Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01840358
Status:
UNKNOWN
Last Update Posted:
2013-04-26
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007854', 'term': 'Lead'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of hypoglycemias', 'timeFrame': '6 days', 'description': 'Frequency of hypoglycemias defined as blood sugars \\< 4.0mmol/l'}], 'secondaryOutcomes': [{'measure': 'Frequency of hyperglycemias', 'timeFrame': '6 days', 'description': 'Frequency of hyperglycemias defined as blood sugars \\> 17.0mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypoglycemias', 'Insulin pump', 'Children'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '28484424', 'type': 'DERIVED', 'citation': 'Manousaki D, Deladoey J, Geoffroy L, Olivier P. Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation. Front Endocrinol (Lausanne). 2017 Apr 24;8:84. doi: 10.3389/fendo.2017.00084. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine\n* Patient about to start insulin pump therapy at the CHU Sainte-Justine\n* Last HbA1c between 7.2 and 9.7%\n* Informed and signed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin \\< 0.5U/kg/day\n* Home of the patient at more than 50km of the CHU Sainte-Justine\n* Refusal to consent'}, 'identificationModule': {'nctId': 'NCT01840358', 'briefTitle': 'Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'HSJ-3638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients starting pump therapy', 'interventionNames': ['Other: Observation of hypoglycemias frequency 3 days before and after pump initiation']}], 'interventions': [{'name': 'Observation of hypoglycemias frequency 3 days before and after pump initiation', 'type': 'OTHER', 'armGroupLabels': ['Patients starting pump therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Patricia Olivier, MD', 'role': 'CONTACT', 'email': 'patricia.olivier.hsj@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '5486'}, {'name': 'Patricia Olivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Patricia Olivier, MD', 'role': 'CONTACT', 'email': 'patricia.olivier.hsj@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '5486'}], 'overallOfficials': [{'name': 'patricia Olivier, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric endocrinologist', 'investigatorFullName': 'Patricia Olivier', 'investigatorAffiliation': "St. Justine's Hospital"}}}}