The FDA has approved the Medtronic MiniMed 770G  hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years.

The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA approved an earlier MiniMed model, the 670G system, for people aged 7 to 13 with Type I diabetes in 2018.

MiniMed 770G System is a Bluetooth-enabled version of the 670G, with other modifications. It works by measuring glucose levels in the body every 5 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 2 to 6 years old with Type 1 diabetes. Study participants wore the device for approximately 3 months to evaluate its performance while at home and at a hotel 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.

“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,” said FDA commissioner Stephen Hahn in a news release. “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.”

As part of this approval, the FDA is requiring Medtronic to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 2 and 6.

Medtronic CEO Geoff Martha told analysts in a recent earnings call that the MiniMed 770G FDA approval was expected and could help Medtronic regain ground in the diabetes sector.

“In diabetes, we continue to execute on our near-term pipeline,” he said.  “We’ve received CE Mark approval for our Minimed 780G, advanced hybrid closed-loop system and we’ll launch this fall.”

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