Therapy Areas: Diabetes
Insulet Receives FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes
22 August 2022 - - US-based tubeless insulin pump technology provider Insulet Corp. (NASDAQ: PODD) has received clearance from the US Food and Drug Administration for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes, the company said.

Omnipod 5, the first tubeless automated insulin delivery system in the US, was originally cleared for use in individuals aged six and older in January 2022.

Omnipod 5 is the first tubeless AID system in the US 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.

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 (
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