Clinical Trial

ROME GS System Study

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-01.
Trial Details
NCT Number NCT07518004
Lead Sponsor Senseonics, Inc.
Conditions Diabetes, Diabetes Melletus, Type 1, Diabetes Mellitus, Type 2
Enrollment 60 participants
Start Date 2026-02-12
Primary Completion 2028-08 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-21