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Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00796848
First received: October 23, 2008
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.


Condition Intervention
Diabetes Mellitus
 Device: Navigator Continuous Glucose Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.

Secondary Outcome Measures:
  • To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

To enroll in this study you must be between the ages of 7 and 20, have type 1 diabetes, and experience at least two episodes of low blood glucose readings weekly that you do not feel. Up to 25 subjects will be enrolled at Stanford and another 25 at the Barbara Davis Center in Colorado. The study will last approximately 8 months for each participant.

  Eligibility

Ages Eligible for Study:   7 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 7 to 20 years old
  2. Have been diagnosed with type 1 diabetes for at least 1 year
  3. Report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the Hypoglycemia Awareness Questionnaire (HAQ) or as determined by Investigator
  4. HbA1c level < 10%
  5. Internet access for downloading continuous glucose monitoring (CGM), access to a PC compatible computer (Windows Vista is not compatible for downloading.)
  6. For females, you are not intending to become pregnant during the study
  7. No expectation that you will be moving out of the area for the duration of the study

Exclusion Criteria:

  1. The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the Investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
  2. Treatment with systemic or inhaled corticosteroids in the last six months
  3. Inpatient psychiatric treatment in the past six months for you or your primary caregiver
  4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the Investigator would be a contraindication to participation in the study
  5. Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
  6. Having a severe hypoglycemic episode in the 30 days prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796848

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Colorado, Denver
Investigators
Principal Investigator: Bruce A. Buckingham Stanford University
  More Information

Additional Information:
Stanford Pediatric Endocrinology Department website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Paula Clinton, RD, CDE, Stanford University
ClinicalTrials.gov Identifier: NCT00796848     History of Changes
Other Study ID Numbers: SU-10172008-1323, Stanford eprotocol #14728
Study First Received: October 23, 2008
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013