Diabetes Type 1NCT07110974
Diabetes Distress and Quality of Life in University Students With Type 1 DM
A study testing Diabetes Distress scale 17 and Quality Of Life Instrument in people with Diabetes Type 1 and Diabetes Distress, run by Sohag University.
Trial summary
This study aims to encourage and support Sohag University Students with type 1 Diabetes Mellitus (T1DM). It will discover students with poor glycemic control, diabetic retinopathy, and renal complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1, Diabetes Distress
- What is being tested?
- Diabetes Distress scale 17 and Quality Of Life Instrument
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Already diagnosed Type 1 diabetes mellitus
- receiving insulin
Who cannot join
- refuses to participate in the study.
- deaf or mute.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dina Abdel-Naby assistant lecturer in Family Medicine contact
About this study
Official title: Assessment of Diabetes Distress and Quality of Life in Sohag University Students With Type 1 Diabetes Mellitus
This study aims to encourage and support Sohag University Students with type 1 Diabetes Mellitus (T1DM). It will discover students with poor glycemic control, diabetic retinopathy, and renal complications. In addition to focus on those students suffering from Diabetes Distress (DD) and poor Quality of Life (QOL) due to type 1 Diabetes Mellitus (T1DM).
Read the detailed description
Data will be collected through personal interviews with type 1 Diabetes Mellitus (T1DM) students using standardized questionnaire. The questionnaire is divided into three sections:
- The first section will gather primarily identification of data such as name, age, gender, father and mother education, order of the student in his/her family, faculty, grade, learning performance, residence; urban or rural, family home or hostile, living alone or with whom, marital status, working, smoking, exercising, history of viral infection as mumps before Diabetes Mellitus (DM), when was first diagnosed with type 1 Diabetes Mellitus (T1DM) and the presentation of the diagnosis, drugs administered for treatment of Diabetes Mellitus (DM) , presence of chronic diseases other than diabetes, history of hospitalization and cause, presence of diabetic complications, and family history of diabetes, we construct the first section according to circumstances in upper Egypt.
- The second section of the questionnaire will be for the assessment of Diabetes Distress (DD) using the valid DDS17 (Diabetes Distress Scale 17) and aims to evaluate distress across four domains: Emotional burden, Physician- related distress, Regimen-related distress, and Interpersonal distress.
- The third section of the questionnaire will be for the assessment of Quality of Life (QOL) using a pre-designed questionnaire called the "Diabetes Quality of Life Instrument" (DQOLI).
- Conditions
- Diabetes Type 1, Diabetes Distress
- Being tested
- Diabetes Distress scale 17 and Quality Of Life Instrument
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Distress scale 17 and Quality Of Life InstrumentBehavioural
questionnaire that assesses the distress resulting from being diabetic patient type 1 and another questionnaire that assesses the quality of life among type 1 diabetic Sohag University students
| Study group | Role | What they receive |
|---|---|---|
| Sohag University students with type 1 diabetes mellitus | Other | Not described Receives: Behavioral: Diabetes Distress scale 17 and Quality Of Life Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress Scale 17 (DDS17). Diabetes Quality of Life Instrument
- Diabetes Distress Scale 17, the degree to which each item may be bothering NOT if the item is true.If that item is not a problem ,circle 1. If it is very bothersome ,circle 6.To score sum the patient's responses and divide by the number of items.
- Diabetes Quality of Life Instrument Domain No. of items Range of score for each item Range of score Converted to percentage Domain No of items Range of score Range of score Converted to % Satisfaction (S) 6 for each item 6-30 (S)/30 x 100 Impact (I) 4 4-20 (I)/20 x 100 Worry (W) 3 1-5 3-15 (W)/15 x 100 Total 13 13-65 Total / 65 x 100
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdelnaby Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110974
- Sponsor's protocol ID
- Soh-Med-25-7--3MD
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Diabetes Distress and Quality of Life in Sohag University Students With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07110974
- Acronym / sponsor ID
- Soh-Med-25-7--3MD
- Conditions
- Diabetes Type 1, Diabetes Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Aug 2025 (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 aims to encourage and support Sohag University Students with type 1 Diabetes Mellitus (T1DM). It will discover students with poor glycemic control, diabetic retinopathy, and renal complications. In addition to focus on those students suffering from Diabetes Distress (DD) and poor Quality of Life (QOL) due to type 1 Diabetes Mellitus (T1DM).
Detailed description
Data will be collected through personal interviews with type 1 Diabetes Mellitus (T1DM) students using standardized questionnaire. The questionnaire is divided into three sections:
- The first section will gather primarily identification of data such as name, age, gender, father and mother education, order of the student in his/her family, faculty, grade, learning performance, residence; urban or rural, family home or hostile, living alone or with whom, marital status, working, smoking, exercising, history of viral infection as mumps before Diabetes Mellitus (DM), when was first diagnosed with type 1 Diabetes Mellitus (T1DM) and the presentation of the diagnosis, drugs administered for treatment of Diabetes Mellitus (DM) , presence of chronic diseases other than diabetes, history of hospitalization and cause, presence of diabetic complications, and family history of diabetes, we construct the first section according to circumstances in upper Egypt.
- The second section of the questionnaire will be for the assessment of Diabetes Distress (DD) using the valid DDS17 (Diabetes Distress Scale 17) and aims to evaluate distress across four domains: Emotional burden, Physician- related distress, Regimen-related distress, and Interpersonal distress.
- The third section of the questionnaire will be for the assessment of Quality of Life (QOL) using a pre-designed questionnaire called the "Diabetes Quality of Life Instrument" (DQOLI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sohag University students with type 1 diabetes mellitus | Other | Behavioral: Diabetes Distress scale 17 and Quality Of Life Instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Already diagnosed Type 1 diabetes mellitus
- receiving insulin
Key exclusion criteria (2 listed)
- refuses to participate in the study.
- deaf or mute.
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 Distress scale 17 and Quality Of Life Instrumentquestionnaire that assesses the distress resulting from being diabetic patient type 1 and another questionnaire that assesses the quality of life among type 1 diabetic Sohag University students | Behavioural | Sohag University students with type 1 diabetes mellitus |
Primary outcome
Diabetes Distress Scale 17 (DDS17). Diabetes Quality of Life Instrument
Time frame: 3 months
1. Diabetes Distress Scale 17, the degree to which each item may be bothering NOT if the item is true.If that item is not a problem ,circle 1. If it is very bothersome ,circle 6.To score sum the patient's responses and divide by the number of items. 2. Diabetes Quality of Life Instrument Domain No. of items Range of score for each item Range of score Converted to percentage Domain No of items Range of score Range of score Converted to % Satisfaction (S) 6 for each item 6-30 (S)/30 x 100 Impact (I) 4 4-20 (I)/20 x 100 Worry (W) 3 1-5 3-15 (W)/15 x 100 Total 13 13-65 Total / 65 x 100
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 8 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Dina Abdel-Naby assistant lecturer in Family Medicine contact
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Distress scale 17 and Quality Of Life Instrument in people with Diabetes Type 1 and Diabetes Distress, run by Sohag 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 2 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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 Dina Abdel-Naby assistant lecturer in Family Medicine (+201061999108, dina_abdelnaby_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Scale 17 (DDS17). Diabetes Quality of Life Instrument (time frame: 3 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 8 Aug 2025.