Insulet starts pivotal EVOLVE study for fully closed-loop Omnipod M
Bottom line
Insulet has enrolled the first participant in EVOLVE, its pivotal U.S. study of an investigational fully closed-loop Omnipod M system for adults with type 2 diabetes who use insulin. The company said the randomized controlled trial will enroll up to 350 adults ages 18 to 75 across as many as 40 U.S. sites, after receiving FDA investigational device exemption approval in March 2026. Unlike current automated insulin delivery approaches that still require some user input, Insulet says its fully closed-loop system is designed to eliminate bolusing, mealtime announcements, and startup settings. The company is targeting a 510(k) submission in 2027 and a commercial launch in 2028. (investor.insulet.com)
Why it matters: For veterinary professionals watching diabetes technology more broadly, EVOLVE is another sign that device makers are pushing toward lower-burden insulin management in type 2 diabetes, especially in primary care settings where Insulet says about 70% of these patients are managed. That matters because simplification, training burden, workflow fit, and safety oversight often determine whether new chronic-disease tools gain traction in everyday practice. The study also builds on earlier Insulet data: the company’s EVOLUTION 2 feasibility results, presented at ATTD 2026, showed average time in range of 68%, a 24-point improvement over standard injection therapy, while Insulet’s earlier SECURE-T2D pivotal program helped support Omnipod 5’s FDA clearance for adults with type 2 diabetes. (investor.insulet.com)
What to watch: Watch for enrollment updates, fuller EVOLVE protocol details, and whether Insulet stays on track for a 2027 FDA filing as it advances the platform amid heightened device-safety scrutiny following its March 12, 2026, correction for certain Omnipod 5 pods in the U.S. (investor.insulet.com)
Key facts
- Study name
- EVOLVE
- Study type
- Randomized controlled U.S. pivotal trial
- Device
- Investigational fully closed-loop Omnipod M system
- Population
- Adults with type 2 diabetes who use insulin
- Enrollment
- Up to 350 adults ages 18 to 75
- Sites
- As many as 40 U.S. sites
- FDA status
- Investigational device exemption approved in March 2026
- Design goal
- Eliminate bolusing, mealtime announcements, and startup settings
- Company timeline
- Targeting a 510(k) submission in 2027 and commercial launch in 2028
Insulet has moved its next type 2 diabetes platform into pivotal testing, announcing that the first participant has been enrolled in EVOLVE, a randomized U.S. trial of the company’s investigational fully closed-loop Omnipod M system. The study is designed to evaluate a more automated insulin delivery model for adults with type 2 diabetes who use insulin, with Insulet positioning the system as a way to reduce day-to-day management burden for both patients and care teams. (investor.insulet.com)
The announcement builds on several years of work by Insulet to expand automated insulin delivery beyond type 1 diabetes. In 2024, the company reported positive SECURE-T2D pivotal results for Omnipod 5 in adults with type 2 diabetes, showing improvements in HbA1c, time in range, hyperglycemia, insulin dose, and diabetes distress in a 305-patient study across 21 U.S. sites. Omnipod 5 has since been cleared by the FDA for adults with type 2 diabetes, giving Insulet a commercial foothold in a population that historically has had limited access to automated insulin delivery tools. (investor.insulet.com)
What’s new here is the degree of automation Insulet is aiming for. According to the company, EVOLVE will enroll up to 350 adults ages 18 to 75 at as many as 40 U.S. centers, including people using basal-only or basal-bolus insulin regimens. Insulet received FDA investigational device exemption approval in March 2026. The company says the fully closed-loop design is intended to remove bolus dosing, mealtime announcements, and startup settings, which could make the system more practical for broader use, particularly outside endocrinology clinics. (investor.insulet.com)
That strategy follows encouraging feasibility data. In EVOLUTION 2, presented at ATTD 2026, Insulet reported average time in range of 68%, representing a 24-percentage-point improvement over standard injection therapy, without mealtime interactions. The company has said EVOLUTION 2 built on its earlier EVOLUTION 1 work, where participants improved time in range from 52% to 65% with minimal hypoglycemia, and used those findings to refine the algorithm before starting the pivotal program. Study investigator Martin de Bock said the results suggested high time in range could be achieved with a fully automated, easier-to-use system. (investor.insulet.com)
Industry context also matters. The American Diabetes Association said its 2026 Standards of Care removed certain treatment prerequisites before starting continuous subcutaneous insulin infusion or automated insulin delivery, signaling a more permissive stance toward broader use of these systems. Insulet has explicitly linked its type 2 strategy to that shift, while also arguing that adoption remains low relative to the estimated 5.5 million U.S. adults with type 2 diabetes who require insulin. The company said its U.S. type 2 prescriber base grew by more than 60% in 2025 to more than 6,500 clinicians. (diabetes.org)
Why it matters: For veterinary professionals, the relevance is less about direct clinical crossover and more about how chronic-disease technology evolves in real-world care. EVOLVE is a case study in where medtech is heading: fewer manual steps, lighter onboarding, broader use in primary care, and stronger emphasis on workflow fit. Those same pressures shape adoption of remote monitoring, connected therapeutics, and long-term management tools across animal health. At the same time, simplification doesn’t remove the need for vigilance. Insulet’s progress comes just weeks after the company initiated a March 12, 2026, voluntary correction for certain Omnipod 5 pods in the U.S., with the FDA later classifying it as a Class I recall tied to leakage-related dosing risk. (investor.insulet.com)
What to watch: The next milestones are enrollment progress, any presentation of the full EVOLVE protocol, and whether Insulet can hit its stated timeline of a 2027 510(k) submission and 2028 launch. It will also be worth watching whether regulators, clinicians, and payers view fully closed-loop use in insulin-treated type 2 diabetes as a meaningful expansion of access, or as a higher bar for evidence and post-market safety monitoring. That’s especially relevant as companies try to move advanced automation into larger, more heterogeneous patient populations. (investor.insulet.com)