Diabetes Mellitus, Type 2NCT06963073
Effects of Nurse-Led Diabetes Education and Telephone Follow-Up in Newly Diagnosed Type 2 Diabetes
A study testing Nurse-Led Diabetes Self-Management Education and Telephone Follow-Up in people with Diabetes Mellitus, Type 2, run by Naile ALANKAYA at 1 site in Cyprus.
Trial summary
This randomized controlled trial evaluated the effects of nurse-led diabetes self-management education supported by telephone follow-up on diabetes knowledge, self-management behaviors, and glycemic control in adults newly diagnosed with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nurse-Led Diabetes Self-Management Education and Telephone Follow-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 19 Sep 2025to 20 Feb 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Diagnosis of type 2 diabetes mellitus within the preceding six months.
- Ability to read, understand, and communicate in the language used for study procedures.
- No previous participation in a structured diabetes self-management education program.
- Ability to participate in face-to-face education and telephone follow-up.
- Willingness to participate and provision of informed consent
Who cannot join
- Diagnosis of type 2 diabetes more than six months before enrollment.
- Severe cognitive impairment or communication difficulties that would prevent participation in education or follow-up.
- Severe visual or hearing impairment that would prevent participation in study procedures.
- Major medical conditions that would substantially interfere with study participation.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Education and Tele-Follow-Up Program Given to New Type 2 Diabetes Patients on Diabetes Self-Management and Blood Glucose Regulation
This randomized controlled trial evaluated the effects of nurse-led diabetes self-management education supported by telephone follow-up on diabetes knowledge, self-management behaviors, and glycemic control in adults newly diagnosed with type 2 diabetes.
Participants were randomly assigned to an intervention group or a control group. The intervention group received structured diabetes self-management education and two follow-up telephone calls at the first and second months to reinforce the education and support self-management. The control group continued to receive routine clinical care without additional structured education or telephone follow-up from the research team during the study.
Read more
Diabetes knowledge and self-management behaviors were assessed at baseline and at three months. Glycemic outcomes, including HbA1c, fasting blood glucose, and postprandial blood glucose, were assessed at baseline and at the first and third months.
The study aimed to determine whether combining structured education with telephone follow-up could improve diabetes self-management and blood glucose control during the early period following a type 2 diabetes diagnosis.
Read the detailed description
This study was conducted as a two-arm, parallel-group randomized controlled trial at the Endocrinology and Diabetes Outpatient Clinic of Dr. Burhan Nalbantoğlu State Hospital in Nicosia, Northern Cyprus.
The study included adults who had been newly diagnosed with type 2 diabetes. The sample size was calculated before data collection using G*Power software. The initial calculation indicated a minimum required sample size of 44 participants (22 per group). To account for possible attrition, the target sample size was increased to 60 participants.
A total of 60 participants were randomized to the intervention group (n = 30) or control group (n = 30). Two participants in the intervention group did not complete follow-up, and 58 participants completed the three-month assessment.
The intervention consisted of nurse-led structured diabetes self-management education followed by two telephone calls at the first and second months. The telephone contacts reinforced the educational content, addressed participants' questions, and supported diabetes self-management. Participants in the control group continued to receive routine clinical care without additional structured education or telephone follow-up from the research team during the study.
Diabetes knowledge and self-management behaviors were assessed at baseline and at three months. HbA1c, fasting blood glucose, and postprandial blood glucose were assessed at baseline, one month, and three months. Body weight was also monitored during the study.
The study evaluated whether structured diabetes self-management education combined with telephone follow-up improved self-management behaviors, diabetes knowledge, and glycemic control during the first three months following a type 2 diabetes diagnosis.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nurse-Led Diabetes Self-Management Education and Telephone Follow-Up
- Keywords
- Diabetes Mellitus, Self-Management, Blood Glucose Regulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Diabetes Self-Management Education and Telephone Follow-UpBehavioural
Participants in the intervention group received individualized, face-to-face, nurse-led diabetes self-management education lasting approximately 30-40 minutes. The education covered diabetes management, healthy nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of complications. Two structured telephone follow-up sessions were conducted at months 1 and 2 to reinforce education, answer questions, and support self-management. Participants in the control group received routine clinical care without additional researcher-led education or telephone follow-up during the three-month study period. Educational materials were provided to the control group after the final outcome assessment.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Diabetes Education and Telephone Follow-Up | Experimental | Thirty participants were randomized to the intervention group. Participants received individualized, face-to-face, nurse-led diabetes self-management education lasting approximately 30-40 minutes. The education addressed diabetes management, nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of complications. Two telephone follow-up sessions were conducted at months 1 and 2 to reinforce education, answer questions, and support self-management throughout the three-month study period. Receives: Behavioral: Nurse-Led Diabetes Self-Management Education and Telephone Follow-Up |
| Routine Clinical Care | No intervention | Thirty participants were randomized to the control group. Participants continued to receive routine clinical care without additional structured diabetes self-management education or telephone follow-up provided by the research team during the three-month study period. After completion of the final three-month outcome assessment, participants were provided with diabetes educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Type 2 Diabetes Self-Management Scale (T2D-SMS) Total Score
The Type 2 Diabetes Self-Management Scale (T2D-SMS), developed by Koç et al. (2024), consists of 19 items across three subscales: healthy lifestyle behaviors (11 items), health service utilization (4 items), and blood glucose management (4 items). Each item is scored from 1 to 5, yielding a total score ranging from 19 to 95. Higher scores indicate better diabetes self-management. The outcome is the change in total score from baseline to month 3.
Measured: Baseline and Month 3
Change in Adult Diabetes Knowledge Scale (ADKS) Total Score
The Adult Diabetes Knowledge Scale (ADKS), developed by Erenel Yavuz and Erol, consists of 28 items across five domains: general diabetes knowledge (6 items), blood glucose measurement and values (5 items), diabetes risk factors (4 items), diabetes symptoms (8 items), and diabetes complications (5 items). Correct responses are scored as 1, while incorrect and "I do not know" responses are scored as 0. Total scores range from 0 to 28, with higher scores indicating greater diabetes knowledge. The outcome is the change in total score from baseline to month 3.
Measured: Baseline and Month 3
Change in Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) was assessed as an indicator of long-term glycemic control. HbA1c values, expressed as percentages (%), were obtained from official hospital laboratory records at baseline, month 1, and month 3. The outcome evaluates changes in HbA1c levels over the three-month follow-up period, with lower values indicating better glycemic control.
Measured: Baseline, Month 1, and Month 3
Change in Fasting Blood Glucose (FBG)
Fasting blood glucose (FBG), expressed in mg/dL, was obtained from official hospital laboratory records at baseline, month 1, and month 3. Changes in FBG levels over the three-month follow-up period were evaluated as an indicator of glycemic control.
Measured: Baseline, Month 1, and Month 3
Change in Postprandial Blood Glucose (PBG)
Postprandial blood glucose (PBG), expressed in mg/dL, was obtained from official hospital laboratory records at baseline, month 1, and month 3. Changes in PBG levels over the three-month follow-up period were evaluated as an indicator of glycemic control.
Measured: Baseline, Month 1, and Month 3
Secondary outcomes (1)
Change in Body Weight (kg)
Body weight was assessed in kilograms (kg) at baseline, month 1, and month 3 to evaluate potential changes associated with the educational intervention. Baseline body weight was measured at the hospital, whereas follow-up measurements were performed by participants at home and reported to the researcher. The outcome was evaluated as an exploratory secondary outcome.
Measured: Baseline, Month 1, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start19 Sep 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a two-arm, parallel-group randomized controlled design. Sixty adults newly diagnosed with type 2 diabetes were randomly assigned to an intervention group (n=30) or a control group (n=30). Both groups underwent baseline assessments. The intervention group received individualized, face-to-face, nurse-led diabetes self-management education, followed by two telephone calls at months 1 and 2. The control group received routine clinical care without additional researcher-led education or telephone follow-up. Educational materials were provided to the control group after the final assessment. Diabetes knowledge and self-management were assessed at baseline and month 3. HbA1c, fasting blood glucose, and postprandial blood glucose were assessed at baseline, month 1, and month 3. Fifty-eight participants completed the three-month follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naile ALANKAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naile ALANKAYA, Çanakkale Onsekiz Mart University
- Investigators
- NAİLE ALANKAYA, Assosiate Prof., Study director, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963073
- Sponsor's protocol ID
- COMU-SBF-NA-01
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2025
- Last updated
- 23 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education and Tele-Follow-Up Program Given to New Type 2 Diabetes Patients on Diabetes Self-Management and Blood Glucose Regulation
- ClinicalTrials.gov ID
- NCT06963073
- Acronym / sponsor ID
- COMU-SBF-NA-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Self-Management, Blood Glucose Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Naile ALANKAYAUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 8 May 2025 (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 randomized controlled trial evaluated the effects of nurse-led diabetes self-management education supported by telephone follow-up on diabetes knowledge, self-management behaviors, and glycemic control in adults newly diagnosed with type 2 diabetes.
Participants were randomly assigned to an intervention group or a control group. The intervention group received structured diabetes self-management education and two follow-up telephone calls at the first and second months to reinforce the education and support self-management. The control group continued to receive routine clinical care without additional structured education or telephone follow-up from the research team during the study.
Diabetes knowledge and self-management behaviors were assessed at baseline and at three months. Glycemic outcomes, including HbA1c, fasting blood glucose, and postprandial blood glucose, were assessed at baseline and at the first and third months.
The study aimed to determine whether combining structured education with telephone follow-up could improve diabetes self-management and blood glucose control during the early period following a type 2 diabetes diagnosis.
Detailed description
This study was conducted as a two-arm, parallel-group randomized controlled trial at the Endocrinology and Diabetes Outpatient Clinic of Dr. Burhan Nalbantoğlu State Hospital in Nicosia, Northern Cyprus.
The study included adults who had been newly diagnosed with type 2 diabetes. The sample size was calculated before data collection using G*Power software. The initial calculation indicated a minimum required sample size of 44 participants (22 per group). To account for possible attrition, the target sample size was increased to 60 participants.
A total of 60 participants were randomized to the intervention group (n = 30) or control group (n = 30). Two participants in the intervention group did not complete follow-up, and 58 participants completed the three-month assessment.
The intervention consisted of nurse-led structured diabetes self-management education followed by two telephone calls at the first and second months. The telephone contacts reinforced the educational content, addressed participants' questions, and supported diabetes self-management. Participants in the control group continued to receive routine clinical care without additional structured education or telephone follow-up from the research team during the study.
Diabetes knowledge and self-management behaviors were assessed at baseline and at three months. HbA1c, fasting blood glucose, and postprandial blood glucose were assessed at baseline, one month, and three months. Body weight was also monitored during the study.
The study evaluated whether structured diabetes self-management education combined with telephone follow-up improved self-management behaviors, diabetes knowledge, and glycemic control during the first three months following a type 2 diabetes diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a two-arm, parallel-group randomized controlled design. Sixty adults newly diagnosed with type 2 diabetes were randomly assigned to an intervention group (n=30) or a control group (n=30). Both groups underwent baseline assessments. The intervention group received individualized, face-to-face, nurse-led diabetes self-management education, followed by two telephone calls at months 1 and 2. The control group received routine clinical care without additional researcher-led education or telephone follow-up. Educational materials were provided to the control group after the final assessment. Diabetes knowledge and self-management were assessed at baseline and month 3. HbA1c, fasting blood glucose, and postprandial blood glucose were assessed at baseline, month 1, and month 3. Fifty-eight participants completed the three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Diabetes Education and Telephone Follow-Up | Experimental | Behavioral: Nurse-Led Diabetes Self-Management Education and Telephone Follow-UpThirty participants were randomized to the intervention group. Participants received individualized, face-to-face, nurse-led diabetes self-management education lasting approximately 30-40 minutes. The education addressed diabetes management, nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of complications. Two telephone follow-up sessions were conducted at months 1 and 2 to reinforce education, answer questions, and support self-management throughout the three-month study period. |
| Routine Clinical Care | No intervention | –Thirty participants were randomized to the control group. Participants continued to receive routine clinical care without additional structured diabetes self-management education or telephone follow-up provided by the research team during the three-month study period. After completion of the final three-month outcome assessment, participants were provided with diabetes educational materials. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-65 years.
- Diagnosis of type 2 diabetes mellitus within the preceding six months.
- Ability to read, understand, and communicate in the language used for study procedures.
- No previous participation in a structured diabetes self-management education program.
- Ability to participate in face-to-face education and telephone follow-up.
Key exclusion criteria (5 listed)
- Diagnosis of type 2 diabetes more than six months before enrollment.
- Severe cognitive impairment or communication difficulties that would prevent participation in education or follow-up.
- Severe visual or hearing impairment that would prevent participation in study procedures.
- Major medical conditions that would substantially interfere with study participation.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Nurse-Led Diabetes Self-Management Education and Telephone Follow-UpParticipants in the intervention group received individualized, face-to-face, nurse-led diabetes self-management education lasting approximately 30-40 minutes. The education covered diabetes management, healthy nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of complications. Two structured telephone follow-up sessions were conducted at months 1 and 2 to reinforce education, answer questions, and support self-management. Participants in the control group received routine clinical care without additional researcher-led education or telephone follow-up during the three-month study period. Educational materials were provided to the control group after the final outcome assessment. | Behavioural | Nurse-Led Diabetes Education and Telephone Follow-Up |
Primary outcome
Change in Type 2 Diabetes Self-Management Scale (T2D-SMS) Total Score
Time frame: Baseline and Month 3
The Type 2 Diabetes Self-Management Scale (T2D-SMS), developed by Koç et al. (2024), consists of 19 items across three subscales: healthy lifestyle behaviors (11 items), health service utilization (4 items), and blood glucose management (4 items). Each item is scored from 1 to 5, yielding a total score ranging from 19 to 95. Higher scores indicate better diabetes self-management. The outcome is the change in total score from baseline to month 3.
Change in Adult Diabetes Knowledge Scale (ADKS) Total Score
Time frame: Baseline and Month 3
The Adult Diabetes Knowledge Scale (ADKS), developed by Erenel Yavuz and Erol, consists of 28 items across five domains: general diabetes knowledge (6 items), blood glucose measurement and values (5 items), diabetes risk factors (4 items), diabetes symptoms (8 items), and diabetes complications (5 items). Correct responses are scored as 1, while incorrect and "I do not know" responses are scored as 0. Total scores range from 0 to 28, with higher scores indicating greater diabetes knowledge. The outcome is the change in total score from baseline to month 3.
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Month 1, and Month 3
Glycated hemoglobin (HbA1c) was assessed as an indicator of long-term glycemic control. HbA1c values, expressed as percentages (%), were obtained from official hospital laboratory records at baseline, month 1, and month 3. The outcome evaluates changes in HbA1c levels over the three-month follow-up period, with lower values indicating better glycemic control.
Change in Fasting Blood Glucose (FBG)
Time frame: Baseline, Month 1, and Month 3
Fasting blood glucose (FBG), expressed in mg/dL, was obtained from official hospital laboratory records at baseline, month 1, and month 3. Changes in FBG levels over the three-month follow-up period were evaluated as an indicator of glycemic control.
Change in Postprandial Blood Glucose (PBG)
Time frame: Baseline, Month 1, and Month 3
Postprandial blood glucose (PBG), expressed in mg/dL, was obtained from official hospital laboratory records at baseline, month 1, and month 3. Changes in PBG levels over the three-month follow-up period were evaluated as an indicator of glycemic control.
1 secondary outcome
Change in Body Weight (kg)
Time frame: Baseline, Month 1, and Month 3
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 23 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. This study is not recruiting at the moment.
NAİLE ALANKAYA, Assosiate Prof. study director
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Diabetes Self-Management Education and Telephone Follow-Up in people with Diabetes Mellitus, Type 2, run by Naile ALANKAYA at 1 site in Cyprus.
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 5 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 23 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 Cyprus. 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?
Change in Type 2 Diabetes Self-Management Scale (T2D-SMS) Total Score (time frame: Baseline and Month 3). The study lists 5 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 23 Oct 2026.