ACTON, Mass. - Insulet Corporation (NASDAQ: PODD), the global leader in tubeless insulin pump technology with its Omnipod brand of products, has announced positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial. These results were shared at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. The landmark study assessed the impact of automated insulin delivery (AID) in a diverse group of people with type 2 diabetes, highlighting the promising outcomes and improved quality of life with the use of Omnipod 5.
The SECURE-T2D trial involved over 1,200 participants with type 2 diabetes across 45 centers. The study aimed to evaluate the efficacy and safety of the Omnipod 5 system, a tubeless insulin pump that automates insulin delivery based on real-time continuous glucose monitoring (CGM) data.
The results of the trial demonstrated significant improvements in both clinical outcomes and quality of life for participants. The use of Omnipod 5 led to a reduction in HbA1c levels, the standard measure of glycemic control, by an average of 1.2%. This reduction was achieved without an increased risk of hypoglycemia, a common concern in diabetes management.
Moreover, participants reported a substantial increase in treatment satisfaction and quality of life. The Omnipod 5 system’s ease of use, personalized settings, and automatic insulin adjustments based on real-time data contributed to a more positive diabetes management experience. Participants experienced fewer interruptions in daily activities, greater convenience, and improved peace of mind.
The trial’s success highlighted the potential for AID technology to revolutionize diabetes management for individuals with type 2 diabetes. By automating insulin delivery and leveraging CGM data, the Omnipod 5 system provides a more precise and personalized approach to glucose control.
Insulet CEO, Shacey Petrovic, expressed her excitement about the positive trial results, stating, We believe that the Omnipod 5 system has the potential to transform diabetes management for people living with type 2 diabetes. These findings demonstrate the significant clinical benefits and improved quality of life that can be achieved with this innovative technology.
The Omnipod 5 system is not yet available for commercial use in the United States, but the positive trial results pave the way for its regulatory approval and subsequent market launch. Insulet plans to submit its application to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
The implications of the SECURE-T2D trial results are far-reaching. The ability to automate insulin delivery and personalize treatment has the potential to alleviate the burden of diabetes management for millions of individuals worldwide. Furthermore, the increased treatment satisfaction and improved quality of life experienced by participants demonstrate the importance of taking a holistic approach to diabetes care.
In conclusion, the SECURE-T2D pivotal trial results demonstrate the significant clinical benefits and improved quality of life that can be achieved with the Omnipod 5 Automated Insulin Delivery System. This innovative technology has the potential to revolutionize type 2 diabetes management by automating insulin delivery and leveraging real-time CGM data. As Insulet works towards regulatory approval and market launch, we eagerly anticipate the positive impact the Omnipod 5 system could have on the lives of individuals with type 2 diabetes.
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