Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 1:58 PM
Study NCT ID:
NCT00772356
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2008-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2008-10-13', 'studyFirstSubmitQcDate': '2008-10-14', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of glucose infusion rate necessary to keep blood glucose constant', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Serum insulin and free fatty acid levels', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients 18-65 years of age\n* Type I diabetes mellitus\n* Currently on continuous subcutaneous insulin infusion therapy\n\nExclusion Criteria:\n\n* Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months\n* Use of systemic corticoids in last 3 months\n* Treatment with medication known to interfere with glucose metabolism'}, 'identificationModule': {'nctId': 'NCT00772356', 'briefTitle': 'A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes', 'orgStudyIdInfo': {'id': 'RD000559'}, 'secondaryIdInfos': [{'id': '05/0377-Basal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Device: Accu-Chek Spirit Insulin Pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Device: Comparator insulin pump']}], 'interventions': [{'name': 'Accu-Chek Spirit Insulin Pump', 'type': 'DEVICE', 'armGroupLabels': ['A']}, {'name': 'Comparator insulin pump', 'type': 'DEVICE', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Bettina Dr. Petersen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Roche Diagnostics GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}