Diabetes Mellitus Type 1NCT05477433
Psychiatric Disorders Related to Diabetes Mellitus Type 1
An observational study of Diabetes Mellitus Type 1 and Adolescents, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders
- What is being tested?
- diabetes mellitus type 1
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Dec 2025
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will be screening for adolescents with diabetes mellitus
Who may be able to join
- 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.
Who cannot join
- Adolescents with an intelligence quotient below 70.
- Adolescents with a history of substance use or psychiatric disorders.
- Adolescents with medical or other neurological conditions.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders
- Being tested
- diabetes mellitus type 1
- 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.
diabetes mellitus type 1Behavioural
Pittsburgh Sleep Quality Index "PSQI": It is used to detect sleep disturbance or deficits. The PSQI has a scoring key that can be used to calculate a patient's seven subscores, which range from 0 to 3. The subscores are added together to produce a "global" score that ranges from 0 to 21. A global score of 5 or higher denotes poor sleep quality, The Strengths and Difficulties Questionnaire (SDQ) The SDQ is a well-validated screening tool for children and adolescents aged 4-17 years that can identify behavioural and emotional issues,Emotional Avoidance Strategy Inventory for Adolescents (EASI) is used. The EASI-A is a 17-item assessing the use of emotionally avoidant strategies in adolescents and higher scores means significants use avoidant strategies, The Toronto Alexithymia Scale (TAS-20) is a self-administered 20-item questionnaire which assesses difficulties in identifying and describing emotions. TAS scores were significantly higher in alexithymia
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 2023 (estimated)
- Study completion1 Dec 2025 (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
- NCT05477433
- Sponsor's protocol ID
- diabetes mellitus
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- 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 Diabetes Mellitus Type 1 Among Adolescents in Egypt
- ClinicalTrials.gov ID
- NCT05477433
- Acronym / sponsor ID
- diabetes mellitus
- 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 2023 (estimated)
- Study completion
- 1 Dec 2025 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will be screening for adolescents with diabetes mellitus
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Adolescents with an intelligence quotient below 70.
- Adolescents with a history of substance use or psychiatric disorders.
- Adolescents with medical or other 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 |
|---|---|---|
| diabetes mellitus type 1Pittsburgh Sleep Quality Index "PSQI": It is used to detect sleep disturbance or deficits. The PSQI has a scoring key that can be used to calculate a patient's seven subscores, which range from 0 to 3. The subscores are added together to produce a "global" score that ranges from 0 to 21. A global score of 5 or higher denotes poor sleep quality, The Strengths and Difficulties Questionnaire (SDQ) The SDQ is a well-validated screening tool for children and adolescents aged 4-17 years that can identify behavioural and emotional issues,Emotional Avoidance Strategy Inventory for Adolescents (EASI) is used. The EASI-A is a 17-item assessing the use of emotionally avoidant strategies in adolescents and higher scores means significants use avoidant strategies, The Toronto Alexithymia Scale (TAS-20) is a self-administered 20-item questionnaire which assesses difficulties in identifying and describing emotions. TAS scores were significantly higher in alexithymia | 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 4 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.