Post Approval Study of the Eversense® Continuous Glucose Monitoring
- Conditions
- Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Diabetes Mellitus
- Interventions
- Device: Eversense® CGM system
- Registration Number
- NCT03908125
- Lead Sponsor
- Senseonics, Inc.
- Brief Summary
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
- Detailed Description
The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.
The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PASstudy will provide safety and effectiveness data up to 27 months of repeated use.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 273
- Subject has diabetes
- Subject is greater than 18 years of age
- Subject is critically ill or hospitalized
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- Subjects on hybrid closed loop systems or closed loop systems
- Subjects on other CGM systems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring Device Eversense® CGM system -
- Primary Outcome Measures
Name Time Method Incidence of procedure-related adverse events 12 months The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity
Time in Range 12 months The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Denver Endocrinology, Diabetes & Thyroid Center
🇺🇸Englewood, Colorado, United States
AM Diabetes & Endocrinology
🇺🇸Bartlett, Tennessee, United States
Diabetes and Endocrinology Specialists, Inc.
🇺🇸Chesterfield, Missouri, United States
Metro Detroit Endocrinology Center
🇺🇸Dearborn, Michigan, United States
Clinical Research Solution, LLC
🇺🇸Cypress, Texas, United States
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Texas Diabetes and Endocrinology
🇺🇸Austin, Texas, United States
Physicians East
🇺🇸Greenville, North Carolina, United States
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
🇺🇸Feasterville, Pennsylvania, United States
MODEL Clinical research
🇺🇸Baltimore, Maryland, United States
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
🇺🇸Newport Beach, California, United States
The Center for Diabetes and Endocrine Care
🇺🇸Fort Lauderdale, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Javara, Inc.
🇺🇸Houston, Texas, United States
Albany Medical College
🇺🇸Albany, New York, United States
Wilmington Health/PMG
🇺🇸Wilmington, North Carolina, United States
Consano Clinical Research, Diabetes and Metabolism Specialists
🇺🇸Shavano Park, Texas, United States