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.
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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…
Contacts

Maggie Lewis

667-218-3309

maggie.lewis@senseonics.com

CONTACT

Susan Huynh

301-407-2923

susan.huynh@senseonics.com

CONTACT