FDA clears Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by people with type 2 diabetes – Insulet Corporation

Insulet Corporation , the global leader in tubeless insulin pump technology with its Omnipod brand of products, 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.

This 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., with approximately 6 million people who require insulin, of which 2.5 million are using multiple daily injections (MDI). 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 targets . 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% . Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified .

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 higher. 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 pump 7 in the U.S., the waterproof, 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 . 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.”