Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT03977727
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2019-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'blevins@texasdiabetes.com', 'phone': '512-334-3505', 'title': 'Thomas Blevins, MD', 'phoneExt': '1', 'organization': 'Texas Diabetes & Endocrinology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 20 weeks. The entire duration of the subjects study period.', 'description': 'Adverse event information was collected at all phone or office visits during the trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Fiasp/Novolog', 'description': '7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Novolog/Fiasp', 'description': '7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non Proliferative Diabetic Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of Seasonal Allergic Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness at infusion site (right abdomen)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trivial tricuspid regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trivial mitral regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'First Degree AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent Heart Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuntivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gasteroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herniated Disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Traveler's Diarrhea", 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatial Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritation at Infusion site (abdoment)', 'notes': 'related to infusion site , not insulin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Thumb laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'erythema at infusion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right index finger dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Triangular fibrocartilage band tear (left wrist)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of hypothyroidsm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myalgia (bilateral shoulders0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis (bilateral hands)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Center involved diabetic macular edema (right eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Herniated Disc', 'notes': 'Subject hospitalized for laminectomy to repair herniated disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '1-Hour Change in Postprandial Plasma Glucose (PPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '105.15', 'spread': '56.73', 'groupId': 'OG000'}, {'value': '154.24', 'spread': '54.25', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '99.90', 'spread': '82.70', 'groupId': 'OG000'}, {'value': '114.94', 'spread': '61.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.35', 'ciLowerLimit': '7.88', 'ciUpperLimit': '48.4', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6th week of therapy', 'description': 'Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': '2-Hour Change in Postprandial Plasma Glucose (PPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '72.55', 'spread': '90.62', 'groupId': 'OG000'}, {'value': '65.00', 'spread': '57.22', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '69.10', 'spread': '92.55', 'groupId': 'OG000'}, {'value': '104.53', 'spread': '80.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.22', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '39.46', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6th week of therapy', 'description': 'Change was calculated as the value at 2 hour minus the value at baseline during meal test', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Between Below 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '1.94', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '2.42', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.4', 'ciLowerLimit': '.05', 'ciUpperLimit': '.73', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom continuous glucose monitoring data was available during the specified time periods'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Between 70 mg/dL and 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '74.80', 'spread': '8.08', 'groupId': 'OG000'}, {'value': '73.67', 'spread': '6.80', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '70.28', 'spread': '8.12', 'groupId': 'OG000'}, {'value': '75.04', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.81', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '-0.31', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom continuous glucose monitoring data was available during the specified time periods'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Above 200 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '14.90', 'spread': '6.90', 'groupId': 'OG000'}, {'value': '15.44', 'spread': '5.65', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '18.57', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '14.11', 'spread': '4.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '.04', 'ciUpperLimit': '2.32', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom continuous glucose monitoring data was available during the specified time periods'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '.46', 'spread': '.53', 'groupId': 'OG000'}, {'value': '.40', 'spread': '.48', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '.50', 'spread': '.50', 'groupId': 'OG000'}, {'value': '.35', 'spread': '.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom continuous glucose monitoring data was available during the specified time periods'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom continuous glucose monitoring data was available during the specified time periods'}, {'type': 'SECONDARY', 'title': '1,5 Anhydroglucitol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '6.50', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '6.28', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '6.95', 'spread': '3.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.2', 'ciLowerLimit': '-.59', 'ciUpperLimit': '.16', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 6, Week 13', 'description': '1,5 anhydroglucitol levels were measured on the 6th week of each therapy', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each period'}, {'type': 'SECONDARY', 'title': 'Fructosamine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '322.60', 'spread': '42.24', 'groupId': 'OG000'}, {'value': '296.35', 'spread': '31.10', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '305.40', 'spread': '32.28', 'groupId': 'OG000'}, {'value': '314.31', 'spread': '28.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-10.32', 'ciUpperLimit': '9.99', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 6, Week 13', 'description': 'Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy', 'unitOfMeasure': 'mcmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each period'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '7.09', 'spread': '.47', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '.31', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '7.09', 'spread': '.44', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.06', 'ciLowerLimit': '-.13', 'ciUpperLimit': '0', 'groupDescription': 'Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 6, Week 13', 'description': 'Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy', 'unitOfMeasure': 'HbA1c%', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each period'}, {'type': 'SECONDARY', 'title': 'Insulin Use - Change in Daily Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '7.45', 'groupId': 'OG000'}, {'value': '.29', 'spread': '13.35', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '1.10', 'spread': '11.80', 'groupId': 'OG000'}, {'value': '-2.65', 'spread': '9.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Use - Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '-4.32', 'spread': '7.85', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '1.83', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '5.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period', 'unitOfMeasure': 'percentage of units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Use - Basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '1.54', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '7.85', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '5.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period', 'unitOfMeasure': 'percentage of units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Use - Automatic Basal Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '.87', 'spread': '.307', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '.65', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '.86', 'spread': '.32', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Average amount per day (units) calculated for each participant under each therapy', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Pump - Active Insulin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '3', 'spread': '.06', 'groupId': 'OG000'}, {'value': '3', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '3', 'spread': '0', 'groupId': 'OG000'}, {'value': '3', 'spread': '.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Average time per day (hours) calculated for each participant under each therapy', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Pump - Auto Mode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '89.28', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '89.31', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '86.17', 'spread': '11.43', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 3 through 6, Weeks 10 through 13', 'description': 'Percentage of time spent in auto-mode after calibration under each therapy', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Insulin Pump - Manual Mode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '10.72', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '10.69', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '13.45', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 3 through 6, Weeks 10 through 13', 'description': 'Percentage of time spent in manual-mode after calibration under each therapy', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Change in Carbohydrate Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '-.27', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-.02', 'spread': '.47', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '-.14', 'spread': '.95', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period', 'unitOfMeasure': 'I:CR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Infusion Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 week treatment period', 'description': 'Number of Infusion site reactions reported by patient', 'unitOfMeasure': 'occurances', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}, {'type': 'SECONDARY', 'title': 'Pump Occlusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiasp/Novolog', 'description': 'Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®'}, {'id': 'OG001', 'title': 'Novolog/Fiasp', 'description': 'Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®'}], 'classes': [{'title': 'Fiasp', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'NovoLog', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 week treatment period', 'description': 'Number of Occlusion events reported by patient', 'unitOfMeasure': 'occurances', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who participated in the meal test after 6 weeks of therapy in each arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fiasp/Novolog', 'description': '7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII'}, {'id': 'FG001', 'title': 'Novolog/Fiasp', 'description': '7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII'}], 'periods': [{'title': 'First Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '45 patients were screened for eligibility between June 11,2019 and November 21, 2019 at a diabetes clinic in Austin, TX', 'preAssignmentDetails': '40 of 45 participants were randomized. All 5 who were not randomized did not meet inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fiasp/Novolog', 'description': '7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII'}, {'id': 'BG001', 'title': 'Novolog/Fiasp', 'description': '7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion\n\nFiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\nNovolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system\n\n670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '13.17', 'groupId': 'BG000'}, {'value': '43.8', 'spread': '12.77', 'groupId': 'BG001'}, {'value': '45.7', 'spread': '27.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '3.69', 'groupId': 'BG000'}, {'value': '27.3', 'spread': '3.15', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '3.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.3', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '83.3', 'spread': '12.45', 'groupId': 'BG001'}, {'value': '81.7', 'spread': '13.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '172.3', 'spread': '10.82', 'groupId': 'BG000'}, {'value': '174.6', 'spread': '7.22', 'groupId': 'BG001'}, {'value': '173.4', 'spread': '9.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-16', 'size': 483228, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-31T17:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2019-04-17', 'resultsFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-20', 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-Hour Change in Postprandial Plasma Glucose (PPG)', 'timeFrame': '6th week of therapy', 'description': 'Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test'}], 'secondaryOutcomes': [{'measure': '2-Hour Change in Postprandial Plasma Glucose (PPG)', 'timeFrame': '6th week of therapy', 'description': 'Change was calculated as the value at 2 hour minus the value at baseline during meal test'}, {'measure': 'Percentage of Time Spent Between Below 70 mg/dL', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)'}, {'measure': 'Percentage of Time Spent Between 70 mg/dL and 180 mg/dL', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)'}, {'measure': 'Percentage of Time Spent Above 200 mg/dL', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)'}, {'measure': 'Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)'}, {'measure': 'Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)'}, {'measure': '1,5 Anhydroglucitol Levels', 'timeFrame': 'Week 6, Week 13', 'description': '1,5 anhydroglucitol levels were measured on the 6th week of each therapy'}, {'measure': 'Fructosamine Levels', 'timeFrame': 'Week 6, Week 13', 'description': 'Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy'}, {'measure': 'HbA1c', 'timeFrame': 'Week 6, Week 13', 'description': 'Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy'}, {'measure': 'Insulin Use - Change in Daily Dose', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period'}, {'measure': 'Insulin Use - Bolus', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period'}, {'measure': 'Insulin Use - Basal', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period'}, {'measure': 'Insulin Use - Automatic Basal Insulin', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Average amount per day (units) calculated for each participant under each therapy'}, {'measure': 'Insulin Pump - Active Insulin Time', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Average time per day (hours) calculated for each participant under each therapy'}, {'measure': 'Insulin Pump - Auto Mode', 'timeFrame': 'Weeks 3 through 6, Weeks 10 through 13', 'description': 'Percentage of time spent in auto-mode after calibration under each therapy'}, {'measure': 'Insulin Pump - Manual Mode', 'timeFrame': 'Weeks 3 through 6, Weeks 10 through 13', 'description': 'Percentage of time spent in manual-mode after calibration under each therapy'}, {'measure': 'Change in Carbohydrate Ratio', 'timeFrame': 'Weeks 1 through 6, Weeks 8 through 13', 'description': 'Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period'}, {'measure': 'Infusion Site Reactions', 'timeFrame': '14 week treatment period', 'description': 'Number of Infusion site reactions reported by patient'}, {'measure': 'Pump Occlusions', 'timeFrame': '14 week treatment period', 'description': 'Number of Occlusion events reported by patient'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33090016', 'type': 'DERIVED', 'citation': 'Ozer K, Cooper AM, Ahn LP, Waggonner CR, Blevins TC. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021 Apr;23(4):286-292. doi: 10.1089/dia.2020.0500. Epub 2021 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.', 'detailedDescription': "This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.\n\nSubjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n2. Male or female, age ≥18 years at the time of signing informed consent\n3. Documented diagnoses of T1DM ≥1 year prior to the day of screening\n4. Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial.\n5. Ability and willingness to use the same insulin infusion sets throughout the trial\n6. Using the same insulin for at least 30 days prior to screening\n7. HbA1c \\< 8.5% as assessed by local laboratory at screening\n8. BMI ≤ 35.0 kg/m2 at screening\n9. Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to trial products or related products\n2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)\n3. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies\n4. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial\n5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening\n6. Subjects classified as being in New York Heart Association (NYHA) Class IV at screening\n7. Planned coronary, carotid or peripheral artery revascularization known on the day of screening.\n8. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic\n\n ≥180 mmHg or diastolic ≥110 mmHg) at screening\n9. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening\n10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \\< 45 ml/min/1.73 m2\n11. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator\n12. Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening\n13. History of hospitalization for ketoacidosis ≤180 days prior to the day of screening\n14. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening\n15. Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.\n16. Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion\n17. Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol\n\n \\-"}, 'identificationModule': {'nctId': 'NCT03977727', 'briefTitle': 'FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump', 'organization': {'class': 'OTHER', 'fullName': 'Texas Diabetes & Endocrinology, P.A.'}, 'officialTitle': 'An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'U1111-1213-9104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiasp/Novolog', 'description': '7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion', 'interventionNames': ['Drug: Fiasp®', 'Drug: Novolog®', 'Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system']}, {'type': 'EXPERIMENTAL', 'label': 'Novolog/Fiasp', 'description': '7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion', 'interventionNames': ['Drug: Fiasp®', 'Drug: Novolog®', 'Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system']}], 'interventions': [{'name': 'Fiasp®', 'type': 'DRUG', 'description': 'Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system', 'armGroupLabels': ['Fiasp/Novolog', 'Novolog/Fiasp']}, {'name': 'Novolog®', 'type': 'DRUG', 'otherNames': ['Aspart'], 'description': 'Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system', 'armGroupLabels': ['Fiasp/Novolog', 'Novolog/Fiasp']}, {'name': '670G hybrid closed loop continuous subcutaneous insulin infusion system', 'type': 'DEVICE', 'otherNames': ['Medtronic 670G pump'], 'description': 'CSII', 'armGroupLabels': ['Fiasp/Novolog', 'Novolog/Fiasp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes & Endocrinology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Thomas Blevins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Diabetes & Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Diabetes & Endocrinology, P.A.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Thomas C. Blevins, M.D.', 'investigatorAffiliation': 'Texas Diabetes & Endocrinology, P.A.'}}}}