Actively Recruiting
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
Led by Senseonics, Inc. · Updated on 2026-04-21
80
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically confirmed diagnosis of diabetes mellitus for at least 1 year
- Signed informed consent form and willingness to follow protocol requirements
You will not qualify if you...
- History of severe hypoglycemia causing loss of consciousness or seizure in past 6 months
- History of diabetic ketoacidosis requiring emergency or hospital visit in past 6 months
- Presence of gastroparesis
- Female subjects of childbearing potential who are pregnant, lactating, planning pregnancy, or not using birth control
- Conditions preventing or complicating sensor placement, operation, or removal, including upper extremity deformities or skin conditions
- Symptomatic coronary artery disease, unstable angina, recent myocardial infarction, transient ischemic attack, stroke, uncontrolled hypertension, current congestive heart failure, or cardiac arrhythmia (except benign PACs and PVCs)
- Hematocrit below 38% or above 60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for seizure disorder without neurologist clearance
- History of adrenal insufficiency
- Receiving immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (except aspirin), topical glucocorticoids over sensor site only, or antibiotics for chronic infection
- Conditions requiring or likely requiring MRI during study
- Known allergy to topical/local anesthetics or glucocorticoids
- Any condition that might prevent study completion or pose safety risks, including psychiatric conditions, substance abuse, or increased hypoglycemia risk
- Participation in another clinical trial within 2 weeks before screening or planned participation during this study
- Presence of any other active implanted device as defined by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Headlands Research - AMCR Institute
Escondido, California, United States, 92025
Actively Recruiting
Research Team
M
Maggie Lewis
CONTACT
S
Susan Huynh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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