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

This study has been terminated.
(The device often failed to detect hypoglycemic episodes in glycogen storage disease patients and the rate of false positive alarms was high.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02338817
First Posted: January 14, 2015
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Diabetes Sentry
Information provided by (Responsible Party):
University of Florida
December 11, 2014
January 14, 2015
October 4, 2016
December 2015
July 2016   (Final data collection date for primary outcome measure)
  • Blood Glucose [ Time Frame: At time of alarm (Average of 24 hours) ]
    glucose level at time of device alarm
  • Blood Lactate [ Time Frame: At time of alarm (Average of 24 hours) ]
    lactate level at time of device alarm
  • Blood Ketones [ Time Frame: At time of alarm (Average of 24 hours) ]
    ketone level at time of device alarm
Same as current
Complete list of historical versions of study NCT02338817 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases
Glycogen Storage Disease
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.
Other Name: non-invasive hypoglycemia detector
  • 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.
    Intervention: Device: Diabetes Sentry
  • 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.
    Intervention: Device: Diabetes Sentry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
July 2016
July 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02338817
IRB201400105
No
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University of Florida
University of Florida
Diabetes Sentry
Principal Investigator: David A Weinstein, MD, MMSc Univeristy of Florida
University of Florida
September 2016