Federal health officials have granted approval to an automated insulin delivery device for young children with type 1 diabetes.
Medtronic’s MiniMed 770G System is a hybrid closed loop diabetes management device that automatically monitors glucose and provides appropriate basal insulin doses, according to the Food and Drug Administration (FDA). It will be available for patients ages 2 years and older and is the first of its kind for children ages 2-6 years.
“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,” FDA Commissioner Stephen M. Hahn, M.D., said in a news release.
The device includes sensors to measure glucose under the skin, an insulin pump and infusion patch connected to the pump. It measures glucose every five minutes and adjusts levels to keep them within a target range. The device also is linked to an app that allows parents and other caregivers to monitor their child’s insulin levels. Users still need to manually request insulin to counter carbohydrates they are eating, according to the FDA.
In a clinical trial, 46 children ages 2-6 years with type 1 diabetes wore the device for three months and did not have any serious adverse events. Medtronic also will conduct a post-market study.