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

NCT06973395 | Not Yet Recruiting DMC

• 2 other identifiers: AU-EBAYRAKTAR_001Research Assistant PhD Student
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  "Change of comprehensive diabetes self-management at 13 weeks"

Study Arms (2)

Group with nursing interventions applied

EXPERIMENTAL

Patient with type 2 diabetes.

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.

Interventions

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

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.

Group with nursing interventions applied

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Ataturk University Institute of Health Sciences

Erzurum, Turkey, 25240, Turkey (Türkiye)

Location

Ataturk University

Erzurum, Turkey, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods; Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Socioeconomic Factors; Population Characteristics

Study Officials

• Reva Balcı Akpınar, Prof. Dr.

  Dean's Office of the Faculty of Nursing, Atatürk University

  STUDY DIRECTOR

Central Study Contacts

Emel Bayraktar, research assistants

CONTACT

05464701384; bayraktaremel84@gmail.com

Reva Balcı Akpınar, Prof. Dr

CONTACT

• 05327173155; reva@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Fundamentals Graduate Student

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)