NCT03039933已完成不适用
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Decrease in scores on the Hypoglycemia Fear Survey
研究概览
简要总结
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adolescents aged 10-17 years and their parent(s) or legal guardian;
- •T1D duration >1 year;
- •insulin pump use >6 months;
- •agreement of both parent and adolescent to participate in intervention sessions;
- •elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.
排除标准
- •developmental disability or reading disorder that prevents understanding of the intervention materials; and
- •non-English speaking adolescents and parents.
结局指标
主要结局
Decrease in scores on the Hypoglycemia Fear Survey
时间窗: Baseline, 3 and 6 months
To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.
次要结局
未报告次要终点
研究者
研究点 (2)
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