Diabetes MellitusNCT07329985
FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES
An observational study of Diabetes Mellitus and Diet, Healthy, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Diet, Healthy, Medication Adherence
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients who applied to a Training and Research Hospital in Türkiye constituted the study population.
Who may be able to join
- 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
Who cannot join
- unable to communicate in the same language having cognitive impairment wanting to leave the study at any stage
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, 1 recruiting
- Recruiting
Bilecik Eğitim ve Araştırma Hastanesi
Bilecik
Burcu Bayrak Kahraman, Assoc. Prof., +905057542411, burcu.bayrak@bilecik.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Diet, Healthy, Medication Adherence, Hypoglycemia
- Keywords
- Diabetes, Medication Adherence, Nursing, Diet
- Medical subject headings
- Diabetes Mellitus, Medication Adherence, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15.01.2026-15.06.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Apr 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329985
- Sponsor's protocol ID
- Burcu Bayrak3
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF FEAR OF HYPOGLYCEMIA ON DIET AND MEDICATION ADHERENCE IN PATIENTS WITH DIABETES
- ClinicalTrials.gov ID
- NCT07329985
- Acronym / sponsor ID
- Burcu Bayrak3
- Conditions
- Diabetes Mellitus, Diet, Healthy, Medication Adherence, Hypoglycemia
- Keywords
- Diabetes, Medication Adherence, Nursing, Diet
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients who applied to a Training and Research Hospital in Türkiye constituted the study population.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- unable to communicate in the same language having cognitive impairment wanting to leave the study at any stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bilecik Eğitim ve Araştırma Hastanesi
Bilecik, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diet, Healthy, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia Fear Levels in Patients (time frame: 15.01.2026-15.06.2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.