An observational study in Diabetes Mellitus (DM), Hypoglycaemia and Self Care, sponsored by Bilecik Seyh Edebali Universitesi. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Bilecik Seyh Edebali Universitesi · Observational
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 200 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Bilecik Seyh Edebali Universitesi is the lead sponsor of 62 studies on the registry; 27 are open to participants now.
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Type 2 diabetes patients receiving outpatient treatment under follow-up at the diabetes clinic
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Exclusion Criteria:
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).
Time frame: 6 months
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.
Time frame: 6 months
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Bilecik Seyh Edebali Universitesi