RecruitingNot ApplicableNCT07386340

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


Sponsor

Senseonics, Inc.

Enrollment

80 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new continuous glucose monitoring (CGM) system called the Eversense Gemini, which is a sensor implanted under the skin that can also be read with a quick scan — similar to how flash glucose monitors work. It is designed for people with diabetes who want long-term glucose tracking without daily finger pricks. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with diabetes (any type) for at least one year - You have signed an informed consent form and are willing to follow the study protocol **You may NOT be eligible if...** - You had a severe low blood sugar episode (causing loss of consciousness or seizure) in the last 6 months - You were hospitalized for diabetic ketoacidosis in the last 6 months - You have gastroparesis (delayed stomach emptying) - You are pregnant, planning to become pregnant, or breastfeeding - You have a serious heart condition, recent stroke or heart attack, or uncontrolled high blood pressure - You have a condition that would interfere with placing the sensor under the skin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous Glucose Monitoring System

Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System


Locations(1)

Headlands Research - AMCR Institute

Escondido, California, United States

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NCT07386340


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