Shots:
- Insulet has presented data from the EVOLUTION 2C feasibility study (n=24, 16-70yrs.) assessing its fully closed-loop (FCL) automated insulin delivery system (AID) for T2D at the ATTD’26
- Trial showed that the final FCL algorithm increased TIR to an average of 68% with no boluses, a 24% improvement vs standard injection therapy, while TBR remained very low, with a median of 0.14% below 70mg/dL, with no severe hypoglycemia or diabetic ketoacidosis events; >90% pts continued into the ongoing extension phase
- Insulet plans to initiate the EVOLVE pivotal trial in 2026 to support a 510(k) submission to the US FDA in 2027, targeting commercial launch in 2028
Ref: Businesswire | Image: Insulet | Press Release
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