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Clinical Trials/NCT03642470
NCT03642470
Completed
Not Applicable

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

University Children's Hospital, Zurich1 site in 1 country197 target enrollmentJune 5, 2018
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
University Children's Hospital, Zurich
Enrollment
197
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2018
End Date
June 22, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Children's Hospital, Zurich
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: 10 minutes

Glycated hemoglobin

Secondary Outcomes

  • psychological health (Trait-Anxiety)(5 minutes)
  • health-related quality of life (diabetes module)(5 minutes)
  • psychological health (Depression)(10 minutes)
  • psychological health (Child Behavior)(10 minutes)
  • health-related quality of life (Chronic generic measure)(5 minutes)

Study Sites (1)

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