Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
Recruiting
N/A
Interventional Study
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 80 (estimated)
- Sponsor
- Senseonics, Inc. · Industry
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About This Trial
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 wil…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 r…
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