Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 7:14 PM
Study NCT ID:
NCT04668612
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized open-label single-center crossover clinical study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-13', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.', 'timeFrame': '14 days', 'description': 'To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.'}], 'secondaryOutcomes': [{'measure': 'Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.', 'timeFrame': '14 days', 'description': 'Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\\<3,9 mmol/L)'}, {'measure': 'Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus', 'timeFrame': '14 days', 'description': 'Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\\>10.0 mmol/L)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.', 'detailedDescription': 'Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.\n\nPrimary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.\n\nTrial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.\n\nTrial population A total of 30 subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.\n2. Insulin pump and CGM initiated at least 3 months prior to the recruitment.\n3. Estimated HbA1c based on the 14-days CGM report above 8.5%.\n4. Daily insulin dose of more than 0.5 international units per kilogram.\n\nExclusion Criteria:\n\n1. Subjects with known diabetes complications.\n2. Elevated tissue transglutaminase IgA antibodies in the last two years.\n3. Children who developed an acute viral infections during the week preceding the recruitment.\n\nExclusion criteria after the Run-in period\n\n1. Basal insulin proportion \\> 55% of daily insulin dose.\n2. Children with any symptoms of an infectious disease or acutely sick during the last two weeks.\n3. Estimated HbA1c \\> 8.5% based on the 14-days CGM report."}, 'identificationModule': {'nctId': 'NCT04668612', 'briefTitle': 'Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-bolus', 'description': 'Standard boluses for all meal', 'interventionNames': ['Device: Standard bolus']}, {'type': 'EXPERIMENTAL', 'label': 'Dual-bolus', 'description': 'Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m', 'interventionNames': ['Device: Dual-bolus']}], 'interventions': [{'name': 'Dual-bolus', 'type': 'DEVICE', 'description': 'Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.', 'armGroupLabels': ['Dual-bolus']}, {'name': 'Standard bolus', 'type': 'DEVICE', 'description': 'Standard boluses for all meals', 'armGroupLabels': ['Standard-bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Estonian Research Council', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pediatric endocrinologist, MD, PhD', 'investigatorFullName': 'Aleksandr Peet', 'investigatorAffiliation': 'Tartu University Hospital'}}}}