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

NCT02338817 | Terminated

• 1 other identifier: IRB201400105
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glycogen Storage Disease

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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

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

Interventions

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.

Also known as: non-invasive hypoglycemia detector

GSD 0, III, VI, or IX; GSD 1

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed and clinically treated at the University of Florida with any of the glycogen storage diseases

You may qualify if:

• 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.

You may not qualify if:

• Patients not clinically treated at the University of Florida.

Sponsors & Collaborators

• University of Florida: lead
• Diabetes Sentry: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Glycogen Storage Disease

Condition Hierarchy (Ancestors)

Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David A Weinstein, MD, MMSc

  Univeristy of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: January 14, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-09

Locations

US (1)