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NCT Number: NCT06973395

The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University, Erzurum, Turkey, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emel Bayraktar, research assistants

CONTACT

[email protected]

05464701384

Reva Balcı Akpınar, Prof. Dr

CONTACT

[email protected]

• 05327173155

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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