Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-01-20 @ 3:24 PM
Study NCT ID:
NCT01588106
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2012-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@gwtonline.de', 'phone': '+49 (0) 351 25933 100', 'title': 'Dr. Carsta Köhler', 'organization': 'GWT-TUD GmbH'}, 'certainAgreement': {'otherDetails': 'The Study being conducted under this Agreement is part of the Overall Study. Publications or lectures on the findings of the present clinical trial either as a whole or at individual investigation sites must be approved by the sponsor in advance, and the sponsor reserves the right to review and comment on such documentation before publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Test Group- CONTOUR Next USB', 'description': "Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.", 'otherNumAtRisk': 78, 'otherNumAffected': 13, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group- Standard CONTOUR', 'description': "Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.", 'otherNumAtRisk': 76, 'otherNumAffected': 9, 'seriousNumAtRisk': 76, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 83, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 106, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders'}], 'seriousEvents': [{'term': 'severe thrombosis of the portal vein', 'notes': 'The patient suffered from severe thrombosis of the portal vein after Visit 1. This event was assessed as not being related to the trial Intervention but rather to the underlying concomitant disease(s).Patient was hospitalized but died in the end.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group- CONTOUR Next USB', 'description': "Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline."}, {'id': 'OG001', 'title': 'Control Group- Standard CONTOUR', 'description': "Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 9 months', 'unitOfMeasure': '% (unit of HbA1c)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from whom HbA1c measurements were recorded at baseline and after 9 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Group- CONTOUR Next USB', 'description': "Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline."}, {'id': 'FG001', 'title': 'Control Group- Standard CONTOUR', 'description': "Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled in 16 sites across Germany. Study start date was in June 2012 and recruitment was stopped in November 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Group- CONTOUR Next USB', 'description': "Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline."}, {'id': 'BG001', 'title': 'Control Group- Standard CONTOUR', 'description': "Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.10', 'spread': '10.28', 'groupId': 'BG000'}, {'value': '65.66', 'spread': '9.08', 'groupId': 'BG001'}, {'value': '63.87', 'spread': '9.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c value at baseline', 'classes': [{'categories': [{'measurements': [{'value': '8.61', 'spread': '0.95', 'groupId': 'BG000'}, {'value': '8.47', 'spread': '0.97', 'groupId': 'BG001'}, {'value': '8.54', 'spread': '0.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2012-04-26', 'resultsFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-19', 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in HbA1c', 'timeFrame': 'Baseline, after 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.\n\nPatients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients of assorted practices', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes\n* Therapy with insulin only (ICT) or ICT in combination with Metformin\n* HbA1c at baseline \\> 7.5% and \\< 11%\n* Patients at least 18 years of age\n* Patients willing to complete all study visits and study procedures including:\n\n * Testing their BG at least 3 times a day during the entire study.\n * Using the paper logbook provided (control group)\n * Using the Auto log meal-marker + reminder feature in CONTOUR Next USB regularly (TEST subjects only)\n * Using the Trends feature in CONTOUR Next USB regularly (TEST subjects only)\n * Uploading the CONTOUR Next USB meter to personal computer (subject must have personal computer at home or access to a computer - see system requirements in appendix for technical details).\n* Patients who are able to speak, read and understand German\n* Patients who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more\n* Patients who are currently adjusting there insulin dosages themselves based on the self-testing of blood glucose at home\n* Written informed consent at beginning of the study\n\nExclusion Criteria:\n\n* Patients who have been using CONTOUR Next USB meter regularly during the previous 12 months\n* Patients treated with oral antidiabetic drugs except for Metformin; or diet alone\n* Change of diabetes therapy within the last 3 months\n* Change of HbA1c level of more than ±0.5% within the last 3 months\n* Patients who are using a continuous blood glucose measurement system regularly\n* Patients with home health aides who assist with their BG testing and /or insulin adjustment\n* Patients with macroalbuminuria\n* Steroid therapy within the last 3 months. Topic or inhalative use is no exclusion criterion when not used regularly (more than 5 times a week).\n* Uncontrolled blood pressure ≥ 170/100 at screening\n* BMI \\> 40 kg/m²\n* Anemia according to WHO-definition (hemoglobin \\< 13 g/100 ml \\[male\\] or \\< 12 g/100 ml \\[female\\])\n* Creatinin \\> 150 µmol/l and/or GFR \\< 50 mmol/min/ 1.73m² (measured within the last 3 months before screening)\n* Operation with inpatient stay planned during the study\n* Current pregnancy or pregnancy planned during the study; or breastfeeding women.\n* Women with childbearing potential who are not practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner\n* Alcohol or drug abuse within the last 3 months\n* Patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:\n\n * Significant visual impairment\n * Significant hearing impairment\n * Cognitive disorder\n * Significant unstable co-morbidity (with notable change within the past 3 months)\n * Severe renal disease, disease with a strong impact on life expectancy\n * Inability to have or use and computer\n * Inability to use a meter correctly\n * Any other condition as per investigator's discretion\n* Current participation in another clinical study. Participation in another trial within 6 weeks before screening.\n* Employees of Bayer Vital Diabetes Care, the GWT or the University of Dresden"}, 'identificationModule': {'nctId': 'NCT01588106', 'acronym': 'CONGO', 'briefTitle': 'Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'GWT-TUD GmbH'}, 'officialTitle': 'Evaluation of the Impact of the CONTOUR® USB Blood Glucose Monitoring System With Integrated Data Management on Glycaemic Control in Insulin-treated Diabetic Patients', 'orgStudyIdInfo': {'id': 'GWT-2011-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group', 'description': 'patients using CONTOUR Next USB'}, {'label': 'Control group', 'description': 'patients using standard CONTOUR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10409', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Diabetespraxis Prenzlauer Allee', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13597', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr. Fießelmann', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13597', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr. Stephan', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44869', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Lorra/Bonnermann', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '09618', 'city': 'Brand-Erbisdorf', 'country': 'Germany', 'facility': 'Praxis Dr. Holderied', 'geoPoint': {'lat': 50.86643, 'lon': 13.32285}}, {'zip': '03096', 'city': 'Burg', 'country': 'Germany', 'facility': 'Spreewaldklinik', 'geoPoint': {'lat': 51.83448, 'lon': 14.14856}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Diabeteszentrum DO', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Studienzentrum Prof. Hanefeld', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden, Medizinische Klinik III', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40211', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Schaden', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '01705', 'city': 'Freital', 'country': 'Germany', 'facility': 'Praxis Dr. Stier', 'geoPoint': {'lat': 51.00166, 'lon': 13.6488}}, {'zip': '39112', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'SMO.MD GmbH', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '80331', 'city': 'München', 'country': 'Germany', 'facility': 'Praxis Dr. Ruhland', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80687', 'city': 'München', 'country': 'Germany', 'facility': 'Metabolicum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81241', 'city': 'München', 'country': 'Germany', 'facility': 'Praxis Dr. Engelmayer', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '04758', 'city': 'Oschatz', 'country': 'Germany', 'facility': 'Diabeteszentrum Oschatz', 'geoPoint': {'lat': 51.30001, 'lon': 13.10984}}], 'overallOfficials': [{'name': 'Peter Schwarz, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Carl Gustav Carus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}