RecruitingNot ApplicableNCT07518004

ROME GS System Study

ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System

Sponsor

Senseonics, Inc.

Enrollment

60 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Diabetes Diabetes Melletus, Type 1

Summary

The purpose of this clinical investigation is to demonstrate that the proposed physical changes to the ROME GS Sensor do not have any adverse impact on safety and performance when compared to the Eversense 365 Sensor.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Continuous Glucose Monitoring System for people with diabetes, diabetes melletus, type 1, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

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 ROME GS System

Locations(4)

Headlands Research - AMCR Institute

Escondido, California, United States

Flourish Research - Diablo Clinical Research

Walnut Creek, California, United States

Flourish Research - San Antonio

San Antonio, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07518004

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ROME GS System Study

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(4)

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