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NCT Number: NCT03908125

Post Approval Study of the Eversense® Continuous Glucose Monitoring

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

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center, Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eversense® CGM System

Device

Continuous Glucose monitoring device

Primary outcomes

  1. The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

    Time frame: 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%.

  2. The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

    Time frame: 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 outcomes

  1. The Additional Effectiveness Endpoint of Average Hours of Use Per Day

    Time frame: up to 27 months

  2. The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline

    Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24

  3. Patient Satisfaction With CGM System Use (CGM-SAT Scale)

    Time frame: 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.

  4. Patient Reported Diabetes Distress Scale (DDS)

    Time frame: 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.

  5. Success Rate of Insertion Procedures: Overall and by HCP Experience

    Time frame: 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.

  6. Success Rate of Removal Procedures: Overall and by HCP Experience

    Time frame: 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.

  7. Rate of Insertion Procedures With Serious Adverse Events

    Time frame: up to 27 months

  8. Rate of Removal Procedures With Serious Adverse Events

    Time frame: up to 27 months

  9. HCP Feedback Questionnaire Regarding Insertion

    Time frame: up to 27 Months

    The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

  10. HCP Feedback Questionnaire Regarding Removal

    Time frame: up to 27 Months

    The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

  11. Residual Dexamethasone Level in Explanted Sensors

    Time frame: up to 27 months

    The residual dexamethasone (DXA) content in Sensors was analyzed after removal.

Sponsors and collaborators

Lead sponsor

Senseonics, Inc.

Industry

Registry information

Official study title

A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

Acronym: PAS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2019
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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