FRIDAY, Sept. 4, 2020 (HealthDay News) -- The U.S. Food and Drug Administration has approved the MiniMed 770G System for patients ages 2 to 6 years with type 1 diabetes, the agency announced Monday.
The hybrid closed-loop diabetes management device automatically measures glucose levels every five minutes and provides appropriate basal insulin doses. The device is a bluetooth-enabled version of the MiniMed 670G system and consists of a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump that is strapped to the body, and an infusion patch that connects to the pump with a catheter that delivers insulin. Caregivers can view user data on a smartphone, and in-app notices are sent when glucose levels are out of range. They can also automatically share the data with clinicians to inform telehealth visits. Users do need to manually request insulin doses at mealtimes to counter carbohydrate consumption.
Approval of the expanded indication for 2- to 6-year-old patients was based on data from a clinical trial of 46 children with type 1 diabetes. The children, who were ages 2 to 6 years old, wore the device for about three months, and researchers evaluated the device's performance during the at-home period and hotel period when the system was stressed with sustained daily exercise. Researchers found no serious adverse events and concluded the device was safe for use.
Risks tied to using the MiniMed 770G device include hypoglycemia, hyperglycemia, and skin irritation or redness around the infusion patch. The device is contraindicated in children younger than 2 years old and in those who require less than eight units of insulin daily. The manufacturer is required by the FDA to conduct a postmarket study evaluating the device's use in real-world settings for children ages 2 to 6 years old.
Approval was granted to Medtronic.