Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
This study has been withdrawn prior to enrollment.
University of Colorado, Denver
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University
First received: October 23, 2008
Last updated: March 5, 2015
Last verified: March 2015
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.
Device: Navigator Continuous Glucose Monitor
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
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.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||7 Years to 20 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 PC 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796848
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
University of Colorado, Denver
||Bruce A. Buckingham
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
||Bruce A. Buckingham, Principle Investigator, Stanford University
History of Changes
|Other Study ID Numbers:
||SU-10172008-1323, Stanford eprotocol #14728
|Study First Received:
||October 23, 2008
||March 5, 2015
||United States: Institutional Review Board