Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Background: Type 1 diabetes is one of the most common chronic illnesses among children and adolescents. Although, intensive medical care is provided for these patients, some of them have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the USA achieve the recommended average blood sugar concentration (HbA1c<7.5%). This is a major problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type 1 diabetes and causes several serious complications, for example kidney failure, blindness, and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1 diabetes Management.
Aim: The aim of this project is to determine the most important risk factors for poor metabolic control in children and adolescents with type 1 diabetes in a cross-sectional design.
Method: The sample consists of children and adolescents (school age: 7-18 years), who were diagnosed with type 1 diabetes over a year ago, and who are in care at the University Children's Hospital of Zurich. Structured interviews are conducted with the patients and the parents are asked to fill out some questionnaires. Additionally, hair samples are collected to investigate the cortisol levels of the past 3 months. The collected data is used to investigate the impact of different psychosocial risk factors including personality and self-efficacy of the patients, stress, social support, family environment, education, and parental factors on the metabolic control (HbA1c) in pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with type 1 diabetes over a year ago
- •in care at the University Children's Hospital of Zurich
- •German speaking
排除标准
- •other severe illness that affects the diabetes management
- •severe developmental disorder
- •pregnancy
结局指标
主要结局
HbA1c
时间窗: 10 minutes
Glycated hemoglobin
次要结局
- psychological health (Trait-Anxiety)(5 minutes)
- health-related quality of life (diabetes module)(5 minutes)
- psychological health (Depression)(10 minutes)
- psychological health (Child Behavior)(10 minutes)
- health-related quality of life (Chronic generic measure)(5 minutes)
