Clinical trial NCT03642470: Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
Official title: Risk Factors of Metabolic Control in Children and Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
metabolic control
psychosocial risk factors
cortisol
children
adolescents
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 197
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic - University Children's Hospital Zurich

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.


Eligibility criteria: Inclusion Criteria:

* diagnosed with type 1 diabetes over a year 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

Primary outcomes:
measure: HbA1c
timeFrame: 10 minutes
Secondary outcomes:
measure: health-related quality of life (Chronic generic measure)
timeFrame: 5 minutes
measure: health-related quality of life (diabetes module)
timeFrame: 5 minutes
measure: psychological health (Depression)
timeFrame: 10 minutes
measure: psychological health (Trait-Anxiety)
timeFrame: 5 minutes
measure: psychological health (Child Behavior)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Markus A Landolt, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Children's Hospital, Zurich
name: Daniel Konrad, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.