Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
次要结局
- To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
研究者
Bruce A. Buckingham
Principle Investigator
Stanford University