Clinical trial NCT03908125: Post Approval Study of the Eversense® Continuous Glucose Monitoring
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Senseonics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 PAS study will provide safety and effectiveness data up to 27 months of repeated use.

Eligibility criteria: 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

Primary outcomes:
measure: The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
timeFrame: up to 27 months
measure: The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: The Additional Effectiveness Endpoint of Average Hours of Use Per Day
timeFrame: up to 27 months
measure: The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline
timeFrame: Baseline, Month 6, Month 12, Month 18, and Month 24
measure: Patient Satisfaction With CGM System Use (CGM-SAT Scale)
timeFrame: up to 27 months
measure: Patient Reported Diabetes Distress Scale (DDS)
timeFrame: Screening, Day 180, Day 360, and Day 720
measure: Success Rate of Insertion Procedures: Overall and by HCP Experience
timeFrame: up to 27 months
measure: Success Rate of Removal Procedures: Overall and by HCP Experience
timeFrame: up to 27 months
measure: Rate of Insertion Procedures With Serious Adverse Events
timeFrame: up to 27 months
measure: Rate of Removal Procedures With Serious Adverse Events
timeFrame: up to 27 months
measure: HCP Feedback Questionnaire Regarding Insertion
timeFrame: up to 27 Months
measure: HCP Feedback Questionnaire Regarding Removal
timeFrame: up to 27 Months
measure: Residual Dexamethasone Level in Explanted Sensors
timeFrame: up to 27 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
state: California
city: Englewood
country: United States
facility: Denver Endocrinology, Diabetes & Thyroid Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Baltimore
country: United States
facility: MODEL Clinical research
state: Maryland
city: Dearborn
country: United States
facility: Metro Detroit Endocrinology Center
state: Michigan
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialists, Inc.
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Feasterville
country: United States
facility: Diabetes & Endocrinology Consultants of Pennsylvania, LLC
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Cypress
country: United States
facility: Clinical Research Solution, LLC
state: Texas
city: Houston
country: United States
facility: Javara, Inc
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
Study officials:
affiliation: Senseonics, Inc.
name: Kathleen Davis
role: STUDY_DIRECTOR
References: