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NCT05477173 Clinical Trial

Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Children in Egypt

Diabetes Mellitus Type 1 Clinical Trial

Official title:
Psychiatric Disorders Related to Children With Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05477173
Other study ID # diabetes children
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 1, 2023

Study information
Verified date July 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Type 1 diabetes is the most common endocrine disorder in children and adolescents. It is characterised by a deficiency in insulin synthesis and requires daily insulin injections to manage glucose levels. Therefore, there are numerous medical approaches to its therapy, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycaemic control during the last 3 months and monitoring of blood glucose levels, influencing the mental health and the quality of life of the patient and family. Hens, the importance of the psychological adjustment to children and adolescents with type 1 diabetes besides insulin injection, adequate diet and regular exercise rises, in order to maintain stable psychological status and functional mental health, and prevent psychological disorders such as anxiety, depression and sleep disorders. Approaching the comorbidity in these children and adolescents starts with the diagnosis and with the health changes in all aspects.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 140
Est. completion date December 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: 1. Both boys and girls aged 6-12 years. 2. Willing of the parents or the caregivers to participate in the study. 3. Duration of type 1 DM of at least 1 year. Exclusion Criteria: 1. Children with intelligence quotient below 70. 2. Children with history of substance use. 3. Children with another medical or neurological conditions.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• The Strengths and Difficulties Questionnaire (SDQ) Parent Version Parent : It consists of 25 questionnaires used to screen for behavioral problems in children aged 4-17 years.
screen by using psychometric scales

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Measure frequency of sleep problems with diabetes mellitus type 1 through study completion, an average of 1 year
Primary Measures frequency of psychiatric problems with diabetes mellitus type 1 through study completion, an average of 1 year
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