Continuous Glucose Monitoring for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new glucose monitoring system, the Eversense Gemini System, to evaluate its effectiveness in measuring blood sugar and its safety for people with diabetes. The goal is to compare its accuracy and safety with other glucose monitoring systems. It suits adults who have had diabetes for at least a year and have not experienced severe low blood sugar or diabetic emergencies recently. As an unphased trial, this study allows participants to contribute to the development of innovative diabetes technology.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving certain treatments like immunosuppressants, chemotherapy, or specific anticoagulants. It's best to discuss your medications with the trial team to see if they affect your eligibility.
What prior data suggests that the Eversense Gemini System is safe for continuous glucose monitoring?
Research shows that the Eversense Gemini System, used for continuous glucose monitoring in people with diabetes, is safe. Studies have found that users generally tolerate the system well, and it accurately tracks glucose levels for up to 180 days. Most users did not experience serious side effects. The system's approval in Europe further supports its safety. Overall, evidence suggests that the Eversense Gemini System is a safe choice for adults with diabetes to monitor their glucose levels.12345
Why are researchers excited about this trial?
The Eversense Gemini System is unique because it offers continuous glucose monitoring (CGM) for up to a year with just one device insertion, unlike traditional CGMs that typically require sensor changes every 7 to 14 days. This system utilizes a small sensor implanted under the skin, which communicates with a wearable transmitter to provide real-time glucose readings directly to a smartphone app. Researchers are excited about this treatment as it promises greater convenience and longer-term monitoring, potentially enhancing diabetes management by reducing the burden of frequent sensor replacements and offering more consistent data for better glucose control.
What evidence suggests that the Eversense Gemini System is effective for continuous glucose monitoring in diabetes?
Research has shown that the Eversense Gemini System, used by participants in this trial, accurately checks glucose levels. One study found it successfully alerted users 96.6% of the time when glucose was too low (70 mg/dL) and 97.9% of the time when it was too high (180 mg/dL). This indicates it can reliably warn users about unsafe glucose levels. The same study found that 90% of the sensors functioned for a full year, suggesting the system is both effective and durable for managing diabetes.2678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with any type of diabetes diagnosed for at least a year. Participants must agree to follow the study rules and have signed an informed consent form.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Eversense Gemini System and Eversense 365 CGM System to evaluate performance and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eversense Gemini System
Trial Overview
The Gemini Study is testing the Eversense Gemini System, a continuous glucose monitoring device with new flash glucose measurement features, comparing its accuracy and safety to standard reference measurements and previous Eversense technology.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Senseonics, Inc.
Lead Sponsor
Citations
Gemini Study: A Prospective, Multicenter Evaluation of ...
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 ...
Evaluation of Accuracy and Safety of the 365-Day ...
The confirmed alert detection rate at 70 mg/dL was 96.6%, and at 180 mg/dL, it was 97.9%. Ninety percent of the sensors survived 365 days.
3.
provider.eversensecgm.com
provider.eversensecgm.com/siteassets/eversense-hcp-resource-library/bailey-et-al-2025-evaluation-of-accuracy-and-safety-of-the-365-day-implantable-eversense-continuous-glucose-monitoring3.pdfEvaluation of Accuracy and Safety of the 365-Day Implantable ...
ENHANCE was a pro- spective, multicenter study evaluating the accuracy and safety of the Eversense 365 CGM system through. 1 year in adults with diabetes.
4.
senseonics.com
senseonics.com/~/media/Files/S/Senseonics-IR/reports-and-presentations/sens-investor-presentation-november-2024.pdfCGM System
The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180.
Safety Information | Eversense CGM
Learn about risks and side effects as well as precautions prior to the use of the Eversense CGM system.
PMA P160048: FDA Summary of Safety and Effectiveness ...
The Eversense CGM System is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is ...
Evaluation of Accuracy and Safety of the Next-Generation Up ...
Conclusion: These data show the next-generation Eversense CGM system had sustained accuracy and safety up to 180 days, with an improved calibration scheme and ...
Senseonics Receives European Approval for Eversense ...
... long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced CE Mark approval for the Eversense®
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