Eversense Gemini System for Diabetes Management
This study is testing a new continuous glucose monitoring (CGM) system called the Eversense Gemini System. It aims to see how well the Gemini System, which has new flash glucose monitoring (FGM) features, measures blood sugar compared to standard tests and the older Eversense 365 CGM System. Researchers also want to make sure the Gemini System is safe to use. You might be able to join if you are at least 18 years old, have had diabetes for at least one year, and are willing to follow the study rules. The main goals are to check how accurately the system measures glucose over 365 days and to track any serious problems related to the device or its insertion/removal during that time. This study is currently unclear on its recruitment status.
- Study design
- This is an interventional study planning to enroll 80 participants. It will evaluate the performance and safety of the Eversense Gemini System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 365 days to assess system agreement and serious adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.365 days
Effectiveness 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.
- Number of device-related or sensor insertion/removal procedure-related serious adverse events365 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.