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临床试验/NCT03642470
NCT03642470已完成不适用

Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes

University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2018年6月5日最近更新:
适应症

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

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)

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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