Insulet Corporation, 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. This is another step forward in our mission to simplify life for people with diabetes.”
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%.
“The daily management of type 1 diabetes is relentless,” said Jose S., father of a pediatric pivotal trial participant. “Caregivers make multiple decisions each day that profoundly affect their loved one’s wellness and safety. Insulet’s Omnipod 5 System reduces this burden by automating much of the decision making. It also provided me peace of mind by mitigating the threat of hypoglycemia.”
Assistant Professor Gregory Forlenza at Barbara Davis Center, University of Colorado and Principal Investigator agreed that Omnipod 5 makes diabetes management simpler, while improving overall clinical results for users.
“The Omnipod 5 System is phenomenal, improving diabetes outcomes for children and adults while greatly reducing the burden of diabetes management,” said Dr. Forlenza. “With the algorithm built into the Pod itself, it is easier than ever for people with diabetes to rely on automated insulin delivery to manage their blood glucose levels and keep them in range. Insulet has created a very impressive device that will surely change lives.”
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.
“It was remarkable how quickly every family learned to trust the automation, allowing people to sleep through the night for the first time in years,” said Professor Irl Hirsch, University of Washington. “The significant improvement in glycemic outcomes they achieved with the use of Omnipod 5, including the remarkably low rates of hypoglycemia, led to a tremendous reduction in the burden of care for so many.”
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.