FDA approved First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

FDA approved First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes. The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population. Patients with Type 1 diabetes, or their caregivers, must consistently monitor their glucose levels throughout the day and inject insulin with a syringe, pen or pump to maintain adequate glucose levels in order to avoid becoming hyperglycemic (high glucose levels) or hypoglycemic (low glucose levels). The MiniMed 770G System measures glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin. This new system is the bluetooth-enabled version of the previously approved MiniMed 670G System, that received CE Mark in 2018 and is currently on the market in select European countries.

September 29th, 2020|