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Trial record 91 of 2357 for:    "Diabetes Mellitus, Insulin-Dependent"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03642470
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

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.


Condition or disease
Type 1 Diabetes

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 10 minutes ]
    Glycated hemoglobin


Secondary Outcome Measures :
  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).

  2. health-related quality of life (diabetes module) [ Time Frame: 5 minutes ]
    Assessed by questionnaire: DISABKIDS diabetes module (The European DISABKIDS Group, 2012).

  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).

  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).

  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic - University Children's Hospital Zurich
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

Information from the National Library of Medicine

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


Locations
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Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Markus A Landolt, Prof. dr. University Children's Hospital, Zurich
Principal Investigator: Daniel Konrad, Prof. dr. University Children's Hospital, Zurich

Publications:
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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03642470     History of Changes
Other Study ID Numbers: 2018-00374-G2
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Children's Hospital, Zurich:
type 1 diabetes
metabolic control
psychosocial risk factors
cortisol
children
adolescents

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases