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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:
Collaborator:
Diabetes Sentry
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02338817
First received: December 11, 2014
Last updated: October 3, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Glycogen Storage Disease
Device: Diabetes Sentry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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


Enrollment: 9
Study Start Date: December 2015
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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 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.
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

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02338817

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Diabetes Sentry
Investigators
Principal Investigator: David A Weinstein, MD, MMSc Univeristy of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02338817     History of Changes
Other Study ID Numbers: IRB201400105
Study First Received: December 11, 2014
Last Updated: October 3, 2016

Additional relevant MeSH terms:
Hypoglycemia
Metabolic Diseases
Glycogen Storage Disease
Glucose Metabolism Disorders
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017