiniMed 770G System, an automated insulin delivery and monitoring system, for use by children between ages two and six diagnosed with type 1 diabetes. It is the first continuous glucose monitoring (CGM) and insulin delivery system for very young children. The device can automatically adjust insulin delivery based on CGM values for this population with little or no input from the users or their caregivers. Users still need to manually request insulin doses to counter carbohydrate consumption at mealtime. On September 1, 2020, the FDA approved the MiniMed 770G system for all ages. Medtronic began accepting orders the week of August 31.
The MiniMed 770G System is a bluetooth-enabled version of Medtronic’s previously approved MiniMed 670G System. On June 21, 2018, the FDA approved the MiniMed 670G System for use by children with type 1 diabetes ages seven and older.
The MiniMed 770G System is a hybrid closed-loop system measures measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes a CGM sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. The system can connect with smartphones to enable caregivers and care partners to see user data remotely on their smartphones. It can send proactive in-app notices when sugar levels are out of range. The data can also be shared automatically with clinical professionals and educators to help facilitate more effective telehealth visits and product trainings.
For this new age group approval, the FDA evaluated data from a clinical trial that included 46 children aged two to six years old with type 1 diabetes. The study participants used the device for about three months. It was tested during a home phase, and a hotel phase where the child engaged in sustained daily exercise. As part of this approval, the FDA is requiring the device manufacturer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of two and six. This device is not approved for use in children younger than two years old and in individuals who require less than eight units of insulin per day.
The U.S. Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. The agency is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
This was reported by the FDA on August 31, 2020.
Contact information: Pamela Reese, Director, Communications, Diabetes Group of Medtronic, 710 Medtronic Parkway, Minneapolis, Minnesota 55432-5604; 818-576-3398; Email: firstname.lastname@example.org; Website: https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-announces-fda-approval-minimedtm-770g-insulin-pump
Contact information: Abby Capobianco, Media Contact, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002; 240-461-9059; Email: email@example.com; Website: https://www.fda.gov