University Children's Hospital Zurich
Zurich, Switzerland
NCT Number: NCT03642470
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.
Looking for future studies?
Notify Me7 year–18 year
All sexes
Observational
Zurich, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 minutes
Glycated hemoglobin
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University Children's Hospital, Zurich
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05488119
Autoimmune Diseases, Diabetes Mellitus
Stanford, California, United States
View Trial DetailsNCT07696780
Autoimmune Diseases, Diabetes Mellitus
Bern, Canton of Bern, Switzerland
View Trial DetailsNCT05610111
Autoimmune Diseases, Diabetes Mellitus
Charlottesville, Virginia, United States
View Trial DetailsNCT06308549
Autoimmune Diseases, Diabetes Distress
Bad Mergentheim, Baden-Wurttemberg, Germany
View Trial Details