Insulet launches EVOLVE trial for fully closed-loop type 2 diabetes system

GERMANY—Insulet has enrolled the first participant in its pivotal EVOLVE study, marking a major step in the development of a fully closed-loop automated insulin delivery (AID) system for adults living with type 2 diabetes (T2D).

The company announced the milestone just days after revealing new clinical data that highlighted the potential of its next-generation diabetes technology.

The investigational system is designed to automate insulin delivery without requiring users to announce meals or initiate bolus doses manually.

By eliminating these routine interactions, Insulet aims to simplify diabetes management for patients while easing the clinical burden associated with insulin therapy.

The EVOLVE study is a multi-centre randomized controlled trial expected to enrol up to 350 adults aged between 18 and 75 across as many as 40 clinical sites in the United States.

Participants must have type 2 diabetes and currently manage their condition using either basal-bolus or basal-only insulin regimens.

The study will compare the safety and effectiveness of the fully closed-loop system against standard therapy.

Designed for primary care settings

Insulet received Investigational Device Exemption approval from the U.S. Food and Drug Administration in March 2026, clearing the way for the trial to begin.

The company says the technology has been specifically designed to improve accessibility for people managed in primary care settings, where nearly 70% of type 2 diabetes patients receive treatment.

Because the system removes complex onboarding steps and dosing set-up requirements, healthcare providers may be able to adopt it more easily across broader care environments.

Dr. Trang Ly, senior vice-president and chief medical officer at Insulet, said the company’s innovation strategy is focused on reducing the daily burden faced by people living with diabetes.

He noted that the enrollment of the first EVOLVE participant marks a significant milestone towards delivering a fully automated insulin delivery platform, powered by a novel algorithm trained on extensive real-world and simulated patient data to safely adjust insulin dosing automatically.

Clinical data builds momentum

The EVOLVE trial follows a three-part feasibility study program, including the recently presented EVOLUTION 2 results at the 19th Advanced Technologies & Treatments for Diabetes 2026 in Barcelona, Spain.

Those findings showed participants achieved an average time-in-range of 68%, representing a 24% improvement over standard injection therapy, without requiring meal boluses.

Researchers also reported no severe hypoglycemia or diabetic ketoacidosis events during the study period.

The company plans to submit a 510(k) application to the FDA in 2027, with commercial launch targeted for 2028.

The latest development follows Insulet’s voluntary recall in March 2026 of select Omnipod 5 pod lots after 18 serious adverse events linked to a system defect, prompting increased focus on product safety as the company advances its next-generation platform.