Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Time spent in blood glucose range
研究概览
简要总结
This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Developmental & Technological Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. Identify and troubleshoot barriers to keeping young children in Auto Mode.
干预措施: Developmental & Technological Demands (Behavioral)
Distress Reduction
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
干预措施: Distress Reduction (Behavioral)
Nutrition, Set Point, & C:I Ratio
Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control.
干预措施: Nutrition, Set Point, & C:I Ratio (Behavioral)
Hypoglycemia management
Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
干预措施: Hypoglycemia management (Behavioral)
Minimal Intervention
A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
干预措施: Minimal Intervention (Behavioral)
结局指标
主要结局
Time spent in blood glucose range
时间窗: Change over 3 months
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
次要结局
- Hemoglobin A1c(Change over 3 months)
- Problem Areas in Diabetes(Change over 3 months)
- State-Trait Anxiety Inventory(Change over 3 months)
- Parent Diabetes Distress Scale(Change over 3 months)
- Patient Health Questionnaire 8(Change over 3 months)
- Pittsburgh Sleep Quality Index(Change over 3 months)
- Health care utilization(Change over 3 months)
- Hypoglycemic Fear Survey - Parents(Change over 3 months)
- Hypoglycemia Confidence Questionnaire(Change over 3 months)
- Pediatric Quality of Life Inventory(Change over 3 months)
- Glucose Monitoring System Satisfaction Survey(Change over 3 months)
- General and diabetes-specific technology use(Change over 3 months)
- Diabetes management behaviors(Change over 3 months)
研究者
Bruce A. Buckingham
Professor, Department of Pediatrics, Endocrinology and Diabetes Division
Stanford University