Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT03478969
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2018-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
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': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up until a maximum of 40 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Accu-Chek® Solo (Parallel Phase)', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 44, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Group B: MDI (Parallel Phase)', 'description': 'Multiple daily injections (MDI) for 26 weeks.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 35, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group C: Mylife™ OmniPod® (Parallel Phase)', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 35, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Group D: Groups A+B+C (Solo Phase)', 'description': 'From Week 26 until Week 39, all Groups (A, B and C) used the Accu-Chek® Solo Micropump system for CSII therapy.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 82, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diabetic ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 743, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 653, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 183, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 838, 'numAffected': 49}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic Ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.9', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '94.8', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': "The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.'}, {'type': 'PRIMARY', 'title': 'Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.1', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '108.7', 'spread': '2.85', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': "The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.'}, {'type': 'SECONDARY', 'title': 'Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '7.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '6.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26 up to Week 39', 'description': 'The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms.'}, {'type': 'SECONDARY', 'title': 'Device Satisfaction and Treatment Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Screening (Blood Glucose Meter)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '35.7', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Blood Glucose Meter)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '34.9', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Blood Glucose Meter)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '34.9', 'spread': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Blood Glucose Meter)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '34.8', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Insulin Pump)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Insulin Pump)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '5.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Insulin Pump)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '31.0', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'HbA1c at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c after 13 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c after 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'HbA1c after 39 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Therapy Success Indicated by Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '25.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '25.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '25.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m\\^2. Change in BMI from Baseline to Week 39.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Therapy Success Indicated by Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '81.7', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '83.4', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.6', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '82.3', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '83.8', 'spread': '17.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '82.2', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '84.3', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '81.8', 'spread': '17.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Weight from Baseline to Week 39', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Glycemic Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Baseline to Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.0', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '68.1', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '68.9', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 to Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '77.1', 'spread': '15.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Glycemic Index from Baseline to Week 39', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'HbA1c goals not met', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Participant wish', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Frequent hypoglycemia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Dawn phenomenon', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Glycemic variability', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Shift working', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 39', 'description': 'Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Therapy Parameters Based on Type of Insulin Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Short Acting Insulin: Insulin aspart (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin glulisine (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin lispro (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Regular human insulin (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulatard (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin degludec (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin detemir (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin glargine (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Protaphane (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin aspart (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin glulisine (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin lispro (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin degludec (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Long Acting Insulin: Insulin detemir (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Long Acting Insulin: Insulin glargine (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Short Acting Insulin: Insulin aspart (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin glulisine (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin lispro (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: NovoRapid (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin degludec (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Long Acting Insulin: Insulin detemir (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Long Acting Insulin: Insulin glargine (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Short Acting Insulin: Insulin aspart (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin glulisine (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Short Acting Insulin: Insulin lispro (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin degludec (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin detemir (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Long Acting Insulin: Insulin glargine (Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 39', 'unitOfMeasure': 'U/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Total Daily Insulin Dose at Baseline compared to dose at Week 39', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39', 'unitOfMeasure': 'SMBGs per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Please note that for this Outcome Measure, incomplete SMBG data was collected which meant that data for Weeks 13, 26 and 39 could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': '<54 mg/dL (Baseline to Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': '<54 mg/dL (Week 13 to Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': '<54 mg/dL (Week 26 to Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': '>=54 and <70 mg/dL (Baseline to Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': '>=54 and <70 mg/dL (Week 13 to Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': '>=54 and <70 mg/dL (Week 26 to Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': '<70 mg/dL (Baseline to Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': '<70 mg/dL (Week 13 to Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': '<70 mg/dL (Week 26 to Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges.', 'unitOfMeasure': 'Percentage of Time Spent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': '>180 to <250 mg/dL (Baseline to Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '11.4', 'groupId': 'OG002'}]}]}, {'title': '>180 to <250 mg/dL (Week 13 to Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': '>180 to <250 mg/dL (Week 26 to Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '26.6', 'spread': '10.5', 'groupId': 'OG002'}]}]}, {'title': '>250 mg/dL (Baseline to Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '16.4', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': '>250 mg/dL (Week 13 to Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '15.5', 'groupId': 'OG002'}]}]}, {'title': '>250 mg/dL (Week 26 to Week 39)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '29.2', 'spread': '16.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges.', 'unitOfMeasure': 'Percentage of Time Spent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Consultations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'timeFrame': 'Baseline up to Week 39', 'description': 'Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that this Outcome Measure was not analysed because data was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Pods/Infusion Assemblies Falling Off Prematurely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'timeFrame': 'Baseline up to Week 39', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that this Outcome Measure was not analysed because data was not collected.'}, {'type': 'SECONDARY', 'title': 'Average Time Spent on Infusion Assembly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'timeFrame': 'Baseline up to Week 39', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that this Outcome Measure was not analysed because data was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Skin Reactions (Including Type and Intensity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'classes': [{'title': 'Baseline (Itching) (Minor Intensity)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Itching) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Itching) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Itching) (Minor Intensity)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Itching) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Itching) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Itching) (Minor Intensity)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Itching) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Itching) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Itching) (Minor Intensity)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Itching) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Itching) (Severe Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Redness) (Minor Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Redness) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Redness) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Redness) (Minor Intensity)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Redness) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Redness) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Redness) (Minor Intensity)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Redness) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Redness) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Redness) (Minor Intensity)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Redness) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Redness) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Swelling) (Minor Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Swelling) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Swelling) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Swelling) (Minor Intensity)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Swelling) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Swelling) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Swelling) (Minor Intensity)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Swelling) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Swelling) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Swelling) (Minor Intensity)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Swelling) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Swelling) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Heat) (Minor Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Heat) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Heat) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Heat) (Minor Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Heat) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Heat) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Heat) (Minor Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Heat) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Heat) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Heat) (Minor Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Heat) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Heat) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Pain) (Minor Intensity)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Pain) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Pain) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Pain) (Minor Intensity)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Pain) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 (Pain) (Severe Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Pain) (Minor Intensity)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Pain) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (Pain) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Pain) (Minor Intensity)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Pain) (Moderate Intensity)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 39 (Pain) (Severe Intensity)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 39', 'description': 'Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely "itching", "redness", "swelling", "heat" and "pain". Each of these questions could be answered with one of four alternatives, "None", "Minor", "Moderate" and "Severe".', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set was defined as all eligible participants who were randomized to one of the three treatment arms. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'timeFrame': 'Baseline up to Week 39', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that this Outcome Measure was not analysed because data was not collected.'}, {'type': 'SECONDARY', 'title': 'Amount of Waste, Inferred by Total Material Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'OG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'timeFrame': 'Baseline up to Week 39', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that this Outcome Measure was not analysed because data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'FG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'FG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'Participants at End of Parallel Phase', 'comment': 'Week 26', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'comment': 'Week 39 (End of Solo Phase)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Covid-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Multiple Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 21 centers in 4 countries.', 'preAssignmentDetails': 'A total of 187 participants were screened into this study, of whom 6 participants were screen failures meaning that a total of 181 participants were randomised into this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'BG001', 'title': 'Group B: MDI, Then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'BG002', 'title': 'Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '39.0', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-21', 'size': 1687144, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-13T05:59', 'hasProtocol': True}, {'date': '2020-05-25', 'size': 632812, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-13T05:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2018-03-13', 'resultsFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-22', 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score', 'timeFrame': '26 weeks', 'description': "The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes."}, {'measure': 'Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score', 'timeFrame': '26 weeks', 'description': "The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes."}], 'secondaryOutcomes': [{'measure': 'Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5', 'timeFrame': 'Week 26 up to Week 39', 'description': 'The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress.'}, {'measure': 'Device Satisfaction and Treatment Preference', 'timeFrame': 'Baseline up to Week 39', 'description': 'Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device.'}, {'measure': 'Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39'}, {'measure': 'Therapy Success Indicated by Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline up to Week 39', 'description': 'This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m\\^2. Change in BMI from Baseline to Week 39.'}, {'measure': 'Therapy Success Indicated by Change in Weight', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Weight from Baseline to Week 39'}, {'measure': 'Change in Glycemic Index', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Glycemic Index from Baseline to Week 39'}, {'measure': 'Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)', 'timeFrame': 'Baseline up to Week 39', 'description': 'Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy.'}, {'measure': 'Change in Therapy Parameters Based on Type of Insulin Used', 'timeFrame': 'Baseline up to Week 39'}, {'measure': 'Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)', 'timeFrame': 'Baseline up to Week 39', 'description': 'Total Daily Insulin Dose at Baseline compared to dose at Week 39'}, {'measure': 'Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)', 'timeFrame': 'Baseline up to Week 39', 'description': 'Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39'}, {'measure': 'Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day', 'timeFrame': 'Baseline up to Week 39', 'description': 'Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39'}, {'measure': 'Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges.'}, {'measure': 'Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges', 'timeFrame': 'Baseline up to Week 39', 'description': 'Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges.'}, {'measure': 'Number of Consultations', 'timeFrame': 'Baseline up to Week 39', 'description': 'Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.'}, {'measure': 'Number of Pods/Infusion Assemblies Falling Off Prematurely', 'timeFrame': 'Baseline up to Week 39'}, {'measure': 'Average Time Spent on Infusion Assembly', 'timeFrame': 'Baseline up to Week 39'}, {'measure': 'Number of Participants With Skin Reactions (Including Type and Intensity)', 'timeFrame': 'Baseline up to Week 39', 'description': 'Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely "itching", "redness", "swelling", "heat" and "pain". Each of these questions could be answered with one of four alternatives, "None", "Minor", "Moderate" and "Severe".'}, {'measure': 'Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard', 'timeFrame': 'Baseline up to Week 39'}, {'measure': 'Amount of Waste, Inferred by Total Material Consumption', 'timeFrame': 'Baseline up to Week 39'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '38456441', 'type': 'DERIVED', 'citation': 'Barnard-Kelly K, Thienel F, Mader JK, Oliver N, Franek E, Vesper I, Dagenbach N, Vogt G, Etter T, Kunsting T. A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections. J Diabetes Sci Technol. 2025 Sep;19(5):1310-1316. doi: 10.1177/19322968241234055. Epub 2024 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus\n* At least 6 months experience with MDI therapy\n* Age ≥18 years and age ≤ 65\n* Able to perform carbohydrate counting\n* Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently\n* HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months)\n* Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures\n* Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase\n* Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study\n\nExclusion Criteria:\n\n* Prior insulin pump use\n* Relevantly impaired hypoglycemia awareness\n* History of \\>1 hospitalization due to severe hypoglycemia within the previous 3 months\n* History of \\>1 hospitalization due diabetic ketoacidosis within the last 3 months\n* Significant manifestation of diabetes-related late complications\n* Pregnant or planning to become pregnant or breastfeeding\n* Known allergic reactions to plaster adhesive\n* Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy\n* Serious or unstable chronic medical or psychological condition(s)\n* Addiction to alcohol or other substance(s) of abuse as determined by the investigator\n* Psychological condition rendering the participant unable to understand the nature and the scope of the study\n* Plans for relocation or extensive travel\n* Participation in another clinical study within 4 weeks prior to the screening visit\n* Dependency on Sponsor or Investigator (e.g. co-worker or family member)'}, 'identificationModule': {'nctId': 'NCT03478969', 'acronym': 'PRO Solo', 'briefTitle': 'Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'RD002718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.', 'interventionNames': ['Device: Accu-Chek® Solo micropump system']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: MDI, then Accu-Chek® Solo', 'description': 'Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.', 'interventionNames': ['Device: Accu-Chek® Solo micropump system', 'Other: Multiple Daily Injections (MDI) therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: mylife™ OmniPod®, then Accu-Chek® Solo', 'description': 'Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.', 'interventionNames': ['Device: Accu-Chek® Solo micropump system', 'Device: mylife™ OmniPod® Insulin Management System']}], 'interventions': [{'name': 'Accu-Chek® Solo micropump system', 'type': 'DEVICE', 'description': 'Medical device for subcutaneous delivery of insulin in a personalized way.', 'armGroupLabels': ['Group A: Accu-Chek® Solo', 'Group B: MDI, then Accu-Chek® Solo', 'Group C: mylife™ OmniPod®, then Accu-Chek® Solo']}, {'name': 'mylife™ OmniPod® Insulin Management System', 'type': 'DEVICE', 'description': 'A patch pump system delivering insulin.', 'armGroupLabels': ['Group C: mylife™ OmniPod®, then Accu-Chek® Solo']}, {'name': 'Multiple Daily Injections (MDI) therapy', 'type': 'OTHER', 'description': "Injecting insulin as per participant's need.", 'armGroupLabels': ['Group B: MDI, then Accu-Chek® Solo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'VIVIT Institut am LKH Felkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH Graz, Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '5026', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hietzing Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Diabetes Klinik Bad Mergentheim GmbH', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'InnoDiab Forschung GmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '36037', 'city': 'Fulda', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis im Altstadt-Carree', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '32791', 'city': 'Lage', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms', 'geoPoint': {'lat': 51.99223, 'lon': 8.79301}}, {'zip': '49610', 'city': 'Quakenbrück', 'country': 'Germany', 'facility': 'Diabeteszentrum am CKQ', 'geoPoint': {'lat': 52.67502, 'lon': 7.94983}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Diabendo Praxiszentrum', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Central Clinical Hospital of the MSWiA in Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Bournemouth Diabetes and Endocrine Centre', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Wolfson Diabetes & Endocrine Clinic', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'DL3 6HX', 'city': 'Darlington', 'country': 'United Kingdom', 'facility': 'Centre for Clinical Research and Innovation', 'geoPoint': {'lat': 54.52429, 'lon': -1.55039}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London, Diabetes Research Group", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London, Diabetes, Endocrinology and Metabolism Division', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary, University Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Iris Vesper', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}