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The device often failed to detect hypoglycemic episodes in glycogen storage disease patients and the rate of false positive alarms was high.
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| Name | Class |
|---|---|
| Diabetes Sentry | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Sentry | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | glucose level at time of device alarm | At time of alarm (Average of 24 hours) |
| Blood Lactate | lactate level at time of device alarm | At time of alarm (Average of 24 hours) |
| Blood Ketones | ketone level at time of device alarm | At time of alarm (Average of 24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases
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| Name | Affiliation | Role |
|---|---|---|
| David A Weinstein, MD, MMSc | Univeristy of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D006008 | Glycogen Storage Disease |
| ID | Term |
|---|---|
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |