An observational study in Glycogen Storage Disease, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-04.
Sponsored by University of Florida · Observational
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.
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.
95 studies on the registry are indexed under Glycogen Storage Disease; 15 are open to participants now.
This study's enrollment of 9 is below the median of 43 across 30 observational studies indexed under Glycogen Storage Disease.
Browse Glycogen Storage Disease studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases
Exclusion Criteria:
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.
Device: 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.
Device: 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.
Also known as: non-invasive hypoglycemia detector
Blood Glucose
glucose level at time of device alarm
Time frame: At time of alarm (Average of 24 hours)
Blood Lactate
lactate level at time of device alarm
Time frame: At time of alarm (Average of 24 hours)
Blood Ketones
ketone level at time of device alarm
Time frame: At time of alarm (Average of 24 hours)
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University of Florida