Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT06176703
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Application for Self-Management of Type 2 Diabetes Mellitus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-11-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-16', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '3-6 months', 'description': 'HbA1c'}, {'measure': 'Glycemic control', 'timeFrame': '3-6 months', 'description': 'Fasting blood sugar'}], 'secondaryOutcomes': [{'measure': 'self-diabetes management', 'timeFrame': '3-6 months', 'description': 'The Thai-Diabetes Management of Self-Efficacy Scale(T-DMSES), total score range from 19 to 95 points(minimum to maximum), each question has 1 to 5 points, higher scores mean better self diabetes management'}, {'measure': 'Quality of life', 'timeFrame': '3-6 months', 'description': 'The Thai version of the EQ-5D-5L Health Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The goal of this Randomized Controlled Trial is to study the effect of mobile Application on glycemic control of type2 diabetes mellitus. The main questions aim to answer are:\n\n* The effect of mobile application on glycemic control and quality of life of diabetes mellitus patients\n* The satisfaction of mobile application of diabetes mellitus patients who used it Participants will be received education about diabetes mellitus and separated into two groups, intervention group(using mobile application) and control group(not using mobile application but also receive standard treatment of diabetes mellitus.\n\nResearchers will compare intervention group to control group about glycemic control including HbA1c, complications of diabetes mellitus etc. and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type2 diabetes mellitus who have HbA1c above 7%\n* Can use application on smartphone\n* age 18 years old or more (relatives are accept if participants have age more than 65 years old and cannot use smartphone)\n* consent to participate the research\n\nExclusion Criteria:\n\n* refuse to participate the research\n* pregnancy\n* using continuous glucose monitoring system or insulin pump\n* disability in sight or hearing\n* have been using the mobile application(RAMAdiabetes) in the past'}, 'identificationModule': {'nctId': 'NCT06176703', 'briefTitle': 'Mobile Application for Self-Management of Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Mobile Application for Self-Management of Type 2 Diabetes Mellitus: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard treatment with mobile application in diabetes mellitus patients', 'interventionNames': ['Device: mobile application']}, {'type': 'NO_INTERVENTION', 'label': 'standard treatment without mobile application in diabetes mellitus patients'}], 'interventions': [{'name': 'mobile application', 'type': 'DEVICE', 'description': 'using mobile application along with standard treatment of diabetes mellitus', 'armGroupLabels': ['Standard treatment with mobile application in diabetes mellitus patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10170', 'city': 'ฺBangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Supasuta Wongdama', 'role': 'CONTACT', 'email': 'poytriplet@gmail.com', 'phone': '0905754190'}], 'facility': 'Faculty of Medicine Ramathibodi Hospital'}], 'centralContacts': [{'name': 'Supasuta Wongdama, Fellowship', 'role': 'CONTACT', 'email': 'poytriplet@gmail.com', 'phone': '0905754190'}], 'overallOfficials': [{'name': 'Chutintorn Sriphrapradang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ramathibodi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Supasuta Wongdama', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}