Type 2 Diabetes Mellitus (T2DM)NCT07383532
Effects of Education and Telephone Support on Type 2 Diabetes Management
A study testing Diabetes Self-Management Education and Telephone Support in people with Type 2 Diabetes Mellitus (T2DM), run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study examined the effects of self-management education combined with follow-up telephone support on diabetes self-management, treatment compliance, and medication self-efficacy in adults with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Diabetes Self-Management Education and Telephone Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a diagnosis of type 2 diabetes for at least 6 months
- Between the ages of 18-64
- Literate
- Planned hospitalisation for at least three days
- Using only insulin or insulin + oral antidiabetics as treatment
Who cannot join
- Individuals with Type 1
- Gestational diabetes,
- Communication disability
- Psychiatric illness
- Severe complications (retinopathy, neuropathy, nephropathy, diabetic foot, cardiovascular disease)
- Condition that prevents physical activity
- Individuals who could not attend at least two sessions of the diabetes education programme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Self-Management Education and Follow-Up Telephone Support on Diabetes Self-Management, Treatment Compliance, and Medication Self-Efficacy in Adults With Type 2 Diabetes
This study examined the effects of self-management education combined with follow-up telephone support on diabetes self-management, treatment compliance, and medication self-efficacy in adults with Type 2 diabetes. A total of 70 adults with type 2 diabetes were randomly assigned to an intervention group or a control group. Participants in the intervention group received diabetes self-management education and follow-up telephone support while the control group received usual care. Data were collected using the Personal Information Form, the Diabetes Self-Management Scale, the Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment, and the Diabetes Medication Use Self-Efficacy Scale.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Diabetes Self-Management Education and Telephone Support
- 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.
Diabetes Self-Management Education and Telephone SupportBehavioural
The intervention consisted of a structured diabetes self-management education program and follow-up telephone support. Participants received three face-to-face education sessions focusing on diabetes self-management, treatment compliance, and medication use. Additionally, two structured follow-up telephone support calls were conducted over a two-month period to reinforce education, support adherence, and address participants' questions.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Self-Management Education and Telephone Support | Experimental | Participants in this arm received a structured diabetes self-management education program combined with follow-up telephone support. The intervention consisted of three face-to-face education sessions covering diabetes self-management, treatment compliance, and medication use. In addition, participants received two structured follow-up telephone support calls over a two-month period to reinforce education content, support adherence, and address participant questions. Outcomes were assessed using pre-test and post-test measurements, including diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters Receives: Behavioral: Diabetes Self-Management Education and Telephone Support |
| Usual Care Control Group | No intervention | Participants in this arm received usual care for Type 2 diabetes without additional diabetes self-management education or follow-up telephone support. They continued routine clinical follow-up and standard treatment as recommended by healthcare providers. Pre-test and post-test assessments were conducted at the same time points as the intervention group, including measures of diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Management Scale
The level of diabetes self-management was assessed using the Diabetes Self-Management Scale. The scale evaluates participants' self-management behaviors across four sub-dimensions: glucose management, diet control, physical activity, and utilization of health services. A minimum score of 0 and a maximum score of 10 is obtained from the total scale and sub-dimensions. Higher scores indicating higher levels of diabetes self-management.
Measured: Baseline and end of the third month after discharge
Secondary outcomes (7)
Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment
Treatment adherence was assessed using the Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment, a validated self-report instrument developed to evaluate adherence behaviors in individuals with Type 2 diabetes. The scale assesses multiple dimensions of attitude and emotional factors, knowledge and personal factors, lifestyle change, feelings of anger, feelings, and behaviours appropriate for adherence, diet bargaining and feelings of denial. The highest score obtained from the scale is 150 and the lowest score is 30. As the score obtained from the scale decreases, the individual's adherence to treatment increases.
Measured: Baseline and end of the third month after discharge
Diabetes Medication Use Self-efficacy Scale
Medication use self-efficacy was assessed using the Diabetes Medication Use Self-Efficacy Scale, a validated instrument measuring individuals' confidence in their ability to use diabetes medications despite potential barriers. The scale evaluates self-efficacy related to obligation, preoccupation, and anxiety associated with medication use. The lowest score in the scale is 19 and the highest score is 57. Higher scores indicate higher levels of medication use self-efficacy.
Measured: Baseline and end of the third month after discharge
Glycated hemoglobin
Glycated hemoglobin (HbA1c) in mmol/mol. This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
Measured: Baseline and end of the third month after discharge
High-density lipoprotein
High-density lipoprotein (HDL) in mg/dL. This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
Measured: Baseline and end of the third month after discharge
Low-density lipoprotein
Low-density lipoprotein (LDL) in mg/dL. This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
Measured: Baseline and end of the third month after discharge
Total cholesterol
Total cholesterol in mg/dL. This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
Measured: Baseline and end of the third month after discharge
Triglyceride
Triglyceride in mg/dL. This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
Measured: Baseline and end of the third month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 May 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Selcuk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the intervention group or the usual care control group and followed in parallel throughout the study period.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alime Selçuk Tosun, Selcuk University
- Investigators
- Alime Selçuk Tosun, Assoc. Prof., Principal investigator, Selcuk University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383532
- Sponsor's protocol ID
- 2023/08
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this study will not be shared because the study was conducted solely for internal research purposes, and participant confidentiality and privacy are protected in accordance with institutional ethical approval. Data sharing was not planned in the study protocol.
Publications
Eroglu N, Sabuncu N. The effect of education given to type 2 diabetic individuals on diabetes self-management and self-efficacy: Randomized controlled trial. Prim Care Diabetes. 2021 Jun;15(3):451-458. doi: 10.1016/j.pcd.2021.02.011. Epub 2021 Mar 3.
PubMed 33674221
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-Management Education and Follow-Up Telephone Support on Diabetes Self-Management, Treatment Compliance, and Medication Self-Efficacy in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07383532
- Acronym / sponsor ID
- 2023/08
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 3 Feb 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 examined the effects of self-management education combined with follow-up telephone support on diabetes self-management, treatment compliance, and medication self-efficacy in adults with Type 2 diabetes. A total of 70 adults with type 2 diabetes were randomly assigned to an intervention group or a control group. Participants in the intervention group received diabetes self-management education and follow-up telephone support while the control group received usual care. Data were collected using the Personal Information Form, the Diabetes Self-Management Scale, the Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment, and the Diabetes Medication Use Self-Efficacy Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the intervention group or the usual care control group and followed in parallel throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Diabetes Self-Management Education and Telephone Support | Experimental | Behavioral: Diabetes Self-Management Education and Telephone SupportParticipants in this arm received a structured diabetes self-management education program combined with follow-up telephone support. The intervention consisted of three face-to-face education sessions covering diabetes self-management, treatment compliance, and medication use. In addition, participants received two structured follow-up telephone support calls over a two-month period to reinforce education content, support adherence, and address participant questions. Outcomes were assessed using pre-test and post-test measurements, including diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters |
| Usual Care Control Group | No intervention | –Participants in this arm received usual care for Type 2 diabetes without additional diabetes self-management education or follow-up telephone support. They continued routine clinical follow-up and standard treatment as recommended by healthcare providers. Pre-test and post-test assessments were conducted at the same time points as the intervention group, including measures of diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals with a diagnosis of type 2 diabetes for at least 6 months
- Between the ages of 18-64
- Literate
- Planned hospitalisation for at least three days
- Using only insulin or insulin + oral antidiabetics as treatment
Key exclusion criteria (7 listed)
- Individuals with Type 1
- Gestational diabetes,
- Communication disability
- Psychiatric illness
- Severe complications (retinopathy, neuropathy, nephropathy, diabetic foot, cardiovascular disease)
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 Self-Management Education and Telephone SupportThe intervention consisted of a structured diabetes self-management education program and follow-up telephone support. Participants received three face-to-face education sessions focusing on diabetes self-management, treatment compliance, and medication use. Additionally, two structured follow-up telephone support calls were conducted over a two-month period to reinforce education, support adherence, and address participants' questions. | Behavioural | Diabetes Self-Management Education and Telephone Support |
Primary outcome
Diabetes Self-Management Scale
Time frame: Baseline and end of the third month after discharge
The level of diabetes self-management was assessed using the Diabetes Self-Management Scale. The scale evaluates participants' self-management behaviors across four sub-dimensions: glucose management, diet control, physical activity, and utilization of health services. A minimum score of 0 and a maximum score of 10 is obtained from the total scale and sub-dimensions. Higher scores indicating higher levels of diabetes self-management.
7 secondary outcomes
Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment
Time frame: Baseline and end of the third month after discharge
Diabetes Medication Use Self-efficacy Scale
Time frame: Baseline and end of the third month after discharge
Glycated hemoglobin
Time frame: Baseline and end of the third month after discharge
High-density lipoprotein
Time frame: Baseline and end of the third month after discharge
Low-density lipoprotein
Time frame: Baseline and end of the third month after discharge
Total cholesterol
Time frame: Baseline and end of the third month after discharge
Triglyceride
Time frame: Baseline and end of the third month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 33674221Eroglu N, Sabuncu N. The effect of education given to type 2 diabetic individuals on diabetes self-management and self-efficacy: Randomized controlled trial. Prim Care Diabetes. 2021 Jun;15(3):451-458. doi: 10.1016/j.pcd.2021.02.011. Epub 2021 Mar 3.
- Individual participant dataSharing planned: No. Individual participant data from this study will not be shared because the study was conducted solely for internal research purposes, and participant confidentiality and privacy are protected in accordance with institutional ethical approval. Data sharing was not planned in the study protocol.
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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. This study is not recruiting at the moment.
Alime Selçuk Tosun, Assoc. Prof. principal investigator
Selcuk University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Education and Telephone Support in people with Type 2 Diabetes Mellitus (T2DM), run by Selcuk 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Scale (time frame: Baseline and end of the third month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07383532, which also lists 1 linked publication.
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 3 Feb 2026.