Viewing Study NCT04235504

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Ignite Creation Date: 2025-12-24 @ 7:50 PM
Ignite Modification Date: 2025-12-31 @ 9:09 AM
Study NCT ID: NCT04235504
Status: COMPLETED
Last Update Posted: 2023-03-27
First Post: 2020-01-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javier.castaneda@medtronic.com', 'phone': '+31 433566566', 'title': 'Javier Castaneda', 'organization': 'Medtronic Diabetes'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A Run-in Phase', 'description': 'Subjects were using MDI with Flash Glucose Monitoring (FGM).', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 21, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort B Run-in Phase', 'description': 'Subjects were using MDI + Real-Time CGM.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort A - Treatment Arm Study Phase', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 19, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort A - Control Arm Study Phase', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 18, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Cohort B - Treatment Arm Study Phase', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort B - Control Arm Study Phase', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'All Patients Continuation Phase', 'description': 'All subjects were using AHCL in continuation phase.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 31, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Abnormal weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Catheter site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Catheter site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Choking sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 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'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c 6 Months Change Between AHCL and MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.54', 'spread': '0.729', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.797', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-1.74', 'ciUpperLimit': '-1.10', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of 6-month study phase', 'description': 'The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 82 subjects in Cohort A. 74 subjects have available measurements.'}, {'type': 'SECONDARY', 'title': 'TIR Between 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.63', 'spread': '9.700', 'groupId': 'OG000'}, {'value': '43.59', 'spread': '15.369', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.59', 'ciLowerLimit': '21.59', 'ciUpperLimit': '33.60', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': '% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.'}, {'type': 'SECONDARY', 'title': 'Time in Hyperglycemic Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.74', 'spread': '10.444', 'groupId': 'OG000'}, {'value': '53.81', 'spread': '16.465', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.86', 'ciLowerLimit': '-34.16', 'ciUpperLimit': '-21.55', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': '% Time spent in hyperglycemic range with SG \\> 180 mg/dL (\\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '1.322', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.436', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.61', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': 'Number of biochemical hypoglycemic events\\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \\< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)', 'unitOfMeasure': 'Events per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 6 Months Change Between AHCL and MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.70', 'spread': '1.039', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '1.259', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '0.00', 'pValueComment': 'Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of 6-month study phase', 'description': 'The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 13 subjects in Cohort B. 12 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'TIR Between 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.63', 'spread': '13.749', 'groupId': 'OG000'}, {'value': '46.41', 'spread': '12.547', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.81', 'ciLowerLimit': '12.34', 'ciUpperLimit': '45.28', 'pValueComment': 'Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': '% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time in Hyperglycemic Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.97', 'spread': '13.512', 'groupId': 'OG000'}, {'value': '50.88', 'spread': '15.630', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.45', 'ciLowerLimit': '-45.27', 'ciUpperLimit': '-11.64', 'pValueComment': 'Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': '% Time spent in hyperglycemic range with SG \\> 180 mg/dL (\\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '1.327', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.135', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.59', 'pValueComment': 'Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months study phase', 'description': 'Number of biochemical hypoglycemic events\\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \\< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).', 'unitOfMeasure': 'Events per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 6 Months Change Within Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.491', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A)', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Continuation phase: 36 subjects in Cohort A Treatment Arm. 33 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 6 Months Change Within Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.777', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A)', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Continuation phase: 38 subjects in Cohort A Control Arm. 31 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 12 Months Change Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.829', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.828', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through the end of 6-month continuation phase (a total of 12 months)', 'description': 'The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort A)', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall study: 82 subjects in Cohort A. 66 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 6 Months Change Within Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.466', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Continuation phase: 8 subjects in Cohort B Treatment Arm. 5 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 6 Months Change Within Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.551', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Continuation phase: 5 subjects in Cohort B Control Arm. 3 subjects have available measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c 12 Months Change Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'OG001', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.122', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '0.529', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through the end of 6-month continuation phase (a total of 12 months).', 'description': 'The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort B).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall study: 13 subjects in Cohort B. 9 subjects have available measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'FG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}, {'id': 'FG002', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'FG003', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}], 'periods': [{'title': 'Study Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects entering the study phase (randomized)', 'groupId': 'FG000', 'numSubjects': '41'}, {'comment': 'Subjects entering the study phase (randomized)', 'groupId': 'FG001', 'numSubjects': '41'}, {'comment': 'Subjects entering the study phase (randomized)', 'groupId': 'FG002', 'numSubjects': '8'}, {'comment': 'Subjects entering the study phase (randomized)', 'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Continuation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': 'One subject in cohort A control arm withdrew at day of completion of study phase', 'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Date of first subject enrollment: 13-JUL-2020, Date of last subject visit (of study phase): 02-DEC-2021 Date of last subject visit (of continuation phase): 30-MAY-2022', 'preAssignmentDetails': '122 adults with type 1 diabetes consented to participate in the study. Of them, 19 subjects are Screen Failure. After 8 patients early exited before randomization, 95 (82 in Cohort A, 13 in Cohort B) subjects were randomized in study phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A - Treatment Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'BG001', 'title': 'Cohort A - Control Arm', 'description': 'In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.\n\nIn continuation phase, subjects started using AHCL.'}, {'id': 'BG002', 'title': 'Cohort B - Treatment Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).\n\nIn continuation phase, subjects continued using AHCL.'}, {'id': 'BG003', 'title': 'Cohort B - Control Arm', 'description': 'In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.\n\nIn continuation phase, subjects started using AHCL.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '41.5', 'spread': '11.63', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '13.12', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '13.32', 'groupId': 'BG002'}, {'value': '36.2', 'spread': '15.80', 'groupId': 'BG003'}, {'value': '40.7', 'spread': '12.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'HbA1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.00', 'spread': '0.972', 'groupId': 'BG000'}, {'value': '9.07', 'spread': '0.716', 'groupId': 'BG001'}, {'value': '8.90', 'spread': '0.457', 'groupId': 'BG002'}, {'value': '9.46', 'spread': '0.611', 'groupId': 'BG003'}, {'value': '9.05', 'spread': '0.815', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All Subjects Randomized to Corresponding Group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-17', 'size': 2359459, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-30T18:34', 'hasProtocol': True}, {'date': '2021-06-08', 'size': 673143, 'label': 'Statistical Analysis Plan: Study Phase', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-30T18:27', 'hasProtocol': False}, {'date': '2022-05-17', 'size': 597777, 'label': 'Statistical Analysis Plan: Continuation Phase', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-19T12:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be 2 Cohort for this study:\n\n1. Cohort A: Subjects on MDI + FGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ FGM)\n2. Cohort B: Subjects on MDI + Real-Time CGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ CGM) (exploratory analysis)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2020-01-16', 'resultsFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-06', 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HbA1c 6 Months Change Between AHCL and MDI', 'timeFrame': 'Baseline and end of 6-month study phase', 'description': 'The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).'}, {'measure': 'TIR Between 70-180 mg/dL', 'timeFrame': '6 months study phase', 'description': '% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).'}, {'measure': 'Time in Hyperglycemic Range', 'timeFrame': '6 months study phase', 'description': '% Time spent in hyperglycemic range with SG \\> 180 mg/dL (\\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).'}, {'measure': 'Hypoglycemic Events', 'timeFrame': '6 months study phase', 'description': 'Number of biochemical hypoglycemic events\\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \\< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).'}, {'measure': 'HbA1c 6 Months Change Within Group', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A)'}, {'measure': 'HbA1c 12 Months Change Between Groups', 'timeFrame': 'Baseline through the end of 6-month continuation phase (a total of 12 months)', 'description': 'The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort A)'}, {'measure': 'HbA1c 6 Months Change Within Group', 'timeFrame': 'End of 6-month study phase and end of 6-month continuation phase', 'description': 'The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B).'}, {'measure': 'HbA1c 12 Months Change Between Groups', 'timeFrame': 'Baseline through the end of 6-month continuation phase (a total of 12 months).', 'description': 'The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort B).'}], 'primaryOutcomes': [{'measure': 'HbA1c 6 Months Change Between AHCL and MDI', 'timeFrame': 'Baseline and end of 6-month study phase', 'description': 'The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).'}], 'secondaryOutcomes': [{'measure': 'TIR Between 70-180 mg/dL', 'timeFrame': '6 months study phase', 'description': '% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).'}, {'measure': 'Time in Hyperglycemic Range', 'timeFrame': '6 months study phase', 'description': '% Time spent in hyperglycemic range with SG \\> 180 mg/dL (\\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).'}, {'measure': 'Hypoglycemic Events', 'timeFrame': '6 months study phase', 'description': 'Number of biochemical hypoglycemic events\\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \\< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Advanced Hybrid Closed Loop', 'Multiple Daily Injections', 'Flash Glucose Monitoring', 'Continuous Glucose Monitoring'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37801658', 'type': 'DERIVED', 'citation': 'Jendle J, Buompensiere MI, Ozdemir Saltik AZ, de Portu S, Smith-Palmer J, Pollock RF, Cohen O. A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2023 Dec;25(12):864-876. doi: 10.1089/dia.2023.0297.'}, {'pmid': '37551542', 'type': 'DERIVED', 'citation': 'Edd SN, Castaneda J, Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, Cellot J, de Portu S, Vorrink L, Shin J, van den Heuvel T, Cohen O; ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2023 Nov;25(11):3212-3222. doi: 10.1111/dom.15217. Epub 2023 Aug 8.'}, {'pmid': '36058207', 'type': 'DERIVED', 'citation': 'Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1.'}, {'pmid': '35110310', 'type': 'DERIVED', 'citation': 'de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.', 'detailedDescription': 'This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period:\n\n1. Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks.\n2. Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm.\n3. Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system.\n\nApproximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is age ≥ 18 years old at time of screening\n2. Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation\n3. On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening\n4. Subject has been followed and treated by the investigator at this investigational site for at least 3 months prior to screening and subject has already undergone local educational therapeutic programs.\n5. Subject is using:\n\n * Flash Glucose Monitoring (FGM) for ≥ 3 months with a daily average number of scans ≥ 5 over and with sensor readings \\> 70% of time over the previous month prior to screening (based on sensor usage from the download summary report of the FGM system over 30 days prior to screening) Or\n * Continuous Glucose Monitoring (CGM) for ≥ 3 months with a frequency of sensor use ≥ 70% of the time over the previous month prior to screening (based on download summary report from the CGM system over 30 days prior to screening).\n6. Subject has a glycosylated hemoglobin (HbA1c) ≥ 8.0% (64 mmol/mol) at time of screening visit (as processed by a Central Lab).\n7. Subject is willing to take or switch to one of the following insulins:\n\n 1. Humalog™ (insulin lispro injection)\n 2. NovoLog™ (insulin aspart)\n8. Subject must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 8 units and a maximum of 250 units.\n9. Subject is willing to upload data from the study pump and meter, must have Internet access and a compatible computer system that meets the requirements for uploading the study pump data at home.\n10. Subject is willing and able to sign and date informed consent, comply with all study procedures and wear all study devices, as required during the study.\n\nExclusion Criteria:\n\n1. Subject has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.\n2. Subject is using pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors at time of screening.\n3. Subject has had renal failure defined by creatinine clearance \\<30 ml/min, as assessed by local lab test ≤ 12 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.\n4. Subject is planning to switch from FGM to CGM therapy during the 6 months study phase. Note: Subject randomized to Control Arm should remain on their current FGM or CGM therapy during the study phase and will be switched to AHCL during the continuation phase.\n5. Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.\n6. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.\n7. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study, per investigator judgment.\n8. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n9. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.\n10. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.\n11. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.\n12. Subject is legally incompetent, illiterate or vulnerable person.\n13. Research staff involved with the study."}, 'identificationModule': {'nctId': 'NCT04235504', 'acronym': 'ADAPT', 'briefTitle': 'ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Diabetes'}, 'officialTitle': 'ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'CIP327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': "The Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0", 'interventionNames': ['Other: MDI', 'Device: AHCL']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'The Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase.', 'interventionNames': ['Device: AHCL']}], 'interventions': [{'name': 'MDI', 'type': 'OTHER', 'description': 'Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM', 'armGroupLabels': ['Control Arm']}, {'name': 'AHCL', 'type': 'DEVICE', 'description': 'Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.\n\nStarting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.', 'armGroupLabels': ['Control Arm', 'Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux - Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon (DIAB-e CARE)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'APM - Hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Hospital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Bergheim', 'country': 'Germany', 'facility': 'Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa', 'geoPoint': {'lat': 50.95572, 'lon': 6.63986}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Zentrum für Diabetologie Bergedorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Lage', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis', 'geoPoint': {'lat': 51.99223, 'lon': 8.79301}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Medical Center am Clemenshospital Dr. Winfried Keuthage', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Harrogate', 'country': 'United Kingdom', 'facility': 'Harrogate and District Hospital - NHS Foundation Trust', 'geoPoint': {'lat': 53.99078, 'lon': -1.5373}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Diabetes', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}