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

May 31, 2021 updated by: University Children's Hospital, Zurich

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic - University Children's Hospital Zurich

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 10 minutes
Glycated hemoglobin
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes
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.
5 minutes
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.
10 minutes
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 minutes
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Markus A Landolt, Prof. dr., University Children's Hospital, Zurich
  • Principal Investigator: Daniel Konrad, Prof. dr., University Children's Hospital, Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Actual)

June 22, 2020

Study Completion (Actual)

June 22, 2020

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 31, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00374-G2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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