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NCT01954459 · ClinicalTrials.gov registry record · Early Phase 1
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
A Early Phase 1 study, sponsored by Yale University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT01954459: Clinical Trial Early Phase 1 study, sponsored by Yale University.
NCT01954459 is a Early Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954459, a Early Phase 1 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.
Primary Outcome
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use, comparing sensor glucose readings and signal data to serum Yellow Springs Instrument (YSI) glucose measurements, with each subject acting as his or her own control.
Interventions
- DEVICE Insupatch
- DEVICE Continuous glucose sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-06 |
| Phase | Early Phase 1 |
Why NCT01954459 stopped before completion
NCT01954459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Insupatch is the first listed.
NCT01954459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954459 about?
NCT01954459 is a clinical study titled "Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?". This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.
What is the current status of trial NCT01954459?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2013-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01954459?
The interventions under investigation include: Insupatch (DEVICE), Continuous glucose sensor (DEVICE).
Who is sponsoring clinical trial NCT01954459?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01954459's enrollment target sits among peer trials
11 1600th of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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