Insulet Presents Pivotal Extension Data for Preschool Children and Other Omnipod® 5 System Clinical Research at American Diabetes Association 82nd Scientific Sessions
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today presented new Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) study results for very young children with type 1 diabetes. Omnipod 5, the first tubeless, wearable automated insulin delivery (AID) system in the U.S., significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years with type 1 diabetes over 12 months of use. This pivotal trial extension data was presented at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans, Louisiana.
“One of our biggest goals in the development of Omnipod 5 was to ease the burden that type 1 diabetes places on families and caregivers of this vulnerable age group,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “With these preschool extension trial results, we have demonstrated improved glycemic results over the long term for very young children managing diabetes. I’m incredibly proud of this remarkable achievement and know that Omnipod 5 will have a big impact on these families.”
In the original three-month pivotal trial, Omnipod 5 was shown to be safe and effective, significantly improving time in range and reducing HbA1c in 80 very young children (ages 2 to 5.9 years) with type 1 diabetes. Insulet previously presented these results at the ADA Virtual 81st Scientific Sessions in 2021.
The pivotal trial participants were invited to continue using the Omnipod 5 System in an ongoing 12+ month extension phase, with 100% electing to participate. Results were analyzed after all participants had completed a total of 12 months of Omnipod 5 use (three months in the pivotal trial and nine months in the extension phase). The extension phase results demonstrated that participants continued to experience significantly improved outcomes compared with baseline throughout 12 months of system use, including lower HbA1c and greater time in range, and there were no episodes of DKA or severe hypoglycemia.
After 12 months of Omnipod 5 use, average HbA1c was 6.9%, compared with 7.4% at baseline and 6.9% at the end of the three-month pivotal trial. Similarly, percent time in range during months 10 – 12 of use was 67.6%, compared with 57.2% during standard therapy and 68.1% during the three-month pivotal trial. Percent time in hypoglycemia (