Type 1 Diabetes MellitusNCT06586879
Psychiatric Comorbidities in Type 1 Diabetes Mellitus.
An observational study of Type 1 Diabetes Mellitus, run by Assiut University.
Trial summary
This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. Assessing the impact of diabetes mellitus type 1 on quality of life. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Sep 2026
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescent Patients with type 1 diabetes medllitus aged 8-15 years old.
Who may be able to join
- Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.
Who cannot join
- Patients with major psychiatric disorders or have cognitive difficulties.
- Patients unable or refuse to give consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.
This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.
Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.
Read the detailed description
Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.
- Conditions
- Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.
This outcome will be measured using:
The Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (K-SADS-PL) version
Measured: 2 years
the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1
this outcome will be measured using:
- Children's Depression Inventory 2 Self Report-Short (CDI-2) (12)
- The Spence Children's Anxiety Scale
- Children's Sleep Habits Questionnaire (CSHQ)
Measured: 2 years
Secondary outcomes (1)
The impact of diabetes mellitus type 1 on quality of life.
This outcome will be measured using:
Pediatric quality of life inventory 4.0 genetic Core scale.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Mohamed Fath-Allah, Assiut University
- Investigators
- Dalia Mahran, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586879
- Sponsor's protocol ID
- Psychiatry in type 1 DM
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ashraf MN, Cheng AYY, Robinson DJ. Emotional, Psychological, and Social Well-being Experience of Long-Term Living with Type 1 Diabetes Mellitus: A Patient-Psychiatrist-Endocrinologist Perspective. Diabetes Ther. 2024 Feb;15(2):317-323. doi: 10.1007/s13300-023-01527-w. Epub 2024 Jan 17.
PubMed 38233629Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul.
PubMed 36000101El-Ziny MA, Salem NA, El-Hawary AK, Chalaby NM, Elsharkawy AA. Epidemiology of childhood type 1 diabetes mellitus in Nile Delta, northern Egypt - a retrospective study. J Clin Res Pediatr Endocrinol. 2014;6(1):9-15. doi: 10.4274/Jcrpe.1171.
PubMed 24637304
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.
- ClinicalTrials.gov ID
- NCT06586879
- Acronym / sponsor ID
- Psychiatry in type 1 DM
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (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 study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.
Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.
Detailed description
Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescent Patients with type 1 diabetes medllitus aged 8-15 years old.
Key inclusion criteria (1 listed)
- Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.
Key exclusion criteria (2 listed)
- Patients with major psychiatric disorders or have cognitive difficulties.
- Patients unable or refuse to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.
Time frame: 2 years
This outcome will be measured using: The Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (K-SADS-PL) version
the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1
Time frame: 2 years
this outcome will be measured using: 1. Children's Depression Inventory 2 Self Report-Short (CDI-2) (12) 2. The Spence Children's Anxiety Scale 3. Children's Sleep Habits Questionnaire (CSHQ)
1 secondary outcome
The impact of diabetes mellitus type 1 on quality of life.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 38233629Ashraf MN, Cheng AYY, Robinson DJ. Emotional, Psychological, and Social Well-being Experience of Long-Term Living with Type 1 Diabetes Mellitus: A Patient-Psychiatrist-Endocrinologist Perspective. Diabetes Ther. 2024 Feb;15(2):317-323. doi: 10.1007/s13300-023-01527-w. Epub 2024 Jan 17.
- Background: PubMed 36000101Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul.
- Background: PubMed 24637304El-Ziny MA, Salem NA, El-Hawary AK, Chalaby NM, Elsharkawy AA. Epidemiology of childhood type 1 diabetes mellitus in Nile Delta, northern Egypt - a retrospective study. J Clin Res Pediatr Endocrinol. 2014;6(1):9-15. doi: 10.4274/Jcrpe.1171.
- Type 1 diabetes in international diabetes FederationLink provided by the sponsor.
- Type 1 diabetes indexLink provided by the sponsor.
- Psychological care of children and adolescents with type 1 diabetesLink provided by the sponsor.
- Evaluation of psychological characteristics of Turkish children with type 1 diabetes mellitus from two demographically and geographically distinct regionsLink provided by the sponsor.
- The cognitive and psychological effects of living with type 1 diabetesLink provided by the sponsor.
- High Rate of Depression among Saudi Children with Type 1 DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dalia Mahran study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, 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 1 inclusion and 2 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 19 Sep 2024. 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?
Contact Omnia Fath-Allah, Physician (+201012304476, omnaya.16266093@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT06586879, which also lists 3 linked publications.
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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.