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

Terminated

• Conditions: Glycogen Storage Disease
• Interventions: Device: Diabetes Sentry

• Registration Number: NCT02338817
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-14
• Study Start: 2015-12
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

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Exclusion Criteria

• Patients not clinically treated at the University of Florida.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GSD 0, III, VI, or IX	Diabetes Sentry	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.
GSD 1	Diabetes Sentry	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.

Primary Outcome Measures

Name	Time	Method
Blood Glucose	At time of alarm (Average of 24 hours)	glucose level at time of device alarm
Blood Lactate	At time of alarm (Average of 24 hours)	lactate level at time of device alarm
Blood Ketones	At time of alarm (Average of 24 hours)	ketone level at time of device alarm

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States