Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-29 @ 11:17 AM
Study NCT ID:
NCT01130558
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2010-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Structured Insulin Order
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-24', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean blood Glucose', 'timeFrame': '6 days'}], 'secondaryOutcomes': [{'measure': 'rates of glucose values less than 60 mg/dl or less than 40 mg/dl', 'timeFrame': '6 days'}, {'measure': 'rate of use of sliding scale insulin', 'timeFrame': '6 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'basal-bolus insulin', 'insulin ordering'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes.', 'detailedDescription': 'The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blood glucose less than 60 mg/dl or greater than 180 mg/dl during hospital stay\n\nExclusion Criteria:\n\n* Diagnosis of Type 1 Diabetes'}, 'identificationModule': {'nctId': 'NCT01130558', 'briefTitle': 'Efficacy of Structured Insulin Order', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Efficacy of Structured Insulin Orders in Improving Glycemic Control', 'orgStudyIdInfo': {'id': '2008P-0022131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ordering template and education', 'description': 'Internal medical residents who were asked to use the insulin order template and received education about basal-bolus insulin ordering.', 'interventionNames': ['Other: Diabetes Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'description': 'Internal medical residents who received education about basal-bolus insulin ordering.', 'interventionNames': ['Other: Diabetes Management']}], 'interventions': [{'name': 'Diabetes Management', 'type': 'OTHER', 'description': 'Using electronic insulin order template for basal-bolus insulin and education', 'armGroupLabels': ['Education', 'Ordering template and education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Enrico Cagliero, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Enrico Cagliero, M.D.', 'oldOrganization': 'Massachusetts General Hospital'}}}}