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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

NCT03642483 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2022-04-21

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Markus A Landolt, Prof. dr. · University Children's Hospital, Zurich

  • Daniel Konrad, Prof. dr. · University Children's Hospital, Zurich

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2022-01-17
Completion
2022-01-17

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642483 on ClinicalTrials.gov