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NCT Number: NCT07110974

Diabetes Distress and Quality of Life in University Students With Type 1 DM

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Already diagnosed Type 1 diabetes mellitus
  • receiving insulin

Exclusion criteria

  • refuses to participate in the study.
  • deaf or mute.

Treatment and study plan

Diabetes Distress scale 17 and Quality Of Life Instrument

Behavioral

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

Primary outcomes

  1. Diabetes Distress Scale 17 (DDS17). Diabetes Quality of Life Instrument

    Time frame: 3 months

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Abdel-Naby assistant lecturer in Family Medicine

CONTACT

[email protected]

+201061999108

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Assessment of Diabetes Distress and Quality of Life in Sohag University Students With Type 1 Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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