FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES

NCT07329985 | Not Yet Recruiting

• 1 other identifier: Burcu Bayrak3
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fear of hypoglycemia has a significant impact on both medication and dietary adherence in individuals with diabetes. Through avoidance behaviors, it can disrupt metabolic control, prevent the achievement of glycemic targets, and increase the risk of long-term complications. Therefore, monitoring only biochemical parameters is insufficient in diabetes management. It is crucial for healthcare professionals to systematically assess the fear of hypoglycemia.

Conditions

Diabetes Mellitus; Diet, Healthy; Medication Adherence; Hypoglycemia

Keywords

Diabetes; Medication Adherence; Nursing; Diet

Outcome Measures

Primary Outcomes (3)

• Hypoglycemia Fear Levels in Patients

  The first measure of the study will be the patients' fear of hypoglycemia. The Hypoglycemia Fear Scale will be used for this purpose. The scale score ranges from 0 to 128. While there is no cutoff point for the scale, a higher average score indicates a higher level of fear of hypoglycemia.

  15.01.2026-15.06.2025

• Patient Medication Adherence

  The second measure of the study will be patient medication adherence. The Medication Adherence Report Scale will be used for this purpose. Scores on the scale range from 5 to 25. Higher scores indicate adherence, while lower scores indicate non-adherence.

  15.01.2026-15.06.2025

• Dietary Adherence of Patients

  Another criterion of the study will be measuring the dietary adherence of the patients. The Mediterranean Diet Adherence Scale will be used for this purpose. A total score of 7 or higher indicates acceptable adherence to the Mediterranean diet, while a score of 9 or higher indicates strict adherence.

  15.01.2026-15.06.2025

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic patients who applied to a Training and Research Hospital in Türkiye constituted the study population.

You may qualify if:

• Diagnosed with diabetes Aged 18-65 Having experienced at least one hypoglycemic attack previously, Using antidiabetic medication (oral pills and/or insulin), Volunteered to participate in the study

You may not qualify if:

• unable to communicate in the same language having cognitive impairment wanting to leave the study at any stage

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-12