Depression in Type 1 Diabetes MellitussNCT07925164
Prevalence and Factors Associated With Depression Among Children and Adolescents With Type 1 Diabetes Mellituss
An observational study of Depression in Type 1 Diabetes Mellituss, run by Asmaa Abdelnasser Madian.
Trial summary
This is cross sectional study conducted at Sohag University Hospital to assess prevalence and factors associated with depression among children and adolescents with type 1 diabetes mellitus .The investigators will include the children and adolescents from 7 to 16 years who are diagnosed with type 1 diabetes mellitus Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Depression in Type 1 Diabetes Mellituss
- What is being tested?
- Observation follow-up
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: paediatric patient from 7 to 16 years diagnosed with type 1 diabetes mellitus and have depression who are followed in Paediatric Endocrinology Department ,Sohag University Hospital .
Who may be able to join
- Adolescents aged 7-16 years . Diagnosed with type 1 diabetes mellitus for at least 6 months . On insulin therapy . Able to understand and complete the questionnaires . Consent from parent/guardian and assent from the adolescent
Who cannot join
- Adolescents with type 2 diabetes or secondary diabetes
- Severe cognitive impairment preventing questionnaire completion
- Acute illness at time of assessment
- Diagnosed psychiatric disorders prior to T1DM diagnosis.
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence and Factors Associated With Depression Among Children and Adolescents With Type 1 Diabetes Mellitus :A Cross-sectional Study
This is cross sectional study conducted at Sohag University Hospital to assess prevalence and factors associated with depression among children and adolescents with type 1 diabetes mellitus .The investigators will include the children and adolescents from 7 to 16 years who are diagnosed with type 1 diabetes mellitus
Read the detailed description
This is single-centre cross sectional study conducted and the paediatric endocrinology Department ,Sohag University Hospital ,Egypt study population.Childern and adolescents from 7 to 16 years diagnosed with type 1 diabetes mellitus to assess prevalence and factors associated with depression .Data collection :Demographic data,anthropometric data, clinical assessment,laboratory results ,depression assessment using the Children Depression Inventory (CDI) .Objectives:to assess the prevalence and factors associated with depression among childern and adolescents with type 1 diabetes mellitus .This study does not involve any experimental interventions .All investigators and management will be according to standard hospital protocols
- Conditions
- Depression in Type 1 Diabetes Mellituss
- Being tested
- Observation follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation follow-upOther
No experimental intervention .Data will be collected from routine clinical care,medical records ,and follow up visits according to standard hospital protocols
| Study group | Role | What they receive |
|---|---|---|
| Children from 7 to 16 years diagnosed depression with type 1 diabetes mellitus | Children and adolescents from 7 to 16 years diagnosed with type 1 diabetes mellitus have depression who are followed at Sohag University Hospital Receives: Other: Observation follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression in type 1 diabetes mellitus
Prevalence and factors associated with depression among children and adolescents with type 1 diabetes mellitus at Sohag University Hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Type 1 Diabetes MellitussStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asmaa Abdelnasser Madian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Abdelnasser Madian, Sohag University
- Investigators
- Asmaa Abdelnaser Madian, Resident doctor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925164
- Sponsor's protocol ID
- Soh-med-26-9-11MS
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and data protection policies at Sohag University Hospital
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Factors Associated With Depression Among Children and Adolescents With Type 1 Diabetes Mellitus :A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07925164
- Acronym / sponsor ID
- Soh-med-26-9-11MS
- Conditions
- Depression in Type 1 Diabetes Mellituss
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asmaa Abdelnasser MadianUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Nov 2026 (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.
This is cross sectional study conducted at Sohag University Hospital to assess prevalence and factors associated with depression among children and adolescents with type 1 diabetes mellitus .The investigators will include the children and adolescents from 7 to 16 years who are diagnosed with type 1 diabetes mellitus
Detailed description
This is single-centre cross sectional study conducted and the paediatric endocrinology Department ,Sohag University Hospital ,Egypt study population.Childern and adolescents from 7 to 16 years diagnosed with type 1 diabetes mellitus to assess prevalence and factors associated with depression .Data collection :Demographic data,anthropometric data, clinical assessment,laboratory results ,depression assessment using the Children Depression Inventory (CDI) .Objectives:to assess the prevalence and factors associated with depression among childern and adolescents with type 1 diabetes mellitus .This study does not involve any experimental interventions .All investigators and management will be according to standard hospital protocols
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children from 7 to 16 years diagnosed depression with type 1 diabetes mellitus | – | Other: Observation follow-upChildren and adolescents from 7 to 16 years diagnosed with type 1 diabetes mellitus have depression who are followed at Sohag University Hospital |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- paediatric patient from 7 to 16 years diagnosed with type 1 diabetes mellitus and have depression who are followed in Paediatric Endocrinology Department ,Sohag University Hospital .
Key inclusion criteria (1 listed)
- Adolescents aged 7-16 years . Diagnosed with type 1 diabetes mellitus for at least 6 months . On insulin therapy . Able to understand and complete the questionnaires . Consent from parent/guardian and assent from the adolescent
Key exclusion criteria (5 listed)
- Adolescents with type 2 diabetes or secondary diabetes
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 |
|---|---|---|
| Observation follow-upNo experimental intervention .Data will be collected from routine clinical care,medical records ,and follow up visits according to standard hospital protocols | Other | Children from 7 to 16 years diagnosed depression with type 1 diabetes mellitus |
Primary outcome
Depression in type 1 diabetes mellitus
Time frame: 6 months
Prevalence and factors associated with depression among children and adolescents with type 1 diabetes mellitus at Sohag University Hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and data protection policies at Sohag University Hospital
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.
Asmaa Abdelnaser Madian, Resident doctor principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Depression in Type 1 Diabetes Mellituss, run by Asmaa Abdelnasser Madian.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Abdelnaser Madian, Resident doctor (01090850159, asmaa.abdelnaser@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression in type 1 diabetes mellitus (time frame: 6 months). 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 9 Nov 2026.