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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386340 on ClinicalTrials.gov