N/A
Completed N=273
Post Approval Study of the Eversense® Continuous Glucose Monitoring
Diabetes · Diabetes Mellitus, Type 1 · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03908125 ↗
Enrolled (actual)
273
Serious AEs
7.7%
Results posted
Jun 2025
Primary outcomePrimary: The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. — 5; 24; 15 Sensor cycle
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. |
5; 24; 15 | — |
| PRIMARY The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. |
62.9; 62.4 | — |
| SECONDARY The Additional Effectiveness Endpoint of Average Hours of Use Per Day |
19 | — |
| SECONDARY The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline |
0; -0.16; -0.14; -0.10; 0.06 | — |
| SECONDARY Patient Satisfaction With CGM System Use (CGM-SAT Scale) |
4.0; 4.1; 4.1 | — |
| SECONDARY Patient Reported Diabetes Distress Scale (DDS) |
1.9; 1.7; 1.7; 1.7 | — |
| SECONDARY Success Rate of Insertion Procedures: Overall and by HCP Experience |
100; 99.8; 99.8 | — |
| SECONDARY Success Rate of Removal Procedures: Overall and by HCP Experience |
96.1; 98.7; 98.4 | — |
| SECONDARY Rate of Insertion Procedures With Serious Adverse Events |
1 | — |
| SECONDARY Rate of Removal Procedures With Serious Adverse Events |
— | — |
| SECONDARY HCP Feedback Questionnaire Regarding Insertion |
1.1; 1.1; 1.1; 1.2 | — |
| SECONDARY HCP Feedback Questionnaire Regarding Removal |
1.5; 1.2; 1.5; 1.4 | — |
| SECONDARY Residual Dexamethasone Level in Explanted Sensors |
82.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03908125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.