The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age up to 7 years
- •insulin pump for at least 6 months
- •more than 6 months of duration of type 1 diabetes
- •complete remission
- •normal blood pressure for age, only therapy insulin.
排除标准
- •age over 8 years
- •type 1 diabetes less than 6 months
- •insulin pump less than 6 months
- •still in remission
- •associated diseases on drug therapy, high blood pressure
结局指标
主要结局
Glycaemic control
时间窗: 3 months
We will determine HbA1c, average blood glucose, number of blood glucose readings/use of sensors, average AUC for sensor users, readings above and under target for both groups at the beginning and afer 3 months.
次要结局
- knowledge on diet and diabetes management(3 months)
研究者
Tadej Battelino
Head, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
University Medical Centre Ljubljana