An observational study in Type 1 Diabetes, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by University Children's Hospital, Zurich · Observational
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 197 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.
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primary care clinic - University Children's Hospital Zurich
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Exclusion Criteria:
HbA1c
Glycated hemoglobin
Time frame: 10 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes
Ran from Jun 2018 to primary completion in Jun 2020, 24 months.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich