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NCT Number: NCT06586879

Psychiatric Comorbidities in Type 1 Diabetes Mellitus.

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.

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Key information

About this study

Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 years

    this outcome will be measured using:

    • Children's Depression Inventory 2 Self Report-Short (CDI-2) (12)
    • The Spence Children's Anxiety Scale
    • Children's Sleep Habits Questionnaire (CSHQ)

Secondary outcomes

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

    Time frame: 2 years

    This outcome will be measured using:

    Pediatric quality of life inventory 4.0 genetic Core scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Omnia Fath-Allah, Physician

CONTACT

[email protected]

+201012304476

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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