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NCT03808376 · ClinicalTrials.gov registry record · NA
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
A NA study, sponsored by Senseonics.
- Completed
- Registry status
- NA
- Development phase
- 208
- Enrollment target
NCT03808376: Completed NA study, sponsored by Senseonics.
NCT03808376 is a NA study that has completed, run by Senseonics. The registered enrollment target is 208 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03808376, a NA study, has completed, sponsored by Senseonics.
- COMPLETED
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
Study Summary
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
Primary Outcome
The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| /
Interventions
- DEVICE Continuous Glucose Monitoring System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2020-05-08 |
| Phase | NA |
What the finished NCT03808376 record still lists
NCT03808376 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Continuous Glucose Monitoring System is the first listed.
NCT03808376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03808376 about?
NCT03808376 is a clinical study titled "PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days". The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the ...
What is the current status of trial NCT03808376?
This trial is currently completed. It is a NA study. The enrollment target is 208 participants. The study started on 2018-12-27. Estimated completion is 2020-05-08.
What interventions are being tested in trial NCT03808376?
The interventions under investigation include: Continuous Glucose Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT03808376?
This trial is sponsored by Senseonics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03808376's enrollment target sits among peer trials
208 496th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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