Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

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. Identifier: NCT00796848
Recruitment Status : Withdrawn (withdrawn because the research efforts at that time followed another path)
First Posted : November 24, 2008
Last Update Posted : June 5, 2018
University of Colorado, Denver
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Device: Navigator Continuous Glucose Monitor Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   7 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796848

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

Additional Information:
Responsible Party: Bruce A. Buckingham, Principle Investigator, Stanford University Identifier: NCT00796848     History of Changes
Other Study ID Numbers: SU-10172008-1323
Stanford eprotocol #14728 ( Other Identifier: Stanford IRB )
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

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