Insulet Launches EVOLVE Pivotal Trial to Accelerate Development of a Fully Closed-Loop Insulin Delivery System for Type 2 Diabetes
Insulet Corporation, a global pioneer in tubeless insulin pump technology through its Omnipod® platform, has taken a significant step forward in diabetes innovation by enrolling the first participant in its pivotal EVOLVE clinical study. This study is designed to evaluate the company’s next-generation fully closed-loop (FCL) automated insulin delivery (AID) system for individuals living with type 2 diabetes (T2D). The development represents a potentially transformative advancement in diabetes care, aiming to simplify disease management while improving glycemic outcomes across a wide range of patient populations and care environments.
The fully closed-loop system under investigation is intended to minimize, and in some cases eliminate, the need for user interaction in insulin delivery. Unlike current AID systems that often require manual input for mealtime boluses or therapy adjustments, Insulet’s FCL technology is designed to autonomously regulate insulin dosing. This includes removing the need for users to announce meals or calculate bolus doses, as well as simplifying system initiation by eliminating complex setup requirements. The ultimate goal is to significantly reduce the daily burden associated with insulin therapy, particularly for individuals with type 2 diabetes who may be managed in primary care settings rather than specialized endocrinology clinics.
According to Dr. Trang Ly, Senior Vice President and Chief Medical Officer at Insulet, the company’s innovation strategy is rooted in improving the lived experience of people with diabetes. She emphasized that the initiation of the EVOLVE study marks an important milestone toward realizing a fully automated insulin delivery system. The technology is powered by a sophisticated algorithm trained on extensive datasets derived from both real-world patient use and simulated scenarios. This algorithm is designed to continuously monitor glucose levels and dynamically adjust insulin delivery in a safe and effective manner, offering a more intuitive and hands-off approach to diabetes management.
The EVOLVE study itself is structured as a multi-center, randomized controlled trial and is expected to enroll up to 350 adult participants across as many as 40 clinical sites in the United States. Eligible participants are between the ages of 18 and 75 and are currently using insulin therapy, whether through basal-only or basal-bolus regimens. The study follows the company’s receipt of Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in March 2026, allowing the investigational system to be tested in a clinical setting.
A key focus of Insulet’s strategy is to expand access to automated insulin delivery technologies, particularly within primary care. Approximately 70% of individuals with type 2 diabetes in the United States receive treatment in primary care settings, where time, resources, and specialized training may be limited. By streamlining onboarding processes and eliminating the need for detailed system configuration, the FCL system is designed to reduce the workload for healthcare providers and make advanced diabetes technology more accessible to a broader patient population. This could play a crucial role in addressing the gap between technological innovation and real-world adoption.
The EVOLVE pivotal study builds upon a series of earlier feasibility studies that informed the design and functionality of the fully closed-loop system. Results from these preliminary studies were presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona, Spain. The findings demonstrated promising improvements in glycemic control, including a 24% increase in time in range (TIR), achieving an average of 68% compared to standard injection therapy. These results suggest that the system has the potential to deliver clinically meaningful benefits for patients.
Insulet’s progress in advancing AID technology for type 2 diabetes is further supported by outcomes from its earlier SECURE-T2D pivotal trial, which evaluated the Omnipod 5 system. In that study, participants experienced significant improvements in glycemic control, including a reduction in HbA1c levels from 8.2% to 7.4% and a 20% increase in time in range—from 45% to 66%, equivalent to an additional 4.8 hours per day spent within target glucose levels. These results contributed to Insulet becoming the first company to receive FDA 510(k) clearance for an automated insulin delivery system specifically indicated for adults with type 2 diabetes.
Since that milestone, adoption of the Omnipod 5 system has grown steadily, supported by encouraging real-world evidence. Data from 2025 indicate that some individuals with optimized system settings achieved time-in-range levels exceeding 80%. Additionally, the number of healthcare providers prescribing Insulet’s technology for type 2 diabetes has increased substantially, with the U.S. prescriber base growing by more than 60% in 2025 to exceed 6,500 clinicians.
Despite this progress, overall adoption of automated insulin delivery systems among people with type 2 diabetes remains relatively low. Of the approximately 5.5 million individuals in the United States who require insulin therapy, fewer than 5% currently use AID systems. Insulet is actively working to close this gap by developing solutions that are easier to use, require less training, and can be seamlessly integrated into routine clinical practice. These efforts align with recommendations from the American Diabetes Association’s 2026 Standards of Care, which advocate for broader use of diabetes technology to improve patient outcomes.
Looking ahead, Insulet plans to submit a 510(k) regulatory filing to the FDA for its fully closed-loop system in 2027, with a potential commercial launch targeted for 2028. If successful, the system could redefine the standard of care for insulin-dependent type 2 diabetes by offering a truly automated solution that reduces both the cognitive and practical burdens of disease management.
It is important to note that the fully closed-loop AID system remains an investigational device and is currently limited to use within clinical trials. It has not yet been reviewed or approved by regulatory authorities. However, the initiation of the EVOLVE study marks a critical step toward bringing this next-generation technology closer to patients who may benefit from a simpler, more effective approach to managing their condition.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.
Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas.
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