Omnipod® 5 Automated Insulin Delivery System Significantly Improves Blood Glucose Results Over 12 Months of Use in Children Ages 2-5.9 Years


Insulet presents essential preschool extension data and other clinical research on the Omnipod® 5 System at the American Diabetes Association 82n/a Scientific Sessions

ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the world’s tubeless insulin pump technology with its Omnipod® brand of products, today presented new study results of the Omnipod® 5 (Omnipod 5) automated insulin delivery system for very young children with type 1 diabetes. Omnipod 5, the first tubeless, wearable automated insulin delivery (AID) system in the United States, has significantly improved on-home time and reduced HbA1c in children aged 2 to 5.9 years with type 1 diabetes for 12 months of use. These essential trial extension data were presented to the American Diabetes Association (ADA) 82n/a Scientific Sessions in New Orleans, Louisiana.

“One of our biggest goals in developing Omnipod 5 was to alleviate the burden that type 1 diabetes places on families and caregivers in this vulnerable age group,” said Dr Trang Ly MBBS , FRACP, PhD, Island Senior Vice President and Medical Director. “With the results of these preschool extension trials, we have demonstrated improved long-term glycemic outcomes for very young children managing diabetes. I am incredibly proud of this remarkable achievement and know that Omnipod 5 will have an impact important to these families.

In the initial three-month pivotal trial, Omnipod 5 was shown to be safe and effective, significantly improving on-stand time and lowering HbA1c in 80 very young children (ages 2-5.9) with diabetes type 1. Insulet previously presented these results at ADA Virtual 81st Scientific Sessions in 2021.

Participants in the pivotal trial were asked to continue using the Omnipod 5 System in a rolling extension phase over 12 months, with 100% electing to participate. Results were analyzed after all participants had completed a total of 12 months of Omnipod 5 use (three months in the pivotal trial and nine months in the extension phase). Results from the extension phase demonstrated that participants continued to experience significantly improved results from baseline throughout 12 months of system use, including lower HbA1c and longer duration in the interval, and there were no episodes of DKA or severe hypoglycaemia.

After 12 months of Omnipod 5 use, mean HbA1c was 6.9%, down from 7.4% at baseline and 6.9% at the end of the three-month pivotal trial. Similarly, the percentage of time in range during months 10-12 of use was 67.6%, compared to 57.2% during standard therapy and 68.1% during the three-month pivotal trial. The percentage of time hypoglycaemia (

“I am delighted to report that the safety and improvement in glycemic outcomes from the initial three-month pivotal study in preschoolers continued for an additional nine months, indicating the potential long-term benefits of the system. Omnipod 5 in very young people with type 1 diabetes,” said Dr. Daniel DeSalvo, MD of Baylor College of Medicine. “It is particularly difficult for caregivers to manage diabetes in children under six years of age. , given their unpredictable eating habits and activity levels.These results, along with the tubeless form factor and ease of use of the system, make the Omnipod 5 an excellent choice for automated drug delivery. insulin in this age group not only to optimize blood glucose results, but also to ease the burden of diabetes on the whole family.

Additional clinical data will be presented demonstrating improved results for adults and children with type 1 diabetes, as well as adults with type 2 diabetes, using the Omnipod 5 System. In particular, Insulet anticipates a large interest in the results of the extension phase of the feasibility trial of Omnipod 5 in people with type 2 diabetes. There are a total of five oral and poster presentations at the ADA.

Here is Omnipod’s schedule of clinical presentations:

Oral presentation:

Friday, June 3, 4:15 p.m. – 4:30 p.m. CT (Hall E-2, Level 1)

33-OR 12-Month Blood Glucose Results in Very Young Children with the Omnipod 5 Automated Insulin Delivery (AID) SystemADA President Selection Summary with Dr. Daniel DeSalvo

Poster presentations:

Saturday, June 4, 12:30 p.m. – 1:30 p.m. CT (ePoster, Theater A)

759-P 15-Month Blood Glucose Results with the Omnipod 5 Automated Insulin Delivery System with Dr. Amy Criego (will also be presented during the general poster session on Sunday from 12:00 p.m. to 1:00 p.m. CT)

Sunday, June 5, 12:00 p.m. – 1:00 p.m. CT (Poster Hall, Halls DE)

769-P Glycemic Results in Adults with Type 2 Diabetes Over 34 Weeks with the Omnipod 5 Automated Insulin Delivery System with Dr. Georgia Davis

766-P Blood Glucose Results with the Omnipod 5 Automated Insulin Delivery System Stratified by Baseline Hypoglycemia Risk in People with Type 1 Diabetes Ages 2 to 70 Years with Dr. Gregory Forlenza

765-P Blood Glucose Results for Total Daily Insulin Doses with the Omnipod 5 Automated Insulin Delivery System in People with Type 1 Diabetes Ages 2 to 70 Years with Dr. Melissa Schoelwer

Promotional activities:

Insulet will host a Product Theatre, “Omnipod® 5 Automated Insulin Delivery System – Simplified Glucose Management and Improved Clinical Outcomes for Type 1 Diabetes,” Monday, June 6 from 10:15 a.m. to 11:00 a.m. CT. During this program, Insulet will share key insights gained from clinical researchers, best practices for optimizing blood glucose management, and several case studies highlighting the simplicity and improved clinical outcomes for those transitioning from metered-dose inhaler and other therapies. Dr. Trang Ly will be the moderator, with Dr. Grazia Alep of Northwestern University’s Feinberg School of Medicine and Dr. Viral Shah of the University of Colorado’s Barbara Davis Center for Diabetes as panelists.

Insulet will launch a new podcast aimed at healthcare providers supporting people with diabetes, recording the first episode in front of a live audience at the Omnipod booth. Dr. Grazia Aleppo and Dr. Amy Criego will be interviewed on Omnipod 5 expansion data and other ADA topics. Dr Diana Isaacs and Dr Gregory Forlenza will also be asked about the importance of the entire diabetes care team, in particular how collaboration between this team can strive to meet the needs of people living with diabetes. diabetes.

Additionally, the Omnipod booth will include a pharmacy area to demonstrate the value of access to Omnipod DASH® and Omnipod 5 at retail pharmacies and educate healthcare providers on prescribing Omnipod products.

Sponsored programs:

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 cutting-edge diabetes developments by key opinion leaders.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making life easier for 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 uninterrupted insulin delivery without the need to see or handle a needle. Insulet’s latest innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system integrated with a continuous blood glucose monitor to manage blood sugar without multiple daily injections, without finger pricks, and is fully controlled by a compatible personal smartphone. Insulet is also leveraging its unique Pod design by adapting its Omnipod technology platform for non-insulin subcutaneous drug delivery in other therapeutic areas. For more information, please visit: and

Forward-looking statement:

This press release may contain forward-looking statements regarding Insulet’s expectations, anticipations, 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 effects on Insulet. There can be no assurance that future developments affecting Insulet will be those anticipated by it. 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 differ materially from those expressed or implied by such 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 on February 24, 2022 in the section entitled “Risk Factors”, and in its other filings of 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 differ materially from those projected in such forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2022 Island Corporation. Omnipod, Omnipod DASH and Omnipod 5 are trademarks or registered trademarks of Insulet Corporation in the United States of America and other jurisdictions. All rights reserved. All other trademarks are the property of their respective owners. Use of third-party marks does not constitute an endorsement or imply a relationship or other affiliation.


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