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NCT07518004 · ClinicalTrials.gov registry record · NA
ROME GS System Study
A NA study, sponsored by Senseonics.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07518004: Recruiting NA study, sponsored by Senseonics.
NCT07518004 is a NA study that is actively recruiting participants, run by Senseonics. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07518004, a NA study, is actively recruiting participants, sponsored by Senseonics.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
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.
Primary Outcome
To determine accuracy of the ROME GS System measurements compared to a reference glucose analyzer. The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively. Neither inferential analysis nor hypothesis testing will be performed.
Interventions
- DEVICE Continuous Glucose Monitoring System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-02-12 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT07518004 shows while recruiting
NCT07518004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Continuous Glucose Monitoring System is the first listed.
NCT07518004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07518004 about?
NCT07518004 is a clinical study titled "ROME GS System Study". 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.
What is the current status of trial NCT07518004?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-02-12. Estimated completion is 2028-12.
What interventions are being tested in trial NCT07518004?
The interventions under investigation include: Continuous Glucose Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT07518004?
This trial is sponsored by Senseonics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07518004's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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