ROME GS System Study
← catalyst calendarNCT07518004 · readout ≤ 743 d
Sponsored by Senseonics, Inc. (industry) · SENS — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Diagnostic
Enrollment
60estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-12 | actual | When the study began enrolling |
| Primary completion | Aug 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diabetes
- Diabetes Melletus, Type 1
- Diabetes Mellitus, Type 2
Intervention
- Device: Continuous Glucose Monitoring System
Primary outcomes
what the primary-completion date above is the date OFMean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion.
measured 365 days post-insertion
Number of device-related or sensor insertion/removal procedure-related serious adverse events
measured 365 days post-insertion and follow-up
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