Clinical Trial

Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature

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Summary
A prospective, multicenter evaluation of performance and safety of the Eversense Gemini System with flash glucose measurement feature. The purpose of this clinical investigation is to evaluate the accuracy of the Gemini System with new technological flash glucose monitoring (FGM) feature enhancements compared to reference glucose measurements and the Eversense 365 CGM System. The investigation will also evaluate safety of the Gemini System usage.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-22
Trial Details
NCT Number NCT07386340
Lead Sponsor Senseonics, Inc.
Conditions Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Enrollment 80 participants
Start Date 2025-12-29
Primary Completion 2027-12 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-21