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Clinical Trials/NCT03642483
NCT03642483CompletedNot Applicable

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

University Children's Hospital, Zurich1 site in 1 country61 target enrollmentStarted: June 5, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
61
Locations
1
Primary Endpoint
HbA1c

Study 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. 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
5 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: 10 minutes

Glycated hemoglobin

Secondary Outcomes

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

Investigators

Sponsor
University Children's Hospital, Zurich
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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