Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
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Phase
Not applicable
Status
Unknown status
Study type
Interventional
Design
Na · None · Diagnostic
Enrollment
350estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-10-20 | actual | When the study began enrolling |
| Primary completion | 2025-03-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-04-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
Intervention
- Device: Continuous Glucose Monitoring System
Primary outcomes
what the primary-completion date above is the date OFEffectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
measured 365 days
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.
measured 365 days
Publications
- PMID 39869118 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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