ROME GS System Study
Part of paid clinical trials in Escondido, California.
- Sponsor
- Senseonics, Inc.
- Study ID
- NCT07518004
- Status
- Recruiting
Conditions
- Diabetes
- Diabetes Melletus, Type 1
- Diabetes Mellitus, Type 2
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Continuous Glucose Monitoring System — DEVICEEversense 365 Continuous Glucose Monitoring System and ROME GS System
Study Details
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.
Key Dates
- Start date
- Feb 12, 2026
- Status verified
- Feb 2026
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Continuous Glucose Monitoring DeviceEversense 365 Continuous Glucose Monitoring System and ROME GS System
Primary Outcome Measure
Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion. [ Time Frame: 365 days post-insertion ]
Central Contacts
- Maggie Lewis667-218-3309
- Susan Huynh301-407-2923
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Headlands Research - AMCR Institute | Escondido | California | 92025 | |
| Flourish Research - Diablo Clinical Research | Walnut Creek | California | 94598 | Mark Christiansen, MD (PRINCIPAL_INVESTIGATOR) |
| Flourish Research - San Antonio | San Antonio | Texas | 78229 | Douglas Denham, DO (PRINCIPAL_INVESTIGATOR) |
| Rainier Clinical Research Center | Renton | Washington | 98057 | Frances Broyles, MD (PRINCIPAL_INVESTIGATOR) |
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