Insulet wins FDA nod to use insulin delivery system in 2 – 5-year-olds
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Insulin pump maker Insulet Corporation (NASDAQ:PODD) announced Monday that the FDA had greenlighted the companyâs Omnipod 5 Automated Insulin Delivery System for use in children aged 2 â 5 years with type 1 diabetes (T1D).
According to the company, Omnipod 5, which includes DexComâs (DXCM) G6 Continuous Glucose Monitoring (CGM) system, is the first tubeless AID system available for preschool children in the U.S.

âWe 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,â noted Dr. Trang Ly, Insuletâs (PODD) Medical Director.
Published data suggest that Omnipod 5 significantly improved key indicators of diabetes such as time in range, reduced HbA1c, and time in hypoglycemia (<70 mg/dL) in very young children with T1D.

The FDA initially cleared the device for those aged six years and above with T1D.