FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES

February 19, 2026 updated by: Bilecik Seyh Edebali Universitesi

THE EFFECT OF FEAR OF HYPOGLYCEMIA ON DIET AND MEDICATION ADHERENCE IN PATIENTS WITH DIABETES

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hypoglycemia Fear Levels in Patients
Time Frame: 15.01.2026-15.06.2025
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
Time Frame: 15.01.2026-15.06.2025
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
Time Frame: 15.01.2026-15.06.2025
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bilecik Seyh Edebali Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Burcu Bayrak3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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