Clearance expands on initial clearance from January 2022.
The US Food and Drug Administration has awarded clearance to Insulet Corporation for its Omnipod 5 Automated Insulin Delivery System for individuals aged 2 years and older with type 1 diabetes.
Less than 7 months after receiving clearance for use in patients with type 1 diabetes aged 6 years and older, the latest clearance was announced by Insulet Corporation on August 22 and indicates the system, which integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin, for use in patients with type 1 diabetes aged 2 years and older.
“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 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.”
With initial clearance for individuals aged 6 years and older in January 2022, the latest clearance grants access to the device for an even younger patient population. Available for prescription through the pharmacy channel, the Omnipod 5 is the only insulin pump in the US available through pharmacy, according to the aforementioned release. The first tubeless AID system that received clearance in the US, the Omnipod 5 consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.
According to the release, a recent study demonstrated use of Omnipod 5 in automated mode was associated with significantly improved time in range as well as reduced HbA1c and time in hypoglycemia. The release also pointed out use of the system was associated with improved sleep quality in the study.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet, at the time of the January clearance. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”