Continuous Glucose Monitoring for Diabetes
Trial Summary
What is the purpose of this trial?
This trial is testing devices that monitor blood sugar levels in adults with diabetes and children with Type 1 Diabetes. The goal is to see how accurate and safe these devices are for managing diabetes. These devices allow people with diabetes to keep track of their blood glucose levels in near real-time.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (except aspirin), or antibiotics for chronic infection, you may not be eligible to participate.
What data supports the effectiveness of the Eversense CGM System for diabetes management?
The Eversense CGM System has shown promising results in managing diabetes by providing accurate and consistent glucose monitoring over multiple cycles, with a high percentage of time spent in the target glucose range and no serious adverse events reported. This system is valued for its long-term implantable sensor, which offers real-time data to help people with diabetes manage their condition effectively.12345
Is the Eversense Continuous Glucose Monitoring System safe for humans?
What makes the Eversense CGM System unique compared to other diabetes treatments?
Eligibility Criteria
Adults and adolescents with diabetes (Type 1 or Type 2) can join this trial. Adults must have had diabetes for at least a year, while teens aged 14-17 need a confirmed diagnosis of Type 1 Diabetes for the same duration. Participants must consent to follow study rules. Those with certain health issues, drug abuse history, severe hypoglycemia, specific infections like hepatitis or HIV, allergies to anesthetics or glucocorticoids, recent heart problems, uncontrolled hypertension, or who are pregnant cannot join.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Eversense 524 CGM System and ROME CGM System to evaluate accuracy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Eversense CGM System (Continuous Glucose Monitoring System)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Senseonics, Inc.
Lead Sponsor