Skip to main content
OpenTrials
Completed

NCT Number: NCT03642470

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HbA1c

    Time frame: 10 minutes

    Glycated hemoglobin

Secondary outcomes

  1. 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).

    Total score range: 12-60. The higher the score, the higher the health-related quality of life.

  2. health-related quality of life (diabetes module)

    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.

  3. 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).

    Total score range: 0-58. The higher the score, the more depressed the participants are.

  4. 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).

    Total score range: 20-60. The higher the score, the higher the trait anxiety.

  5. 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).

    Total score range: 0-224. The higher the score, the more behavioral problems.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Jun 3, 2021

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.