Automated Insulin Delivery and Monitoring System Approved for Use in Young Pediatric Patients

02 September 2020

GMP News

The 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 approval of the MiniMed 770G hybrid closed loop system was granted to Medtronic.

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.

The MiniMed 770G System, a bluetooth-enabled version of the previously approved MiniMed 670G System (with other modifications). 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 2 to 6 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 2 to 6 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 2 and 6.

This device is not approved for use in children younger than 2 years old and in individuals who require less than eight units of insulin per day.

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