Status:
WITHDRAWN
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Lead Sponsor:
Stanford University
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
7-20 years
Phase:
NA
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 stud...
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 subject...
Eligibility Criteria
Inclusion
- Be at least 7 to 20 years old
- Have been diagnosed with type 1 diabetes for at least 1 year
- 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
- HbA1c level \< 10%
- Internet access for downloading continuous glucose monitoring (CGM), access to a compatible computer (Windows Vista is not compatible for downloading.)
- For females, you are not intending to become pregnant during the study
- No expectation that you will be moving out of the area for the duration of the study
Exclusion
- 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
- Treatment with systemic or inhaled corticosteroids in the last six months
- Inpatient psychiatric treatment in the past six months for you or your primary caregiver
- 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
- Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
- Having a severe hypoglycemic episode in the 30 days prior to enrollment
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00796848
Start Date
March 1 2009
End Date
March 1 2010
Last Update
June 6 2018
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305