Insulet Corporation presented compelling real-world evidence demonstrating the clinical impact of its Omnipod 5 automated insulin delivery (AID) system in people with type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions in Chicago. The data showcased outcomes from more than 23,000 people with type 2 diabetes using the system in the United States, alongside new analyses from pivotal clinical trials.
Strong Adoption Following FDA Expansion
Since receiving FDA approval for expanded use in type 2 diabetes in August 2024, Insulet has seen significant uptake in this patient population. Eric Benjamin, Insulet's chief product and customer experience officer, reported that more than 30% of new patient starts in the first quarter of 2025 were people with type 2 diabetes.
"The human impact has been tremendous," Benjamin said, noting increased interest from healthcare providers and "really good" insurance coverage for both type 1 and type 2 diabetes users. All of Insulet's patch pumps are distributed through the pharmacy channel.
Clinical Evidence of Reduced Diabetes Distress
A key highlight was new analysis from the SECURE-T2D pivotal trial, which supported the FDA's expanded indication. The analysis revealed that Omnipod 5 significantly reduced diabetes distress in users over 13 weeks, based on validated questionnaires assessing worries about hypoglycemia, long-term health concerns, care access challenges, and daily diabetes management demands.
The single-arm study enrolled 305 people with type 2 diabetes and was funded by Insulet. Dr. Trang Ly, Insulet's Senior Vice President and Chief Medical Officer, emphasized the importance of these findings: "We are thrilled to share more details that dive deeper into the clinical outcomes from our groundbreaking SECURE-T2D and RADIANT trials, as well as the real-world outcomes we are seeing, especially with type 2 diabetes."
Comprehensive ADA Presentation Program
Insulet's ADA presence included multiple oral presentations and poster sessions. Notable presentations included real-world glycemic outcomes in adults with type 2 diabetes using Omnipod 5, presented by Dr. Sean Oser, and analysis of the RADIANT study showing improved outcomes across baseline time-in-range levels compared to multiple daily injections in type 1 diabetes.
Dr. Ly led a panel discussion titled "Setting the Standard with Omnipod 5: Remarkable Results with Unmatched Simplicity," featuring prominent diabetes specialists including Dr. Anders L. Carlson from the International Diabetes Center, Dr. Gregory Forlenza from the Barbara Davis Center for Diabetes, and Dr. Emma Wilmot from the University of Nottingham.
Next-Generation AID Development Pipeline
Insulet is advancing development of more sophisticated automated insulin delivery systems. The company began enrolling patients in March for its STRIVE study to test a next-generation hybrid closed-loop system featuring a lower glucose set point, enhanced personalization, and improved quality of life benefits.
For fully automated systems, Insulet is prioritizing type 2 diabetes development due to lower hypoglycemia risk compared to type 1 diabetes. "The most salient thing we learned in the first set of studies is that we can do this in a reasonable timeline for people with Type 2 diabetes," Benjamin explained. The company plans to initiate its second set of EVOLUTION studies for the type 2 diabetes closed-loop program in the second half of 2025.
Benjamin noted that faster-acting insulins will likely be necessary for fully automated systems in type 1 diabetes, describing the ultimate goal as "the closest you can get to technology performing the functions of a working pancreas."
Market Position and Competition
As competitors including Tandem, Medtronic, and Beta Bionics develop their own patch pump technologies, Benjamin acknowledged the competitive landscape, stating that "imitation is the finest form of flattery." Insulet's Omnipod 5 system integrates with continuous glucose monitors to manage blood sugar without multiple daily injections or fingersticks, controllable via compatible smartphones or the dedicated Omnipod 5 Controller.
