The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes.
The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older.
Medtronic’s MiniMed 670G diabetes management system includes a sensor that attaches directly to a person’s body to assess glucose levels, an insulin pump and an infusion patch to deliver insulin. In a 105-person study, children ages 7 to 11 wore the device for 3.5 months. The study, which evaluated at-home use and remote use of the system, found that the MiniMed 670G was safe for use in young children with Type I diabetes.
“Type I diabetes is a life-threatening chronic condition requiring continuous and life-long management that can be stressful for patients and their caregivers, especially when the patients are young children,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks. “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. Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children.”
In connection with the approval, the FDA noted that it’s requiring Medtronic to conduct a post-market study evaluating the real-world performance of the MiniMed system in children ages 7 to 13.
“We are thrilled to be able to offer this advanced insulin management system to younger patients and their caregivers to help alleviate some of the burden associated with this unrelenting disease and to improve their quality of life” Dr. Francine Kaufman, CMO & VP of global regulatory, medical and clinical affairs of Medtronic’s diabetes group, said in a release. “This expanded age indication provides an important new treatment option for pediatric clinicians and parents of young children with Type I diabetes, and further demonstrates our strong commitment to improving outcomes across the full diabetes care continuum.”
