The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. Data from the pediatric study was included as part of an application to the FDA, as Medtronic looks to expand MiniMed’s indication to include children between the ages of 7 and 13.
Medtronic’s hybrid closed-loop system is the first of its kind to be formally approved by the FDA. The medtech giant landed the regulatory win September of 2016, clearing the product for use in people with Type I diabetes.
The MiniMed 670G system is designed to automatically track and adjust blood sugar levels based on blood glucose values measured and recorded every five minutes.
Medtronic is also studying the system in kids ranging from 2-6 years old and plans to present data from that trial at an undisclosed date.
“It is incredibly rewarding on both a professional and personal level to evaluate a therapy that has the potential to alleviate the enormous weight of responsibility experienced by parents and caregivers of children with Type I diabetes,” primary study investigator, Dr. Kevin Kaiserman, said in prepared remarks. “I’m very pleased to see that the positive results observed in the pivotal trial studying older patients were also sustained in this study.”
“This important data shows that the MiniMed 670G system can lead to more time in the desired glucose target range in school-aged children, while it reduces both time spent in hypoglycemia and hyperglycemia,” Dr. Francine Kaufman, chief medical officer of Medtronic’s diabetes business, added.
“This hopefully should enable children with Type I diabetes to decrease the risk of experiencing short and long-term diabetes complications.”