The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.
The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.
As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.
“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The device was approved in September 2017 for use in patients aged 14 years and older.
Read more about this approval in the full FDA.