Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-01-03 @ 7:35 PM
Study NCT ID:
NCT06973395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nursing outcomes level', 'timeFrame': 'Change in "Blood glucose level", "Hyperglycemia regimen", "Hypoglycemia regimen", "Diabetes management" and "Nutritional status" at 13 weeks', 'description': 'Primary Outcome Measure 1:\n\nName: Blood Glucose Level Time Frame: At weeks 1, 4, and 13 Description: Blood glucose level will be measured in mg/dL.\n\nPrimary Outcome Measure 2:\n\nName: 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.\n\nPrimary Outcome Measure 3:\n\nName: 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).'}, {'measure': 'Comprehensive diabetes self-management performance level', 'timeFrame': '"Change of comprehensive diabetes self-management at 13 weeks"', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'blood glucose variability', 'nursing diagnoses (NANDA)', 'nursing interventions (NIC)', 'nursing outcomes (NOC)', 'diabetes self-management'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThis 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.\n\nIf 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Including the data of those aged 18-65,\n* Those receiving oral antidiabetic treatment,\n* Those who can use a smartphone and have internet access,\n* Those who know how to write, read and speak Turkish,\n* Those who do not have communication skills,\n* Those who do not have a mental illness and are on psychiatric medication.\n\nExclusion Criteria:\n\n* Individuals with liver and kidney failure, myocardial infarction, cerebrovascular accident and cancer\n* Individuals receiving insulin treatment\n* Individuals using steroid treatment will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT06973395', 'briefTitle': 'The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AU-EBAYRAKTAR_001'}, 'secondaryIdInfos': [{'id': 'Research Assistant PhD Student', 'type': 'OTHER', 'domain': 'Ataturk University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group with nursing interventions applied', 'description': 'Patient with type 2 diabetes.', 'interventionNames': ['Behavioral: Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.']}, {'type': 'NO_INTERVENTION', 'label': 'Group without nursing interventions applied', 'description': 'Patient with type 2 diabetes. Only the survey will be applied to the control group.'}], 'interventions': [{'name': 'Nursing interventions, education, and follow-up will be provided to Type 2 diabetes patients for blood glucose variability.', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group with nursing interventions applied']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahmet Kızıltunç, Prof. Dr.', 'role': 'CONTACT', 'email': 'sagbilenst@atauni.edu.tr', 'phone': '05464701384', 'phoneExt': '+90442 2316612'}, {'name': 'Emel Bayraktar, ResearchAssistants PhD Student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Reva Balcı Akpınar, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ataturk University Institute of Health Sciences', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'zip': '25240', 'city': 'Erzurum', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahmet Kızıltunç', 'role': 'CONTACT', 'email': 'sagbilenst@atauni.edu.tr', 'phone': '90 442 231 (6612)'}, {'name': 'Emel Bayraktar, ResearchAssistants PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Reva Balcı Akpınar, PROF. DR.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Emel Bayraktar, research assistants', 'role': 'CONTACT', 'email': 'bayraktaremel84@gmail.com', 'phone': '05464701384'}, {'name': 'Reva Balcı Akpınar, Prof. Dr', 'role': 'CONTACT', 'email': 'reva@atauni.edu.tr', 'phone': '• 05327173155'}], 'overallOfficials': [{'name': 'Reva Balcı Akpınar, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Dean's Office of the Faculty of Nursing, Atatürk University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nursing Fundamentals Graduate Student', 'investigatorFullName': 'Emel Bayraktar', 'investigatorAffiliation': 'Ataturk University'}}}}