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The US Food and Drug Administration (FDA) has approved Medtronic’s hybrid closed loop diabetes management device for use in children aged 2 to 6 years.
The US Food and Drug Administration (FDA) has approved Medtronic’s MiniMed 770G System, which is a hybrid closed loop diabetes management device that automatically monitors glucose and provides basal insulin doses with very little input from users or caregivers.1 The system is meant for use in children aged 2 to 6 years who have been diagnosed with type 1 diabetes. It is not approved for use in children aged younger than 2 years and in children who require less than 8 units of insulin per day. It is the first legally marketed product of this type for children in this age range. The MiniMed 770G, which is Bluetooth-enabled version of the MiniMed 670G system, measures glucose levels every 5 minutes and then adjusts insulin delivery, either withholding or delivering insulin.
The approval was informed by a clinical trial of 46 children aged 2 to 6 years. Each study participant wore the MiniMed 770G for 3 months. During this time, the device’s performance during at-home periods and a hotel period that stressed the system with sustained daily exercise. No serious adverse events were found during the study period. There are some risks associated with the device, however, including hyperglycemia, hypoglycemia, and skin irritation linked to the infusion patch. The FDA also requires Medtronic to run a post-market study that evaluates the device’s performance in the real world.
In the press release for the approval, FDA commissioner Stephen M. Hahn, MD, said, “Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition. The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition—which can particularly impact children—is safe and effective.”
US Food and Drug Administration. FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young pediatric patients. US Food and Drug Administration. Published August 31, 2020. Accessed September 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-automated-insulin-delivery-and-monitoring-system-use-young-pediatric