NCT06586879

Brief Summary

This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.

Trial Health

65
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Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Oct 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

August 27, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

August 27, 2024

Last Update Submit

September 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.

    This outcome will be measured using: The Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (K-SADS-PL) version

    2 years

  • the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1

    this outcome will be measured using: 1. Children's Depression Inventory 2 Self Report-Short (CDI-2) (12) 2. The Spence Children's Anxiety Scale 3. Children's Sleep Habits Questionnaire (CSHQ)

    2 years

Secondary Outcomes (1)

  • The impact of diabetes mellitus type 1 on quality of life.

    2 years

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children and adolescent Patients with type 1 diabetes medllitus aged 8-15 years old.

You may qualify if:

  • Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.

You may not qualify if:

  • Patients with major psychiatric disorders or have cognitive difficulties.
  • Patients unable or refuse to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ashraf MN, Cheng AYY, Robinson DJ. Emotional, Psychological, and Social Well-being Experience of Long-Term Living with Type 1 Diabetes Mellitus: A Patient-Psychiatrist-Endocrinologist Perspective. Diabetes Ther. 2024 Feb;15(2):317-323. doi: 10.1007/s13300-023-01527-w. Epub 2024 Jan 17.

    PMID: 38233629BACKGROUND
  • Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul.

    PMID: 36000101BACKGROUND
  • El-Ziny MA, Salem NA, El-Hawary AK, Chalaby NM, Elsharkawy AA. Epidemiology of childhood type 1 diabetes mellitus in Nile Delta, northern Egypt - a retrospective study. J Clin Res Pediatr Endocrinol. 2014;6(1):9-15. doi: 10.4274/Jcrpe.1171.

    PMID: 24637304BACKGROUND

Related Links

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

  • Dalia Mahran

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Omnia Fath-Allah, Physician

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

August 27, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share