Home FDA Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes

Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) 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 the first tubeless AID system in the U.S. that integrates with the Dexcom G6 CGM system and a compatible smartphone1 to automatically adjust insulin and help protect against high and low glucose levels 2. The system3 consists of the tubeless Pod enhanced with SmartAdjustTM technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.

“Omnipod 5 has allowed our family to think less about diabetes,” said Kara Hornbuckle, an Omnipod 5 user with two children also using the system. “Omnipod 5 has provided more control and greater peace of mind for all three of us, especially during the nighttime when we are all most vulnerable. The impact that this device has had on my family cannot be understated. We are just so grateful!”

In a recent publication by Sherr et al. in Diabetes Care4, Omnipod 5 significantly improved time in range, and reduced HbA1c and time in hypoglycemia (<70 mg/dL) in very young children (aged 2 – 5.9 years) with type 1 diabetes. In addition, parents and caregivers of study participants reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)5, a questionnaire considered to be the gold standard in measuring subjective sleep quality.

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.

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