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

Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Observational


Primary Outcome

Blood Glucose


Condition

Glycogen Storage Disease

Intervention

Diabetes Sentry

Study Arms / Comparison Groups

 GSD 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

9

Start Date

December 2015

Completion Date

July 2016

Primary Completion Date

July 2016

Eligibility 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.
      

Gender

All

Ages

N/A - 70 Years

Accepts Healthy Volunteers

No

Contacts

David A Weinstein, MD, MMSc, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02338817

Organization ID

IRB201400105


Responsible Party

Sponsor

Study Sponsor

University of Florida

Collaborators

 Diabetes Sentry

Study Sponsor

David A Weinstein, MD, MMSc, Principal Investigator, Univeristy of Florida


Verification Date

September 2016