Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-31 @ 4:31 AM
Study NCT ID:
NCT01016457
Status:
UNKNOWN
Last Update Posted:
2009-11-19
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-18', 'lastUpdatePostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C', 'timeFrame': 'Start of study, after 3 months, after 6 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Before and after connecting to sensor'}, {'measure': 'Number of night hypoglycemias', 'timeFrame': 'During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting'}, {'measure': 'Mean glucose level', 'timeFrame': 'During the first week of connecting to sensor and during the last week of connecting'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Duration of diabetes for more than 6 months\n* Use of insulin pump for more than 3 months'}, 'identificationModule': {'nctId': 'NCT01016457', 'briefTitle': 'Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SHEBA-07-4980-KMA-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Guardian RT', 'type': 'DEVICE', 'otherNames': ['Real-time continuous glucose monitoring'], 'description': 'The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Kineret Mazor-Aronovitch', 'role': 'CONTACT', 'email': 'kineret@gmail.com'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Kineret Mazor-Aronovitch, MD', 'role': 'CONTACT', 'email': 'kineret@gmail.com', 'phone': '972-3-5305022'}, {'name': 'Orit Pinhas-Hamiel, MD', 'role': 'CONTACT', 'email': 'Orit.Hamiel@sheba.health.gov.il', 'phone': '972-3-5305015'}], 'overallOfficials': [{'name': 'Kineret Mazor-Aronovitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Kineret Mazor-Aronovitch', 'oldOrganization': "Ped Endocrine & Diabetes Unit, Safra's Children Hospital, Sheba Medical Center"}}}}