Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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As a participant the following will take place:

The Diabetes Sentry device, which is non-invasive and is worn on the wrist will be used while an inpatient at the University of Florida Health \& Shands Hospital. Participants will be monitored for the duration of the observational period on the unit, an expected average will be 24 hours. The device is designed to alarm during periods of perspiration and drops in body temperature. When this occurs, a blood draw will be taken to test for glucose, lactate, and ketone values at those times if there is not an already scheduled clinical care blood draw for normal clinical care.

Conditions

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Glycogen Storage Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GSD 1

These will be subjects with GSD I. The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.

Diabetes Sentry

Intervention Type DEVICE

The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.

GSD 0, III, VI, or IX

These will be subjects with GSD 0, III, VI, or IX. The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.

Diabetes Sentry

Intervention Type DEVICE

The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.

Interventions

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Diabetes Sentry

The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.

Intervention Type DEVICE

Other Intervention Names

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non-invasive hypoglycemia detector

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases I, III, VI, IX, 0 will be asked to participate in this study.