Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-28 @ 5:28 AM
Study NCT ID:
NCT04843592
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2021-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOKARY Mobile Application With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the patient's compliance after using SOKARY mobile app", 'timeFrame': '3 months', 'description': "Increase level of Patients' compliance"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile phone application', 'DM type II', 'EGYPT', 'Compliance'], 'conditions': ['Type II Diabetes']}, 'descriptionModule': {'briefSummary': 'Android mobile application named (SOKARY)', 'detailedDescription': 'Android mobile application named (SOKARY) which means diabetes was selected as an example of mobile health application as it has the advantage of Arabic interface, free use it allows users to record his/their blood glucose level, nutrition and physical activity, then provide the user with statistics for those readings. The application also sends notifications to the users such as medication reminders and healthy lifestyle advice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with type II DM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be familiar with the use of mobile health applications.\n* Own a smartphone with an android operating system.\n* Able to use the internet either through Wi-Fi network and\\\\or mobile data.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04843592', 'acronym': 'DM', 'briefTitle': 'SOKARY Mobile Application With Type II Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effectiveness of Using SOKARY Mobile Application on Compliance of Patient With Type II Diabetes: A Quasi- Experimental Study', 'orgStudyIdInfo': {'id': 'EC10082019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type II diabetes', 'description': 'using mobile app', 'interventionNames': ['Device: SOKARY Mobile']}], 'interventions': [{'name': 'SOKARY Mobile', 'type': 'DEVICE', 'description': 'Effectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes', 'armGroupLabels': ['Type II diabetes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magda Bayoumi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Magda Bayoumi', 'investigatorAffiliation': 'Beni-Suef University'}}}}