Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- HbA1c level
研究概览
简要总结
The purpose of this study is to assess HbA1c reduction after supportive care by SMS among adolescents with poorly controlled type 1 diabetes.
详细描述
In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with 60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text message is one of the strategies to enhance adherence. The main aim of this study is to assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial. This study is a prospective randomized monocentric trial. Sixty adolescents with type 1 diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The patients will receive one SMS before each injection of insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 12 and 21 years old
- •with type 1 diabetes for more than 6 months
- •HbA1c at enrollment > 8.5%
- •non-opposition of one of the parents
- •previous medical exam (art. L.1121-11 du CSP)
- •Possible follow-up for 6 months
- •social welfare coverage
- •Adolescents with a mobile phone, able to receive short text message
排除标准
- •aged less than 12 or higher than 21 years old
- •with HbA1c at enrollment < 8.5%
- •pregnancy
- •psychiatric disease
- •do not understand french
研究组 & 干预措施
Text message arm
干预措施: Text message arm (Behavioral)
No text message arm
结局指标
主要结局
HbA1c level
时间窗: 6 months
次要结局
- Quality of life(6 months)
- Compliance(3 months)
- Quality of life(3 months)
- HbA1c level(3 months)
- Compliance(6 months)
- Satisfaction survey(6 months)