Shots:
- Insulet has enrolled the first patient in its EVOLVE study to evaluate safety & efficacy of its fully closed-loop (FCL) Omnipod M System, an automated insulin delivery system for T2D vs standard therapy
- Trial will assess the system in ~350 T2D pts (18-75yrs.) using insulin (basal-bolus or basal-only), across the US, with prior feasibility data (presented at ATTD’26) showing 24% improvement in time in range, averaging 68%, vs standard injection therapy
- Additionally, the company is planning for 510(k) submission of its FCL Omnipod M System for T2D to the FDA in 2027, with launch anticipated in 2028
Ref: Businesswire | Image: Insulet | Press Release
Related News: Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes
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