Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT03505268
Status:
UNKNOWN
Last Update Posted:
2018-04-23
First Post:
2017-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents 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': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-05-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes', 'timeFrame': '6 months', 'description': 'The glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycosylated hemoglobin A1c (HbA1c), Telemedicine'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23340893', 'type': 'RESULT', 'citation': 'Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.'}, {'pmid': '18779236', 'type': 'RESULT', 'citation': "Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8."}, {'pmid': '20648399', 'type': 'RESULT', 'citation': "Tonella P, Fluck CE, Mullis PE. Metabolic control of type 1 diabetic patients followed at the University Children's Hospital in Berne: have we reached the goal? Swiss Med Wkly. 2010 Jul 16;140:w13057. doi: 10.4414/smw.2010.13057. eCollection 2010."}, {'pmid': '19643436', 'type': 'RESULT', 'citation': 'Jean AM, Hassoun A, Hughes J, Pomeranz C, Fennoy I, McMahon DJ, Oberfield SE. Utility of early insulin response and proinsulin to assess insulin resistance. J Pediatr. 2009 Dec;155(6):893-9. doi: 10.1016/j.jpeds.2009.06.002. Epub 2009 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of telemedicine intervention program upon glycemic control in type 1 diabetes mellitus children and their parents in Israel. Half of the participants will receive the telemedicine intervention for a period of six months while the other half will receive the regular treatment then vice versa. Each group will receive in the intervention period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse.\n\nThe investigators hypothesized that the participants that are recieving the telemedicine intervention will have a better glycemic control after 6 months.', 'detailedDescription': 'The prevalence of type 1 diabetes has been steadily increasing for the past few decades and is a relatively common chronic disease of childhood (1). Managing type 1 diabetes in young children presents unique challenges to the patient, parents, and to the pediatric health care provider. The diabetes regimen includes intensive blood glucose monitoring, multiple daily injections of insulin ,and frequent insulin dose adjustments according to the amount of carbohydrate eaten, blood sugar, and physical activity. The Diabetes Control and Complications Trail (DCCT) showed a significant link between blood glucose control and a slower onset and progression of diabetes complications, with improved glycemic control decreasing the risk of micro- and macro- vascular complication (2,3,4).\n\nGlycosylated hemoglobin A1c (HbA1c) measures the\n\nIn the past decade a significant progress took place in therapy and treatment of diabetes. However poor glycemic control is recorded in a significant proportion of adolescents.\n\nTelehealthcare is the use of telecommunications to deliver healthcare services and involves the remote interaction between a primary care provider and specialist. Telemedicine represents a useful and cost-effective solution to the strict follow-up required in diabetes management ,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosed with typ1 1 diabetes for at least 6 months insulin dependent participants provided consent to participate in the study consent to use the Accu-Chek Connect diabetes management app -\n\nExclusion Criteria:\n\nnew onset of diabetes type 1 not specified as type 1 diabetes\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03505268', 'briefTitle': 'The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Hospital Systems'}, 'officialTitle': 'The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2016033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telemedicine intervention', 'description': 'The intervention group, in addition to usual care, will get 10 telemedicine interventions by a certified nurse and dietitian who both specialize in treatment of type 1 diabetes.', 'interventionNames': ['Behavioral: Telemedicine']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'Usual care consisted of visits to the diabetes center every three months and communication with their doctor by phone when needed.'}], 'interventions': [{'name': 'Telemedicine', 'type': 'BEHAVIORAL', 'description': 'Patients of the Intervention Group will have once biweekly telephonic intervention conversation with dietitian, specialized in diabetes and diabetes nurse. The patients of the control group will have a routine care.', 'armGroupLabels': ['telemedicine intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Zohar Landau, MD', 'role': 'CONTACT', 'email': 'landau.zohar@gmail.com', 'phone': '+972544822792'}], 'facility': 'AssutaHA', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Zohar Landau, MD', 'role': 'CONTACT', 'email': 'landau.zohar@gmail.com', 'phone': '+97235028420'}, {'name': 'Neriya Levran, RD', 'role': 'CONTACT', 'email': 'neriyale@gmail.com', 'phone': '+972545432176'}], 'overallOfficials': [{'name': 'Zohar Landau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuta Hospital Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Hospital Systems', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zohar Landau', 'investigatorAffiliation': 'Assuta Hospital Systems'}}}}