Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-30 @ 7:58 AM
Study NCT ID:
NCT01694758
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2012-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 733}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1', 'timeFrame': 'after 12 months of follow-up', 'description': 'To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1'}], 'secondaryOutcomes': [{'measure': 'Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure', 'timeFrame': 'after 12 months of follow-up versus baseline', 'description': 'To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure'}, {'measure': 'Markers of preventive screening', 'timeFrame': 'after 12 months of follow-up versus baseline', 'description': 'To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity'}, {'measure': 'The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines', 'timeFrame': 'after 12 months of follow-up versus baseline', 'description': 'To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines'}]}, 'conditionsModule': {'keywords': ['Benchmarking could improve quality of patient care', 'ESC and ATP III Guidelines'], 'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'descriptionModule': {'briefSummary': 'OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent.\n\nIn this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes type 2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects suffering from diabetes type 2,\n* treated or untreated,\n* insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)\n\nExclusion Criteria:\n\n* Type 1 diabetes Pregnancy diabetes\n* Hospitalization at the moment of enrollment in the study'}, 'identificationModule': {'nctId': 'NCT01694758', 'acronym': 'OPTIMISE', 'briefTitle': 'OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)', 'orgStudyIdInfo': {'id': 'NIS-CME-XXX-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diabetes type 2'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blagoevgrad', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Alexandria', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 43.98333, 'lon': 25.33333}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Constanța', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Galati', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Giurgiu', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88664, 'lon': 25.9627}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Oradea', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'city': 'Piteşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'city': 'Ploieşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Satu Mare', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.79926, 'lon': 22.86255}}, {'city': 'Tg Jiu', 'country': 'Romania', 'facility': 'Research Site'}, {'city': 'Tg Mures', 'country': 'Romania', 'facility': 'Research Site'}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Dan Isacoff, ASSOC. PROF.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy Carol Davila, Bucharest, Romania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}