Post Approval Study of the Eversense® Continuous Glucose Monitoring
NCT ID: NCT03908125
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
273 participants
INTERVENTIONAL
2019-03-19
2024-02-01
Brief Summary
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Detailed Description
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The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Continuous Glucose Monitoring Device
Commercial Continuous Glucose Monitoring Device
Eversense® CGM System
Continuous Glucose monitoring device
Interventions
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Eversense® CGM System
Continuous Glucose monitoring device
Eligibility Criteria
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Inclusion Criteria
2. Subject is greater than 18 years of age
Exclusion Criteria
2. Subject has a known contraindication to dexamethasone or dexamethasone acetate
3. Subjects requiring intravenous mannitol or mannitol irrigation solutions
4. Female subjects who are pregnant, planning on becoming pregnant or nursing
5. Subjects on hybrid closed loop systems or closed loop systems
6. Subjects on other CGM systems
18 Years
ALL
No
Sponsors
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Senseonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Davis
Role: STUDY_DIRECTOR
Senseonics, Inc.
Locations
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Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
Newport Beach, California, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
MODEL Clinical research
Baltimore, Maryland, United States
Metro Detroit Endocrinology Center
Dearborn, Michigan, United States
Diabetes and Endocrinology Specialists, Inc.
Chesterfield, Missouri, United States
Albany Medical College
Albany, New York, United States
Physicians East
Greenville, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
Feasterville, Pennsylvania, United States
AM Diabetes & Endocrinology
Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Clinical Research Solution, LLC
Cypress, Texas, United States
Javara, Inc
Houston, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTP-0034
Identifier Type: -
Identifier Source: org_study_id
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