- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05477433
Psychiatric Disorders Related to Diabetes Mellitus Type 1
July 25, 2022 updated by: Gellan Karamalllah Ramadan Ahmed, Assiut University
Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Adolescents in Egypt
The most common endocrine illness in children and adolescents is type 1 diabetes.
It is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control.
As a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life.
Type 1 diabetes complications and poor quality of life are widespread.
Diabetes therapy is difficult during puberty and adolescence.
Adolescents with T1D have poor metabolic control and a higher rate of acute complications.
Because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.
Study Overview
Status
Not yet recruiting
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
10 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study will be screening for adolescents with diabetes mellitus
Description
Inclusion Criteria:
- Both males and females were included.
- Age ranges from 10 to 19 years.
- Willing of the parents or the caregivers to participate in the study.
- Duration of T1DM of at least 1 year.
Exclusion Criteria
- Adolescents with an intelligence quotient below 70.
- Adolescents with a history of substance use or psychiatric disorders.
- Adolescents with medical or other 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
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
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, 2023
Study Completion (ANTICIPATED)
December 1, 2025
Study Registration Dates
First Submitted
July 22, 2022
First Submitted That Met QC Criteria
July 25, 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 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetes mellitus
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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