Back to resultsPost Approval Study of the Eversense® Continuous Glucose Monitoring (PAS)
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eversense® CGM system
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Subject has diabetes
- Subject is greater than 18 years of age
Exclusion Criteria:
- 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
Sites / Locations
- Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
- Denver Endocrinology, Diabetes & Thyroid Center
- The Center for Diabetes and Endocrine Care
- Atlanta Diabetes Associates
- MODEL Clinical research
- Metro Detroit Endocrinology Center
- Diabetes and Endocrinology Specialists, Inc.
- Albany Medical College
- Physicians East
- Wilmington Health/PMG
- Diabetes & Endocrinology Consultants of Pennsylvania, LLC
- AM Diabetes & Endocrinology
- Texas Diabetes and Endocrinology
- Clinical Research Solution, LLC
- Javara, Inc.
- Diabetes and Glandular Disease Clinic
- Consano Clinical Research, Diabetes and Metabolism Specialists
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Continuous Glucose Monitoring Device
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03908125
Brief Title
Post Approval Study of the Eversense® Continuous Glucose Monitoring
Acronym
PAS
Official Title
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
February 3, 2024 (Anticipated)
Study Completion Date
August 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senseonics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Glucose Monitoring Device
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Eversense® CGM system
Intervention Description
Continuous Glucose monitoring device that lasts up to 90 days
Primary Outcome Measure Information:
Title
Incidence of procedure-related adverse events
Description
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 Frame
12 months
Title
Time in Range
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has diabetes
Subject is greater than 18 years of age
Exclusion Criteria:
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
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Denver Endocrinology, Diabetes & Thyroid Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
MODEL Clinical research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Metro Detroit Endocrinology Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Diabetes and Endocrinology Specialists, Inc.
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Physicians East
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wilmington Health/PMG
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
AM Diabetes & Endocrinology
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Clinical Research Solution, LLC
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Javara, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Diabetes and Glandular Disease Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Consano Clinical Research, Diabetes and Metabolism Specialists
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Approval Study of the Eversense® Continuous Glucose Monitoring
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