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

Part of paid clinical trials in Escondido, California.

Sponsor
Senseonics, Inc.
Study ID
NCT07386340
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitoring System — DEVICE
    Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System

Study Details

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.

Key Dates

Start date
Dec 29, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Continuous Glucose Monitoring Device
    Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System

Primary Outcome Measure

System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. [ Time Frame: 365 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Headlands Research - AMCR InstituteEscondidoCalifornia92025
Jenine Yager Stone, PhD, MSN, FNP-C
[email protected]
760-466-1520

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EndocrinologyMetabolic healthWeight loss
By research site
Headlands Research - AMCR Institute· Escondido, CA

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