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Insulet’s Omnipod® 5 Pivotal Study Extension Data Shows Significant Improvements in Glycemic Control With One Year of Use
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its
About this update from Insulet Corporation
[{"type":"text","content":" ACTON, Mass.--(BUSINESS WIRE)--\nInsulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, has presented positive pivotal trial extension phase results for the Omnipod® 5 Automated Insulin Delivery System (Omnipod 5). 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 over a period of 12 months. The data was presented at EASD 2021, the annual meeting of the European Association for the Study of Diabetes.\n\n”Reducing burden and making diabetes management easier through innovative technology is our number one goal at Insulet,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “We are very pleased that the positive safety and efficacy outcomes resulting from our pivotal study continued for those patients who used Omnipod 5 for a total of 12 months. This product is having an enduring positive impact on trial participants’ health, and we couldn’t be more proud.”\n\nInsulet also presented new clinical outcomes data for people with type 1 diabetes using the Omnipod DASH® System (Omnipod DASH) for 90 days, as well as overall positive self-management behaviors among individuals using Omnipod DASH, Continuous Glucose Monitoring (CGM) and a cloud-based diabetes data management system.\n\nOmnipod 5 System Extension Data Overview\n\nFollowing completion of the 3-month pivotal trial, the results of which were previously shared, 95% of study participants chose to continue use of Omnipod 5 in an ongoing extension study. Insulet presented its data in two groups of extension study participants with type 1 diabetes: 114 adults and adolescents between 14 and 70 years old, and 110 children aged 6 to 13.9 years. The participants used Omnipod 5 at home for a period of 12 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections. The results were presented in 3-month intervals: months 1-3 (the pivotal study), months 4-6, months 7-9, and months 10-12.\n\nAfter 3 months of system use, adults and adolescents had a decrease in HbA1c from 7.2% to 6.8%. T...