NCT07518004

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Senseonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, non-randomized, multi-center evaluation of accuracy and safety of the ROME GS system. 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. The investigation will also determine the accuracy of the ROME GS Sytem measurements compored to a reference glucose analyzer. Additionally, the study will demonstrate the safety of the ROME GS System post-sensor insertion or removal and follow-up by measuring the incidence of device-related and insertion/removal procedure-related serious adverse events during the investigation.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring System	Eversense 365 Continuous Glucose Monitoring System and ROME GS System

Timeline

• Start date: 2026-02-12
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study