ACTON, Mass .– (BUSINESS WIRE) – Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the world’s leading supplier of tubing-free insulin pump technology with its Omnipod® product brand, today announced positive results from the first pivotal study for the Omnipod® 5 automated insulin delivery system. Omnipod 5, the world’s first tubeless, portable system that continuously adjusts insulin delivery based on glucose levels and trends, dramatically improving range, and reducing HbA1c in children, adolescents and adults aged 6 to 70 with type 1 diabetes. The data was presented at ENDO 2021, the annual meeting of the Endocrine Society and a leading global forum for endocrinology research and clinical care.
“Our team is committed to developing a hybrid, closed-loop insulin delivery system to advance the treatment of insulin-dependent diabetes,” said Trang Ly MBBS, FRACP, PhD, senior vice president and medical director of Insulet. “Our pivotal study achieved a remarkable improvement in glucose control, which translates into impressive reductions in HbA1c and improved range, as well as the lowest hypoglycaemia rates. We are incredibly proud of these results, which show the system is safe and effective in a wide variety of age groups. This is another step forward in our mission to make life easier 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 the ages of 14 and 70 and 112 children between the ages of 6 and 13.9 years. Participants used the Omnipod 5 system at home for a period of 3 months after a period of 14 days using their standard therapy, which included both pump therapy and multiple daily injections.
The Omnipod 5 System showed a significant increase in time span (70-180 mg / dL) from 65% to 74%, or an additional 2.2 hours per day, and an overall decrease in HbA1c of 7.16% in adults and adolescents. to 6.78%. Participants also saw a decrease in mean glucose from 161 to 154 mg / dL. The median time below 70 mg / dl improved from 2.0 to 1.1%. With a target glucose of 110 mg / dl, the subjects achieved a time span of 76% in the range.
In children, the time improved in the area from 53% to 68%, which equates to an additional 3.7 hours per day in the target area. In addition, HbA1c improved from 7.67% to 6.99% and the mean glucose level decreased from 183 to 160 mg / dl. The mean time below 70 mg / dl remained remarkably low at 1.5%.
“The day-to-day management of type 1 diabetes is relentless,” said Jose S., father of a pediatric pivotal study participant. “Caregivers make multiple decisions each day that have a profound impact on the wellbeing and safety of their loved ones. Insulet’s Omnipod 5 system reduces this burden by automating much of the decision-making process. It also gave me security by reducing the risk of hypoglycemia. ”
Assistant Professor Gregory Forlenza of the University of Colorado’s Barbara Davis Center and the Principal Investigator agreed that Omnipod 5 simplifies diabetes management while improving overall clinical outcomes for users.
“The Omnipod 5 System is phenomenal and improves diabetes outcomes for children and adults while significantly reducing the burden of diabetes management,” said Dr. Forlenza. “With the algorithm built into the pod itself, it’s easier than ever for people with diabetes to rely on automatic insulin delivery to control their blood sugar levels and keep them within reach. Insulet has created a very impressive device that is sure to change lives. ”
Virtually all participants completed the core study (98% of all participants), and virtually all participants chose to continue using the Omnipod 5 system during an extension of the study. The study results and participants’ desire to continue the extension phase demonstrate their overall satisfaction with the Omnipod 5 system.
“It was remarkable how quickly every family learned to trust automation so that people could sleep through the night for the first time in years,” said Professor Irl Hirsch of the University of Washington. “The significant improvement in glycemic outcomes they achieved with the Omnipod 5, including remarkably low hypoglycemia rates, resulted in a tremendous reduction in the burden of care for so many.”
The Omnipod 5 system has been identified as a breakthrough by the U.S. Food and Drug Administration and is currently under review. The company expects to launch limited edition Omnipod 5 in the first half of 2021.
About Insulet Corporation:
Massachusetts-based Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to simplifying the lives of people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System offers a unique alternative to traditional insulin delivery methods. With its simple, portable design, the disposable pod provides up to three days of non-stop insulin delivery without the need to see or manipulate a needle. Insulet also capitalizes on its pod’s unique design by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs in other therapeutic areas. More information is available at: www.insulet.com and www.omnipod.com.
This press release may contain forward-looking statements about Insulet’s expectations, expectations, intentions, beliefs, or strategies about the future. These forward-looking statements are based on current expectations and beliefs regarding future developments and their possible effects on Insulet. There can be no assurance that future developments regarding Insulet will be those anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond your control) or other assumptions that could cause actual results or performance to differ materially from those expressed or implied in these forward-looking statements, as well as other risks and uncertainties described in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission under the “Risk Factors” section in February 2021, and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should one of the assumptions prove to be incorrect, the actual results may differ in material respects from those projected in these forward-looking statements. Insulet assumes no obligation to publicly update or revise any forward-looking statements.
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