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NCT02338817 · ClinicalTrials.gov registry record
Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
A clinical trial, sponsored by University of Florida.
- Terminated
- Registry status
- 9
- Enrollment target
NCT02338817: Clinical Trial study, sponsored by University of Florida.
NCT02338817 is a clinical trial that was terminated before completion, run by University of Florida. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338817 was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- 9 participants
- Enrollment target
Study Summary
Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia, putting them at risk for several complications, such as hepatomegaly, adenomas, and cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive hypoglycemia detector designed like a watch, has been available for diabetic patients to non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types 0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD patients in managing hypoglycemia, both clinically and at home.
Primary Outcome
glucose level at time of device alarm
Interventions
- DEVICE Diabetes Sentry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-07 |
Why NCT02338817 stopped before completion
NCT02338817 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Diabetes Sentry is the first listed.
NCT02338817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02338817 about?
NCT02338817 is a clinical study titled "Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population". Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia, putting them at risk for several complications, such as hepatomegaly, adenomas, and cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick glucose meters to monitor their glycemi...
What is the current status of trial NCT02338817?
This trial is currently terminated. The enrollment target is 9 participants. The study started on 2015-12. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02338817?
The interventions under investigation include: Diabetes Sentry (DEVICE).
Who is sponsoring clinical trial NCT02338817?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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