FDA approves automated insulin delivery and monitoring system for pediatric patients 

Sept. 4, 2020

The U.S. Food and Drug Administration (FDA) stated it has 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 two to six with type 1 diabetes. 

The approval of the system was granted to Medtronic. The system 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, a bluetooth-enabled version of the previously approved MiniMed 670G System (with other modifications), is a hybrid closed loop system that works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes: a 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. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime.  

The FDA evaluated data from a clinical trial that included 46 children aged two to six years old with type 1 diabetes.  Study participants wore the device for approximately three months to evaluate the performance of the device during both the at-home periods, as well as a hotel period, to stress the system with sustained daily exercise. That study found no serious adverse events and that the device is safe for use. Data from that study was used to help support the expanded indication for patients two to six years old.  

Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. 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 to 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.  

FDA has the release

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