Influence du Type de Traitement du diabète de Type 1 (DT1) Sur la Charge Mentale Des Adolescents Avec un DT1 et Des Parents Ayant un Enfant Avec DT1.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.
研究概览
简要总结
Influence of the type of treatment for type 1 diabetes (pump versus multiple injections versus closed loop) on the treatment burden of children and adolescents and their parents.
详细描述
"The guidelines for the treatment of children and adolescents with type 1 diabetes emphasise an individualised approach to the child and provide target values (time in range, glycaemia and coefficient of variation). These recommendations aim to prevent long-term complications. It is rarely possible to achieve and maintain this level of control over the long term. Achieving these recommendations requires a great deal of investment from children and their families, which can significantly increase their psychological workload and reduce their quality of life.
The main aim of this study was to assess burden of treatment according to the treatment type (pump versus multiple injections versus closed loop) on a large scale."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children over the age of 8 whose type 1 diabetes has been diagnosed for at least 6 months
- •Parents or people involved in the day-to-day life of children with type 1 diabetes who have been diagnosed for at least 6 months
排除标准
- •Parents not involved in managing their child's type 1 diabetes (child in care)
- •Have already completed the questionnaire (one questionnaire completed per child and their parents or family caregivers)
结局指标
主要结局
The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.
时间窗: 1 day
The primary outcome is the treatment burden according to the treatment modality (semi-closed loop versus insulin pump versus multi-injection) assessed using a specific questionnaire
次要结局
未报告次要终点