Trials / Recruiting
RecruitingNCT07386340
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Senseonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Glucose Monitoring System | Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System |
Timeline
- Start date
- 2025-12-29
- Primary completion
- 2027-12-01
- Completion
- 2028-05-01
- First posted
- 2026-02-04
- Last updated
- 2026-02-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07386340. Inclusion in this directory is not an endorsement.