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Evaluating the Eversense CGM System for diabetes management

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

Not applicable Interventional Senseonics, Inc. · NCT04836546

This study is testing if the Eversense Continuous Glucose Monitoring system helps people with Type 1 or Type 2 diabetes manage their condition better than traditional blood sugar checks.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment925 (estimated)
Ages18 Years and up
SexAll
SponsorSenseonics, Inc. Industry-sponsored
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT04836546 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Eversense Continuous Glucose Monitoring (CGM) System in managing diabetes compared to traditional self-monitoring of blood glucose (SMBG). Participants with Type 1 or Type 2 diabetes will first use SMBG for 6 months, followed by 6 months of using the Eversense CGM System. The study is non-blinded and involves both clinic visits and home use, with participants serving as their own control. The total duration of the study is 12 months, with a focus on the impact of the CGM system on diabetes management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with either Type 1 or Type 2 diabetes who can comply with the study protocol.

Not a fit: Patients who are critically ill, hospitalized, or have extensive prior use of continuous glucose monitoring may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method for managing diabetes, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring systems for diabetes management, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject has diabetes
2. Subject is ≥18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion Criteria:

1. Subject is critically ill or hospitalized
2. Prior use of CGM defined as:

   * No more than 1 week of continuous CGM use in the last 6 months, and
   * At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DiabetesType 1 DiabetesType 2 Diabetes
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.