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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
Headlands Research - AMCR Institute
Escondido, California, United States
RECRUITINGEffectiveness Objective: To determine accuracy of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
The effectiveness measure will be 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. Effectiveness measures will be evaluated descriptively and compared to the Eversense 365 CGM System.
Time frame: 365 days
Safety Objective: To demonstrate safety of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events in clinic and during home use from sensor insertion through removal and follow-up.
Time frame: 365 days
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