Participant flow

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes · Source last updated 2024-11-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. 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. 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. Whether 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

   FG000

   title

   HCL and Placebo

2. 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. 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. Whether 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

   FG001

   title

   HCL and Verapamil

3. 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. 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. Whether 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

   FG002

   title

   Non-HCL and Verapamil

4. 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. 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. Whether 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

   FG003

   title

   Non-HCL and Placebo

5. 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. 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. HCL: Hybrid Closed Loop Therapy

   id

   FG004

   title

   HCL Only

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. 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. non-HCL: Usual diabetes care

   id

   FG005

   title

   Non-HCL Only

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         22

      3. group Id

         FG002

         num Subjects

         25

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         19

      6. group Id

         FG005

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         23

      4. group Id

         FG003

         num Subjects

         19

      5. group Id

         FG004

         num Subjects

         19

      6. group Id

         FG005

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice