RecruitingDiabetesDiabetes Melletus, Type 1Diabetes Mellitus, Type 2
ROME GS System Study
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Senseonics, Inc.
You may qualify if…
- ✓ Subjects meeting all of the following inclusion criteria will be included in this study:
- ✓ 1. Subjects ≥18 years of age
- ✓ 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- ✓ 3. Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
You may not qualify if…
- ✕ Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- ✕ 1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- ✕ 2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- ✕ 3. Subjects with gastroparesis
- ✕ 4. 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.
- ✕ 5. A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
- ✕ 6. 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.
- ✕ 7. Hematocrit \<38% or \>60% at screening
Where it's recruiting
Source: ClinicalTrials.gov · NCT07518004 · last updated 2026-04-21