In a double boost for patients with diabetes, the FDA signed off on expanding the use of Medtronic’s hybrid closed-loop insulin pump system to include patients between the ages of 7 to 13 with Type 1 diabetes and approved the Eversense continuous glucose monitoring system for patients 18 and older.
The Eversense device is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.
Considered the world’s first “artificial pancreas,” the Medtronic’s MiniMed 670G was first approved by the regulatory agency last year for use in patients with Type 1 diabetes aged 14 and older.
The system includes a glucose sensor that measures glucose levels in the fluid just under the skin, the MiniMed 670G insulin pump and an infusion patch, which delivers insulin through a catheter. It uses an algorithm to self-adjust the delivery of basal, or background, insulin every five minutes based on real-time data gathered from the sensor.
“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,” Scott Gottlieb, M.D., the FDA commissioner, said in a statement. “Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks.”
In reviewing the device for use in the new age bracket, the FDA evaluated data from a clinical trial of the device that included 105 patients aged 7 to 11 years old. Study participants wore the MiniMed 670G for about 3-1/2 months and took part in three phases of the study to evaluate both at-home use as well as remote use. That study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people age 7 to 13 years with Type 1 diabetes, the agency said.
Eversense’s CGM system uses a small sensor that is implanted just under the skin. Once in place, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The sensor uses a light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high or too low.