The maker of the Omnipod 5 — the world’s first available tubeless, wearable, automated insulin delivery system — said during a 2025 Investor Day event that it plans to bring its first fully closed-loop system to the type 2 diabetes population by 2028. President and CEO Ashley McEvoy laid out some of those plans in a November 2025 interview with Drug Delivery Business News.
Acton, Massachusetts-based Insulet says that the latest study results help to bring it another step closer to addressing unmet needs in type 2 diabetes.
It shared findings from the EVOLUTION 2 study at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona. EVOLUTION 2 marks the second in a series of feasibility studies support the development of a fully closed-loop Omnipod system.
“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,” said Dr. Trang Ly, SVP and chief medical officer of Insulet. “Our latest EVOLUTION study brings us another important step closer to addressing significant unmet needs while redefining both the provider and user experience.”
The advances in fully closed-loop technology come as CamDiab yesterday unveiled its own fully closed-loop offering for type 1 diabetes.
More about the study results from Insulet
Insulet said it designed its multicenter feasibility study to drive rapid innovation. It allowed investigators to evaluate multiple versions of its algorithm to support continued fully closed-loop system development.
The study included 24 adults in a highly diverse cohort from New Zealand, aged 16-70 years with type 2 diabetes using insulin. Participants had lived with type 2 diabetes for an average of 16 years. Dr. Martin de Bock served as chief investigator for the EVOLUTION 2 study.
When using the final algorithm version of fully closed-loop with no boluses, time in range increased to an average of 68%. That marked a 24% improvement over standard injection therapy.
Time below range remained very low, with a median of 0.14% below 70 mg/dL. That lands under the ADA’s recommended threshold of less than 4%. Investigators observed no severe hypoglycemia or diabetic ketoacidosis (DKA) events.
Users experienced improved glycemic outcomes without compromising on low glucose events, Insulet said. Investigators observed benefits across a diverse group 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. Insulet said this demonstrated strong interest and positive experiences with the fully closed-loop 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 de Bock.
