Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ Subjects meeting all of the following inclusion criteria will be included in this study:
• 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
Locations
United States
California
Headlands Research - AMCR Institute
RECRUITING
Escondido
Contact Information
Primary
Maggie Lewis
maggie.lewis@senseonics.com
667-218-3309
Backup
Susan Huynh
susan.huynh@senseonics.com
301-407-2923
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2028-05
Participants
Target number of participants: 80
Treatments
Experimental: Continuous Glucose Monitoring Device
Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
Related Therapeutic Areas
Sponsors
Leads: Senseonics, Inc.