Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-28 @ 9:24 AM
Study NCT ID:
NCT00970567
Status:
COMPLETED
Last Update Posted:
2009-09-02
First Post:
2009-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)
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'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-01', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose metabolism, time course of positive ketone bodies', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['therapy after positive ketone bodies in the blood', 'timepoint of diagnosis', 'timepoint of metabolic normalisation'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate.', 'detailedDescription': 'Individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 diabetes\n\nExclusion Criteria:\n\n* severe hypo- or hyperglycemia during last 6 months\n* acute illness'}, 'identificationModule': {'nctId': 'NCT00970567', 'briefTitle': 'Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Ketoacidosis in Individuals With T1DM', 'orgStudyIdInfo': {'id': 'EA4/039/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'stop after positive ketone bodies in urine', 'interventionNames': ['Behavioral: Different insulin therapy at different time points']}, {'type': 'OTHER', 'label': 'Arm 2', 'description': 'stop after positive ketone bodies in blood, normal therapy', 'interventionNames': ['Behavioral: Different insulin therapy at different time points']}, {'type': 'OTHER', 'label': 'Arm 3', 'description': 'stop after positive ketone bodies in blood, additional therapy', 'interventionNames': ['Behavioral: Different insulin therapy at different time points']}], 'interventions': [{'name': 'Different insulin therapy at different time points', 'type': 'BEHAVIORAL', 'description': 'different insulin therapy after positive blood ketones', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Joachim Spranger, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charité, CBF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Professor J. Spranger', 'oldOrganization': 'Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition'}}}}