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

Rhea-AI Summary

Insulet (NASDAQ: PODD) announced that its Omnipod 5 Automated Insulin Delivery System has received FDA clearance for use in people with type 2 diabetes aged 18 and older in the U.S. This makes Omnipod 5 the first and only AID system approved for both type 1 and type 2 diabetes. The expansion opens up the market to approximately 6 million insulin-requiring type 2 diabetes patients.

The SECURE-T2D clinical study showed significant improvements in health outcomes for type 2 diabetes patients using Omnipod 5, including a 0.8% overall reduction in HbA1c and a 20% improvement in time in range. The system simplifies diabetes management by automatically adjusting insulin delivery every 5 minutes using SmartAdjust™ technology.

Positive

• FDA clearance for Omnipod 5 use in type 2 diabetes patients expands the potential market
• First and only AID system approved for both type 1 and type 2 diabetes
• Clinical study showed 0.8% overall reduction in HbA1c and 20% improvement in time in range
• Simplifies diabetes management with automatic insulin adjustment
• Widely covered by insurance plans, including Medicare Part D

Negative

• None.

Medical Device Expert

The FDA clearance of Omnipod 5 for type 2 diabetes is a significant breakthrough in diabetes management. As the first AID system approved for both type 1 and type 2 diabetes, it addresses a important gap in treatment options. With 6 million insulin-requiring type 2 diabetes patients in the U.S., this expansion could substantially increase Insulet's market reach.

The system's ability to reduce HbA1c levels by 0.8% overall and 2.1% in high-risk patients is clinically significant. The 20% improvement in time-in-range, equating to 4.8 additional hours daily, could lead to better long-term health outcomes. These results, coupled with reduced insulin doses and improved quality of life, position Omnipod 5 as a game-changer in type 2 diabetes care.

Financial Analyst

This FDA clearance opens up a substantial new market for Insulet. With 2.5 million type 2 diabetes patients on multiple daily injections, the potential for market penetration is significant. As the #1 prescribed and favorite pump in the U.S., Omnipod 5's expanded indication could drive strong revenue growth.

The system's coverage by many insurance plans, including Medicare Part D, reduces barriers to adoption. This, combined with its pharmacy distribution model, positions Insulet for increased market share and potential economies of scale. Investors should monitor adoption rates and revenue growth in the coming quarters to gauge the impact of this expansion on Insulet's financial performance.

Healthcare Policy Expert

The approval of Omnipod 5 for type 2 diabetes aligns with the growing focus on technology-driven healthcare solutions. With only 25% of insulin-using type 2 diabetes patients achieving recommended HbA1c targets, this innovation addresses a critical public health need.

The system's ability to simplify insulin management and improve outcomes could lead to reduced healthcare costs associated with diabetes complications. However, ensuring equitable access to this technology will be crucial. Policymakers and healthcare providers should consider how to integrate such advanced systems into standard care protocols, potentially reshaping diabetes management guidelines and insurance coverage policies.

• 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

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: 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 (NASDAQ: 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240826534708/en/

Investor Relations:

Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation

FAQ

What is the new FDA clearance for Insulet's Omnipod 5 (PODD)?

Insulet's Omnipod 5 Automated Insulin Delivery System has received FDA clearance for use in people with type 2 diabetes aged 18 and older in the U.S., making it the first AID system approved for both type 1 and type 2 diabetes.

How many potential new users does this FDA clearance open up for Omnipod 5 (PODD)?

The FDA clearance for type 2 diabetes opens up the market to approximately 6 million insulin-requiring type 2 diabetes patients in the U.S.

What were the key results of the SECURE-T2D clinical study for Omnipod 5 (PODD)?

The SECURE-T2D clinical study showed that Omnipod 5 use resulted in a 0.8% overall reduction in HbA1c, a 20% improvement in time in range (increasing by 4.8 hours per day), and reduced time in hyperglycemia and total daily insulin dose for type 2 diabetes patients.

How does Insulet's Omnipod 5 (PODD) simplify diabetes management?

Omnipod 5 simplifies diabetes management by automatically adjusting insulin delivery every 5 minutes using its SmartAdjust™ technology, eliminating the need for multiple daily injections and communicating with a continuous glucose monitor.