Psychiatric Comorbidities in Type 1 Diabetes Mellitus.

Not yet recruiting

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT06586879
• Lead Sponsor: Assiut University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-08-27
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Study Start: 2024-10
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.	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
the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1	2 years	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)

Secondary Outcome Measures

Name	Time	Method
The impact of diabetes mellitus type 1 on quality of life.	2 years	This outcome will be measured using: Pediatric quality of life inventory 4.0 genetic Core scale.