Insulet has commenced patient enrolment in its pivotal EVOLVE study, evaluating a fully closed-loop automated insulin delivery (AID) system for adults with type 2 diabetes (T2D).
The system eliminates the need for user-initiated bolusing and mealtime announcements, streamlining diabetes management in a range of care environments.
The multi-centre randomised control trial will include up to 350 adult participants, aged between 18 and 75, who have T2D and currently use either basal-bolus or basal-only insulin. It is recruiting at as many as 40 sites across the US.
Insulet gained investigational device exemption (IDE) approval from the US Food and Drug Administration in March 2026.
With this fully closed-loop system, the company aims to improve access and usability for people managed in primary care, which accounts for approximately 70% of the T2D population.
By removing onboarding and dosing set-up requirements, the system is intended to reduce workload for healthcare providers.
The pivotal EVOLVE study follows a three-part feasibility study sequence, results of which were presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona, Spain.
The company anticipates a 510(k) submission for its fully closed-loop AID system in 2027 and market launch in 2028.
Insulet diabetes products division senior vice-president and chief medical officer Dr Trang Ly said: “Our innovation strategy is grounded in empathy and steadfast in our mission to transform the lives of people with diabetes. Enrolling the first EVOLVE study participant marks an important step toward a fully closed-loop AID system.
“Powered by a novel algorithm trained on extensive real and simulated patient data to safely titrate dosing and automatically adjust insulin delivery, our fully closed-loop AID system is uniquely designed to further reduce the burden for people with type 2 diabetes and their care teams.”
In March 2026, Insulet initiated a voluntary recall for certain lots of its Omnipod 5 pods following 18 serious adverse event (SAE) reports associated with a defect in the AID system.
