Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 5:46 PM
Study NCT ID:
NCT01382459
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-06-24', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['children'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.", 'detailedDescription': "The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:\n\n* A decrease in HbA1C levels.\n* A decrease in Hypoglycemia events.\n* A decrease in DKA events.\n* A decrease in patients' visits in ER and hospitalizations.\n* An improvement in the knowledge of the patients and their families about the disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 DM diagnosis from at least 8 months/\n* HbA1C levels \\>8\n* Signed inform consent.\n\nExclusion Criteria:\n\n\\- Children who are not in educational settings and are not hebrew or arabic speakers.'}, 'identificationModule': {'nctId': 'NCT01382459', 'briefTitle': 'Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes', 'orgStudyIdInfo': {'id': 'sor517111ctil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 1 DM children- intervention group', 'description': 'will have home visits and trainings at school'}, {'label': 'type 1 DM children- control group', 'description': 'will receive the standard care at the clinic'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'Eli Hershkovitz, PI', 'role': 'CONTACT', 'email': 'elih@bgu.ac.il', 'phone': '972-522629025'}], 'facility': 'Soroka medical center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Eli Hershkovitz, PI', 'role': 'CONTACT', 'email': 'elih@bgu.ac.il', 'phone': '972- 522629025'}, {'name': 'Addi Maabari, S.C', 'role': 'CONTACT', 'email': 'adimaa@clalit.org.il', 'phone': '972-547280902'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clalit Health Services', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Eli Hershkovitz', 'oldOrganization': 'Pediatric endocrinology and diabetes unit'}}}}