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

July 26, 2022 updated by: Gellan Karamalllah Ramadan Ahmed, Assiut University

Psychiatric Disorders Related to Children With Diabetes Mellitus

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children with Diabetes Mellitus Type 1

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure frequency of sleep problems with diabetes mellitus type 1
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Measures frequency of psychiatric problems with diabetes mellitus type 1
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetes children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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