Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05224258
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Poland', 'Sweden']}, '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': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.troub@medtronic.com', 'phone': '8052089091', 'title': 'Thomas Troub, Sr Clinical Research Program Manager', 'organization': 'Medtronic Diabetes'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3-month Study Period', 'description': 'Only Adverse Events during the study period were posted', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects 7-17 Years of Age Study Period', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 26, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subjects 18-80 Years of Age Study Period', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 30, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Infusion site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Infusion site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Allergy to vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Infusion site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Medical device site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Acetonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint - Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'OG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean difference from baseline to exit', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.1', 'estimateComment': 'This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Mean difference from baseline to exit', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '-0.2', 'estimateComment': 'This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Population with available data. Three subjects aged 7-17 and two subjects aged 18-80 did not collect A1C at the end of the study period, so 104 subjects aged 7-17 and 114 subjects aged 18-80 were analyzed at end of study period and the change from baseline to end of study period.'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'OG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.7', 'ciLowerLimit': '63.5', 'ciUpperLimit': '67.9', 'estimateComment': 'This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.1', 'ciLowerLimit': '75.4', 'ciUpperLimit': '78.9', 'estimateComment': 'This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Last 6-7 weeks of 3-month study period', 'description': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]). Non-inferiority test.', 'unitOfMeasure': 'Percentage of Time in Range (TIR 70-180)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.'}, {'type': 'SECONDARY', 'title': 'Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'OG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.4', 'estimateComment': 'This is one arm study, the Percent of Time in Hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The mean % of time in hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.4', 'estimateComment': 'This is one arm study, the Percent of Time in Hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The mean % of time in hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Last 6-7 weeks of 3 month study period', 'description': 'The mean % of time in hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]). Non-inferiority test.', 'unitOfMeasure': 'Percentage of Time in Hypoglycemia (< 54', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.'}, {'type': 'SECONDARY', 'title': 'Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'OG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.208', 'groupIds': ['OG000'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.7', 'ciLowerLimit': '63.5', 'ciUpperLimit': '67.9', 'estimateComment': 'This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Mean of Final Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.1', 'ciLowerLimit': '75.4', 'ciUpperLimit': '78.9', 'estimateComment': 'This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Last 6-7 weeks of 3 month study period', 'description': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]).Superiority test.', 'unitOfMeasure': 'Percentage of Time in Range (TIR 70-180)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'FG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Product No Longer in Use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '240 subjects (115 with age 7-17 and 125 with age 18-80) enrolled at the beginning, with 14 (5 with age 7-17 and 9 with age 18-80) screen failure, 3 subjects with age 7-17 early withdrawn prior the study period, 223 subjects (107 with age 7-17 and 116 with age 18-80) started the study and became the Intention to Treat Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects 7-17 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'BG001', 'title': 'Subjects 18-80 Years of Age', 'description': 'Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.\n\nMiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '31.9', 'spread': '20.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '26.4', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention to Treat Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-07', 'size': 2011180, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-04T16:03', 'hasProtocol': True}, {'date': '2024-06-17', 'size': 727443, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-04T16:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2022-01-24', 'resultsFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint - Change in HbA1c', 'timeFrame': '3 months', 'description': 'The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.'}, {'measure': 'Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])', 'timeFrame': 'Last 6-7 weeks of 3-month study period', 'description': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]). Non-inferiority test.'}], 'secondaryOutcomes': [{'measure': 'Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])', 'timeFrame': 'Last 6-7 weeks of 3 month study period', 'description': 'The mean % of time in hypoglycemia (\\< 54 mg/dL \\[3.0 mmol/L\\]). Non-inferiority test.'}, {'measure': 'Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])', 'timeFrame': 'Last 6-7 weeks of 3 month study period', 'description': 'The mean % of time in range (TIR 70-180 mg/dL \\[3.9 -10.0 mmol/L\\]).Superiority test.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.', 'detailedDescription': 'This global study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using Fiasp insulin as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.\n\nA total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n1. Age 7 - 80 years at time of screening.\n2. Has a clinical diagnosis of type 1 diabetes:\n\n 1. 14 - 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.\n 2. 7 - 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.\n3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.\n4. Subject or parent/caregiver is literate and able to read one of the languages offered in the pump.\n5. Subject and/or legally authorized representative is willing to provide informed consent for participation.\n6. Is willing to perform fingerstick blood glucose measurements as needed.\n7. Is willing to wear the system continuously throughout the study.\n8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and maximum total daily dose of 250 units or less.\n9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.\n\n Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.\n10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.\n11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience)\n12. Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.\n13. Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations as required during the run-in period:\n\n 1. Humalog (insulin lispro injection)\n 2. NovoLog/NovoRapid (insulin aspart injection)\n14. Is willing to take Fiasp insulin during the study period (supplied via Sponsor).\n\nEXCLUSION CRITERIA:\n\n1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp.\n2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:\n\n 1. Medical assistance (i.e., Paramedics, Emergency Room \\[ER\\] or Hospitalization)\n 2. Coma\n 3. Seizures\n3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.\n4. Has had DKA in the last 6 months prior to screening visit.\n5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.\n6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n7. Is female of child-bearing potential and result of pregnancy test is positive at screening.\n8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.\n9. Is female and plans to become pregnant during the course of the study.\n10. Is being treated for hyperthyroidism at time of screening.\n11. Has diagnosis of adrenal insufficiency.\n12. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.\n13. Is using hydroxyurea at time of screening or plans to use it during the study.\n14. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.\n15. Is currently abusing illicit drugs.\n16. Is currently abusing marijuana.\n17. Is currently abusing prescription drugs.\n18. Is currently abusing alcohol.\n19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.\n20. Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.\n21. Has elective surgery planned that requires general anesthesia during the course of the study.\n22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.\n23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.\n24. Is diagnosed with current eating disorder such as anorexia or bulimia.\n25. Has been diagnosed with chronic kidney disease that results in chronic anemia.\n26. Has a hematocrit that is below the normal reference range of lab used.\n27. Is on dialysis.\n28. Has serum creatinine of \\>2 mg/dL.\n29. Has celiac disease that is not adequately treated as determined by the investigator.\n30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.\n31. Has had history of cardiovascular event 1 year or more from the time of screening without\n\n 1. a normal EKG and stress test within 6 months prior to screening or during screening or\n 2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.\n32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:\n\n * Age \\>35 years\n * Type 1 diabetes of \\>15 years' duration\n * Presence of any additional risk factor for coronary artery disease\n * Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)\n * Presence of peripheral vascular disease\n * Presence of autonomic neuropathy\n33. Is a member of the research staff involved with the study.\n34. Has used a MiniMed 780G pump prior to screening."}, 'identificationModule': {'nctId': 'NCT05224258', 'briefTitle': 'Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Diabetes'}, 'officialTitle': 'Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)', 'orgStudyIdInfo': {'id': 'CIP336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MiniMed 780G System Utilizing Insulin Fiasp', 'description': 'Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.', 'interventionNames': ['Device: MiniMed 780G System']}], 'interventions': [{'name': 'MiniMed 780G System', 'type': 'DEVICE', 'description': '780G System used with Insulin Fiasp® (Insulin Aspart Injection)', 'armGroupLabels': ['MiniMed 780G System Utilizing Insulin Fiasp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Medical Investigations, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Institute for Medical Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady's Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endocrine Research Solutions', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Barry J Reiner MD, LLC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'The Docs, LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Physicians East', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes and Glandular Disease Clinic, P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Institute for Research & Innovation', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '2305', 'city': 'New Lambton', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'John Hunter Childrens Hospital', 'geoPoint': {'lat': -32.92838, 'lon': 151.7085}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital Research Institute", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Clinical Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'David Liljenquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Clinical Research'}, {'name': 'Mark Warren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physicians East'}, {'name': 'John Reed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrine Research Solutions'}, {'name': 'Frances Broyles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rainier Clinical Research Center'}, {'name': 'Dorothy Shulman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}, {'name': 'Bruce Bode, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Diabetes Associates'}, {'name': 'Halis Akturk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Paul Norwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Valley Research'}, {'name': 'Carla Demeterco-Berggren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Rady's Children's Hospital"}, {'name': 'Alexander Abitbol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMC Clinical Research'}, {'name': 'Daniele Pacaud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Alberta Children's Hospital Research Institute"}, {'name': 'James Thrasher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Investigations, Inc.'}, {'name': 'Bhuvana Sunil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MultiCare Institute for Research & Innovation'}, {'name': 'Mark Kipnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes and Glandular Disease Clinic, P.A.'}, {'name': 'Asheesh Dewan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Docs LLC'}, {'name': 'Barry Reiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barry J Reiner MD LLC'}, {'name': 'Gnanagurudasan Prakasam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sutter Institute for Medical Research'}, {'name': 'Bruce King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'John Hunter Childrens Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Diabetes', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}