nsulet Corporation presented new Omnipod(R) 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) 82(nd) Scientific Sessions in New Orleans, Louisiana. 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 81(st) 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, % 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. % time in hypoglycemia (<70 mg/dL) was reduced compared with standard therapy: the median was 1.9% during months 10 -- 12 of use compared with 2.2% during standard therapy and 1.9% during the three-month pivotal trial. "I'm delighted to report that the safety and improved glycemic outcomes from the initial three-month pivotal study in pre-school aged children continued for an additional nine months, indicating the potential long-term benefit of the Omnipod 5 System in very young people with type 1 diabetes," said Dr. Daniel DeSalvo, MD of Baylor College of Medicine.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.