The MiniMed 770G becomes the first system to receive approval for children in this age group.
The US Food and Drug Administration (FDA) has announced the approval of the MiniMed770G System from Medtronic for pediatric patients with type 1 diabetes between the ages of 2 and 6 years old.
A first of its kind hybrid closed loop diabetes management system, the MiniMed 770G System becomes the first legally marketed device with the ability to automatically adjust insulin delivery based on continuous glucose monitor values in this age group with the approval.
“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,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition—which can particularly impact children—is safe and effective.”
A Bluetooth-enabled version of the MiniMed 670G System, which has received approval for use in diabetics ages 7 and older, the 770G System approved by the FDA includes a sensor that attaches to the body to measure glucose levels, an insulin pump strapped to the body, and an infusion patch connected to the pump. According to the aforementioned statement, the FDA’s decision to approve the device was based on a clinical trial that included 46 children aged 2-6 years old.
In the study, patients wore the MiniMed 770G System for approximately 3 months in an effort to examine the safety and efficacy of the through evaluating performance during the at-home periods and the hotel period. Upon conclusion of the study, investigators found no serious adverse events had occurred and the FDA used this to determine the device was safe for use.
The FDA pointed out there are multiple risks associated with use of the system. These risks include hypoglycemia, hyperglycemia, and skin irritation or redness around the device’s infusion patch. Furthermore, the FDA noted they are requiring Medtronic to conduct a post-market study to evaluate device performance in real-world settings among this patient population.
This is a breaking story and will be updated as more information becomes available.