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Type 1 DiabetesNCT03642483

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

An observational study of Type 1 Diabetes, run by University Children's Hospital, Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Type 1 Diabetes
How many people
61 participants
Where
1 siteSwitzerland
Study dates
5 Jun 2018to 17 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: primary care clinic - University Children's Hospital Zurich

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Children's Hospital Zurich

    Zurich

Other trials in Switzerland

About this study

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
Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Glycated hemoglobin

    Measured: 10 minutes

Secondary outcomes (5)

  1. health-related quality of life (Chronic generic measure)

    Assessed by questionnaire: DISABKIDS Chronic generic measure - short version (DCGM-12; the European DISABKIDS Group, 2012).

    Total score range: 12-60. The higher the score, the higher the health-related quality of life.

    Measured: 5 minutes

  2. health-related quality of life (diabetes module)

    Assessed by questionnaire: DISABKIDS diabetes module (The European DISABKIDS Group, 2012).

    Total score range: 10-50. The higher the score, the higher the health-related quality of life.

    Measured: 5 minutes

  3. psychological health (Depression)

    Assessed by questionnaire: German Version of the Children's Depression Inventory (Depressionsinventar für Kinder und Jugendliche [DIKJ]; Stiensmeier-Pelster, Braune-Krickau, Schürmann \& Duda, 2014).

    Total score range: 0-58. The higher the score, the more depressed the participants are.

    Measured: 10 minutes

  4. psychological health (Trait-Anxiety)

    Assessed by questionnaire: German Version of the Trait-Anxiety Inventory for Children (Trait Angstinventar für Kinder [STAIK-T]; Unnewehr, Joormann, Schneider \& Margraf, 1992).

    Total score range: 20-60. The higher the score, the higher the trait anxiety.

    Measured: 5 minutes

  5. psychological health (Child Behavior)

    Assessed by questionnaire: German Version of the Child Behavior Checklist (CBCL 6-18R; Döpfner, Plück \& Kinnen, 2014) Total score range: 0-224. The higher the score, the more behavioral problems.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start5 Jun 2018
  3. Primary completion17 Jan 2022
  4. Study completion17 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642483
Sponsor's protocol ID
2018-00374-G1
Other IDs
2018
Status last verified
Apr 2022
First submitted
3 Jul 2018
Last updated
21 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26084580

  • 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.

    PubMed 19754628

  • 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.

    PubMed 22492662

  • 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.

    PubMed 25789107

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by University Children's Hospital, Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642483, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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