Insulet Corporation announced positive results from the first pivotal trial for the Omnipod® 5 Automated Insulin Delivery System. Omnipod 5, the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting and a leading forum for endocrinology research and clinical care worldwide. Insulet presented its data in two groups of type 1 diabetes patients: 128 adults and adolescents between 14 and 70 years old, and 112 children age 6 to 13.9 years. The participants used the Omnipod 5 System at home for a period of 3 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections. The Omnipod 5 System showed a significant increase in time in range (70-180 mg/dL) in the adults and adolescents, from 65% to 74%, or an additional 2.2 hours per day, and an overall reduction of HbA1c from 7.16% to 6.78%. Participants also saw a decrease in mean glucose from 161 to 154 mg/dL. Median time below 70 mg/dL improved from 2.0 to 1.1%. At a target glucose of 110 mg/dL, subjects achieved 76% time in range. In children, time in range improved from 53% to 68%, corresponding to an additional 3.7 hours per day in target range. Additionally, HbA1c improved from 7.67% to 6.99% and the mean glucose level decreased from 183 to 160 mg/dL. Median time below 70 mg/dL stayed remarkably low at 1.5%. The Omnipod 5 System received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The Company expects to launch Omnipod 5 in limited release during the first half of 2021.