Omnipod® 5 Insulin Delivery System FDA-Cleared for Type 2 Diabetes

Insulet Corporation, a global leader in tubeless insulin pump technology, has announced the FDA clearance of its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by adults with type 2 diabetes. This marks the first time an Automated Insulin Delivery (AID) system has been approved for both type 1 and type 2 diabetes management in the United States.

Jim Hollingshead, President and CEO of Insulet, hailed the announcement as a significant breakthrough in diabetes care. He emphasized the system's potential to improve health outcomes and enhance the quality of life for people with type 2 diabetes by offering a more user-friendly and effective insulin delivery method.

In the United States, over 30 million people live with type 2 diabetes, and around 6 million of them require insulin. Of these, 2.5 million use multiple daily injections (MDI). Despite advancements in diabetes treatments, the percentage of adults achieving recommended HbA1c levels has not significantly changed in the past two decades. Only 25% of those on insulin therapy achieve an HbA1c of 7.0% or less, and 50% have HbA1c levels exceeding 8.0%. Treatment guidelines recommend timely initiation and intensification of insulin therapy, yet this is frequently delayed or inadequately executed.

Insulet's recent data presentations support the effectiveness of Omnipod 5 in improving health outcomes for people with type 2 diabetes. The SECURE-T2D clinical study highlighted significant reductions in HbA1c levels, with an overall decrease of 0.8% and a 2.1% reduction in individuals with HbA1c levels of 9.0% or higher. Additionally, the study indicated decreased time in hyperglycemia, lower total daily insulin doses, and a 20% improvement in time spent within target glucose range, with an increase of 4.8 hours per day. Importantly, these benefits were achieved without increasing the time spent in hypoglycemia, and patients reported reduced diabetes-related distress.

Omnipod 5 simplifies diabetes management by eliminating the need for multiple daily injections and automatically adjusting insulin delivery every five minutes through its advanced SmartAdjust technology. As the most prescribed and favored insulin pump in the U.S., Omnipod 5 is also waterproof, discreet, and wearable. It is the first tubeless AID system that connects with a continuous glucose monitor to proactively manage blood glucose levels, offering protection against both hyperglycemia and hypoglycemia around the clock.

Dr. Anne L. Peters, Director of the University of Southern California Westside Center for Diabetes, praised the system's ability to help patients maintain their target glucose levels more easily than with injections. She highlighted the significant improvements in clinical outcomes and overall quality of life that Omnipod 5 offers, predicting that this innovation could transform diabetes care for those requiring insulin.

Insulet Corporation is headquartered in Massachusetts and is dedicated to improving the lives of people with diabetes and other conditions through its Omnipod product platform. The company’s flagship product, the Omnipod Insulin Management System, offers a unique alternative to traditional insulin delivery methods. By integrating with a continuous glucose monitor, Omnipod 5 manages blood sugar levels without the need for multiple daily injections or fingersticks, and can be controlled via a compatible smartphone or the Omnipod 5 Controller. Insulet is also exploring the application of its Pod technology for delivering non-insulin drugs subcutaneously.

With the FDA clearance for type 2 diabetes, Omnipod 5 sets a new standard in diabetes management, providing an innovative, patient-centric solution that promises to significantly enhance the lives of those managing insulin-dependent diabetes.