Acton, Massachusetts-based Insulet aims to bring a fully closed-loop (FCL) system to the type 2 diabetes population to further improve glycemic outcomes with less burden for users across diverse settings. That includes eliminating user interactions for bolusing and mealtime announcements. It also helps eliminate settings to start and onboard users.
The maker of the Omnipod 5 platform looks to build on the world’s first available tubeless, wearable, automated insulin delivery system. The patch-based pump system proactively corrects for glucose highs every five minutes and protect against lows with insulin dosing.
“Our innovation strategy is grounded in empathy and steadfast in our mission to transform the lives of people with diabetes,” said Insulet SVP and Chief Medical Officer, Dr. Trang Ly. “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.”
Read more from McEvoy and other Insulet leaders from the company’s 2025 Investor Day event.
More on the new technology from Insulet and the EVOLVE study
Insulet plans for EVOLVE to enroll up to 350 adults across a maximum of 40 U.S. sites. It intends to evaluate participants between 18-75 years of age, living with type 2 diabetes and using insulin (basal-bolus or basal-only).
The company received FDA investigational device exemption to conduct the study in March. It follows positive data from the EVOLUTION 2 feasibility study evaluating FCL for type 2.
Insulet said it aims to remove barriers and expand access to automated insulin delivery. It hopes to streamline onboarding and training while eliminating startup settings. The company believes this reduces workload and supports healthcare professionals across specialties and care settings.
Two years ago, Insulet became the first company to receive FDA 510(k) clearance for an automated insulin delivery system for type 2. It said it aims to continue expanding adoption of automated insulin delivery for this population.
Next, Insulet plans to submit the technology to the FDA for 510(k) clearance in 2027. It aims to bring the technology to market in 2028.
