Clinical trial NCT06973395: The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Scientific Research Projects Coordınatıon Unit of Atatürk University
First posted: 2025-05-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nursing outcomes level
timeFrame: Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks
measure: Comprehensive diabetes self-management performance level
timeFrame: "Change of comprehensive diabetes self-management at 13 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Institute of Health Sciences
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Dean's Office of the Faculty of Nursing, Atatürk University
name: Reva Balcı Akpınar, Prof. Dr.
role: STUDY_DIRECTOR
References: