Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT01950650
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of insulin omission/non-adherence', 'timeFrame': 'In the past 30 days prior to the day when responding to the survey (patient survey)'}, {'measure': 'Reasons for insulin omission/non-adherence reported by patient and physician', 'timeFrame': 'Day 1 (when responding to the survey)'}], 'secondaryOutcomes': [{'measure': 'Impact of insulin treatment on life domains (patient survey)', 'timeFrame': 'Day 1 (when responding to the online questionnaire)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22313123', 'type': 'RESULT', 'citation': 'Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Insulin treated patients with diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENTS WITH DIABETES:\n* Age 18 years or older\n* Treated with insulin\n* Type 1 or Type 2 diabetes\n* PHYSICIANS:\n* In practice for more than 1 year since completing residency\n* See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10)\n* Initiate insulin treatment for patients with diabetes'}, 'identificationModule': {'nctId': 'NCT01950650', 'briefTitle': 'GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GAPP1'}, 'secondaryIdInfos': [{'id': 'U1111-1136-2507', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diabetes', 'interventionNames': ['Behavioral: No treatment given']}, {'label': 'Physicians', 'interventionNames': ['Behavioral: survey']}], 'interventions': [{'name': 'No treatment given', 'type': 'BEHAVIORAL', 'description': 'Survey conducted through computer-assisted telephone interviewing.', 'armGroupLabels': ['Patients with diabetes']}, {'name': 'survey', 'type': 'BEHAVIORAL', 'description': 'Survey conducted via the Internet.', 'armGroupLabels': ['Physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '100004', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '92932', 'city': 'Paris La Défense Cedex', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '55127', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '560001', 'city': 'Bangalore', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '1000005', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '119330', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '34335', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'RH11 9RT', 'city': 'Crawley', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}], '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'}}}}