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 range18 Years

SexALL

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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.
✕. Hematocrit \<38% or \>60% at screening
✕. History of hepatitis B, hepatitis C, or HIV

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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