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Instead, they will be randomized 2:1 to HCL or non-HCL.\\] HCL: Hybrid Closed Loop therapy verapamil 120mg tablet: verapamil tablet","id":"EG000","otherNumAffected":20,"otherNumAtRisk":22,"seriousNumAffected":3,"seriousNumAtRisk":22,"title":"HCL and Verapamil"},{"deathsNumAffected":0,"deathsNumAtRisk":20,"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":"EG001","otherNumAffected":16,"otherNumAtRisk":20,"seriousNumAffected":1,"seriousNumAtRisk":20,"title":"HCL and Placebo"},{"deathsNumAffected":0,"deathsNumAtRisk":25,"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":"EG002","otherNumAffected":19,"otherNumAtRisk":25,"seriousNumAffected":1,"seriousNumAtRisk":25,"title":"Non-HCL and Verapamil"},{"deathsNumAffected":0,"deathsNumAtRisk":21,"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":"EG003","otherNumAffected":14,"otherNumAtRisk":21,"seriousNumAffected":3,"seriousNumAtRisk":21,"title":"Non-HCL and Placebo"},{"deathsNumAffected":0,"deathsNumAtRisk":19,"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":"EG004","otherNumAffected":18,"otherNumAtRisk":19,"seriousNumAffected":1,"seriousNumAtRisk":19,"title":"HCL Only"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"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":"EG005","otherNumAffected":4,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Non-HCL Only"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system 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(10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cardiac Arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"1st Degree Heart 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(10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ear Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Otitis Externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":19,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Otitis Media Acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pain in Ear"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":22,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":19,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Thyroiditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acid Indegestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bloody Stool"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":19,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Celiac Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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(10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Stomach 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