FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES

NCT ID: NCT07329985

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fear of hypoglycemia can directly affect individuals' adherence to treatment, dietary habits, and self-management behaviors. Low levels of fear can lead to ignoring the risk of hypoglycemia, downplaying symptoms, and creating a predisposition to subsequent hypoglycemic attacks, increasing the risk of life-threatening complications. On the other hand, excessively high levels of fear can create constant anxiety, emotional stress, discomfort, and feelings of insecurity, reducing quality of life and triggering depressive symptoms. Furthermore, individuals with high levels of fear tend to maintain higher glucose levels to avoid hypoglycemia. This leads to impaired metabolic control and an increased risk of long-term complications. Additionally, fear of hypoglycemia can significantly affect how individuals regulate their insulin doses, physical activity, and food intake.The literature indicates that fear of hypoglycemia triggers avoidance behaviors in individuals with diabetes, which often leads to poor treatment adherence. These avoidance behaviors include strategies such as consciously reducing insulin doses, skipping oral antidiabetic medications, or not adhering to the treatment plan. This makes it difficult to reach target glycemic levels, increasing the risk of complications in the long term. Fear of hypoglycemia can negatively affect not only medication adherence but also dietary and nutritional behaviors. It is common for individuals who want to avoid hypoglycemia to consume more carbohydrates than planned meals, add excessive snacks to protect against nocturnal hypoglycemia, or develop irregular eating habits. These behaviors can lead to impaired glycemic control, weight gain, and hyperglycemia, hindering the achievement of metabolic goals. This study aims to address an important gap in diabetes management by examining the impact of fear of hypoglycemia on dietary and medication adherence in patients with diabetes. Fear of hypoglycemia may lead patients to consciously or unconsciously reduce medication doses, skip meals, or deviate from recommended dietary plans. Such behaviors can result in poor glycemic control and increase the risk of diabetes-related complications in the long term. The findings of this study are expected to help healthcare professionals identify fear of hypoglycemia at an early stage and develop individualized education, counseling, and care plans. Consequently, improving treatment adherence and enhancing the quality of life of patients with diabetes may be achieved.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Diet, Healthy Medication Adherence Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bilecik Seyh Edebali Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Burcu Bayrak3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hypoglycemia Prevention and Awareness Program
NCT06775288 ACTIVE_NOT_RECRUITING NA