Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-28 @ 4:55 PM
Study NCT ID:
NCT00918151
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Capillary or venous blood will be drawn for analysing HbA1c'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1932}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean age of onset of type 1 and type 2 diabetes mellitus, respectively', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean duration of treatment of type 2 diabetes mellitus.', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) therapy, respectively', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean duration of diabetes in type 1 and type 2 diabetic patients respectively', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively', 'timeFrame': 'at baseline visit/study start'}], 'secondaryOutcomes': [{'measure': "Patients' perception will be analysed through patient questionnaire measuring psychological well-being, quality of life and patients' compliant to treatment", 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Physician perception of diabetes and its management will be analysed through physician questionnaire measuring awareness about: HbA1c test and its goal, anti-diabetic treatment, barriers towards optimum diabetes control', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Duration of diabetes associated with highest number of diabetic complications', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)', 'timeFrame': 'at baseline visit/study start'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, and complications in diabetic subjects in Asia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes mellitus (both type 1 and type 2) being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients registered in the particular centre for more than 12 months.\n* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.\n* Patients willing to sign informed consent form.\n\nExclusion Criteria:\n\n* Repetition of any patient as patients should not be included twice for any reason.\n* Unwilling to participate or unable to comply with protocol requirements.'}, 'identificationModule': {'nctId': 'NCT00918151', 'acronym': 'DiabCare Asia', 'briefTitle': 'A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'DiabCare Asia 2008 (Korea): A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Asia', 'orgStudyIdInfo': {'id': 'INS-3781'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Subject will only fill out a questionaire when entering the observational study', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-920', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452), Project Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}