Type 1 diabetes patients need to monitor their glucose levels throughout the day and inject insulin as needed. This can be stressful for young patients (and their parents), but the US Food and Drug Administration just approved a system for kids aged 2 to 6 that will monitor their sugar levels and automatically adjust insulin with little or no input required.
Medtronic’s MiniMed 770G system is “the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values” for kids this young, the FDA said this week.
It measures glucose levels every five minutes and adjusts insulin as needed. Users will have to manually request insulin doses to counter carbohydrate consumption at mealtimes, though.
The MiniMed 770G is an update to the MiniMed 670G System, which was only approved for patients ages seven and up. The new MiniMed 770G also adds Bluetooth support.
“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,” FDA Commissioner Stephen M. Hahn, M.D. said in a statement.
The 770G was deemed safe after a three-month test on 46 children aged 2 to 6 with Type I diabetes. It’s not approved for kids younger than 2 years old and those who need less than eight units of insulin per day, the FDA said. Medtronic also still has to carry out a real-world study on the device’s effectiveness before patients can get their hands on one.