Diabetes Mellitus (DM)NCT07316699
Evaluation of the Psychometric Properties of the Turkish Version of the Hypoglycaemia Self-Care Behaviour Scale
An observational study of Diabetes Mellitus (DM) and Hypoglycaemia, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to validate the validity and reliability of the Hypoglycaemia Self-Care Behaviour Scale, developed to assess hypoglycaemia self-care behaviours in patients with type 2 diabetes, through a prospective cross-sectional study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus (DM), Hypoglycaemia, Self Care
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2026to 1 Dec 2026
- Phase
- Observational
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
Study population: Type 2 diabetes patients receiving outpatient treatment under follow-up at the diabetes clinic
Who may be able to join
- Aged 18 years or older,
- With type 2 diabetes mellitus,
- Who have had blood sugar levels <70 mg/dL at least once in the last six months,
- Who can read and write Turkish and communicate effectively.
Who cannot join
- Patients diagnosed with mental and/or cognitive disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University
Bilecik, Bilecik, 11000
About this study
The aim of this study is to validate the validity and reliability of the Hypoglycaemia Self-Care Behaviour Scale, developed to assess hypoglycaemia self-care behaviours in patients with type 2 diabetes, through a prospective cross-sectional study.
Read the detailed description
Diabetes is a chronic metabolic disease with a rapidly increasing prevalence worldwide that significantly impacts individuals' quality of life. One of the primary goals in diabetes management is to maintain optimal glycaemic control in order to prevent both acute and chronic complications. However, hypoglycaemia, which occurs when blood glucose levels drop to dangerous levels, particularly in individuals using insulin or sulphonylurea group drugs, is not only a significant clinical problem but also a powerful source of psychological stress. As an acute complication of diabetes, hypoglycaemia can have serious consequences for the patient's health. Therefore, the management and prevention of hypoglycaemic events are very important in diabetes self-care.
People with diabetes need comprehensive knowledge and self-care skills, including regular blood glucose monitoring, diet, exercise, and medication management, to effectively self-manage their condition and achieve optimal glycaemic control. Only patients with the correct care information can demonstrate appropriate self-care behaviour.
The fact that individuals with diabetes face lifelong management challenges emphasises the importance of correct self-care behaviours. In this context, rapid assessment tools are needed to evaluate behaviours for coping with and preventing hypoglycaemic episodes. The aim of this study is to validate the validity and reliability of the Hypoglycaemia Self-Care Behaviour Scale, developed to assess hypoglycaemia self-care behaviour in diabetic patients, in the Turkish population.
- Conditions
- Diabetes Mellitus (DM), Hypoglycaemia, Self Care
- Keywords
- diabetes mellitus, Hypoglycaemia, Self-Care Behaviour, Scale
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycaemia Self-Care Behaviour Scale
Developed in 2025 by Huang and colleagues. The scale consists of 10 items and 4 subscales: 'recognising hypoglycaemia and carbohydrate supplementation', 'preventing hypoglycaemia during exercise', 'carbohydrate assessment' and 'seeking medical help'. Each item is rated on a 5-point scale ranging from 1 (never) to 5 (always). The maximum possible score on the scale is 50, and scores below 30 indicate a need for hypoglycaemia education. The internal consistency of the developed scale ranges from 0.73 to 0.94, indicating strong reliability (Huang et al., 2025).
Measured: 6 months
Secondary outcomes (1)
Hypoglycaemic Confidence Scale
A 9-item self-report scale developed in 2017 by William Polonsky et al. to examine the degree to which people with diabetes feel confident and comfortable in their ability to protect themselves from hypoglycaemic problems. It was adapted into Turkish in 2021 by Büyükkaya Besen and Dervisoglu. Scale items are scored on a 1-4 scale. The ninth scale item for individuals with diabetes who have a partner is interpreted as follows: 1; does not trust at all 2; trusts a little 3; trusts moderately 4; trusts a lot. Scale scores are calculated by dividing the total item score by the number of completed items (for participants without a spouse, the calculation is based on 8 items).It is a unidimensional measure; an increase in the average score obtained from the scale indicates an increase in the level of confidence. The scale has no cut-off point.
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 posted5 Jan 2026
- Study start31 Jan 2026
- Primary completion30 Jul 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (DM)Studies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semanur Bilgiç, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316699
- Sponsor's protocol ID
- semanur bilgiç diyabet ölçek
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No