ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that positive results from the most recent clinical trial of the Omnipod® Horizon™ Automated Insulin Delivery System (Omnipod Horizon System) were presented during the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco, California. The study demonstrated that the investigational Omnipod Horizon System performed well and was safe for up to four days of use in children as young as two years old with type 1 diabetes.1
The study was conducted in a supervised hotel setting under free-living conditions with unrestricted meals and daily exercise and included pediatric participants between two and six years old. The study was preceded by seven days of their usual therapy at home with continuous glucose monitoring. Study participants spent significantly less time in hyperglycemia (≥250 mg/dL), spent significantly more time in the target glucose range (70-180 mg/dL), and had better overnight glycemic control compared to their usual therapy, which is in line with the positive performance observed in earlier studies including older pediatric, adolescent and adult study participants. During the study, glucose control was maintained in the target range for 73% of the time overall and 85% of the time during the overnight period. The percentage of time spent in the hypoglycemic range (<70 mg/dL) was very low, at 2.9% overall and 2.0% overnight. The investigational Omnipod Horizon System includes unique features that allow diabetes management to be customized by adjusting the target blood glucose levels and insulin delivery.
“Critical for the pediatric population is the ability for caregivers, or kids, to customize insulin delivery to maintain optimal glycemic control, especially during exercise and following high fat meals or periods after increased activity,” said Jennifer L. Sherr, MD, PhD, of Yale University School of Medicine. “These data show that Insulet’s Omnipod Horizon System is able to meet that need in our youngest patients. This is critical, as children aged two- to six-years face unique diabetes management challenges and they are frequently under studied.”
“We believe it’s critical to test innovations for patients of all ages. The results for the Omnipod Horizon System in pediatric patients as young as two years of age are promising,” said Dr. Trang Ly, Senior Vice President and Medical Director at Insulet. “We strive to be a game-changer for people with diabetes and bring them safe and effective diabetes management therapies that fit into their day-to-day lives at all stages, from baby’s first steps to running a 5K and beyond.”
The Omnipod Horizon System is anticipated for commercial release in the second half of 2020 and will expand upon the current Omnipod DASH System platform. Six additional abstracts with data on Insulet’s Omnipod Insulin Management System were selected for presentation at the ADA scientific sessions during June 7-11, 2019.
For more about Insulet’s future innovation pipeline, please visit myomnipod.com/innovation.
1Buckingham BA, Forlenza GP, Sherr JL, Galderisi A, Lee JB, O’Connor JB, Dumais B, Huyett LM, Layne JE, Ly TT. Safety and Performance of the Omnipod Hybrid Closed-Loop System in Young Children Aged 2-6 Years with Type 1 Diabetes. Presented at the ADA 79th Scientific Sessions, June 9, 2019.
About the Omnipod DASH System:
Insulet’s Omnipod DASH System was designed to serve as the foundation for the Company’s future innovation. Designed with patient discretion and convenience in mind, the Omnipod DASH is a continuous insulin delivery system consisting of two simple components: a tubeless, waterproof*, Bluetooth® wireless technology Pod (pump) that holds up to 200 units of U-100 insulin and a modern, color touch-screen Personal Diabetes Manager (PDM) that controls the Pod. The Omnipod DASH System will have a suite of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making the lives of people with diabetes and other conditions easier through the use of its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod, by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas.
This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission in February 2019 in the section entitled "Risk Factors," 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 any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
*The Pod has a waterproof IP28 rating for up to 25 feet for 60 minutes. The PDM is not waterproof.
© 2019 Insulet Corporation. Omnipod, DASH, and Horizon are trademarks or registered trademarks of Insulet Corporation. All rights reserved.