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WASHINGTON -- A closed-loop insulin delivery system, combining a continuous glucose monitoring device with an insulin pump, was approved for U.S. marketing Wednesday, the FDA announced.
Medtronic's MinMed 670G hybrid system is the first such device to be approved, the agency said. It is indicated for patients age 14 and older with type 1 diabetes requiring at least 8 units of insulin daily.
"This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in a .
A required post-marketing study will examine how well the product works in "real-world settings," the agency noted.
The system delivers basal insulin in amounts adjusted according to blood glucose levels detected with the continuous monitor, with "little or no input from the user," the FDA said. Glucose levels are measured every 5 minutes.
Patients still need to manually request postprandial insulin doses to cope with carbohydrates eaten at meals, the agency noted.
Data from a trial with 123 participants underpinned the approval. Patients used it for 3 months; no serious adverse events such as severe hypoglycemia or diabetic ketoacidosis were seen.
Nevertheless, hyperglycemia and hypoglycemia can still occur with the device, the FDA said. Skin irritation at the site of the infusion patch is also possible.
Medtronic is currently testing the system in children 7-13 years old with an eye toward securing approval in that age group.