Insulet’s Omnipod 5 automated insulin delivery system improves clinical outcomes in type 1 diabetes
Insulet Corporation (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, 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.
“Our team has been committed to developing a hybrid closed-loop insulin delivery system to advance the treatment of insulin-dependent diabetes,” said Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “Our pivotal study has achieved remarkable improvement in glucose control, evidenced by impressive reduction in HbA1c and improved time in range, together with the lowest rates of hypoglycemia. We are incredibly proud of these results, which demonstrate the system is safe and effective across a wide range of age groups.
Omnipod 5 System Pivotal Study Overview: 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%.
Nearly all participants completed the pivotal study (98% of all participants) and virtually all of those opted to continue using the Omnipod 5 System during an extension phase of the study. The study results and participants’ desire to continue with the extension phase demonstrates their overall satisfaction with the Omnipod 5 System.
The Omnipod 5 System received breakthrough device designation from the FDA and is currently under review. The Company expects to launch Omnipod 5 in limited release during the first half of 2021.