FDA Approves Medtronic Insulin Device For Children With Type 1 Diabetes

(RTTNews) - The U.S. Food and Drug Administration has approved Medtronic's (MDT) MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose, for children aged 2 to 6 with Type 1 diabetes.

It is a first-of-a-kind device for children of such a young age- and is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.

"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," commented FDA Commissioner Stephen Hahn.

Patients with Type 1 diabetes, or their caregivers, must normally consistently monitor their glucose levels throughout the day and inject insulin to maintain adequate glucose levels.

For the approval, the FDA evaluated data from a clinical trial that included 46 children aged 2 to 6 years old with Type 1 diabetes, which found no serious adverse events and that the device is safe for use.