Post Approval Study of the Eversense® Continuous Glucose Monitoring

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Mellitus

Registration Number: NCT03908125

Lead Sponsor: Senseonics, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 273

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.	up to 27 months	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%.
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.	Baseline and Month 12	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.

Secondary Outcome Measures

Name	Time	Method
The Additional Effectiveness Endpoint of Average Hours of Use Per Day	up to 27 months
HCP Feedback Questionnaire Regarding Removal	up to 27 Months	The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Patient Satisfaction With CGM System Use (CGM-SAT Scale)	up to 27 months	CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.
Success Rate of Insertion Procedures: Overall and by HCP Experience	up to 27 months	Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.
Patient Reported Diabetes Distress Scale (DDS)	Screening, Day 180, Day 360, and Day 720	The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.
Success Rate of Removal Procedures: Overall and by HCP Experience	up to 27 months	Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.
HCP Feedback Questionnaire Regarding Insertion	up to 27 Months	The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Rate of Insertion Procedures With Serious Adverse Events	up to 27 months
Rate of Removal Procedures With Serious Adverse Events	up to 27 months
Residual Dexamethasone Level in Explanted Sensors	up to 27 months	The residual dexamethasone (DXA) content in Sensors was analyzed after removal.
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

Trial Locations

Locations (17): PMG Research of Wilmington, LLC
🇺🇸
Wilmington, North Carolina, United States
Javara, Inc
🇺🇸
Houston, Texas, United States
Consano Clinical Research, LLC
🇺🇸
Shavano Park, Texas, United States
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
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PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States