Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT00874159
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2009-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Survey to Evaluate Diabetes Management, Control, Complications and Psychosocial Aspects of Diabetic Patients in Philippines
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': 770}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean age of onset of type 1 diabetes mellitus', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean age of onset of type 2 diabetes mellitus', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean duration of treatment of type 2 DM', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of patients on Insulin therapy', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of patients on OAD therapy', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean duration of diabetes in type 1 and type 2 patients respectively', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean FPG of diabetic patients', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean PPG of diabetic patients', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Mean HbA1c of diabetic patients', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients with HbA1c target below 7.0%', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients with HbA1c target below 6.5%', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having dyslipidemia and hypertension', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having cardiovascular complications', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having peripheral vascular disease', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having diabetic nephropathy', 'timeFrame': 'at baseline visit/study start'}, {'measure': 'Percentage of diabetic patients having diabetic eye complications', 'timeFrame': 'at baseline visit/study start'}], 'secondaryOutcomes': [{'measure': "Patients' perception will be analysed through Patient questionnaire measuring: Psychological well-being, Quality of life, 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:o 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 describe the diabetes management, control status and complication profile in a diabetic population of Philippines.'}, '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 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': 'NCT00874159', 'acronym': 'DiabCare Asia', 'briefTitle': 'A Survey to Evaluate Diabetes Management, Control, Complications and Psychosocial Aspects of Diabetic Patients in Philippines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'DiabCare Asia 2008 Philippines A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Philippines & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Philippines', 'orgStudyIdInfo': {'id': 'INS-3712'}}, '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': '1605', 'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}