Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
NCT07386340 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-04-21
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.
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
Interventions
- DEVICE
-
Continuous Glucose Monitoring System
Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
Sponsors & Collaborators
-
Senseonics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-29
- Primary Completion
- 2027-12-31
- Completion
- 2028-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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