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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This study has been withdrawn prior to enrollment.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

October 23, 2008
May 23, 2011
March 2009
March 2010   (final data collection date for primary outcome measure)
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
Same as current
Complete list of historical versions of study NCT00796848 on ClinicalTrials.gov Archive Site
To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
Same as current
Not Provided
Not Provided
 
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Device: Navigator Continuous Glucose Monitor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
7 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796848
SU-10172008-1323, Stanford eprotocol #14728
Not Provided
Paula Clinton, RD, CDE, Stanford University
Stanford University
University of Colorado, Denver
Principal Investigator: Bruce A. Buckingham Stanford University
Stanford University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP