WASHINGTON —The FDA approved a hybrid closed loop diabetes management system called the MiniMed 770G System for kids ages 2-6 years with type 1 diabetes (T1D).
This first-of-a-kind device, a modified, Bluetooth-enabled version of the previously approved MiniMed 670G System, “works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin,” and requires little or no input from users or their caregivers, the FDA explained.
This is the first legally marketed device designed to automatically adjust insulin delivery based on continuous monitoring for this patient population.
“The system includes: a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime,” the agency noted.
This approval was based on results from a clinical trial in which 46 children ages 2-6 with T1D wore the device for approximately three months “to evaluate the performance of the device during both the at-home periods, as well as a hotel period, to stress the system with sustained daily exercise,” the FDA wrote. “That study found no serious adverse events and that the device is safe for use. Data from that study was used to help support the expanded indication for patients 2 to 6 years old.”
Adverse effects associated with this device included hypoglycemia, hyperglycemia, and skin irritation or redness around the device’s infusion patch. And, in order to confirm the safety and efficacy of this device, the FDA is requiring the device manufacturer conduct a post-marketing study to assess device performance in real-world settings. The FDA also noted that this device is not approved for use in children younger than 2 years or kids who need less than eight units of insulin per day.
The MiniMed 770G System is manufactured by Medtronic.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 138
Topic ID: 85,138,730,12,138,192,669,725