NCT03642470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

July 3, 2018

Last Update Submit

May 31, 2021

Conditions

Type 1 Diabetes

Keywords

type 1 diabetesmetabolic controlpsychosocial risk factorscortisolchildrenadolescents

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

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic - University Children's Hospital Zurich

You may qualify if:

  • diagnosed with type 1 diabetes over a year 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich

Zurich, Switzerland

Location

Related Publications (3)

  • 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: 26084580BACKGROUND

  • 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: 19754628BACKGROUND

  • 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: 25789107BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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
CROSS SECTIONAL
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

June 22, 2020

Study Completion

June 22, 2020

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

CH(1)