Post Approval Study of the Eversense® Continuous Glucose Monitoring
PAS
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
1 other identifier
interventional
273
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Mar 2019
Longer than P75 for not_applicable diabetes-mellitus
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2019
CompletedFirst Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedResults Posted
Study results publicly available
June 12, 2025
CompletedJune 12, 2025
March 1, 2025
4.9 years
March 22, 2019
March 28, 2025
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.
up to 27 months
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.
Baseline and Month 12
Secondary Outcomes (11)
The Additional Effectiveness Endpoint of Average Hours of Use Per Day
up to 27 months
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline
Baseline, Month 6, Month 12, Month 18, and Month 24
Patient Satisfaction With CGM System Use (CGM-SAT Scale)
up to 27 months
Patient Reported Diabetes Distress Scale (DDS)
Screening, Day 180, Day 360, and Day 720
Success Rate of Insertion Procedures: Overall and by HCP Experience
up to 27 months
- +6 more secondary outcomes
Study Arms (1)
Continuous Glucose Monitoring Device
OTHERCommercial Continuous Glucose Monitoring Device
Interventions
Eligibility Criteria
You may qualify if:
- Subject has diabetes
- Subject is greater than 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Senseonics, Inc.lead
Study Sites (17)
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
Newport Beach, California, 92663, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
MODEL Clinical research
Baltimore, Maryland, 21204, United States
Metro Detroit Endocrinology Center
Dearborn, Michigan, 48126, United States
Diabetes and Endocrinology Specialists, Inc.
Chesterfield, Missouri, 63017, United States
Albany Medical College
Albany, New York, 12206, United States
Physicians East
Greenville, North Carolina, 27834, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
Feasterville, Pennsylvania, 19053, United States
AM Diabetes & Endocrinology
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
Clinical Research Solution, LLC
Cypress, Texas, 77433, United States
Javara, Inc
Houston, Texas, 77095, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director of Clinical Operations
- Organization
- Senseonics, Inc.
Study Officials
- STUDY DIRECTOR
Kathleen Davis
Senseonics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2019
First Posted
April 9, 2019
Study Start
March 19, 2019
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
June 12, 2025
Results First Posted
June 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share