Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT04233034
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2020-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014700', 'term': 'Verapamil'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cbauza@jaeb.org', 'phone': '813-975-8690', 'title': 'Colleen Bauza', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data where collected during the 52 week RCT phase.', 'eventGroups': [{'id': 'EG000', 'title': 'HCL and Verapamil', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil 120mg tablet: verapamil tablet', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 20, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'HCL and Placebo', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy placebo: placebo pill manufactured to mimic verapamil 120mg tablet', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Non-HCL and Verapamil', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] verapamil 120mg tablet: verapamil tablet non-HCL: Usual diabetes care', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 19, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Non-HCL and Placebo', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] non-HCL: Usual diabetes care placebo: placebo pill manufactured to mimic verapamil 120mg tablet', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 14, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nHCL: Hybrid Closed Loop Therapy', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Non-HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nnon-HCL: Usual diabetes care', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Swollen Glands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': '2nd Degree Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': '1st Degree Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Premature Ventricular Contractions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Otitis Externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain in Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acid Indegestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bloody Stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Celiac Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomach Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomach Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 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{'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Contact Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ingrown toe nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lipohypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin Bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin Disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tinea Corporis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth Extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Benign Essential Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-peptide Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '0.44', 'spread': '0.30', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.04', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.27', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.', 'unitOfMeasure': '(pmol/ml)*minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was not analyzed. All other participants with at least one available measurement of C-Peptide AUC were included in the analysis model.'}, {'type': 'SECONDARY', 'title': 'C-peptide AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '0.69', 'spread': '0.23', 'groupId': 'OG003'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '0.62', 'spread': '0.25', 'groupId': 'OG003'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '0.52', 'spread': '0.28', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.09', 'pValueComment': 'P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.69', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.08', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.'}, {'pValue': '0.08', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.28', 'pValueComment': 'P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '13, 26 and 39 weeks', 'description': 'C-peptide AUC between treatment groups. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.', 'unitOfMeasure': '(pmol/ml)*minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was not analyzed. All other participants had at least one available measurement of C-peptide AUC and were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Peak C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '0.89', 'spread': '0.27', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '0.78', 'spread': '0.27', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '0.76', 'spread': '0.30', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '0.63', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '0.55', 'spread': '0.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Maximum of all C-peptide values during the MMTT', 'unitOfMeasure': 'pmol/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was excluded from the analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Peak C-peptide >= 0.2 Pmol/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage where maximum of all C-peptide values during the MMTT \\>= 0.2 pmol/ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed. N missing in each group are as follows; HCL (N=1 at baseline, N=3 at 13 weeks, N=4 at 26 weeks, N=4 at 39 weeks, N=2 at 52 weeks); Non-HCL (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks , N=6 at 39 weeks, N=5 at 52 weeks); Verapamil (N=1 at baseline, N=1 at 13 weeks, N=2 at 26 weeks, N=4 at 39 Weeks, N=4 at 52 weeks); Placebo (N=0 at baseline, N=1 at 13 weeks, N=3 at 26 weeks, N=3 at 39 weeks, N=2 at 52 weeks).'}, {'type': 'SECONDARY', 'title': 'CGM Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '129', 'spread': '12', 'groupId': 'OG000'}, {'value': '139', 'spread': '29', 'groupId': 'OG001'}, {'value': '131', 'spread': '23', 'groupId': 'OG002'}, {'value': '132', 'spread': '22', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '132', 'spread': '15', 'groupId': 'OG000'}, {'value': '140', 'spread': '26', 'groupId': 'OG001'}, {'value': '134', 'spread': '22', 'groupId': 'OG002'}, {'value': '134', 'spread': '22', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '135', 'spread': '17', 'groupId': 'OG000'}, {'value': '152', 'spread': '35', 'groupId': 'OG001'}, {'value': '138', 'spread': '32', 'groupId': 'OG002'}, {'value': '144', 'spread': '27', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '140', 'spread': '19', 'groupId': 'OG000'}, {'value': '161', 'spread': '36', 'groupId': 'OG001'}, {'value': '141', 'spread': '23', 'groupId': 'OG002'}, {'value': '155', 'spread': '38', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '145', 'spread': '19', 'groupId': 'OG000'}, {'value': '167', 'spread': '42', 'groupId': 'OG001'}, {'value': '151', 'spread': '27', 'groupId': 'OG002'}, {'value': '159', 'spread': '41', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25', 'ciLowerLimit': '-37', 'ciUpperLimit': '-14', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-25', 'ciUpperLimit': '16', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Mean glucose between treatment groups', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the Non-HCL+Placebo group dropped at the randomization visit and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time in Range (70-180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '86', 'spread': '8', 'groupId': 'OG000'}, {'value': '84', 'spread': '9', 'groupId': 'OG001'}, {'value': '85', 'spread': '15', 'groupId': 'OG002'}, {'value': '84', 'spread': '13', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '84', 'spread': '9', 'groupId': 'OG000'}, {'value': '79', 'spread': '16', 'groupId': 'OG001'}, {'value': '83', 'spread': '15', 'groupId': 'OG002'}, {'value': '84', 'spread': '13', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '83', 'spread': '10', 'groupId': 'OG000'}, {'value': '73', 'spread': '20', 'groupId': 'OG001'}, {'value': '81', 'spread': '17', 'groupId': 'OG002'}, {'value': '78', 'spread': '17', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '80', 'spread': '11', 'groupId': 'OG000'}, {'value': '68', 'spread': '21', 'groupId': 'OG001'}, {'value': '80', 'spread': '15', 'groupId': 'OG002'}, {'value': '72', 'spread': '20', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '78', 'spread': '11', 'groupId': 'OG000'}, {'value': '64', 'spread': '22', 'groupId': 'OG001'}, {'value': '74', 'spread': '18', 'groupId': 'OG002'}, {'value': '70', 'spread': '21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '10', 'ciUpperLimit': '22', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-9', 'ciUpperLimit': '13', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values from 70 to 180 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the Non-HCL+Placebo group dropped at the randomization visit and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time in Range 70-140 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '69', 'spread': '11', 'groupId': 'OG000'}, {'value': '60', 'spread': '22', 'groupId': 'OG001'}, {'value': '67', 'spread': '19', 'groupId': 'OG002'}, {'value': '66', 'spread': '18', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '67', 'spread': '13', 'groupId': 'OG000'}, {'value': '59', 'spread': '22', 'groupId': 'OG001'}, {'value': '65', 'spread': '19', 'groupId': 'OG002'}, {'value': '65', 'spread': '19', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '64', 'spread': '13', 'groupId': 'OG000'}, {'value': '51', 'spread': '21', 'groupId': 'OG001'}, {'value': '61', 'spread': '20', 'groupId': 'OG002'}, {'value': '57', 'spread': '19', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '60', 'spread': '14', 'groupId': 'OG000'}, {'value': '46', 'spread': '21', 'groupId': 'OG001'}, {'value': '58', 'spread': '19', 'groupId': 'OG002'}, {'value': '51', 'spread': '20', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '56', 'spread': '13', 'groupId': 'OG000'}, {'value': '43', 'spread': '21', 'groupId': 'OG001'}, {'value': '51', 'spread': '19', 'groupId': 'OG002'}, {'value': '49', 'spread': '21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '10', 'ciUpperLimit': '22', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-8', 'ciUpperLimit': '14', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values from 70 to 140 mg/dL between treatment groups', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the Non-HCL+Placebo group dropped at the randomization visit and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CGM Time in Range 70-180 mg/dL >=70% at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.53', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.32', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': 'Percentage of patients with \\>=70% sensor glucose values from 70 to 180 mg/dL between treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'N missing in each group are as follows; HCL (N=2 at 52 weeks); Non-HCL (N=4 at 52 weeks); Verapamil (N=3 at 52 weeks); Placebo (N=3 at 52 weeks).'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time >140 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '29', 'spread': '11', 'groupId': 'OG000'}, {'value': '38', 'spread': '23', 'groupId': 'OG001'}, {'value': '32', 'spread': '19', 'groupId': 'OG002'}, {'value': '32', 'spread': '18', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '32', 'spread': '13', 'groupId': 'OG000'}, {'value': '40', 'spread': '22', 'groupId': 'OG001'}, {'value': '34', 'spread': '19', 'groupId': 'OG002'}, {'value': '33', 'spread': '20', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '34', 'spread': '13', 'groupId': 'OG000'}, {'value': '47', 'spread': '22', 'groupId': 'OG001'}, {'value': '36', 'spread': '20', 'groupId': 'OG002'}, {'value': '41', 'spread': '20', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '38', 'spread': '14', 'groupId': 'OG000'}, {'value': '53', 'spread': '21', 'groupId': 'OG001'}, {'value': '40', 'spread': '19', 'groupId': 'OG002'}, {'value': '47', 'spread': '21', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '42', 'spread': '14', 'groupId': 'OG000'}, {'value': '56', 'spread': '22', 'groupId': 'OG001'}, {'value': '47', 'spread': '19', 'groupId': 'OG002'}, {'value': '49', 'spread': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values \\>140 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time >180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '12', 'spread': '8', 'groupId': 'OG000'}, {'value': '19', 'spread': '19', 'groupId': 'OG001'}, {'value': '13', 'spread': '15', 'groupId': 'OG002'}, {'value': '14', 'spread': '14', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '14', 'spread': '9', 'groupId': 'OG000'}, {'value': '19', 'spread': '17', 'groupId': 'OG001'}, {'value': '15', 'spread': '15', 'groupId': 'OG002'}, {'value': '15', 'spread': '14', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '15', 'spread': '10', 'groupId': 'OG000'}, {'value': '25', 'spread': '20', 'groupId': 'OG001'}, {'value': '17', 'spread': '17', 'groupId': 'OG002'}, {'value': '21', 'spread': '18', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '18', 'spread': '11', 'groupId': 'OG000'}, {'value': '30', 'spread': '21', 'groupId': 'OG001'}, {'value': '19', 'spread': '15', 'groupId': 'OG002'}, {'value': '26', 'spread': '21', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '20', 'spread': '11', 'groupId': 'OG000'}, {'value': '34', 'spread': '22', 'groupId': 'OG001'}, {'value': '25', 'spread': '18', 'groupId': 'OG002'}, {'value': '28', 'spread': '21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16', 'ciLowerLimit': '-22', 'ciUpperLimit': '-9', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-13', 'ciUpperLimit': '9', 'estimateComment': 'Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values \\>180 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time >250 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '1', 'spread': '2', 'groupId': 'OG000'}, {'value': '3', 'spread': '4', 'groupId': 'OG001'}, {'value': '1', 'spread': '1', 'groupId': 'OG002'}, {'value': '2', 'spread': '3', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '2', 'spread': '3', 'groupId': 'OG000'}, {'value': '3', 'spread': '4', 'groupId': 'OG001'}, {'value': '2', 'spread': '2', 'groupId': 'OG002'}, {'value': '2', 'spread': '3', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '2', 'spread': '3', 'groupId': 'OG000'}, {'value': '6', 'spread': '8', 'groupId': 'OG001'}, {'value': '2', 'spread': '3', 'groupId': 'OG002'}, {'value': '4', 'spread': '6', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '3', 'spread': '3', 'groupId': 'OG000'}, {'value': '9', 'spread': '12', 'groupId': 'OG001'}, {'value': '3', 'spread': '4', 'groupId': 'OG002'}, {'value': '7', 'spread': '9', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '4', 'spread': '4', 'groupId': 'OG000'}, {'value': '10', 'spread': '13', 'groupId': 'OG001'}, {'value': '5', 'spread': '6', 'groupId': 'OG002'}, {'value': '8', 'spread': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-7', 'ciUpperLimit': '-1', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-6', 'ciUpperLimit': '4', 'estimateComment': 'Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\>250 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time <54 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '0.27', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '0.26', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.17', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\<54 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of CGM Time <70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\<70 mg/dL between treatment groups', 'unitOfMeasure': 'Percent of Time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'CGM Coefficient of Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': '6 Weeks', 'categories': [{'measurements': [{'value': '31', 'spread': '5', 'groupId': 'OG000'}, {'value': '30', 'spread': '6', 'groupId': 'OG001'}, {'value': '28', 'spread': '5', 'groupId': 'OG002'}, {'value': '30', 'spread': '6', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '31', 'spread': '6', 'groupId': 'OG000'}, {'value': '30', 'spread': '7', 'groupId': 'OG001'}, {'value': '29', 'spread': '6', 'groupId': 'OG002'}, {'value': '29', 'spread': '6', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '32', 'spread': '5', 'groupId': 'OG000'}, {'value': '32', 'spread': '6', 'groupId': 'OG001'}, {'value': '30', 'spread': '6', 'groupId': 'OG002'}, {'value': '31', 'spread': '5', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '34', 'spread': '6', 'groupId': 'OG000'}, {'value': '33', 'spread': '6', 'groupId': 'OG001'}, {'value': '31', 'spread': '6', 'groupId': 'OG002'}, {'value': '33', 'spread': '5', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '34', 'spread': '6', 'groupId': 'OG000'}, {'value': '33', 'spread': '5', 'groupId': 'OG001'}, {'value': '32', 'spread': '6', 'groupId': 'OG002'}, {'value': '33', 'spread': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Coefficient of variation between treatment groups. Calculated as the standard deviation of CGM glucose values divided by the mean of CGM glucose values.', 'unitOfMeasure': 'Coefficient of Variation Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '10.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '1.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.3', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.65', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.4', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'HbA1c between treatment groups', 'unitOfMeasure': 'Percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of participants with HbA1c \\< 7.0% between treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed. N missing in each group are as follows; HCL (N=1 at baseline, N=3 at 13 weeks, N=4 at 26 weeks, N=2 at 39 weeks, N=2 at 52 weeks); Non-HCL (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks , N=5 at 39 weeks, N=3 at 52 weeks); Verapamil (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks, N=4 at 39 Weeks, N=4 at 52 weeks); Placebo (N=1 at baseline, N=1 at 13 weeks, N=3 at 26 weeks, N=1 at 39 weeks, N=1 at 52 weeks).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HbA1c <6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of participants with HbA1c \\< 6.5% between treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed. N missing in each group are as follows; HCL (N=1 at baseline, N=3 at 13 weeks, N=4 at 26 weeks, N=2 at 39 weeks, N=2 at 52 weeks); Non-HCL (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks , N=5 at 39 weeks, N=3 at 52 weeks); Verapamil (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks, N=4 at 39 Weeks, N=4 at 52 weeks); Placebo (N=1 at baseline, N=1 at 13 weeks, N=3 at 26 weeks, N=1 at 39 weeks, N=1 at 52 weeks).'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Per kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '0.64', 'spread': '0.27', 'groupId': 'OG003'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '0.28', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '0.58', 'spread': '0.29', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '0.74', 'spread': '0.34', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.20', 'estimateComment': 'Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.52', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.05', 'estimateComment': 'Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Total daily insulin per kg between treatment groups', 'unitOfMeasure': 'U/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Basal:Bolus Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}, {'value': '1.1', 'groupId': 'OG003'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '0.89', 'groupId': 'OG002'}, {'value': '0.85', 'groupId': 'OG003'}]}]}, {'title': '13 Weeks', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0.89', 'groupId': 'OG002'}, {'value': '0.82', 'groupId': 'OG003'}]}]}, {'title': '26 Weeks', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000'}, {'value': '0.85', 'groupId': 'OG001'}, {'value': '0.72', 'groupId': 'OG002'}, {'value': '0.75', 'groupId': 'OG003'}]}]}, {'title': '39 Weeks', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000'}, {'value': '0.72', 'groupId': 'OG001'}, {'value': '0.75', 'groupId': 'OG002'}, {'value': '0.72', 'groupId': 'OG003'}]}]}, {'title': '52 Weeks', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000'}, {'value': '0.75', 'groupId': 'OG001'}, {'value': '0.82', 'groupId': 'OG002'}, {'value': '0.72', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Ratio of basal:bolus insulin between treatment groups', 'unitOfMeasure': 'Daily Basal/Bolus Ratio', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Frequency of episodes of severe hypoglycemia between treatment groups', 'unitOfMeasure': 'Number of Severe Hypoglycemic Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DKA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HCL and Intensive Management', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil'}, {'id': 'OG001', 'title': 'Non-HCL and Standard Care', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care'}, {'id': 'OG002', 'title': 'Verapamil', 'description': 'Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Frequency of episodes of DKA between treatment groups', 'unitOfMeasure': 'Number of DKA Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HCL and Placebo', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nHCL: Hybrid Closed Loop therapy\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}, {'id': 'FG001', 'title': 'HCL and Verapamil', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nHCL: Hybrid Closed Loop therapy\n\nverapamil 120mg tablet: verapamil tablet'}, {'id': 'FG002', 'title': 'Non-HCL and Verapamil', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nverapamil 120mg tablet: verapamil tablet\n\nnon-HCL: Usual diabetes care'}, {'id': 'FG003', 'title': 'Non-HCL and Placebo', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]\n\nnon-HCL: Usual diabetes care\n\nplacebo: placebo pill manufactured to mimic verapamil 120mg tablet'}, {'id': 'FG004', 'title': 'HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nHCL: Hybrid Closed Loop Therapy'}, {'id': 'FG005', 'title': 'Non-HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nnon-HCL: Usual diabetes care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'HCL and Verapamil', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil 120mg tablet: verapamil tablet'}, {'id': 'BG001', 'title': 'HCL and Placebo', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy placebo: placebo pill manufactured to mimic verapamil 120mg tablet'}, {'id': 'BG002', 'title': 'Non-HCL and Verapamil', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] verapamil 120mg tablet: verapamil tablet non-HCL: Usual diabetes care'}, {'id': 'BG003', 'title': 'Non-HCL and Placebo', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site. \\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\] non-HCL: Usual diabetes care placebo: placebo pill manufactured to mimic verapamil 120mg tablet'}, {'id': 'BG004', 'title': 'HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nHCL: Hybrid Closed Loop Therapy'}, {'id': 'BG005', 'title': 'Non-HCL Only', 'description': 'Participants weighing \\<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL.\n\nParticipants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nnon-HCL: Usual diabetes care'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '3', 'groupId': 'BG000'}, {'value': '12', 'spread': '2', 'groupId': 'BG001'}, {'value': '13', 'spread': '3', 'groupId': 'BG002'}, {'value': '13', 'spread': '2', 'groupId': 'BG003'}, {'value': '8', 'spread': '1', 'groupId': 'BG004'}, {'value': '9', 'spread': '1', 'groupId': 'BG005'}, {'value': '12', 'spread': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '49', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '64', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}]}, {'title': 'Black/African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Hispanic', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'More than One', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Household Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': '<$50,000', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': '$50,000-<$100,000', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}, {'title': '>=$100,000', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Parental Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': "Less than Bachelor's", 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': "Bachelor's", 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}, {'title': 'Advanced Degree', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Insurance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Private', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}, {'title': 'Public', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'None', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI Percentile at Randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '90'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '86'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '89'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '37', 'upperLimit': '80'}, {'value': '43', 'groupId': 'BG004', 'lowerLimit': '22', 'upperLimit': '47'}, {'value': '32', 'groupId': 'BG005', 'lowerLimit': '26', 'upperLimit': '37'}, {'value': '56', 'groupId': 'BG006', 'lowerLimit': '28', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentile', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '1 participant in the Non-HCL placebo group was missing BMI percentile at randomization.'}, {'title': 'Time Since Diagnosis at Randomization (days)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '24', 'spread': '5', 'groupId': 'BG000'}, {'value': '24', 'spread': '5', 'groupId': 'BG001'}, {'value': '24', 'spread': '5', 'groupId': 'BG002'}, {'value': '25', 'spread': '4', 'groupId': 'BG003'}, {'value': '23', 'spread': '5', 'groupId': 'BG004'}, {'value': '23', 'spread': '5', 'groupId': 'BG005'}, {'value': '24', 'spread': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lab HbA1c at Randomization (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '111', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '10.3', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '10.6', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '10.1', 'spread': '1.4', 'groupId': 'BG003'}, {'value': '10.6', 'spread': '1.2', 'groupId': 'BG004'}, {'value': '9.4', 'spread': '1.5', 'groupId': 'BG005'}, {'value': '10.6', 'spread': '1.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant randomized to HCL + Placebo and 1 participant randomized to Non-HCL + Placebo were missing HbA1c at randomization.'}, {'title': 'Systolic Blood Pressure at Randomization (mmHg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '108', 'spread': '11', 'groupId': 'BG000'}, {'value': '107', 'spread': '9', 'groupId': 'BG001'}, {'value': '111', 'spread': '7', 'groupId': 'BG002'}, {'value': '108', 'spread': '9', 'groupId': 'BG003'}, {'value': '103', 'spread': '8', 'groupId': 'BG004'}, {'value': '95', 'spread': '9', 'groupId': 'BG005'}, {'value': '107', 'spread': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure at Randomization (mmHg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '7', 'groupId': 'BG000'}, {'value': '62', 'spread': '6', 'groupId': 'BG001'}, {'value': '65', 'spread': '8', 'groupId': 'BG002'}, {'value': '65', 'spread': '8', 'groupId': 'BG003'}, {'value': '62', 'spread': '8', 'groupId': 'BG004'}, {'value': '63', 'spread': '7', 'groupId': 'BG005'}, {'value': '63', 'spread': '7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'DKA at Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tanner Staging', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Group 1', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}, {'title': 'Group 2-5', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '69', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tanner stages assess pubertal development in adolescents. Higher stages indicate more advanced pubertal development. Stages are determined by the pubic hair scale for both males and females, the female breast development scale, and the male external genitalia scale.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 711839, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-15T15:39', 'hasProtocol': True}, {'date': '2022-09-27', 'size': 773898, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-15T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2020-01-14', 'resultsFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-20', 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-peptide Area Under the Curve (AUC)', 'timeFrame': '52 weeks', 'description': 'The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.'}], 'secondaryOutcomes': [{'measure': 'C-peptide AUC', 'timeFrame': '13, 26 and 39 weeks', 'description': 'C-peptide AUC between treatment groups. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.'}, {'measure': 'Peak C-peptide', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Maximum of all C-peptide values during the MMTT'}, {'measure': 'Number of Participants With a Peak C-peptide >= 0.2 Pmol/ml', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage where maximum of all C-peptide values during the MMTT \\>= 0.2 pmol/ml'}, {'measure': 'CGM Mean Glucose', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Mean glucose between treatment groups'}, {'measure': 'Percentage of CGM Time in Range (70-180 mg/dL)', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values from 70 to 180 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time in Range 70-140 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values from 70 to 140 mg/dL between treatment groups'}, {'measure': 'Number of Participants With CGM Time in Range 70-180 mg/dL >=70% at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'Percentage of patients with \\>=70% sensor glucose values from 70 to 180 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time >140 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values \\>140 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time >180 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'CGM sensor glucose values \\>180 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time >250 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\>250 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time <54 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\<54 mg/dL between treatment groups'}, {'measure': 'Percentage of CGM Time <70 mg/dL', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of CGM sensor glucose values \\<70 mg/dL between treatment groups'}, {'measure': 'CGM Coefficient of Variation', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Coefficient of variation between treatment groups. Calculated as the standard deviation of CGM glucose values divided by the mean of CGM glucose values.'}, {'measure': 'HbA1c', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'HbA1c between treatment groups'}, {'measure': 'Number of Participants With HbA1c <7.0%', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of participants with HbA1c \\< 7.0% between treatment groups'}, {'measure': 'Number of Participants With HbA1c <6.5%', 'timeFrame': '13, 26, 39 weeks and 52 weeks', 'description': 'Percentage of participants with HbA1c \\< 6.5% between treatment groups'}, {'measure': 'Total Daily Insulin Per kg', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Total daily insulin per kg between treatment groups'}, {'measure': 'Basal:Bolus Ratio', 'timeFrame': '6, 13, 26, 39 weeks and 52 weeks', 'description': 'Ratio of basal:bolus insulin between treatment groups'}, {'measure': 'Severe Hypoglycemia', 'timeFrame': '52 weeks', 'description': 'Frequency of episodes of severe hypoglycemia between treatment groups'}, {'measure': 'DKA', 'timeFrame': '52 weeks', 'description': 'Frequency of episodes of DKA between treatment groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['new onset', 'verapamil', 'hybrid closed loop', 'hcl', 'beta cell', 'diabetes', 'children', 'T1D', 'c-peptide', 'pediatric'], 'conditions': ['Type1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38860154', 'type': 'DERIVED', 'citation': 'Ekhlaspour L, Buckingham B, Bauza C, Clements M, Forlenza GP, Neyman A, Norlander L, Schamberger M, Sherr JL, Bailey R, Beck RW, Kollman C, Beasley S, Cobry E, DiMeglio LA, Paprocki E, Van Name M, Moran A; CLVer Study Group. Safety and prescribing recommendations for verapamil in newly diagnosed pediatric type 1 diabetes (T1D): The CLVer experience. J Clin Transl Endocrinol. 2024 May 18;36:100352. doi: 10.1016/j.jcte.2024.100352. eCollection 2024 Jun.'}, {'pmid': '36826844', 'type': 'DERIVED', 'citation': 'Forlenza GP, McVean J, Beck RW, Bauza C, Bailey R, Buckingham B, DiMeglio LA, Sherr JL, Clements M, Neyman A, Evans-Molina C, Sims EK, Messer LH, Ekhlaspour L, McDonough R, Van Name M, Rojas D, Beasley S, DuBose S, Kollman C, Moran A; CLVer Study Group. Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Mar 28;329(12):990-999. doi: 10.1001/jama.2023.2064.'}, {'pmid': '36826834', 'type': 'DERIVED', 'citation': 'McVean J, Forlenza GP, Beck RW, Bauza C, Bailey R, Buckingham B, DiMeglio LA, Sherr JL, Clements M, Neyman A, Evans-Molina C, Sims EK, Messer LH, Ekhlaspour L, McDonough R, Van Name M, Rojas D, Beasley S, DuBose S, Kollman C, Moran A; CLVer Study Group. Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Mar 28;329(12):980-989. doi: 10.1001/jama.2023.2063.'}]}, 'descriptionModule': {'briefSummary': 'Randomized trial of youth aged 7-\\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \\<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.', 'detailedDescription': "After informed consent is obtained, potential participants will be assessed for eligibility, including eliciting medical history, physical examination, and laboratory testing (including HbA1c, auto-antibody measurement \\[unless positive auto-antibody results already available\\], and pregnancy test for females with childbearing potential).\n\nParticipants who already have positive auto-antibodies can be randomized immediately. All other participants will be scheduled for a randomization visit after the auto-antibody results are available; positive auto-antibodies are required for randomization.\n\nEligible participants with body weight ≥30 kg (Cohort A) will be randomly assigned to one of 4 groups: HCL and placebo, HCL and verapamil, non-HCL and placebo or non-HCL and verapamil. Eligible individuals with body weight \\<30 kg (Cohort B) will be randomly assigned 2:1 to either HCL or non-HCL. Randomization schedules will be separate for Cohort A and Cohort B and will be stratified by site.\n\nParticipants assigned to HCL will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nParticipants assigned to non-HCL will receive a Dexcom G6 continuous glucose monitor (CGM) and diabetes management will follow usual care by their personal diabetes health care provider.\n\nParticipants will be followed for 12 months from diagnosis, completing a 6 week visit timed from randomization and 13, 26, 39, and 52 week visits timed from diagnosis. Participants will have a MMTT performed, HbA1c measured, and blood drawn for mechanistic studies at Randomization, 13, 26, 39 and 52 weeks. At all follow-up visits, a physical exam will be performed, pregnancy testing performed (if indicated), insulin dose (units/kg/day) recorded, and device data downloaded.\n\nSafety assessments will be made throughout the study by querying about episodes of severe hypoglycemia and DKA, and overall health.\n\nParticipants already enrolled in the study and using the Medtronic 670G 4.0 AHCL may transition to the Medtronic 780G if desired. Contacts will be performed to review CareLink data and check for adverse events and device deficiencies on days 1, 3 and 5 after transition from 670G 4.0 AHCL to 780G.\n\nPrior to the 780G system becoming commercially available, study participants using the Medtronic system at 52 weeks will have the opportunity to continue using the 780G system at home until the system is commercially available OR until the CLVer trial is complete (last participant's 52-week visit), whichever comes first.\n\nAdditional Procedures for Cohort A:\n\nDrug will be double blinded. Drug dose will be weight-dependent and will be escalated at 2-4 week intervals, up to a weight-dependent maximum if tolerated. Cohort A will have additional safety visits 1 week after initiation of study drug and after each study drug dose increase, to test blood pressure and pulse.\n\nLocal lab measurement of aspartate aminotransferase/alanine aminotransferase (AST/ALT) and creatinine will occur, and an EKG will be performed at Screening, 6, 26, and 52 weeks. Over the course of the trial, study drug dose may be decreased or discontinued if side effects occur."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Participant Inclusion Criteria:\n\n 1. New-onset stage 3 T1D within 21 days of diagnosis (timed from start of insulin therapy), with ability to be randomized within 31 days of diagnosis (time from diagnosis to screening can be longer provided all screening testing can be completed within 31 days of diagnosis)\n 2. At least one positive type 1 diabetes auto-antibody\n 3. Age 7 - \\<18 years at the time of enrollment\n 4. Willing to have a parent or legal guardian provide informed consent and child assent\n 5. In a female participant with childbearing potential, not currently pregnant and willing to avoid pregnancy and breastfeeding and undergo pregnancy testing throughout the study\n 6. English speaking/reading\n 7. Able to swallow pills (tested with an inert imitation tablet in clinic prior to randomization)\n 8. Willing to not use any non-insulin glucose-lowering agents\n 9. Willing to use an insulin approved for the pump (if assigned to HCL)\n 10. Willing to avoid medications containing acetaminophen, and no contraindications for ibuprofen use (in case assigned to Medtronic HCL system)\n* Participant Exclusion Criteria:\n\n 1. Ongoing use of medications known to influence glucose tolerance such as systemic steroids\n 2. Other systemic disease which in the opinion of the investigator precludes participation (including psychiatric illness)\n 3. Unwilling to abstain from use of HCL therapy for 12 months\n\n a. Personal pump and CGM use, including systems with a "suspend-before-low" function, will be allowed for participants randomized to non-HCL groups\n 4. "Silent" diabetes-i.e., Stage 3 diabetes that is identified by routine oral glucose tolerance testing (OGTT) or in the course of surveillance studies but is not accompanied by fasting hyperglycemia or classic symptoms of diabetes\n 5. Participation in another research study that involves diabetes care\n* Additional exclusion criteria for Cohort A:\n\n 1. Blood pressure (either systolic or diastolic) \\<5th percentile for age, gender, and height on two out of three measurements\n 2. Pulse \\<2nd percentile for age and gender on two out of three measurements\n 3. History of vasovagal syncopal episodes related to hypotension\n 4. Abnormal EKG rhythm unless cleared for study participation by a cardiologist\n 5. Underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (ex. Atrioventricular block (AV) block, accessory pathway such as Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), known liver dysfunction, known renal impairment, Duchenne\'s muscular dystrophy, active Graves disease or hyperthyroidism, and untreated hypothyroidism\n 6. Estimated glomerular filtration rate (eGFR) \\< 90\n 7. AST and/or ALT greater than 1.5 times the upper limit of normal\n 8. Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine, or aspirin\n 9. Any known hypersensitivity reaction to Verapamil'}, 'identificationModule': {'nctId': 'NCT04233034', 'acronym': 'CLVer', 'briefTitle': 'Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer)', 'orgStudyIdInfo': {'id': 'CLVer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HCL and placebo', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]', 'interventionNames': ['Device: HCL', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HCL and verapamil', 'description': 'Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]', 'interventionNames': ['Device: HCL', 'Drug: verapamil 120mg tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-HCL and verapamil', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nVerapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]', 'interventionNames': ['Drug: verapamil 120mg tablet', 'Device: non-HCL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-HCL and placebo', 'description': 'Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider.\n\nPlacebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets.\n\nWhether drug is active or placebo is blinded to both participant and site.\n\n\\[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\\]', 'interventionNames': ['Device: non-HCL', 'Drug: placebo']}], 'interventions': [{'name': 'HCL', 'type': 'DEVICE', 'description': 'Hybrid Closed Loop therapy', 'armGroupLabels': ['HCL and placebo', 'HCL and verapamil']}, {'name': 'verapamil 120mg tablet', 'type': 'DRUG', 'description': 'verapamil tablet', 'armGroupLabels': ['HCL and verapamil', 'non-HCL and verapamil']}, {'name': 'non-HCL', 'type': 'DEVICE', 'description': 'Usual diabetes care', 'armGroupLabels': ['non-HCL and placebo', 'non-HCL and verapamil']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo pill manufactured to mimic verapamil 120mg tablet', 'armGroupLabels': ['HCL and placebo', 'non-HCL and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Antoinette Moran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota'}, {'name': 'Gregory Forlenza, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barbara Davis Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}