Diabetes Mellitus Type 1NCT05477173
Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Children in Egypt
An observational study of Diabetes Mellitus Type 1 and Adolescents, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children with Diabetes Mellitus Type 1
Who may be able to join
- Both boys and girls aged 6-12 years.
- Willing of the parents or the caregivers to participate in the study.
- Duration of type 1 DM of at least 1 year.
Who cannot join
- Children with intelligence quotient below 70.
- Children with history of substance use.
- Children with another medical or neurological conditions.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders
- Being tested
- 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.
- Medical subject headings
- Diabetes Mellitus, Type 1, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
Also called The Children's Alexithymia Measure (CAM) : The CAM comprises 14 components rated in a range of 0 to 3.Total scores can vary from 0 to 42, with higher numbers indicating more alexithymia, the Children's Sleep Habits Questionnaire (CSHQ-A) was used to assess sleeping difficulties.
screen by using psychometric scales
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure frequency of sleep problems with diabetes mellitus type 1
Measured: through study completion, an average of 1 year
Measures frequency of psychiatric problems with diabetes mellitus type 1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477173
- Sponsor's protocol ID
- diabetes children
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders Related to Children With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05477173
- Acronym / sponsor ID
- diabetes children
- Conditions
- Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with Diabetes Mellitus Type 1
Key inclusion criteria (3 listed)
- Both boys and girls aged 6-12 years.
- Willing of the parents or the caregivers to participate in the study.
- Duration of type 1 DM of at least 1 year.
Key exclusion criteria (3 listed)
- Children with intelligence quotient below 70.
- Children with history of substance use.
- Children with another medical or neurological conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.Also: The Children's Alexithymia Measure (CAM) : The CAM comprises 14 components rated in a range of 0 to 3.Total scores can vary from 0 to 42, with higher numbers indicating more alexithymia, the Children's Sleep Habits Questionnaire (CSHQ-A) was used to assess sleeping difficulties.screen by using psychometric scales | Behavioural | – |
Primary outcome
Measure frequency of sleep problems with diabetes mellitus type 1
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 1 and Adolescents, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure frequency of sleep problems with diabetes mellitus type 1 (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.