Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Ge… (NCT07386340) | Clinical Trial Compass
RecruitingNot Applicable
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
United States80 participantsStarted 2025-12-29
Plain-language summary
A prospective, multicenter evaluation of performance and safety of the Eversense Gemini System with flash glucose measurement feature. The purpose of this clinical investigation is to evaluate the accuracy of the Gemini System with new technological flash glucose monitoring (FGM) feature enhancements compared to reference glucose measurements and the Eversense 365 CGM System. The investigation will also evaluate safety of the Gemini System usage.
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 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.
What they're measuring
1
System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL.
Timeframe: 365 days
2
Number of device-related or sensor insertion/removal procedure-related serious adverse events
✕. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 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.