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

NCT ID: NCT06973395

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group with nursing interventions applied

Patient with type 2 diabetes.

Group Type EXPERIMENTAL

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

Intervention Type 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 without nursing interventions applied

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Emel Bayraktar

Nursing Fundamentals Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reva Balcı Akpınar, Prof. Dr.

Role: STUDY_DIRECTOR

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

Locations

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Ataturk University Institute of Health Sciences

Erzurum, Turkey, Turkey (Türkiye)

Site Status

Ataturk University

Erzurum, Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Emel Bayraktar, research assistants

Role: CONTACT

05464701384

Reva Balcı Akpınar, Prof. Dr

Role: CONTACT

• 05327173155

Facility Contacts

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Ahmet Kızıltunç, Prof. Dr.

Role: primary

05464701384 ext. +90442 2316612

Ahmet Kızıltunç

Role: primary

90 442 231 (6612)

Other Identifiers

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Research Assistant PhD Student

Identifier Type: OTHER

Identifier Source: secondary_id

AU-EBAYRAKTAR_001

Identifier Type: -

Identifier Source: org_study_id

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