Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 6:58 AM
Study NCT ID:
NCT05286450
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-compliance on Treatment Among Diabetic Students at Sohag University
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'portal@med.sohag.edu.eg', 'phone': '(093)- 4602963', 'title': 'dr magdy mohamed amin', 'organization': 'Sohag University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distribution of Participants Responses as Regards DSMQ Glucose Management Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 18 and 25 years old in different faculties in Sohag University'}], 'classes': [{'title': 'I check my blood sugar levels with care and attention.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '56', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'I take my diabetes medication (e. g. insulin, tablets) as prescribed', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'I record my blood sugar levels regularly (or analyse the value chart with my blood glucose meter).', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'I do not check my blood sugar levels frequently as required for achieving good blood glucose control', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '61', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'I tend to forget to take or skip my diabetes medication (e. g. insulin, tablets).', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '120', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'through a standardized questionnaire DSMQ (Diabetes self management questionnaire)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Distribution of Participants Responses as Regards DSMQ Dietary Control Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University'}], 'classes': [{'title': 'The food I choose to eat makes it easy to achieve optimal blood sugar levels.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Occasionally I eat lots of sweets or other foods rich in carbohydrates', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'I strictly follow the dietary recommendations given by my doctor or diabetes specialist.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': "Sometimes I have real 'food binges' (not triggered by hypoglycemia).", 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'non compliance on treatment among diabetic students', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Distribution of Participants Responses as Regards DSMQ Physical Activity Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University'}], 'classes': [{'title': 'I do regular physical activity to achieve optimal blood sugar levels.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '90', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'I avoid physical activity, although it would improve my diabetes.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'I tend to skip planned physical activity.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'mesurment of non compliance among diabetic students at sohag university', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Distribution of Participants Responses as Regards DSMQ Health Care Use Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University'}], 'classes': [{'title': "I keep all doctors' appointments recommended for my diabetes treatment", 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': "I tend to avoid diabetes-related doctors' appointments", 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '72', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Regarding my diabetes care, I should see my medical practitioner(s) more often.', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'My diabetes self-care is poor', 'categories': [{'title': 'Does not apply to me', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Applies to me to some degree', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'Applies to me to a consider-able degree', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Applies to me very much', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'measurment of non compliance among diabetic students at sohag university', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diabetic Students at Sohag University', 'description': '153 diabetic students aged between 17 and 25 years old in different faculties in Sohag University'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-14', 'size': 210656, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-06T07:06', 'hasProtocol': True}, {'date': '2022-03-14', 'size': 544759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-06T07:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2022-03-09', 'resultsFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-06', 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of Participants Responses as Regards DSMQ Glucose Management Domain', 'timeFrame': '2 months', 'description': 'through a standardized questionnaire DSMQ (Diabetes self management questionnaire)'}, {'measure': 'Distribution of Participants Responses as Regards DSMQ Dietary Control Domain', 'timeFrame': '2 months', 'description': 'non compliance on treatment among diabetic students'}, {'measure': 'Distribution of Participants Responses as Regards DSMQ Physical Activity Domain', 'timeFrame': '2 months', 'description': 'mesurment of non compliance among diabetic students at sohag university'}, {'measure': 'Distribution of Participants Responses as Regards DSMQ Health Care Use Domain', 'timeFrame': '2 months', 'description': 'measurment of non compliance among diabetic students at sohag university'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'A cross-sectional study on diabetic students in Sohag University will be conducted to collect data about factors affecting compliance and adherence to diabetes treatment and its impact on development of complications.', 'detailedDescription': 'Personal interviews with diabetic students through a questionnaire :\n\n1. To determine factors affecting non compliance on treatment among diabetic students.\n2. To detect relation between non compliance on treatment and development of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all the diabetic students in sohag university from different faculties', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic students at Sohag University age from 17 to 25\n\nExclusion Criteria:\n\n* Healthy students\n* Students in other universities'}, 'identificationModule': {'nctId': 'NCT05286450', 'briefTitle': 'Non-compliance on Treatment Among Diabetic Students at Sohag University', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Non-compliance on Treatment Among Diabetic Students at Sohag University', 'orgStudyIdInfo': {'id': 'Soh-Med-22-03-14'}}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Samah W. Elkhayat, demonstrator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator at Family Medicine Department', 'investigatorFullName': 'Samah Wagdy Abdelaziz', 'investigatorAffiliation': 'Sohag University'}}}}