Insulet shared new clinical data at Advanced Technologies & Treatment for Diabetes (ATTD) 2026 in Barcelona, moving its investigational fully closed-loop automated insulin delivery system for people with type 2 diabetes closer to real-world use.
In the EVOLUTION 2 feasibility study, adults with type 2 diabetes achieved an average time in range of 68% without any mealtime boluses, a gain of about 24 percentage points over standard injection-based therapy and 7% higher than its hybrid closed-loop algorithm. Median time below range was around 0.14% with no reports of severe hypoglycemia.
The trial enrolled 24 participants in New Zealand, ages 16 to 70, testing how an adaptive closed-loop algorithm could independently manage glucose around meals, during activity, and overnight. Continuous glucose monitoring data confirmed steady control across the full 24-hour period without any manual bolus dosing, underscoring the potential for a truly hands-off insulin delivery experience.
24-hour glucose profile demonstrating reduced overall glucose levels without mealtime boluses.
Researchers evaluated three consecutive versions of the control algorithm during the study, with each new version improving performance. The second iteration was considered the "Goldilocks" design, balancing glucose control and safety.
Using the second algorithm, participants reached 68% time in range while keeping hypoglycemia minimal across all subgroups, including differences in weight, ethnicity, sex, and starting glucose control.
Three algorithm design iterations, with Version 2 identified as the optimal design.
Insulet's roadmap for the fully closed-loop program shows two feasibility phases now complete and additional studies planned before regulatory submission.
The company expects to launch the pivotal EVOLVE study in 2026 to support a planned 510(k) submission in 2027 and a potential commercial launch in 2028. Insulet says this algorithm will set the stage for an eventual fully closed-loop algorithm for people with type 1 diabetes, but no word on timing.
Clinical trials roadmap with two phases completed and EVOLUTION 3 and EVOLVE studies remaining before regulatory submission.
This fully closed-loop effort runs in parallel with Insulet's broader innovation pipeline, including the next-generation Omnipod 6 system and the new Discover data platform, reflecting a push toward more automated diabetes management.