Type 2 Diabetes MellitusNCT07861308
Diabetes Distress, Medication Adherence Barriers, Self-Management, and Glycemic Control in Adults With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by Bilecik Seyh Edebali Universitesi.
Trial summary
This observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diabetes Distress, Medication Adherence Barriers and Diabetes self-managemen
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 15 Dec 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: Adults with type 2 diabetes mellitus who attend the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye, have had type 2 diabetes for at least six months, and meet the study eligibility criteria.
Who may be able to join
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus for at least six months.
- Attending the Diabetes Nursing Unit.
- Using oral antidiabetic medication and/or insulin.
- Having an HbA1c result measured within the previous three months.
- Able to communicate in Turkish.
- Voluntarily agrees to participate in the study.
Who cannot join
- Diagnosis of type 1 diabetes mellitus or gestational diabetes.
- No HbA1c result measured within the previous three months, or the result is unavailable.
- Withdraws from the study.
- Study forms are substantially incomplete.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Mediating Role of Diabetes Self-Management in the Relationship Between Diabetes Distress, Medication Adherence Barriers, and Glycemic Control Among Patients With Type 2 Diabetes
This observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Participants who meet the study criteria and agree to take part will complete questionnaires about their personal and clinical characteristics, diabetes distress, medication-taking barriers, and diabetes self-management. With their permission, the most recent HbA1c result measured within the previous three months will be obtained from their medical record. No treatment or medication changes will be made for this study. The researchers plan to include at least 137 participants.
Read the detailed description
This single-center, cross-sectional observational study will be conducted at the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye. The study will examine whether diabetes self-management statistically mediates the relationships between diabetes distress and glycemic control, and between practical medication adherence barriers and glycemic control, as measured by HbA1c.
Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least six months, receiving oral antidiabetic medication and/or insulin, and with an HbA1c result measured within the previous three months will be eligible. Participants must be able to communicate in Turkish and provide informed consent. Individuals with type 1 or gestational diabetes, those unable to complete the questionnaires because of cognitive or other serious communication difficulties, and those without a recent HbA1c result will be excluded.
Data will be collected once through a personal information form, the Diabetes Distress Scale, the Medication Practical Barriers to Adherence Questionnaire, and the Type 2 Diabetes Self-Management Scale. The most recent HbA1c result will be obtained from the participant's medical record or hospital information system with permission. Completing the study forms is expected to take approximately 15-20 minutes. No intervention will be provided, and participants' usual care will not be changed. The planned sample size is at least 137 participants.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diabetes Distress, Medication Adherence Barriers, Diabetes self-managemen
- Keywords
- Medication Adherence, Diabetes Self-Management, Glycemic Control, Hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes DistressOther
Diabetes distress will be assessed once using the 17-item Diabetes Distress Scale (DDS). No intervention will be assigned, and participants' usual diabetes care will not be changed.
Medication Adherence BarriersOther
Practical barriers to medication adherence will be assessed once using the 15-item Medication Practical Barriers to Adherence Questionnaire. No intervention will be assigned, and participants' usual diabetes care will not be changed.
Diabetes self-managemenOther
Diabetes self-management will be assessed once using the 19-item Type 2 Diabetes Self-Management Scale. No intervention will be assigned, and participants' usual diabetes care will not be changed.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Type 2 Diabetes Mellitus | Adults aged 18 years or older with type 2 diabetes for at least 6 months who meet the study eligibility criteria. All participants will be assessed in a single group. Receives: Other: Diabetes Distress; Other: Medication Adherence Barriers; Other: Diabetes self-managemen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control measured by glycated hemoglobin (HbA1c)
The primary outcome is glycemic control, assessed by the most recent HbA1c result recorded within 3 months before enrollment. With permission, HbA1c will be obtained from the participant's medical record or hospital information system. Cross-sectional associations of HbA1c with diabetes distress and medication adherence barriers, and the statistical mediating role of diabetes self-management in these relationships, will be examined.
Measured: At study enrollment; the most recent HbA1c result measured within the previous 3 months.
Secondary outcomes (3)
Mean score on the 17-item Diabetes Distress Scale
Diabetes distress will be measured using the 17-item Diabetes Distress Scale (DDS). Each item is rated from 1 to 6, and the overall score is calculated as the mean of the 17 item scores, resulting in a score range of 1 to 6. Higher scores indicate greater diabetes distress (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management.
Measured: Once at study enrollment.
Total score on the Medication Practical Barriers to Adherence Questionnaire
Practical barriers to medication adherence will be assessed using the 15-item Medication Practical Barriers to Adherence Questionnaire (MPRAQ). Each item is rated on a 5-point Likert scale. The total score ranges from 15 (minimum) to 75 (maximum). Higher scores indicate greater practical barriers to medication adherence (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management.
Measured: Once at study enrollment
Diabetes self-management score
Diabetes self-management will be assessed using the 19-item Type 2 Diabetes Self-Management Scale. Its statistical mediating role in the relationships of diabetes distress and medication adherence barriers with HbA1c will be examined.
Measured: Once 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 posted6 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Dec 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 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
- 137 participants (estimated)
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
- NCT07861308
- Sponsor's protocol ID
- T2DM-DSM-2026
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers. The study protocol does not include an IPD-sharing plan. Participant confidentiality will be protected, and only aggregate study findings may be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Diabetes Self-Management in the Relationship Between Diabetes Distress, Medication Adherence Barriers, and Glycemic Control Among Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07861308
- Acronym / sponsor ID
- T2DM-DSM-2026
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Medication Adherence, Diabetes Self-Management, Glycemic Control, Hemoglobin A1c
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 6 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 observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Participants who meet the study criteria and agree to take part will complete questionnaires about their personal and clinical characteristics, diabetes distress, medication-taking barriers, and diabetes self-management. With their permission, the most recent HbA1c result measured within the previous three months will be obtained from their medical record. No treatment or medication changes will be made for this study. The researchers plan to include at least 137 participants.
Detailed description
This single-center, cross-sectional observational study will be conducted at the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye. The study will examine whether diabetes self-management statistically mediates the relationships between diabetes distress and glycemic control, and between practical medication adherence barriers and glycemic control, as measured by HbA1c.
Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least six months, receiving oral antidiabetic medication and/or insulin, and with an HbA1c result measured within the previous three months will be eligible. Participants must be able to communicate in Turkish and provide informed consent. Individuals with type 1 or gestational diabetes, those unable to complete the questionnaires because of cognitive or other serious communication difficulties, and those without a recent HbA1c result will be excluded.
Data will be collected once through a personal information form, the Diabetes Distress Scale, the Medication Practical Barriers to Adherence Questionnaire, and the Type 2 Diabetes Self-Management Scale. The most recent HbA1c result will be obtained from the participant's medical record or hospital information system with permission. Completing the study forms is expected to take approximately 15-20 minutes. No intervention will be provided, and participants' usual care will not be changed. The planned sample size is at least 137 participants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Type 2 Diabetes Mellitus | – | Other: Diabetes Distress, Other: Medication Adherence Barriers, Other: Diabetes self-managemenAdults aged 18 years or older with type 2 diabetes for at least 6 months who meet the study eligibility criteria. All participants will be assessed in a single group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type 2 diabetes mellitus who attend the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye, have had type 2 diabetes for at least six months, and meet the study eligibility criteria.
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus for at least six months.
- Attending the Diabetes Nursing Unit.
- Using oral antidiabetic medication and/or insulin.
- Having an HbA1c result measured within the previous three months.
Key exclusion criteria (4 listed)
- Diagnosis of type 1 diabetes mellitus or gestational diabetes.
- No HbA1c result measured within the previous three months, or the result is unavailable.
- Withdraws from the study.
- Study forms are substantially incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes DistressDiabetes distress will be assessed once using the 17-item Diabetes Distress Scale (DDS). No intervention will be assigned, and participants' usual diabetes care will not be changed. | Other | Adults With Type 2 Diabetes Mellitus |
| Medication Adherence BarriersPractical barriers to medication adherence will be assessed once using the 15-item Medication Practical Barriers to Adherence Questionnaire. No intervention will be assigned, and participants' usual diabetes care will not be changed. | Other | Adults With Type 2 Diabetes Mellitus |
| Diabetes self-managemenDiabetes self-management will be assessed once using the 19-item Type 2 Diabetes Self-Management Scale. No intervention will be assigned, and participants' usual diabetes care will not be changed. | Other | Adults With Type 2 Diabetes Mellitus |
Primary outcome
Glycemic control measured by glycated hemoglobin (HbA1c)
Time frame: At study enrollment; the most recent HbA1c result measured within the previous 3 months.
The primary outcome is glycemic control, assessed by the most recent HbA1c result recorded within 3 months before enrollment. With permission, HbA1c will be obtained from the participant's medical record or hospital information system. Cross-sectional associations of HbA1c with diabetes distress and medication adherence barriers, and the statistical mediating role of diabetes self-management in these relationships, will be examined.
3 secondary outcomes
Mean score on the 17-item Diabetes Distress Scale
Time frame: Once at study enrollment.
Total score on the Medication Practical Barriers to Adherence Questionnaire
Time frame: Once at study enrollment
Diabetes self-management score
Time frame: Once 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 6 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared with other researchers. The study protocol does not include an IPD-sharing plan. Participant confidentiality will be protected, and only aggregate study findings may be reported in publications.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Bilecik Seyh Edebali Universitesi.
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 7 inclusion and 4 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Burcu Bayrak Kahraman, PhD (+905057542411, burcu.bayrak@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control measured by glycated hemoglobin (HbA1c) (time frame: At study enrollment; the most recent HbA1c result measured within the previous 3 months.). 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 6 Oct 2026.