Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT03557892
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D036501', 'term': 'Metered Dose Inhalers'}], 'ancestors': [{'id': 'D009330', 'term': 'Nebulizers and Vaporizers'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ilaria.dicembrini@unifi.it', 'phone': '+393387861041', 'title': 'Dr Ilaria Dicembrini', 'organization': 'University of Florence Medical School and AOU Careggi'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months for each treatment arm', 'eventGroups': [{'id': 'EG000', 'title': 'CSII+CGM', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MDI With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Local skin reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSII+CGM', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM'}, {'id': 'OG001', 'title': 'MDI With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSII+CGM', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM'}, {'id': 'OG001', 'title': 'MDI With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSII+CGM', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM'}, {'id': 'OG001', 'title': 'MDI With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of participants with local reactions at infusion/glucose monitoring site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Subcutaneous Insulin Infusion+Continuous Glucose Monitoring (CSII+CGM)', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM'}, {'id': 'FG001', 'title': 'Multiple Daily Injections Regimen (MDI) With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSII+CGM', 'description': 'CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM'}, {'id': 'BG001', 'title': 'MDI With Degludec', 'description': 'MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '71'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '72'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'HbA1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'spread': '4', 'groupId': 'BG000'}, {'value': '62', 'spread': '5', 'groupId': 'BG001'}, {'value': '61', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-21', 'size': 77163, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-19T03:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2018-06-05', 'resultsFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-19', 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '4 months', 'description': 'Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)'}], 'secondaryOutcomes': [{'measure': 'Severe Hypoglycemia', 'timeFrame': '4 months', 'description': 'Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase'}, {'measure': 'Local Reactions', 'timeFrame': '4 months', 'description': 'Number of participants with local reactions at infusion/glucose monitoring site'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec.\n\nThis study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Duration of diabetes \\> 2 years\n* Current treatment with MDI, using insulin analogues as bolus and basal insulin\n* HbA1c\\<64 mmol/mol\n\nExclusion Criteria:\n\n* HbA1c\\>64 mmol/mol\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03557892', 'briefTitle': 'Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'T1DM001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSII+CGM', 'interventionNames': ['Device: CGM+CSII']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MDI with degludec', 'interventionNames': ['Device: MDI with degludec']}], 'interventions': [{'name': 'CGM+CSII', 'type': 'DEVICE', 'description': 'Animas Vibe Platinum insulin pump and Dexcom G4 CGM', 'armGroupLabels': ['CSII+CGM']}, {'name': 'MDI with degludec', 'type': 'DEVICE', 'description': 'Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin', 'armGroupLabels': ['MDI with degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Diabetologia AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Diabetology', 'investigatorFullName': 'Edoardo Mannucci', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}