Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-30 @ 6:47 AM
Study NCT ID:
NCT01050868
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2010-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2010-01-15', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.', 'timeFrame': '6 hours after meal'}], 'secondaryOutcomes': [{'measure': 'To compare the absolute difference between the SMBG value and the target value between the calculators', 'timeFrame': '6 hours after meal'}, {'measure': 'To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators', 'timeFrame': '6 hours after meal'}, {'measure': 'To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators', 'timeFrame': '6 hours after meal'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': "This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects \\>/= 18 years at screening\n* Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit\n* Subjects have to use a fast acting analog insulin\n* HbA1c = 9% (measured with DCA 2000)\n* Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (\\~10 tests per day) with skipped meals and testmeals\n* Willing to use the 3 different bolus calculators during the course of the study\n* Willing to undergo planned hyperglycemia\n* Willing to perform high frequency BG monitoring (\\> 20 / day) during the experiment\n\nExclusion Criteria:\n\n* Type 2 Diabetes\n* Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)\n* Current addiction to alcohol or substances of abuse\n* Pregnant or lactating women\n* Any known life-threatening disease'}, 'identificationModule': {'nctId': 'NCT01050868', 'briefTitle': 'Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'RD000811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Device: Accu-Chek Combo Kit mg DE/de']}], 'interventions': [{'name': 'Accu-Chek Combo Kit mg DE/de', 'type': 'DEVICE', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Bettina Petersen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Roche Diagnostics GmbH / Diabetes Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}