FDA approves first automated insulin system for kids

Testing blood sugar frequently and administering insulin as needed throughout the day isn’t easy, especially if the individual with diabetes is a young child who can’t do it on their own yet. Now, there’s an FDA-sanctioned device that could make things easier for parents and caregivers: The agency has approved Medtronic’s MiniMed 770G System for use in children aged 2 to 6 with type 1 diabetes. It’s the first of its kind that can be legally marketed towards kids in that age range.

The 770G is a follow—up to MiniMed 670G, the first automated insulin system the FDA gave its blessing to back in 2016. It comes with several improvements over its predecessor and is Bluetooth—enabled. While 670G can only be used for individuals 7 and up, 770G can be used for younger kids after it was tested on 46 children with type 1 diabetes over a period of three months. The children wore the device inside and outside their homes, and the study found the system safe for use.

The device’s sensor that’s attached to the patient’s body can measure glucose levels under the skin every five minutes. It also comes with a pump and an infusion patch connected to the pump with a catheter to deliver insulin. That means the device will automatically adjust or withhold insulin to regulate the patient’s sugar levels without a caregiver having to do anything at all. However, caregivers still have to manually administer insulin after meals and can’t use the device on children under two years old.

FDA Commissioner Stephen M. Hahn, M.D. said in a statement:

“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/ 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.”

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Despite the FDA’s approval, Medtronic’s work isn’t done. It’s still required to conduct a post-market study evaluating the 770G’s performance in real-world settings.

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