{"analyses":[{"ciLowerLimit":"-7","ciNumSides":"TWO_SIDED","ciPctValue":"95","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.003","paramType":"Mean Difference (Final Values)","paramValue":"-4","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6","ciNumSides":"TWO_SIDED","ciPctValue":"95","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.","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.74","paramType":"Mean Difference (Final Values)","paramValue":"-1","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2","value":"1"},{"groupId":"OG001","spread":"4","value":"3"},{"groupId":"OG002","spread":"1","value":"1"},{"groupId":"OG003","spread":"3","value":"2"}]}],"title":"6 Weeks"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3","value":"2"},{"groupId":"OG001","spread":"4","value":"3"},{"groupId":"OG002","spread":"2","value":"2"},{"groupId":"OG003","spread":"3","value":"2"}]}],"title":"13 Weeks"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3","value":"2"},{"groupId":"OG001","spread":"8","value":"6"},{"groupId":"OG002","spread":"3","value":"2"},{"groupId":"OG003","spread":"6","value":"4"}]}],"title":"26 Weeks"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3","value":"3"},{"groupId":"OG001","spread":"12","value":"9"},{"groupId":"OG002","spread":"4","value":"3"},{"groupId":"OG003","spread":"9","value":"7"}]}],"title":"39 Weeks"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4","value":"4"},{"groupId":"OG001","spread":"13","value":"10"},{"groupId":"OG002","spread":"6","value":"5"},{"groupId":"OG003","spread":"10","value":"8"}]}],"title":"52 Weeks"}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"40"}],"units":"Participants"}],"description":"Percentage of CGM sensor glucose values \\>250 mg/dL between treatment groups","dispersionType":"Standard Deviation","groups":[{"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":"OG000","title":"HCL and Intensive Management"},{"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":"OG001","title":"Non-HCL and Standard Care"},{"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":"OG002","title":"Verapamil"},{"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","id":"OG003","title":"Placebo"}],"paramType":"MEAN","populationDescription":"1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.","reportingStatus":"POSTED","timeFrame":"6, 13, 26, 39 weeks and 52 weeks","title":"Percentage of CGM Time >250 mg/dL","type":"SECONDARY","unitOfMeasure":"Percent of Time"}