Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03642470|
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
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.
|Condition or disease|
|Type 1 Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes|
|Actual Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
- HbA1c [ Time Frame: 10 minutes ]Glycated hemoglobin
- health-related quality of life (Chronic generic measure) [ Time Frame: 5 minutes ]Assessed by questionnaire: DISABKIDS Chronic generic measure - short version (DCGM-12; the European DISABKIDS Group, 2012).
- health-related quality of life (diabetes module) [ Time Frame: 5 minutes ]Assessed by questionnaire: DISABKIDS diabetes module (The European DISABKIDS Group, 2012).
- psychological health (Depression) [ 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).
- psychological health (Trait-Anxiety) [ 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).
- psychological health (Child Behavior) [ Time Frame: 10 minutes ]Assessed by questionnaire: German Version of the Child Behavior Checklist (CBCL 6-18R; Döpfner, Plück & Kinnen, 2014).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642470
|University Children's Hospital Zurich|
|Principal Investigator:||Markus A Landolt, Prof. dr.||University Children's Hospital, Zurich|
|Principal Investigator:||Daniel Konrad, Prof. dr.||University Children's Hospital, Zurich|