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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with type 1 diabetes over a year ago in care at the University Children's Hospital of Zurich German speaking Exclusion Criteria: other severe illness that affects the diabetes management severe developmental disorder pregnancy

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycated hemoglobin | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life (Chronic generic measure) | 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. | 5 minutes | 
| health-related quality of life (diabetes module) | 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. | 5 minutes | 
| psychological health (Depression) | 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. | 10 minutes | 
| psychological health (Trait-Anxiety) | 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. | 5 minutes | 
| psychological health (Child Behavior) | 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. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, metabolic control, psychosocial risk factors, cortisol, children, adolescents