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 | Completed

• 1 other identifier: 2018-00374-G1
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; metabolic control; psychosocial risk factors; FEPB; children; adolescents

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated hemoglobin

  10 minutes

Secondary Outcomes (5)

• health-related quality of life (Chronic generic measure)

  5 minutes

• health-related quality of life (diabetes module)

  5 minutes

• psychological health (Depression)

  10 minutes

• psychological health (Trait-Anxiety)

  5 minutes

• psychological health (Child Behavior)

  10 minutes

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic - University Children's Hospital Zurich

You may qualify if:

• diagnosed with type 1 Diabetes 2-4 weeks ago
• in care at the University Children's Hospital of Zurich
• German speaking

You may not qualify if:

• other severe illness that affects the diabetes Management
• severe developmental disorder
• pregnancy

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, Switzerland

Location

Related Publications (4)

• Datye KA, Moore DJ, Russell WE, Jaser SS. A review of adolescent adherence in type 1 diabetes and the untapped potential of diabetes providers to improve outcomes. Curr Diab Rep. 2015 Aug;15(8):51. doi: 10.1007/s11892-015-0621-6.

  PMID: 26084580 BACKGROUND

• Delamater AM. Psychological care of children and adolescents with diabetes. Pediatr Diabetes. 2009 Sep;10 Suppl 12:175-84. doi: 10.1111/j.1399-5448.2009.00580.x. No abstract available.

  PMID: 19754628 BACKGROUND

• Kazak AE, Brier M, Alderfer MA, Reilly A, Fooks Parker S, Rogerwick S, Ditaranto S, Barakat LP. Screening for psychosocial risk in pediatric cancer. Pediatr Blood Cancer. 2012 Nov;59(5):822-7. doi: 10.1002/pbc.24166. Epub 2012 Apr 10.

  PMID: 22492662 BACKGROUND

• Litmanovitch E, Geva R, Rachmiel M. Short and long term neuro-behavioral alterations in type 1 diabetes mellitus pediatric population. World J Diabetes. 2015 Mar 15;6(2):259-70. doi: 10.4239/wjd.v6.i2.259.

  PMID: 25789107 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Markus A Landolt, Prof. dr.

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

• Daniel Konrad, Prof. dr.

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 22, 2018
• Study Start: June 5, 2018
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

CH (1)