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NCT04233034 · OUTCOME

Percentage of CGM Time >250 mg/dL

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.

Measure
MEAN
Unit
Percent of Time
Interval / dispersion
Standard Deviation
Time frame
6, 13, 26, 39 weeks and 52 weeks

What was measured

Percentage of CGM sensor glucose values \>250 mg/dL between treatment groups

Analysis population: 1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.

Groups in this outcome

HCL and Intensive Management

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. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil

Non-HCL and Standard Care

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. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care

Verapamil

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

Placebo

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. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HCL and Intensive Management61
Non-HCL and Standard Care51
Verapamil47
Placebo40

Reported measurements

6 Weeks
Values in Percent of Time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HCL and Intensive Management12Not reportedNot reportedNot reported
Non-HCL and Standard Care34Not reportedNot reportedNot reported
Verapamil11Not reportedNot reportedNot reported
Placebo23Not reportedNot reportedNot reported
13 Weeks
Values in Percent of Time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HCL and Intensive Management23Not reportedNot reportedNot reported
Non-HCL and Standard Care34Not reportedNot reportedNot reported
Verapamil22Not reportedNot reportedNot reported
Placebo23Not reportedNot reportedNot reported
26 Weeks
Values in Percent of Time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HCL and Intensive Management23Not reportedNot reportedNot reported
Non-HCL and Standard Care68Not reportedNot reportedNot reported
Verapamil23Not reportedNot reportedNot reported
Placebo46Not reportedNot reportedNot reported
39 Weeks
Values in Percent of Time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HCL and Intensive Management33Not reportedNot reportedNot reported
Non-HCL and Standard Care912Not reportedNot reportedNot reported
Verapamil34Not reportedNot reportedNot reported
Placebo79Not reportedNot reportedNot reported
52 Weeks
Values in Percent of Time · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HCL and Intensive Management44Not reportedNot reportedNot reported
Non-HCL and Standard Care1013Not reportedNot reportedNot reported
Verapamil56Not reportedNot reportedNot reported
Placebo810Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1
    estimate Comment
    Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.003
    param Type
    Mean Difference (Final Values)
    param Value
    -4
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4
    estimate Comment
    Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.74
    param Type
    Mean Difference (Final Values)
    param Value
    -1
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1
    estimate Comment
    Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.003
    param Type
    Mean Difference (Final Values)
    param Value
    -4
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4
    estimate Comment
    Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.74
    param Type
    Mean Difference (Final Values)
    param Value
    -1
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2
        value
        1
      2. group Id
        OG001
        spread
        4
        value
        3
      3. group Id
        OG002
        spread
        1
        value
        1
      4. group Id
        OG003
        spread
        3
        value
        2
    title
    6 Weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3
        value
        2
      2. group Id
        OG001
        spread
        4
        value
        3
      3. group Id
        OG002
        spread
        2
        value
        2
      4. group Id
        OG003
        spread
        3
        value
        2
    title
    13 Weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3
        value
        2
      2. group Id
        OG001
        spread
        8
        value
        6
      3. group Id
        OG002
        spread
        3
        value
        2
      4. group Id
        OG003
        spread
        6
        value
        4
    title
    26 Weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3
        value
        3
      2. group Id
        OG001
        spread
        12
        value
        9
      3. group Id
        OG002
        spread
        4
        value
        3
      4. group Id
        OG003
        spread
        9
        value
        7
    title
    39 Weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4
        value
        4
      2. group Id
        OG001
        spread
        13
        value
        10
      3. group Id
        OG002
        spread
        6
        value
        5
      4. group Id
        OG003
        spread
        10
        value
        8
    title
    52 Weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      47
    4. group Id
      OG003
      value
      40
    units
    Participants
description
Percentage of CGM sensor glucose values \>250 mg/dL between treatment groups
dispersion Type
Standard Deviation
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. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil
    id
    OG000
    title
    HCL and Intensive Management
  2. 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. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care
    id
    OG001
    title
    Non-HCL and Standard Care
  3. 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. 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
    id
    OG002
    title
    Verapamil
  4. 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. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet
    id
    OG003
    title
    Placebo
param Type
MEAN
population Description
1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed.
reporting Status
POSTED
time Frame
6, 13, 26, 39 weeks and 52 weeks
title
Percentage of CGM Time >250 mg/dL
type
SECONDARY
unit Of Measure
Percent of Time

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Preserved source evidence · Not medical advice