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

September 29, 2025 updated by: Emel Bayraktar, Ataturk University

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Reva Balcı Akpınar, Prof. Dr
  • Phone Number: • 05327173155
  • Email: reva@atauni.edu.tr

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Erzurum, Turkey, Turkey (Türkiye), 25240
        • Ataturk University Institute of Health Sciences
        • Contact:
        • Sub-Investigator:
          • Emel Bayraktar, ResearchAssistants PhD Student
        • Principal Investigator:
          • Reva Balcı Akpınar, PROF. DR.
      • Erzurum, Turkey, Turkey (Türkiye), 25240
        • Ataturk University
        • Principal Investigator:
          • Reva Balcı Akpınar, PROF. DR.
        • Contact:
        • Principal Investigator:
          • Emel Bayraktar, ResearchAssistants PhD Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
No Intervention: Group without nursing interventions applied
Patient with type 2 diabetes. Only the survey will be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks
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.
"Change of comprehensive diabetes self-management at 13 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Collaborators

Scientific Research Projects Coordınatıon Unit of Atatürk University

Investigators

  • Study Director: Reva Balcı Akpınar, Prof. Dr., Dean's Office of the Faculty of Nursing, Atatürk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-EBAYRAKTAR_001
  • Research Assistant PhD Student (Other Identifier: Ataturk University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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