Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes

• Label expansion makes Omnipod 5 commercially available to 6 million people living with insulin-requiring type 2 diabetes
• Omnipod 5 is the first and only automated insulin delivery (AID) system indicated for both type 1 and type 2 diabetes

Insulet Corporation PODD (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management.

"Today's announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes," said Jim Hollingshead, Insulet President and Chief Executive Officer. "Insulet is paving the way for these individuals to achieve better health outcomes while living with greater confidence and freedom through the game-changing benefits of tubeless Pod therapy. Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community."

There are over 30 million people living with type 2 diabetes in the U.S.¹, with approximately 6 million people who require insulin, of which 2.5 million are using multiple daily injections (MDI)². Despite advances in medical therapy over the past 20 years, there has been no significant change in the percentage of adults with type 2 diabetes achieving recommended HbA1c targets³. Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%⁴. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified⁵.

Insulet recently presented data showing that Omnipod 5 significantly improves health outcomes while making life easier for people with type 2 diabetes. The SECURE-T2D clinical study demonstrated that compared to prior insulin therapy methods in adults with type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher⁶. Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.

The Omnipod 5 System simplifies diabetes management and leads to improved results by eliminating the need for MDI and automatically adjusting insulin delivery every 5 minutes using its advanced SmartAdjust^™ technology. As the #1 prescribed and #1 favorite pump⁷ in the U.S., the waterproof⁸, discreet, and wearable Omnipod 5 is the first tubeless AID system that communicates with a continuous glucose monitor, proactively correcting for highs and protecting against lows, day and night ^9,10. The system is easy to prescribe through the pharmacy and widely covered by many insurance plans, including Medicare Part D.

"I've seen first-hand how difficult it is for patients to reach their targets with injections," said Dr. Anne L. Peters, Director of the University of Southern California Westside Center for Diabetes. "Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life. I believe this innovative technology has the potential to transform the lives of insulin-requiring people with type 2 diabetes."

For more information, visit omnipod.com.

¹National Diabetes Statistics Report: https://www.cdc.gov/diabetes/php/data-research/

²Insulet data on file.

³Fang M, et al. Trends in diabetes treatment and control in U.S. Adults, 1999-2018. N Engl J Med 2021;384:2219–28.

⁴Venkatraman S, et al. Trends and Disparities in Glycemic Control and Severe Hyperglycemia Among U.S. Adults with Diabetes Using Insulin, 1988-2020. JAMA Netw Open. 2022 Dec 1;5(12).

⁵Gavin JR, et al. Therapeutic Inertia and Delays in Insulin Intensification in Type 2 Diabetes: A Literature Review. Diabetes Spectr. 2023 Fall;36(4):379-384.

⁶Pasquel FJ, et al. Presented at: ADA 84^th Scientific Sessions. June 21-24, 2024. Orlando, FL.

⁷USA 2023, Data on file.

⁸The Pod has an IP28 rating for up to 7.6 meters (25 feet) for 60 minutes. The Omnipod 5 controller is not waterproof.

⁹Sherr JL, et al. Diabetes Care (2022). Study in 80 people with type 1 diabetes (T1D) aged 2 - 5.9 years involving two weeks standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode.

¹⁰Brown et al. Diabetes Care (2021). Study in 240 people with T1D aged 6 - 70 years involving two weeks standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode.

About Insulet Corporation:

Insulet Corporation PODD, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. 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. For more information, please visit insulet.com and omnipod.com.

©2024 Insulet Corporation. Omnipod and SmartAdjust are trademarks or registered trademarks of Insulet Corporation. All rights reserved.

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