Type 2 DiabetesNCT07888972
Digital Health Literacy and Diabetes Management in Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the relationships between digital health literacy, diabetes distress, diabetes self-management, and glycated hemoglobin (HbA1c) levels in individuals with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 348 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2026to 23 Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adult patients (aged 18 years and older) clinically diagnosed with Type 2 Diabetes Mellitus for at least 6 months, receiving outpatient care at internal medicine and endocrinology clinics of hospitals in Bolu, Turkey. Eligible participants include individuals who voluntarily provide informed consent, possess sufficient literacy and communication capabilities to complete the study questionnaires, and have recorded HbA1c levels available from the past 3 months in their medical records. Data are collected from a non-probability convenience sample during routine follow-up visits.
Who may be able to join
- 18 years or older.
- Diagnosed with type 2 diabetes mellitus by a physician at least 6 months prior to enrollment.
- Able to read and write.
- Able to communicate in Turkish and possess sufficient cognitive and communication abilities to understand and respond to the data collection instruments.
- Have an HbA1c measurement obtained within the previous 3 months.
- Willing to participate in the study voluntarily.
Who cannot join
- Having visual, hearing, cognitive, or communication impairments that prevent the participant from completing the data collection instruments.
- Experiencing an acute diabetic complication during data collection or having a general health condition that prevents the participant from completing the data collection instruments.
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
Bolu Izzet Baysal State Hospital, BAIBU Training and Research Hospital
Bolu
About this study
Official title: The Relationship Between Digital Health Literacy and Diabetes Distress, Diabetes Self-Management and HbA1c Levels in Individuals With Type 2 Diabetes
This study aims to examine the relationships between digital health literacy, diabetes distress, diabetes self-management, and glycated hemoglobin (HbA1c) levels in individuals with type 2 diabetes mellitus (T2DM). The relationships between these variables will also be evaluated after controlling for relevant sociodemographic and clinical characteristics. The findings may contribute to a better understanding of factors associated with diabetes management and inform future nursing education and counseling interventions.
Read the detailed description
Type 2 diabetes mellitus (T2DM) requires ongoing self-management to maintain glycemic control and reduce the risk of complications. Diabetes distress may make daily disease management more challenging, while digital health literacy may help individuals access, understand, and evaluate online health information relevant to their condition. This study aims to examine the relationships between digital health literacy, diabetes distress, diabetes self-management, and glycated hemoglobin (HbA1c) levels in individuals with T2DM. It will also evaluate these relationships after controlling for relevant sociodemographic and clinical characteristics. The findings may improve understanding of the relationships between digital health literacy, psychological distress, self-management behaviors, and glycemic control. They may also provide evidence to inform future individualized nursing education and counseling interventions for individuals with T2DM.
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Distress, Glycated Hemoglobin, Digital Health Literacy, Self-Management, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 Diabetes Mellitus | Adult patients diagnosed with Type 2 Diabetes Mellitus who meet the study inclusion criteria. Digital health literacy, diabetes distress, diabetes self-management, and HbA1c levels will be assessed in this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Health Literacy Instrument (DHLI)
Digital health literacy will be assessed using the Digital Health Literacy Instrument (DHLI). The instrument measures participants' ability to access, understand, evaluate, and use health-related information obtained through digital technologies. The DHLI score will be calculated according to the scoring guidelines of the version used in the study. Higher scores indicate higher digital health literacy, according to the instrument's scoring method.
Measured: At study enrollment.
Secondary outcomes (3)
Diabetes Self-Management Questionnaire (DSMQ)
Diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DSMQ). The questionnaire evaluates diabetes-related self-management behaviors. Scores will be calculated according to the instrument's scoring guidelines, with higher scores indicating more effective diabetes self-management, as defined by the instrument.
Measured: At study enrollment.
Diabetes Distress Scale (DDS)
Diabetes-related distress will be assessed using the Diabetes Distress Scale (DDS). The scale measures emotional distress associated with living with and managing diabetes. Scores will be calculated according to the instrument's scoring guidelines, with higher scores indicating greater diabetes distress.
Measured: At study enrollment.
HbA1c Levels
Glycemic control will be assessed using glycated hemoglobin (HbA1c) levels, expressed as a percentage (%). HbA1c reflects average blood glucose levels over approximately the preceding 2-3 months and is an important clinical indicator for evaluating long-term glycemic control in individuals with type 2 diabetes mellitus. HbA1c values will be examined in relation to digital health literacy, diabetes distress, and diabetes self-management. The analysis will also consider relevant sociodemographic and clinical variables to assess whether digital health literacy is associated with HbA1c levels independently of these factors. Higher HbA1c levels generally indicate poorer glycemic control.
Measured: At study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888972
- Sponsor's protocol ID
- BAIBU-SBF-BS-01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Digital Health Literacy and Diabetes Distress, Diabetes Self-Management and HbA1c Levels in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07888972
- Acronym / sponsor ID
- BAIBU-SBF-BS-01
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Distress, Glycated Hemoglobin, Digital Health Literacy, Self-Management, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 22 Oct 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.
This study aims to examine the relationships between digital health literacy, diabetes distress, diabetes self-management, and glycated hemoglobin (HbA1c) levels in individuals with type 2 diabetes mellitus (T2DM). The relationships between these variables will also be evaluated after controlling for relevant sociodemographic and clinical characteristics. The findings may contribute to a better understanding of factors associated with diabetes management and inform future nursing education and counseling interventions.
Detailed description
Type 2 diabetes mellitus (T2DM) requires ongoing self-management to maintain glycemic control and reduce the risk of complications. Diabetes distress may make daily disease management more challenging, while digital health literacy may help individuals access, understand, and evaluate online health information relevant to their condition. This study aims to examine the relationships between digital health literacy, diabetes distress, diabetes self-management, and glycated hemoglobin (HbA1c) levels in individuals with T2DM. It will also evaluate these relationships after controlling for relevant sociodemographic and clinical characteristics. The findings may improve understanding of the relationships between digital health literacy, psychological distress, self-management behaviors, and glycemic control. They may also provide evidence to inform future individualized nursing education and counseling interventions for individuals with T2DM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes Mellitus | – | –Adult patients diagnosed with Type 2 Diabetes Mellitus who meet the study inclusion criteria. Digital health literacy, diabetes distress, diabetes self-management, and HbA1c levels will be assessed in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult patients (aged 18 years and older) clinically diagnosed with Type 2 Diabetes Mellitus for at least 6 months, receiving outpatient care at internal medicine and endocrinology clinics of hospitals in Bolu, Turkey. Eligible participants include individuals who voluntarily provide informed consent, possess sufficient literacy and communication capabilities to complete the study questionnaires, and have recorded HbA1c levels available from the past 3 months in their medical records. Data are collected from a non-probability convenience sample during routine follow-up visits.
Key inclusion criteria (6 listed)
- 18 years or older.
- Diagnosed with type 2 diabetes mellitus by a physician at least 6 months prior to enrollment.
- Able to read and write.
- Able to communicate in Turkish and possess sufficient cognitive and communication abilities to understand and respond to the data collection instruments.
- Have an HbA1c measurement obtained within the previous 3 months.
Key exclusion criteria (2 listed)
- Having visual, hearing, cognitive, or communication impairments that prevent the participant from completing the data collection instruments.
- Experiencing an acute diabetic complication during data collection or having a general health condition that prevents the participant from completing the data collection instruments.
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
Digital Health Literacy Instrument (DHLI)
Time frame: At study enrollment.
Digital health literacy will be assessed using the Digital Health Literacy Instrument (DHLI). The instrument measures participants' ability to access, understand, evaluate, and use health-related information obtained through digital technologies. The DHLI score will be calculated according to the scoring guidelines of the version used in the study. Higher scores indicate higher digital health literacy, according to the instrument's scoring method.
3 secondary outcomes
Diabetes Self-Management Questionnaire (DSMQ)
Time frame: At study enrollment.
Diabetes Distress Scale (DDS)
Time frame: At study enrollment.
HbA1c Levels
Time frame: At study enrollment.
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 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Type 2 Diabetes, run by Abant Izzet Baysal University 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Oct 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?
Contact Buse SAYDAM (+90 543 431 4359, busesaydam.21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Health Literacy Instrument (DHLI) (time frame: At study enrollment.). 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 22 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.