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.
|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|
- To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
- To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796848
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Bruce A. Buckingham||Stanford University|