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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Denver Endocrinology, Diabetes & Thyroid Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33312
      • The Center for Diabetes and Endocrine Care
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Model Clinical Research
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Metro Detroit Endocrinology Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes and Endocrinology Specialists, Inc.
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical College
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Pennsylvania
    • Feasterville, Pennsylvania, United States, 19053
      • Diabetes & Endocrinology Consultants of Pennsylvania, LLC
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes & Endocrinology
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology
    • Cypress, Texas, United States, 77433
      • Clinical Research Solution, LLC
    • Houston, Texas, United States, 77095
      • Javara, Inc
    • San Antonio, Texas, United States, 78229
      • Diabetes and Glandular Disease Clinic
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Glucose Monitoring Device; Commercial Continuous Glucose Monitoring Device	Device: Eversense® CGM System; Continuous Glucose monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.	up to 27 months
Patient Reported Diabetes Distress Scale (DDS)	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.	Screening, Day 180, Day 360, and Day 720
Success Rate of Insertion Procedures: Overall and by HCP Experience	Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.	up to 27 months
Success Rate of Removal Procedures: Overall and by HCP Experience	Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.	up to 27 months
Rate of Insertion Procedures With Serious Adverse Events		up to 27 months
Rate of Removal Procedures With Serious Adverse Events		up to 27 months
HCP Feedback Questionnaire Regarding Insertion	The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.	up to 27 Months
HCP Feedback Questionnaire Regarding Removal	The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.	up to 27 Months
Residual Dexamethasone Level in Explanted Sensors	The residual dexamethasone (DXA) content in Sensors was analyzed after removal.	up to 27 months

Collaborators and Investigators

• Sponsor: Senseonics, Inc.
• Investigators: Study Director: Kathleen Davis, Senseonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CTP-0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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