ROME GS System Study (NCT07518004)
ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Headlands Research - AMCR Institute — Escondido, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Headlands Research - AMCR Institute — Escondido, California
- Flourish Research - Diablo Clinical Research — Walnut Creek, California
- Flourish Research - San Antonio — San Antonio, Texas
- Rainier Clinical Research Center — Renton, Washington
📞 Contact the Study Coordinator
Phone: (667) 218-3309
Email: maggie.lewis@senseonics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.