Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT01820169
Status:
TERMINATED
Last Update Posted:
2016-09-05
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Only 2 patients screened but none of them were enrolled.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in HbA1c in 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '1. Comparison with historical control in HbA1c change.', 'timeFrame': 'Baseline to 6 months'}, {'measure': '2. Change in blood gulucose.', 'timeFrame': 'Baseline to 6 months'}, {'measure': '3. Change in BMI.', 'timeFrame': 'Baseline to 6 months'}, {'measure': '4. Occurance of sever hypoglycemia.', 'timeFrame': 'Baseline to 6 months'}, {'measure': "5. Doctor's opinion for Accu-Chek 360° View.", 'timeFrame': 'Baseline to 6 months'}]}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive effect on the subjects overall glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age:= and \\>20 years. 2. Intend to paticipate in this study after education of structured testing. 3.HbA1c:= and \\>7.5% in the recect 2 months.\n\nExclusion Criteria:\n\n1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor'}, 'identificationModule': {'nctId': 'NCT01820169', 'briefTitle': 'Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG', 'orgStudyIdInfo': {'id': 'RD001551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'interventionNames': ['Device: ;Accu-Chek Compact Plus LCM bulk Japan']}], 'interventions': [{'name': ';Accu-Chek Compact Plus LCM bulk Japan', 'type': 'DEVICE', 'description': 'HbA1c would be changed by more careful control in blood glucose with SMBG.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '612-8555', 'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Naoki Sakane', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National organization Hospital Kyoto Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}