Post Approval Study of the Eversense® Continuous Glucose Monitoring
Part of paid clinical trials in Newport Beach, California.
- Sponsor
- Senseonics, Inc.
- Study ID
- NCT03908125
- Status
- Completed
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Eversense® CGM System — DEVICEContinuous Glucose monitoring device
Study Details
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System
Key Dates
- Start date
- Mar 19, 2019
- Status verified
- Mar 2025
- Primary completion
- Feb 1, 2024
- Completion
- Feb 1, 2024
Study Design
- Enrollment
- 273 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Other: Continuous Glucose Monitoring DeviceCommercial Continuous Glucose Monitoring Device
Primary Outcome Measure
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. [ Time Frame: up to 27 months ]
Locations (17)
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Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center· Newport Beach, CADenver Endocrinology, Diabetes & Thyroid Center· Englewood, COThe Center for Diabetes and Endocrine Care· Fort Lauderdale, FLAtlanta Diabetes Associates· Atlanta, GAMODEL Clinical research· Baltimore, MDMetro Detroit Endocrinology Center· Dearborn, MI
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