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NCT Number: NCT03642483

Evaluation of an Early Screener to Identify Long-term Problems With Regard to Metabolic Control and Treatment Adherence Among 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. Therefore, an instrument is needed to identify children and adolescents with poor metabolic control in their course of disease as soon as possible. With an early identification of such risk patients, better support can be provided. However, there is no such instrument yet for pediatric patients with type 1 diabetes. To fill this gap, a questionnaire (FEPB) based on the PAT 2.0© (Psychosocial Assessment Tool; an instrument used in oncology) was developed for this project.

Aim: The aim of this project is to evaluate and validate a new instrument (FEPB) for an early identification of children and adolescents with poor metabolic control in their course of disease in a longitudinal design.

Method: The sample consists of children and adolescents (age: 5-18 years), who were newly diagnosed with type 1 diabetes (2-4 weeks 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 at two times: first, 2-4 weeks after the diagnosis (T1) and second 6 month later (T2). With the new instrument (FEPB) a risk score can be calculated for each patient at T1. Statistical analysis will be performed to determine whether that risk score can predict which patients have poor metabolic control (HbA1c > 7.5%) at T2.

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Key information

Age range

5 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 2-4 weeks 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
2022
Study completion
2022
First posted
Aug 22, 2018
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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