Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT03642470
- Lead Sponsor
- University Children's Hospital, Zurich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- diagnosed with type 1 diabetes over a year ago
- in care at the University Children's Hospital of Zurich
- German speaking
- other severe illness that affects the diabetes management
- severe developmental disorder
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c 10 minutes Glycated hemoglobin
- Secondary Outcome Measures
Name Time Method psychological health (Trait-Anxiety) 5 minutes Assessed by questionnaire: German Version of the Trait-Anxiety Inventory for Children (Trait Angstinventar für Kinder \[STAIK-T\]; Unnewehr, Joormann, Schneider \& Margraf, 1992).
Total score range: 20-60. The higher the score, the higher the trait anxiety.health-related quality of life (diabetes module) 5 minutes Assessed by questionnaire: DISABKIDS diabetes module (The European DISABKIDS Group, 2012).
Total score range: 10-50. The higher the score, the higher the health-related quality of life.psychological health (Depression) 10 minutes Assessed by questionnaire: German Version of the Children's Depression Inventory (Depressionsinventar für Kinder und Jugendliche \[DIKJ\]; Stiensmeier-Pelster, Braune-Krickau, Schürmann \& Duda, 2014).
Total score range: 0-58. The higher the score, the more depressed the participants are.psychological health (Child Behavior) 10 minutes Assessed by questionnaire: German Version of the Child Behavior Checklist (CBCL 6-18R; Döpfner, Plück \& Kinnen, 2014).
Total score range: 0-224. The higher the score, the more behavioral problems.health-related quality of life (Chronic generic measure) 5 minutes Assessed by questionnaire: DISABKIDS Chronic generic measure - short version (DCGM-12; the European DISABKIDS Group, 2012).
Total score range: 12-60. The higher the score, the higher the health-related quality of life.
Trial Locations
- Locations (1)
University Children's Hospital Zurich
🇨🇭Zurich, Switzerland