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NCT03908125 Clinical Trial

Post Approval Study of the Eversense® Continuous Glucose Monitoring

Diabetes Mellitus, Type 2 Clinical Trial

— PAS  

Official title:
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03908125
Other study ID # CTP-0034
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date August 3, 2024

Study information
Verified date August 2023
Source Senseonics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Active, not recruiting
Enrollment 273
Est. completion date August 3, 2024
Est. primary completion date February 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject has diabetes 2. Subject is greater than 18 years of age Exclusion Criteria: 1. Subject is critically ill or hospitalized 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Eversense® CGM system
Continuous Glucose monitoring device that lasts up to 90 days

Locations
Country Name City State
United States Albany Medical College Albany New York
United States Atlanta Diabetes Associates Atlanta Georgia
United States Texas Diabetes and Endocrinology Austin Texas
United States MODEL Clinical research Baltimore Maryland
United States AM Diabetes & Endocrinology Bartlett Tennessee
United States Diabetes and Endocrinology Specialists, Inc. Chesterfield Missouri
United States Clinical Research Solution, LLC Cypress Texas
United States Metro Detroit Endocrinology Center Dearborn Michigan
United States Denver Endocrinology, Diabetes & Thyroid Center Englewood Colorado
United States Diabetes & Endocrinology Consultants of Pennsylvania, LLC Feasterville Pennsylvania
United States The Center for Diabetes and Endocrine Care Fort Lauderdale Florida
United States Physicians East Greenville North Carolina
United States Javara, Inc. Houston Texas
United States Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center Newport Beach California
United States Diabetes and Glandular Disease Clinic San Antonio Texas
United States Consano Clinical Research, Diabetes and Metabolism Specialists Shavano Park Texas
United States Wilmington Health/PMG Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of procedure-related adverse events 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 12 months
Primary Time in Range 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 12 months
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