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Not yet recruitingNCT06973395Updated Sep 30, 2025

The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes

An interventional study of Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability. in Type 2 Diabetes Mellitus (T2DM), sponsored by Ataturk University. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Ataturk University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)

Keywords

  • Type 2 diabetes
  • blood glucose variability
  • nursing diagnoses (NANDA)
  • nursing interventions (NIC)
  • nursing outcomes (NOC)
  • diabetes self-management
03

In context

Diabetes Mellitus, Type 2

9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 72 is close to the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Group with nursing interventions applied

    Patient with type 2 diabetes.

    Behavioral: Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.

  • No intervention
    Group without nursing interventions applied

    Patient with type 2 diabetes. Only the survey will be applied to the control group.

Interventions

  • BehavioralNursing 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks

  2. 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.

    Time frame: "Change of comprehensive diabetes self-management at 13 weeks"

07

Study locations

2 sites
  • Ataturk University Institute of Health Sciences
    Erzurum, Turkey 25240, Turkey (Türkiye)
    • Ahmet Kızıltunç, Prof. Dr. · Contact · sagbilenst@atauni.edu.tr · 05464701384
    • Emel Bayraktar, ResearchAssistants PhD Student · Sub investigator
    • Reva Balcı Akpınar, Prof. Dr. · Principal investigator
  • Ataturk University
    Erzurum, Turkey 25240, Turkey (Türkiye)
    • Ahmet Kızıltunç · Contact · sagbilenst@atauni.edu.tr · 90 442 231 (6612)
    • Emel Bayraktar, ResearchAssistants PhD Student · Principal investigator
    • Reva Balcı Akpınar, PROF. DR. · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06973395
Lead sponsor
Ataturk University
Responsible party
Emel Bayraktar (Nursing Fundamentals Graduate Student, Ataturk University) — Principal investigator
First posted
May 15, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 30, 2025

Study contacts

Emel Bayraktar, research assistants
Contact
bayraktaremel84@gmail.com
05464701384
Reva Balcı Akpınar, Prof. Dr
Contact
reva@atauni.edu.tr
• 05327173155
Reva Balcı Akpınar, Prof. Dr.
study director · Dean's Office of the Faculty of Nursing, Atatürk University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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