Insulet has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes (T1D). Omnipod 5, the first tubeless automated insulin delivery (AID) system in the U.S., was originally cleared for use in individuals aged six and older in January 2022.
“We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”
Omnipod 5 is a tubeless AID system that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin and help protect against high and low glucose levels. The system consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.
Healthcare professionals can now prescribe Omnipod 5 to their patients with insurance coverage and patients can access their prescription through the pharmacy channel, which means there is no contract and no commitment. The Omnipod brand is the only insulin pump in the U.S. available through the pharmacy.
