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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03642470
Enrollment
197
Registered
2018-08-22
Start date
2018-06-05
Completion date
2020-06-22
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, metabolic control, psychosocial risk factors, cortisol, children, adolescents

Brief summary

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.

Interventions

None listed

Sponsors

University Children's Hospital, Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1c10 minutesGlycated hemoglobin

Secondary

MeasureTime frameDescription
health-related quality of life (Chronic generic measure)5 minutesAssessed 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.
health-related quality of life (diabetes module)5 minutesAssessed 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.
psychological health (Depression)10 minutesAssessed 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.
psychological health (Trait-Anxiety)5 minutesAssessed 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.
psychological health (Child Behavior)10 minutesAssessed 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026