Insulet Presents Clinical Data for Omnipod 6 and Closed-Loop Systems

What happened

Insulet released clinical trial data for two diabetes management systems at the 2026 American Diabetes Association Scientific Sessions. The STRIVE pivotal trial evaluated the Omnipod 6 automated insulin delivery system across 132 participants (98 with type 1 diabetes, 34 with type 2 diabetes). Results showed that type 1 diabetes patients achieved 77% time in the standard glucose range (70-180 mg/dL) with Omnipod 6, compared to 73% with the existing Omnipod 5 system. Type 2 diabetes patients showed similar improvements (76% versus 73%). The trial also included a bolus-optional phase where participants reduced daily insulin injections while maintaining glucose control-type 1 patients averaged 2.2 fewer boluses per day and type 2 patients 2.5 fewer. The EVOLUTION 3 feasibility study tested a fully closed-loop system in 36 adults with type 2 diabetes. This system achieved 64% time in range, a 12% improvement, while reducing daily insulin requirements from 86 units to 58 units without causing weight gain. Safety profiles remained strong across both studies, with no severe hypoglycemia or diabetic ketoacidosis reported.

Why it matters

These results demonstrate meaningful progress in automated insulin delivery technology for diabetes patients. The Omnipod 6 system delivers up to 50% more automated insulin and operates at a tighter glucose target (100 mg/dL versus 110 mg/dL for Omnipod 5), which translates to better glucose control with less patient effort. For type 1 diabetes patients aged 14 and older, time in the tighter target range (70-140 mg/dL) was 54% with Omnipod 6 compared to 47% with Omnipod 5. The bolus-optional results are particularly significant because they show patients can reduce daily insulin injections while maintaining glycemic control-addressing a major compliance challenge in diabetes management. The fully closed-loop system for type 2 diabetes represents a potential breakthrough by automating mealtime insulin decisions, which could simplify treatment and expand adoption among healthcare providers. The substantial reduction in daily insulin use without weight gain addresses two key concerns for type 2 diabetes patients.

Bigger picture

Automated insulin delivery systems represent the frontier of diabetes technology, moving beyond traditional insulin pumps that require constant user input. Insulet's tubeless Omnipod platform differentiates itself in a competitive market that includes established players with tethered systems. The progression from Omnipod 5 to Omnipod 6, and toward fully closed-loop systems, reflects the industry's push toward minimizing patient burden while improving outcomes. Type 2 diabetes represents a particularly large opportunity-these patients have historically had lower adoption rates of insulin pump technology due to complexity and workflow challenges. A simplified, fully automated system could significantly expand the addressable market. The company has initiated enrollment in the EVOLVE pivotal trial based on EVOLUTION 3 results, with plans to file for FDA approval in 2027 and target a 2028 commercial launch for the fully closed-loop type 2 diabetes system.

What to watch

Monitor progress of the EVOLVE pivotal trial enrollment and results, which will determine whether the fully closed-loop system advances to regulatory review. The planned 2027 FDA filing timeline and 2028 commercial launch target for the type 2 diabetes system represent key milestones. Regulatory decisions on the Omnipod 6 system will also be important, though specific approval timelines were not disclosed in the presented data. Watch for physician and patient adoption patterns as these next-generation systems become available, particularly among type 2 diabetes patients who have traditionally been underserved by automated insulin delivery technology. Competitive developments from other insulin delivery system manufacturers will also shape market dynamics.