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ROME GS System Study

NCT07518004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Diabetes
  • Diabetes Melletus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Continuous Glucose Monitoring System

Eversense 365 Continuous Glucose Monitoring System and ROME GS 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
2026-02-12
Primary Completion
2028-08-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07518004 on ClinicalTrials.gov