Medtronic Bags FDA Authorization for Pioneering Medical Device to Combat Pediatric Diabetes
The regulatory agency approved the MiniMed 770G System, a first-of-its-kind, hybrid closed-loop diabetes management device that can monitor glucose and automatically provide appropriate amounts of basal insulin in young patients with Type 1 diabetes.
By T. Chakraborty, Ph.D.
Type 1 diabetes (T1D) is an autoimmune disease that occurs in the human body when the person’s pancreas refuses to produce insulin, the hormone responsible for controlling blood sugar levels. T1D majorly affects children and adults with scientists often terming the disease as “juvenile diabetes”. Approximately, in the US alone,1.6 million people are living with T1D which includes roughly about 200,000 youth and over 1 million adults . With a generally quick onset, T1D can be managed with the use of insulin, which can be either injected or via an insulin pump.
On August 31st, the U.S. Food and Drug Administration (USFDA) approved the use of MiniMed 770G System, a hybrid diabetes management device that automatically monitors glucose levels and provides appropriate insulin doses with extremely little input from the user or caregiver.
Stephen M. Hahn, M.D, FDA Commissioner said “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. 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.”
MiniMed 770G System
The MiniMed 770G System is a Bluetooth version of the previously approved MiniMed 670G System and functions by measuring glucose levels in the body every five minutes, based on which it adjusts insulin delivery. The system comprises a sensor that attaches to the body and helps in measuring glucose levels under the skin; an insulin pump which remains strapped to the body; and an infusion patch, responsible for delivering insulin and attached to the pump by means of a catheter.
Although the device adjusts insulin when needed, users need to manually request insulin to counteract carbohydrate consumption during meals. The 770G system is the first device intended for monitoring instantaneous glucose levels and provides insulin for patients aged between 2 to 6 years old. However, the 770G system is not approved for use in children less than 2 years of age and individuals requiring less than eight units of insulin on a daily basis .
The approval from the FDA comes from clinical trial data that consisted of 46 children aged 2 to 6 years old with pre-existing type 1 diabetes. The patients wore the device for around a period of three months, to judge the device’s performance both at home and a hotel period, needed to understand the system’s response to daily exercise. The associated risks in using this system may include hypoglycemia, hyperglycemia, and skin irritation around the patch. The study concluded that there remain no serious adverse events that occurred during the study period and that the device is acutely safe for use.
The approval of the MiniMed 770G system was granted to Medtronic, a medical services company headquartered in Dublin, Ireland. As part of this approval, the FDA is mandating that the device manufacturer needs to conduct a post-market study to comprehend the device performance in real-world scenarios in children .
Editor: Rajaneesh K. Gopinath, Ph.D.