Insulet Presents Promising Study Results for Fully Closed-Loop Automated Insulin Delivery System

Insulet Corporation is sharing new clinical evidence regarding the development of its first fully closed-loop (FCL)^A automated insulin delivery (AID) system for type 2 diabetes.

“Developing and bringing to market a fully closed-loop AID system for people with type 2 diabetes—one that delivers therapy effortlessly and adapts automatically with no mealtime interactions or adjustments—is more than evolutionary; it’s revolutionary,” Insulet Senior Vice President/Chief Medical Officer Dr. Trang Ly, Ph.D., said. “Our latest EVOLUTION study brings us another important step closer to addressing significant unmet needs^B while redefining both the provider and user experience.”

Presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona, Spain, EVOLUTION 2^C is the second in a series of feasibility studies supporting the development of an Omnipod fully closed-loop system.

The multicenter feasibility study was designed to drive rapid innovation, allowing investigators to evaluate multiple versions of an algorithm that would support FCL system development. It included 24 adults in a highly diverse cohort from New Zealand, ages 16-70 with type 2 diabetes using insulin (basal-bolus or basal-only, pumps or injections with HbA1c under 12%). The participants had been living with type 2 diabetes for an average of 16 years.

When using the final algorithm version of FCL with no boluses, the participants’ time in range (TIR) increased to an average of 68%, a 24% improvement over standard injection therapy. Time Below Range (TBR) remained very low, with a median of 0.14% below 70 mg/dL—well under the American Diabetes Association’s recommended threshold of less than 4%, the company reported. No severe hypoglycemia or diabetic ketoacidosis (DKA) events were observed. Users experienced improved glycemic outcomes without compromising on low glucose events, and the benefits were observed across a diverse set of participant characteristics, including sex, ethnicity, baseline HbA1c, and body mass index. More than 90% of participants chose to continue into the ongoing extension phase, showing strong interest and positive experiences with the FCL system.

“The EVOLUTION 2 study results show a high time in range can be reached using an easy-to-use, intuitive system that is fully automated with no mealtime interactions. This adds to the growing evidence in support of automated insulin delivery and how innovations grounded in science can improve outcomes, reduce stress, and make diabetes a smaller part of everyday life,” said Dr. Martin de Bock, professor and pediatric endocrinologist at the University of Otago, Christchurch, New Zealand. Dr. de Bock was chief investigator for the EVOLUTION 2 study.

EVOLUTION 2 builds on the 2024 EVOLUTION 1^D feasibility study, which initially evaluated the Omnipod FCL algorithm in adults with type 2 diabetes. EVOLUTION 1 study participants experienced significant improvements in TIR, from 52% to 65%, without boluses, representing more than three additional hours per day in the target range with minimal hypoglycemia.

Insulet used these results to fine-tune the algorithm design, focusing on further simplifying the user experience and laying the groundwork for additional improvements studied with EVOLUTION 2.

The company plans to start its pivotal study (EVOLVE) this year to support a U.S. Food and Drug Administration 510(k) filing in 2027 and a commercial launch in 2028.

Headquartered in Massachusetts, Insulet Corporation is a medical device company striving to simplify life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides an 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 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 U.S. smartphone or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for delivering non-insulin subcutaneous drugs across other therapeutic areas.

References
^A The FCL AID System is an investigational device. Limited by Federal (or United States) law to investigational use. This product has not been reviewed by the FDA or other regulatory agency.
^B Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%, Venkatraman S, et al. Trends and Disparities in Glycemic Control and Severe Hyperglycemia Among U.S. Adults with Diabetes Using Insulin, 1988-2020. JAMA Netw Open. 2022 Dec 1;5(12).
^C https://clinicaltrials.gov/study/NCT07039981
^D https://journals.sagepub.com/doi/full/10.1089/dia.2024.0463