FDA approves hybrid closed-loop system for use in younger pediatric patients

The FDA has extended approval of the MiniMed 670G hybrid closed-loop system to younger individuals aged 7 to 13 years with type 1 diabetes.

As previously reported by Endocrine Today, the closed-loop system (Medtronic) was originally granted FDA approval in September 2017 for use in patients aged 14 years and older.

The MiniMed 670G measures glucose levels every 5 minutes and automatically adjusts insulin delivery by administering or withholding insulin. The system includes a subcutaneous sensor, an insulin pump and an infusion patch connected to the pump via catheter to deliver insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime, according to the FDA press release.

Extended approval of the closed-loop system was based on a clinical trial of 105 participants aged 7 to 13 years with type 1 diabetes. Researchers analyzed the system during a 2-week baseline period in open-loop mode followed by a 3-mont in-home study period with the hybrid-closed loop (SmartGuard Auto Mode) enabled. Results showed the percentage of time in range increased from 56.2% to 65% and HbA1c improved by 7.9% to 7.5%. Researchers reported no incidences of diabetic ketoacidosis while in Auto Mode and no severe hypoglycemic or serious device-related adverse events, according to a company press release.

“In the pediatric clinical trial, there was an increase in time in range (70-180 mg/dL) for sensor glucose values and a reduction in time spent in both hypoglycemia and hyperglycemia, which is compelling in light of the well-known challenges associated with maintaining stable glucose levels throughout the day and night in this younger age group,” Jennifer Sherr, MD, PhD, pediatric endocrinologist at Yale New Haven Children’s Hospital’s diabetes clinic and associate professor of pediatric endocrinology at Yale School of Medicine, stated in the company release.

As part of the extended approval, the FDA has required a postmarket study to evaluate performance of the MiniMed 670G in real-world settings in individuals aged 7 to 13 years.

The FDA noted that the closed-loop system is not approved for children aged 6 years or younger and those who require less than 8 units of insulin per day.

Disclosure: Endocrine Today could not confirm relevant financial disclosures at the time of publication.

Editor’s note: This article was updated on June 22 to include additional information about the hybrid closed-loop system.