RecruitingNot Applicable

ROME GS System Study

United States60 participantsStarted 2026-02-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects ≥18 years of age
. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
. Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements

Exclusion criteria

. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
. Subjects with gastroparesis
. Female subjects of childbearing capacity (defined as of childbearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
. A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm HG or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g. CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion.

Timeframe: 365 days post-insertion

Number of device-related or sensor insertion/removal procedure-related serious adverse events

Timeframe: 365 days post-insertion and follow-up

Trial details

NCT IDNCT07518004

SponsorSenseonics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Maggie Lewis

667-218-3309 maggie.lewis@senseonics.com

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