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NCT04233034 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      22
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      25
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      19
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      113
    units
    Participants
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. 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
    BG000
    title
    HCL and Verapamil
  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. 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
    BG001
    title
    HCL and Placebo
  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
    BG002
    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
    BG003
    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
    BG004
    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
    BG005
    title
    Non-HCL Only
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3
          value
          13
        2. group Id
          BG001
          spread
          2
          value
          12
        3. group Id
          BG002
          spread
          3
          value
          13
        4. group Id
          BG003
          spread
          2
          value
          13
        5. group Id
          BG004
          spread
          1
          value
          8
        6. group Id
          BG005
          spread
          1
          value
          9
        7. group Id
          BG006
          spread
          3
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          64
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          86
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Black/African American
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          15
        title
        Hispanic
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        American Indian/Alaskan Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        More than One
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
      title
      Race/Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          17
        title
        <$50,000
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          26
        title
        $50,000-<$100,000
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          62
        title
        >=$100,000
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Annual Household Income
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          28
        title
        Less than Bachelor's
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          48
        title
        Bachelor's
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          37
        title
        Advanced Degree
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Highest Parental Education
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          92
        title
        Private
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          18
        title
        Public
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        None
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Health Insurance
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34
          upper Limit
          90
          value
          78
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          86
          value
          53
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          89
          value
          58
        4. group Id
          BG003
          lower Limit
          37
          upper Limit
          80
          value
          65
        5. group Id
          BG004
          lower Limit
          22
          upper Limit
          47
          value
          43
        6. group Id
          BG005
          lower Limit
          26
          upper Limit
          37
          value
          32
        7. group Id
          BG006
          lower Limit
          28
          upper Limit
          85
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          112
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    population Description
    1 participant in the Non-HCL placebo group was missing BMI percentile at randomization.
    title
    BMI Percentile at Randomization
    unit Of Measure
    Percentile
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5
          value
          24
        2. group Id
          BG001
          spread
          5
          value
          24
        3. group Id
          BG002
          spread
          5
          value
          24
        4. group Id
          BG003
          spread
          4
          value
          25
        5. group Id
          BG004
          spread
          5
          value
          23
        6. group Id
          BG005
          spread
          5
          value
          23
        7. group Id
          BG006
          spread
          5
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Diagnosis at Randomization (days)
    unit Of Measure
    Days
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.6
          value
          10.1
        2. group Id
          BG001
          spread
          1.1
          value
          10.3
        3. group Id
          BG002
          spread
          1.7
          value
          10.6
        4. group Id
          BG003
          spread
          1.4
          value
          10.1
        5. group Id
          BG004
          spread
          1.2
          value
          10.6
        6. group Id
          BG005
          spread
          1.5
          value
          9.4
        7. group Id
          BG006
          spread
          1.7
          value
          10.6
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          111
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 participant randomized to HCL + Placebo and 1 participant randomized to Non-HCL + Placebo were missing HbA1c at randomization.
    title
    Lab HbA1c at Randomization (%)
    unit Of Measure
    Percentage of glycosylated hemoglobin
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11
          value
          108
        2. group Id
          BG001
          spread
          9
          value
          107
        3. group Id
          BG002
          spread
          7
          value
          111
        4. group Id
          BG003
          spread
          9
          value
          108
        5. group Id
          BG004
          spread
          8
          value
          103
        6. group Id
          BG005
          spread
          9
          value
          95
        7. group Id
          BG006
          spread
          10
          value
          107
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Systolic Blood Pressure at Randomization (mmHg)
    unit Of Measure
    mmHg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7
          value
          62
        2. group Id
          BG001
          spread
          6
          value
          62
        3. group Id
          BG002
          spread
          8
          value
          65
        4. group Id
          BG003
          spread
          8
          value
          65
        5. group Id
          BG004
          spread
          8
          value
          62
        6. group Id
          BG005
          spread
          7
          value
          63
        7. group Id
          BG006
          spread
          7
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Diastolic Blood Pressure at Randomization (mmHg)
    unit Of Measure
    mmHg
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          51
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          60
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    DKA at Diagnosis
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      22
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      25
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      19
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      113
    units
    Participants
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. 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
    BG000
    title
    HCL and Verapamil
  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. 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
    BG001
    title
    HCL and Placebo
  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
    BG002
    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
    BG003
    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
    BG004
    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
    BG005
    title
    Non-HCL Only
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3
          value
          13
        2. group Id
          BG001
          spread
          2
          value
          12
        3. group Id
          BG002
          spread
          3
          value
          13
        4. group Id
          BG003
          spread
          2
          value
          13
        5. group Id
          BG004
          spread
          1
          value
          8
        6. group Id
          BG005
          spread
          1
          value
          9
        7. group Id
          BG006
          spread
          3
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          64
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          86
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Black/African American
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          15
        title
        Hispanic
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        American Indian/Alaskan Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        More than One
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
      title
      Race/Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          17
        title
        <$50,000
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          26
        title
        $50,000-<$100,000
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          62
        title
        >=$100,000
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Annual Household Income
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          28
        title
        Less than Bachelor's
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          48
        title
        Bachelor's
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          37
        title
        Advanced Degree
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Highest Parental Education
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          92
        title
        Private
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          18
        title
        Public
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        None
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Health Insurance
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34
          upper Limit
          90
          value
          78
        2. group Id
          BG001
          lower Limit
          21
          upper Limit
          86
          value
          53
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          89
          value
          58
        4. group Id
          BG003
          lower Limit
          37
          upper Limit
          80
          value
          65
        5. group Id
          BG004
          lower Limit
          22
          upper Limit
          47
          value
          43
        6. group Id
          BG005
          lower Limit
          26
          upper Limit
          37
          value
          32
        7. group Id
          BG006
          lower Limit
          28
          upper Limit
          85
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          112
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    population Description
    1 participant in the Non-HCL placebo group was missing BMI percentile at randomization.
    title
    BMI Percentile at Randomization
    unit Of Measure
    Percentile
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5
          value
          24
        2. group Id
          BG001
          spread
          5
          value
          24
        3. group Id
          BG002
          spread
          5
          value
          24
        4. group Id
          BG003
          spread
          4
          value
          25
        5. group Id
          BG004
          spread
          5
          value
          23
        6. group Id
          BG005
          spread
          5
          value
          23
        7. group Id
          BG006
          spread
          5
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Diagnosis at Randomization (days)
    unit Of Measure
    Days
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.6
          value
          10.1
        2. group Id
          BG001
          spread
          1.1
          value
          10.3
        3. group Id
          BG002
          spread
          1.7
          value
          10.6
        4. group Id
          BG003
          spread
          1.4
          value
          10.1
        5. group Id
          BG004
          spread
          1.2
          value
          10.6
        6. group Id
          BG005
          spread
          1.5
          value
          9.4
        7. group Id
          BG006
          spread
          1.7
          value
          10.6
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          111
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 participant randomized to HCL + Placebo and 1 participant randomized to Non-HCL + Placebo were missing HbA1c at randomization.
    title
    Lab HbA1c at Randomization (%)
    unit Of Measure
    Percentage of glycosylated hemoglobin
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11
          value
          108
        2. group Id
          BG001
          spread
          9
          value
          107
        3. group Id
          BG002
          spread
          7
          value
          111
        4. group Id
          BG003
          spread
          9
          value
          108
        5. group Id
          BG004
          spread
          8
          value
          103
        6. group Id
          BG005
          spread
          9
          value
          95
        7. group Id
          BG006
          spread
          10
          value
          107
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Systolic Blood Pressure at Randomization (mmHg)
    unit Of Measure
    mmHg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7
          value
          62
        2. group Id
          BG001
          spread
          6
          value
          62
        3. group Id
          BG002
          spread
          8
          value
          65
        4. group Id
          BG003
          spread
          8
          value
          65
        5. group Id
          BG004
          spread
          8
          value
          62
        6. group Id
          BG005
          spread
          7
          value
          63
        7. group Id
          BG006
          spread
          7
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Diastolic Blood Pressure at Randomization (mmHg)
    unit Of Measure
    mmHg
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          51
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          60
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          113
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    DKA at Diagnosis
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice