ACTON, Mass. — Insulet Corporation (NASDAQ: PODD), the global leader in tubeless insulin pump technology through its Omnipod brand of products, has reported new clinical evidence supporting the development of its first fully closed-loop automated insulin delivery system designed for adults with type 2 diabetes.
The findings come from the EVOLUTION 2 feasibility study, which showed that participants using the fully closed-loop system achieved an average time in range of 68 percent without requiring bolus insulin dosing. The results were presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona, Spain.
“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, MBBS, FRACP, PhD, Senior Vice President and Chief Medical Officer. “Our latest EVOLUTION study brings us another important step closer to addressing significant unmet needs while redefining both the provider and user experience.”
EVOLUTION 2 is the second in a series of feasibility studies supporting the development of an Omnipod fully closed-loop system. The multicenter trial was designed to accelerate innovation by allowing investigators to test multiple algorithm versions as part of the system’s development.
The study enrolled 24 adults in New Zealand aged 16 to 70 who have type 2 diabetes and use insulin therapy, including both basal-bolus and basal-only regimens delivered through pumps or injections. Participants had an average duration of diabetes of 16 years and baseline HbA1c levels below 12 percent.
Using the final version of the fully closed-loop algorithm with no boluses, participants achieved an average time in range of 68 percent, representing a 24 percent improvement compared with standard injection therapy. Time below range remained extremely low, with a median of 0.14 percent of readings below 70 mg/dL, well below the American Diabetes Association’s recommended threshold of less than 4 percent. No cases of severe hypoglycemia or diabetic ketoacidosis were reported.
Investigators said the system improved glycemic outcomes while maintaining low rates of hypoglycemia. Benefits were observed across a diverse group of participants regardless of sex, ethnicity, baseline HbA1c levels, or body mass index. More than 90 percent of participants opted to continue into the ongoing extension phase of the study.
“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 in New Zealand, who served as Chief Investigator for the EVOLUTION 2 study.
The EVOLUTION 2 results build on findings from the 2024 EVOLUTION 1 feasibility study, which was the first evaluation of the Omnipod fully closed-loop algorithm in adults with type 2 diabetes. Participants in that study increased their time in range from 52 percent to 65 percent without boluses, representing more than three additional hours per day within target glucose levels and minimal hypoglycemia.
Insulet used insights from EVOLUTION 1 to refine the algorithm and further simplify the user experience before testing improvements in the EVOLUTION 2 study.
The company plans to begin a pivotal clinical trial called EVOLVE in 2026 to support a 510(k) regulatory filing in 2027, with a potential commercial launch targeted for 2028. (Source: IANS)
