Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03697369
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical difficulties differences', 'timeFrame': '2 years from patient first enrollment', 'description': 'All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion'}, {'measure': 'Quality Of Life (QOL)', 'timeFrame': '2 years from patient first enrollment', 'description': 'QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately \\[14\\]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.'}, {'measure': 'Skin reactions differences', 'timeFrame': '2 years from patient first enrollment', 'description': 'skin assessment at the pump insertion site (itching and redness).'}, {'measure': 'Discontinuation rate differences', 'timeFrame': '2 years from patient first enrollment', 'description': 'Comparison between constant pump users and those who discontinued'}], 'secondaryOutcomes': [{'measure': 'Glycemic control and metabolic parameters differences: Insulin TDD', 'timeFrame': '2 years from patient first enrollment', 'description': 'The difference in glycemic control parameters and metabolic parameters after 3, 6 and 12 months of follow up, between the pumps devices. Insulin TDD, as reported by pump printout data'}, {'measure': 'Glycemic control and metabolic parameters differences: HbA1c%', 'timeFrame': '2 years from patient first enrollment', 'description': 'The difference in HbA1c% as measured by each center ll local lab.'}, {'measure': 'Glycemic control and metabolic parameters differences:Glucose Mean & SD', 'timeFrame': '2 years from patient first enrollment', 'description': 'Glucose Mean \\& SD as recorded by SMBG'}, {'measure': 'Glycemic control and metabolic parameters differences:Number of SMBG per day', 'timeFrame': '2 years from patient first enrollment', 'description': 'Data derived from data recorded by SMBG'}, {'measure': 'Glycemic control and metabolic parameters differences:BMI SDS', 'timeFrame': '2 years from patient first enrollment', 'description': 'according to Center for Disease Control (CDC) growth charts scale'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T1DM']}, 'descriptionModule': {'briefSummary': 'Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.\n\nObjective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .\n\nMethods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes Center).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T1D recorded by a pediatric endocrinologist\n* Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.\n\nExclusion Criteria:\n\n• No restrictions on HbA1c value at study recruitment or on use of CGMS -'}, 'identificationModule': {'nctId': 'NCT03697369', 'briefTitle': 'Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps', 'orgStudyIdInfo': {'id': '0073-15-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation group', 'description': 'Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Maccabi Healthcare Services, Israel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}