The Omnipod® 5 Automated Insulin Delivery System significantly improves glycemic outcomes over 12 months in children ages 2 to 5.9 years
Insulet presents pivotal preschooler extension data and other clinical research on the Omnipod® 5 System at the American Diabetes Association 82nd Scientific Sessions
ACTON, Mass., June 3, 2022–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (or the “Company”), the global leader in tube-less insulin pump technology through its Omnipod® product brand, today announced study results for the new Omnipod® 5 (Omnipod 5) automated insulin delivery system very young children with type 1 diabetes. Omnipod 5, the first tubeless, wearable automated insulin delivery (AID) system in the US, significantly improved range and lowered HbA1c levels in children ages 2 to 5.9 years with type 1 diabetes over a period of 12 months. Data from this pivotal study extension were presented at the American Diabetes Association (ADA) 82nd Scientific meetings in New Orleans, Louisiana.
“One of our biggest goals in developing Omnipod 5 was to reduce the burden that type 1 diabetes places on families and caregivers of this vulnerable age group,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “With these results from the preschool extension study, we have demonstrated long-term improved glycemic outcomes for very young children with diabetes. I am incredibly proud of this remarkable achievement and I know that Omnipod 5 will have a huge impact on these families.”
In the original 3-month pivotal study, Omnipod 5 was shown to be safe and effective, significantly improving time in action and reducing HbA1c in 80 very young children (ages 2 to 5.9 years) with type 1 diabetes . Insulet previously presented these results at ADA Virtual 81St Scientific sessions in 2021.
Participants in the pivotal study were invited to continue using the Omnipod 5 System in an ongoing extension period of more than 12 months, with 100% choosing to participate. Results were analyzed after all participants had used Omnipod 5 for a total of 12 months (three months in the pivotal study and nine months in the extension phase). Results from the extension phase showed that participants continued to experience significantly improved outcomes, including lower HbA1c and longer time in range, compared to baseline throughout their 12-month use of the system, and there were no episodes of DKA or severe hypoglycemia.
After 12 months of Omnipod 5 use, mean HbA1c was 6.9%, compared to 7.4% at baseline and 6.9% at the end of the 3-month pivotal study. Similarly, the percentage of time in range at months 10-12 of use was 67.6% compared to 57.2% during standard therapy and 68.1% during the 3-month pivotal study. The percentage of hypoglycemic time (
“I am pleased to report that the safety and improved glycemic results from the first three-month pivotal study in preschool children continued for an additional nine months, indicating the potential long-term benefit of the Omnipod 5 System in very young children, according to People with type 1 diabetes,” said Dr. Daniel DeSalvo, MD of Baylor College of Medicine. “Given their unpredictable eating habits and activity levels, it is particularly difficult for caregivers to manage diabetes in children under the age of six. These findings, along with the The tubeless form factor and the ease of use of the system make the Omnipod 5 an excellent choice for automated insulin delivery in this age group, not only to optimize glycemic outcomes but also to alleviate the burden of diabetes for the whole family.”
Additional clinical data will be presented showing improved outcomes for adults and children with type 1 diabetes and adults with type 2 diabetes with the Omnipod 5 System. In particular, Insulet anticipates great interest in the results from the extension phase of the Omnipod 5 proof of concept study in people with type 2 diabetes. There are a total of five oral and poster presentations at ADA.
Below is the schedule of Omnipod clinical presentations:
Friday, June 3, 4:15 p.m. – 4:30 p.m. CT (Hall E-2, Level 1)
33-OR 12-month glycemic outcomes in very young children using the Omnipod 5 Automated Insulin Delivery (AID) SystemSelect Abstract of the ADA Presidents with Dr. Daniel DeSalvo
Saturday, June 4, 12:30 p.m. – 1:30 p.m. CT (ePoster, Room A)
759-P Glycemic results over 15 months with the Omnipod 5 automated insulin delivery system with dr Amy Criego (will also be presented in the general poster session on Sunday from 12:00 – 1:00 pm CT)
Sunday, June 5, 12:00 p.m. – 1:00 p.m. CT (Poster Hall, Halls DE)
769-P Glycemic outcomes in adults with type 2 diabetes over 34 weeks using the Omnipod 5 Automated Insulin Delivery System with dr Georgia Davis
766-P Glycemic results with the Omnipod 5 automated insulin delivery system stratified by baseline risk of hypoglycemia in people with type 1 diabetes aged 2 to 70 years with dr Gregory Forlenza
765-P Glycemic results across total daily insulin doses using the Omnipod 5 automated insulin delivery system in people with type 1 diabetes aged 2 to 70 years with dr Melissa Schoelwer
Insulet will host a product theater,”Omnipod® 5 Automated Insulin Delivery System – Simplified Glucose Management and Improved Clinical Outcomes in Type 1 Diabetes”, on Monday, June 6 from 10:15am – 11:00am CT. During this program, Insulet will share key clinical investigator insights, best practices for optimizing glycemic management, and multiple case studies highlighting the simplicity and improved clinical outcomes for those transitioning from MDI and other therapies. dr Trang Ly will moderate, with Dr. Grazia Aleppo of the Feinberg School of Medicine at Northwestern University and Dr. Viral Shah of the Barbara Davis Center for Diabetes at the University of Colorado will be on the panel.
Insulet will introduce a new podcast aimed at healthcare providers who care for people with diabetes and will record the first episode in front of a live audience at the Omnipod booth. dr Grazia Aleppo and Dr. Amy Criego will be interviewed on the Omnipod 5 expansion dates and other ADA topics. dr Diana Isaacs and Dr. Gregory Forlenza are also interviewed about the importance of the entire diabetes care team, specifically how the collaboration between this team can strive to meet the needs of people with diabetes.
Additionally, the Omnipod booth will include a pharmacy area to demonstrate the value of having access to the Omnipod DASH® and Omnipod 5 in retail pharmacies and to educate healthcare providers on how to prescribe Omnipod products.
Insulet will also sponsor the Diabetes Mine d-data Exchange, an annual program focused on diabetes technology and innovation, and the TCOYD diaTribe Diabetes Forum, an impactful and sophisticated discussion of the latest developments in diabetes from key thought leaders.
About Islet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying the lives of people with diabetes and other diseases 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 single-use pod provides up to three days of uninterrupted insulin delivery without seeing or touching a needle. Insulet’s latest innovation, the Omnipod 5 automated insulin delivery system, is a tube-free automated insulin delivery system integrated with a continuous glucose monitor to control blood glucose without multiple daily injections and without finger sticks, and is fully controlled from a compatible personal smartphone. Insulet is also leveraging its pod’s unique design by adapting its Omnipod technology platform for the delivery of subcutaneous non-insulin drugs in other therapeutic areas. For more information, visit: insulet.com and omnipod.com.
This press release may contain forward-looking statements regarding Insulet’s expectations, expectations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs regarding future developments and their potential impact on Insulet. There can be no assurance that future developments affecting Insulet will meet expectations. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that could cause actual results or performance to differ materially from those expressed or implied by 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 on February 24, 2022, under the “Risk Factors” section and in its other filings with the Securities and Exchange Commission from time to time . 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.
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Source: Insulet Corporation