Insulet Corporation (NASDAQ: PODD), a leader in tubeless insulin pump technology with its Omnipod® brand, has announced that its Omnipod 5 Automated Insulin Delivery System is now FDA-cleared for adults with type 2 diabetes in the U.S. This makes Omnipod 5 the first and only automated insulin delivery (AID) system approved for both type 1 and type 2 diabetes management.
Jim Hollingshead, President and CEO of Insulet Corporation, emphasized the significance of the FDA’s recent approval for the Omnipod 5 Automated Insulin Delivery System, stating, “This milestone marks a major advancement in patient-centric technology for managing type 2 diabetes. With Omnipod 5, we are providing individuals with an innovative solution that offers greater health outcomes and enhances their quality of life through the benefits of tubeless Pod therapy. We are excited about the impact this technology will have on the type 2 diabetes community.”
In the U.S., over 30 million people have type 2 diabetes, with approximately 6 million requiring insulin. Of these, 2.5 million use multiple daily injections (MDI). Despite advancements in medical therapy, achieving recommended HbA1c targets has remained challenging. Only 25% of insulin-requiring individuals reach an HbA1c of 7.0% or less, while half have an HbA1c above 8.0%. Insulin therapy is often delayed or not intensified despite guidelines recommending it for advanced disease.
Recent data from the SECURE-T2D clinical study highlights the benefits of Omnipod 5. Compared to previous insulin methods, Omnipod 5 led to significant reductions in HbA1c—0.8% overall and 2.1% in individuals with initial HbA1c levels of 9.0% or higher. The system also decreased time in hyperglycemia, reduced daily insulin doses, and improved time in range by 20%, equivalent to an additional 4.8 hours per day, without increasing hypoglycemia. Additionally, the study showed a meaningful reduction in diabetes distress.
The Omnipod 5 System simplifies diabetes management by eliminating MDI and automatically adjusting insulin delivery every 5 minutes using SmartAdjust™ technology. As the top-prescribed and most favored pump in the U.S., Omnipod 5 is a waterproof, discreet, and wearable AID system that communicates with a continuous glucose monitor to adjust insulin delivery and manage glucose levels proactively. The system is easy to prescribe, widely covered by insurance plans, including Medicare Part D.
Dr. Anne L. Peters from the University of Southern California Westside Center for Diabetes noted, “Omnipod 5 makes it significantly easier for people with type 2 diabetes to manage their insulin and stay within target ranges, leading to substantial improvements in clinical outcomes and overall quality of life. This innovative technology has the potential to transform the lives of those requiring insulin for type 2 diabetes.”
