Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | January 2019 |
| Contact: | David A Weinstein, MD, MMSc |
| Email: | weinsda@peds.ufl.edu |
| Phone: | 352-273-8546 |
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.
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.
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.
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.
Exclusion Criteria:
- Patients not clinically treated at the University of Florida.
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: David Weinstein, MD,MMSc
Phone: 352-273-6655
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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