Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-28 @ 5:57 AM
Study NCT ID:
NCT01978704
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2013-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-01', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-01', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily plasma glucose excursion', 'timeFrame': '1 week'}, {'measure': 'mean plasma glucose concentrations', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'postprandial plasma glucose concentrations', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes treated by insulin pump\n\nExclusion Criteria:\n\n* Preganncy\n* HbA1c \\> 9%\n\n * Any serious acute or chronic illness a part diabetes'}, 'identificationModule': {'nctId': 'NCT01978704', 'acronym': 'GLUT', 'briefTitle': 'Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy', 'orgStudyIdInfo': {'id': '37/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycaemic load', 'interventionNames': ['Other: Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrates content', 'interventionNames': ['Other: Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal']}], 'interventions': [{'name': 'Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal', 'type': 'OTHER', 'armGroupLabels': ['Glycaemic load']}, {'name': 'Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal', 'type': 'OTHER', 'armGroupLabels': ['Carbohydrates content']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'rivellese angela', 'investigatorAffiliation': 'Federico II University'}}}}