Type 2 Diabetes Mellitus (T2DM)NCT06973395
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
A study testing Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability. in people with Type 2 Diabetes Mellitus (T2DM), run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
Type 2 diabetes is a chronic disease with an increasing prevalence worldwide and in our country. In managing type 2 diabetes, the primary goal in the nursing process is to ensure blood glucose stability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Including the data of those aged 18-65,
- Those receiving oral antidiabetic treatment,
- Those who can use a smartphone and have internet access,
- Those who know how to write, read and speak Turkish,
- Those who do not have communication skills,
- Those who do not have a mental illness and are on psychiatric medication.
Who cannot join
- Individuals with liver and kidney failure, myocardial infarction, cerebrovascular accident and cancer
- Individuals receiving insulin treatment
- Individuals using steroid treatment will not be included in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Ataturk University Institute of Health Sciences
Erzurum, Turkey, 25240
Ahmet Kızıltunç, Prof. Dr., 05464701384 ext. +90442 2316612, sagbilenst@atauni.edu.tr
Emel Bayraktar, ResearchAssistants PhD Student
Ataturk University
Erzurum, Turkey, 25240
Ahmet Kızıltunç, 90 442 231 (6612), sagbilenst@atauni.edu.tr
Emel Bayraktar, ResearchAssistants PhD Student
About this study
Official title: The Effect of Individualized Nursing Interventions for Blood Glucose Variability Risk on Nursing Outcomes and Self-Management of Diabetes in Patients With Type 2 Diabetes
Type 2 diabetes is a chronic disease with an increasing prevalence worldwide and in our country. In managing type 2 diabetes, the primary goal in the nursing process is to ensure blood glucose stability. In this regard, it is essential to provide individualized nursing interventions and diabetes management education to individuals. The Comprehensive Self-Management of Diabetes Scale can be used to determine individuals' level of diabetes management. Implementing systematic nursing interventions to maintain blood glucose stability and evaluating their impact on nursing outcomes and diabetes management are crucial. Although the NANDA, NIC, and NOC (NNN) system is used for this purpose, research in this area remains limited. There is a need for studies investigating the effects of individualized nursing interventions based on the NNN system on nursing outcomes and comprehensive self-management of diabetes in patients with type 2 diabetes who are at risk of blood glucose variability.
This study is planned as a randomized controlled trial with repeated measurements. The topic is original in terms of implementing individualized nursing interventions, providing education, and monitoring patients according to the NNN system to address the risk of blood glucose variability in patients with type 2 diabetes, as well as evaluating its impact on nursing outcomes and comprehensive self-management of diabetes. Another unique aspect of the study is that the effects of the interventions will also be assessed through laboratory results, including fasting blood glucose (FBG), postprandial blood glucose (PBG), HbA1c, height, weight, waist circumference, blood pressure, and pulse measurements.
Read more
This research aims to improve glycemic control, prevent potential complications of the disease, ensure patient safety, enhance the quality and satisfaction of nursing care, reduce additional treatment costs, and decrease diabetes-related morbidity and mortality.
If this study yields positive results, it will contribute to the widespread implementation of individualized nursing interventions using the NNN system to manage blood glucose variability risk, reduce diabetes-related health problems, ensure patient safety, and lower additional treatment costs. Furthermore, it is expected to guide clinical nurses, nurse researchers, and nurse managers in caring for individuals with type 2 diabetes, improve care quality and satisfaction, and support the planning of in-service training programs. From a healthcare institution perspective, it is anticipated to help reduce additional financial burdens and enhance care quality.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.
- Keywords
- Type 2 diabetes, blood glucose variability, nursing diagnoses (NANDA), nursing interventions (NIC), nursing outcomes (NOC), diabetes self-management
- 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.
Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.Behavioural
Implementation of individual nursing interventions and provision of trainingIndividual nursing interventions will be applied to individuals with Type 2 diabetes regarding the risk of variability in blood glucose, and education and follow-up will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Group with nursing interventions applied | Experimental | Patient with type 2 diabetes. Receives: Behavioral: Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability. |
| Group without nursing interventions applied | No intervention | Patient with type 2 diabetes. Only the survey will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing outcomes level
Primary Outcome Measure 1:
Name: Blood Glucose Level Time Frame: At weeks 1, 4, and 13 Description: Blood glucose level will be measured in mg/dL.
Primary Outcome Measure 2:
Name: Severity of Hyperglycemia Time Frame: At weeks 1, 4, and 13 Description: Severity of hyperglycemia will be evaluated based on blood glucose levels measured in mg/dL. Hyperglycemia level >135 mg/dL.
Primary Outcome Measure 3:
Name: Severity of Hypoglycemia Time Frame: At weeks 1, 4, and 13 Description: Severity of hypoglycemia will be evaluated based on blood glucose levels measured in mg/dL. (Hypoglycemia level <60 mg/dL) Primary Outcome Measure 4 Name: Nutritional Status Time Frame: At weeks 1, 4, and 13 Description: Nutritional status will be assessed using Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks
Comprehensive diabetes self-management performance level
The effect of individualized clinical interventions targeting the risk of blood glucose variability on the level of comprehensive diabetes self-management of Type 2 Diabetic Patients will be measured. Evaluation of changes in diabetes self-management behaviors using the Comprehensive Diabetes Self-Management Scale (CDSMS). Higher scores indicate better self-management.
Measured: "Change of comprehensive diabetes self-management at 13 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start11 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 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 Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Ataturk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was planned as a randomized controlled screening study with repeated measurements and follow-ups, including pre-test, interim test and post-test, with experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Bayraktar, Ataturk University
- Investigators
- Reva Balcı Akpınar, Prof. Dr., Study director, Dean's Office of the Faculty of Nursing, Atatürk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973395
- Sponsor's protocol ID
- AU-EBAYRAKTAR_001
- Other IDs
- Research Assistant PhD Student
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Nursing Interventions for Blood Glucose Variability Risk on Nursing Outcomes and Self-Management of Diabetes in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06973395
- Acronym / sponsor ID
- AU-EBAYRAKTAR_001
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 diabetes, blood glucose variability, nursing diagnoses (NANDA), nursing interventions (NIC), nursing outcomes (NOC), diabetes self-management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 11 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 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.
Type 2 diabetes is a chronic disease with an increasing prevalence worldwide and in our country. In managing type 2 diabetes, the primary goal in the nursing process is to ensure blood glucose stability. In this regard, it is essential to provide individualized nursing interventions and diabetes management education to individuals. The Comprehensive Self-Management of Diabetes Scale can be used to determine individuals' level of diabetes management. Implementing systematic nursing interventions to maintain blood glucose stability and evaluating their impact on nursing outcomes and diabetes management are crucial. Although the NANDA, NIC, and NOC (NNN) system is used for this purpose, research in this area remains limited. There is a need for studies investigating the effects of individualized nursing interventions based on the NNN system on nursing outcomes and comprehensive self-management of diabetes in patients with type 2 diabetes who are at risk of blood glucose variability.
This study is planned as a randomized controlled trial with repeated measurements. The topic is original in terms of implementing individualized nursing interventions, providing education, and monitoring patients according to the NNN system to address the risk of blood glucose variability in patients with type 2 diabetes, as well as evaluating its impact on nursing outcomes and comprehensive self-management of diabetes. Another unique aspect of the study is that the effects of the interventions will also be assessed through laboratory results, including fasting blood glucose (FBG), postprandial blood glucose (PBG), HbA1c, height, weight, waist circumference, blood pressure, and pulse measurements.
This research aims to improve glycemic control, prevent potential complications of the disease, ensure patient safety, enhance the quality and satisfaction of nursing care, reduce additional treatment costs, and decrease diabetes-related morbidity and mortality.
If this study yields positive results, it will contribute to the widespread implementation of individualized nursing interventions using the NNN system to manage blood glucose variability risk, reduce diabetes-related health problems, ensure patient safety, and lower additional treatment costs. Furthermore, it is expected to guide clinical nurses, nurse researchers, and nurse managers in caring for individuals with type 2 diabetes, improve care quality and satisfaction, and support the planning of in-service training programs. From a healthcare institution perspective, it is anticipated to help reduce additional financial burdens and enhance care quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research was planned as a randomized controlled screening study with repeated measurements and follow-ups, including pre-test, interim test and post-test, with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Group with nursing interventions applied | Experimental | Behavioral: Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.Patient with type 2 diabetes. |
| Group without nursing interventions applied | No intervention | –Patient with type 2 diabetes. Only the survey will be applied to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Including the data of those aged 18-65,
- Those receiving oral antidiabetic treatment,
- Those who can use a smartphone and have internet access,
- Those who know how to write, read and speak Turkish,
- Those who do not have communication skills,
Key exclusion criteria (3 listed)
- Individuals with liver and kidney failure, myocardial infarction, cerebrovascular accident and cancer
- Individuals receiving insulin treatment
- Individuals using steroid treatment will not be included in the study.
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 |
|---|---|---|
| Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.Implementation of individual nursing interventions and provision of trainingIndividual nursing interventions will be applied to individuals with Type 2 diabetes regarding the risk of variability in blood glucose, and education and follow-up will be provided. | Behavioural | Group with nursing interventions applied |
Primary outcome
Nursing outcomes level
Time frame: Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks
Primary Outcome Measure 1: Name: Blood Glucose Level Time Frame: At weeks 1, 4, and 13 Description: Blood glucose level will be measured in mg/dL. Primary Outcome Measure 2: Name: Severity of Hyperglycemia Time Frame: At weeks 1, 4, and 13 Description: Severity of hyperglycemia will be evaluated based on blood glucose levels measured in mg/dL. Hyperglycemia level >135 mg/dL. Primary Outcome Measure 3: Name: Severity of Hypoglycemia Time Frame: At weeks 1, 4, and 13 Description: Severity of hypoglycemia will be evaluated based on blood glucose levels measured in mg/dL. (Hypoglycemia level <60 mg/dL) Primary Outcome Measure 4 Name: Nutritional Status Time Frame: At weeks 1, 4, and 13 Description: Nutritional status will be assessed using Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).
Comprehensive diabetes self-management performance level
Time frame: "Change of comprehensive diabetes self-management at 13 weeks"
The effect of individualized clinical interventions targeting the risk of blood glucose variability on the level of comprehensive diabetes self-management of Type 2 Diabetic Patients will be measured. Evaluation of changes in diabetes self-management behaviors using the Comprehensive Diabetes Self-Management Scale (CDSMS). Higher scores indicate better self-management.
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 28 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.
Reva Balcı Akpınar, Prof. Dr. study director
Dean's Office of the Faculty of Nursing, Atatürk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability. in people with Type 2 Diabetes Mellitus (T2DM), run by Ataturk University at 2 sites 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 3 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 28 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 2 sites 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 Emel Bayraktar, research assistants (05464701384, bayraktaremel84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing outcomes level (time frame: Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks). The study lists 2 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 28 Oct 2026.