ID

44882

Descripción

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 9

Palabras clave

  1. 1/9/16 1/9/16 -
  2. 5/9/16 5/9/16 -
  3. 28/9/16 28/9/16 -
  4. 28/9/16 28/9/16 -
  5. 28/9/16 28/9/16 -
  6. 19/2/22 19/2/22 - Martin Dugas
Titular de derechos de autor

Astellas Pharma Inc

Subido en

19 de febrero de 2022

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0

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    Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

    Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

    Date of Visit
    Descripción

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Descripción

    Visit date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Physical Examination
    Descripción

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Was the physical examination performed? Record any abnormal findings/conditions identified during the exam on the appropriate form.
    Descripción

    Physical Examination

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C2985720
    Orthostatic vital signs
    Descripción

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766
    Not Done:
    Descripción

    Assessment

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1516048
    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C2985720
    Assessment Time
    Descripción

    Assessment Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C0040223
    Vital Signs Position
    Descripción

    Vital Signs Position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Location of blood pressure measurement
    Descripción

    Location of blood pressure measurement

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0005823
    Systolic blood pressure
    Descripción

    Systolic blood pressure

    Tipo de datos

    text

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    text

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse Rate
    Descripción

    Pulse Rate

    Tipo de datos

    text

    Unidades de medida
    • Beats/min
    Alias
    UMLS CUI [1]
    C0232117
    Beats/min
    12 Lead ECG 1
    Descripción

    12 Lead ECG 1

    Alias
    UMLS CUI [1]
    C0430456
    Date ECG was performed
    Descripción

    ECG Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    ECG Time performed
    Descripción

    ECG time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    ECG Interpretation
    Descripción

    ECG Interpretation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0459471
    Weight
    Descripción

    Weight

    Alias
    UMLS CUI-1
    C0005910
    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C2985720
    Body weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Waist and Hip Circumference
    Descripción

    Waist and Hip Circumference

    Alias
    UMLS CUI-1
    C0455829
    UMLS CUI-3
    C0562350
    Waist circumference
    Descripción

    Waist circumference

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0455829
    cm
    Hip circumference
    Descripción

    Hip circumference

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0562350
    cm
    Pregnancy Test
    Descripción

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Select "Not done" if urine sample was not taken.
    Descripción

    Urine Sample

    Tipo de datos

    integer

    Date of Sample Taken
    Descripción

    Pregnancy Test: Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Descripción

    Pregnancy test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0427777
    EQ-5D
    Descripción

    EQ-5D

    Alias
    UMLS CUI-1
    C2733251
    ADDQol
    Descripción

    ADDQol

    Diab-MedSat
    Descripción

    Diab-MedSat

    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Over the past two weeks how bothered have you been by the amount of home monitoring (blood sugar testing) required as part of using your medication(s)?
    Descripción

    Bothered, Blood sugar testing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174324
    UMLS CUI [1,2]
    C0005803
    Over the past two weeks how bothered have you been by the number of times you need to take your medication(s) daily?
    Descripción

    bothered, medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174324
    UMLS CUI [1,2]
    C0013227
    Over the past two weeks how bothered have you been by the need to adjust the dosing (amount) of your medication(s)?
    Descripción

    bothered, adjusting medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174324
    UMLS CUI [1,2]
    C0013227
    Over the past two weeks how bothered have you been by how your medication(s) interferes with your daily life?
    Descripción

    bothered medication interference

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174324
    UMLS CUI [1,2]
    C0013227
    Over the past two weeks how bothered have you been by any of the following due to your diabetes medication(s)? Unwanted weight gain
    Descripción

    weight gain bothered

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0043094
    UMLS CUI [1,2]
    C3174324
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Pain or discomfort
    Descripción

    pain or discomfort

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3639378
    UMLS CUI [1,2]
    C3174324
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Gas and bloating
    Descripción

    gas and bloating

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0946092
    UMLS CUI [1,2]
    C3174324
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Diarrhea
    Descripción

    diarrhea

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0011991
    UMLS CUI [1,2]
    C3174324
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Symptoms of low blood sugar (trembling, sweating, dizziness or blurred vision)
    Descripción

    low blood sugar

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0020615
    UMLS CUI [1,3]
    C3174324
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... keep your blood sugar levels stable (avoids highs and lows)?
    Descripción

    blood glucose stable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0392201
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [1,3]
    C0086715
    UMLS CUI [1,4]
    C0242428
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... help you from feeling tired and lacking energy?
    Descripción

    lack of energy

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0015672
    UMLS CUI [1,2]
    C0242428
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the ease and convenience of your diabetes medications
    Descripción

    convenience

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3831015
    UMLS CUI [1,2]
    C0242428
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your physical well being?
    Descripción

    physical well being

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018684
    UMLS CUI [1,2]
    C0242428
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your emotional well being?
    Descripción

    emotional well being

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0025353
    UMLS CUI [1,2]
    C0242428
    Thinking about your diabetes medication(s) over the past two weeks ... how difficult has it been for your to plan your daily activities around your medication(s)?
    Descripción

    daily activities

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0001288
    UMLS CUI [1,2]
    C0013216
    Thinking about your diabetes medication(s) over the past two weeks ... how much burden has it been for you to take your medication(s) as prescribed?
    Descripción

    burden to take medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2828008
    UMLS CUI [1,2]
    C0013216
    Thinking about your diabetes medication(s) over the past two weeks ... how embarrassed or awkward have you felt of taking your medication(s) as prescribed?
    Descripción

    embarrassed to take medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174033
    UMLS CUI [1,2]
    C0013216
    Thinking about your diabetes medication(s) over the past two weeks ... how worries have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
    Descripción

    worry med not show/prevent complication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0850735
    UMLS CUI [1,2]
    C0013216
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... be flexible with planning meals (when you eat and what you are able to eat)?
    Descripción

    Medication Interferes with meals

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C1998602
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... do your recommended physical activity or exercise?
    Descripción

    Medication Interferes with exercise

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0015259
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITh your ability to... follow your recommended diet?
    Descripción

    Medication Interferes with meals

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0012155
    Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how DISSATISFIED or SATISFIED have you been with your current diabetes medication(s)?
    Descripción

    Satisfaction with medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0242428
    UMLS CUI [1,2]
    C0013216
    Overall, based on your current experiences with your diabetes medication(s), how INTERESTED would you be to change the type of medication(s) you take or the way you take it, if it was possible?
    Descripción

    Overall Insterest to change medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0580105

    Similar models

    Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Date of Visit
    C1320303 (UMLS CUI-1)
    Visit date
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Physical Examination
    Item
    Was the physical examination performed? Record any abnormal findings/conditions identified during the exam on the appropriate form.
    boolean
    C0031809 (UMLS CUI [1])
    Assessment Date
    Item
    Assessment Date
    date
    C0031809 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Orthostatic vital signs
    C0518766 (UMLS CUI-1)
    Assessment
    Item
    Not Done:
    boolean
    C0518766 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Assessment Date
    Item
    Assessment Date
    date
    C0518766 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C2985720 (UMLS CUI [1,3])
    Assessment Time
    Item
    Assessment Time
    time
    C0518766 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Vital Signs Position
    integer
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Code List
    Vital Signs Position
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    Item
    Location of blood pressure measurement
    integer
    C0005823 (UMLS CUI [1])
    Code List
    Location of blood pressure measurement
    CL Item
    Right Arm (1)
    CL Item
    Left Arm (2)
    Systolic blood pressure
    Item
    Systolic blood pressure
    text
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    text
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse Rate
    text
    C0232117 (UMLS CUI [1])
    Item Group
    12 Lead ECG 1
    C0430456 (UMLS CUI [1])
    ECG Date
    Item
    Date ECG was performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    ECG time
    Item
    ECG Time performed
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    ECG Interpretation
    integer
    C1623258 (UMLS CUI [1,1])
    C0459471 (UMLS CUI [1,2])
    Code List
    ECG Interpretation
    CL Item
    Normal  (0 )
    CL Item
    Abnormal - not clinically significant  (1 )
    CL Item
    Abnormal - clinically significant (2 )
    Item Group
    Weight
    C0005910 (UMLS CUI-1)
    Assessment Date
    Item
    Assessment Date
    date
    C0005910 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Waist and Hip Circumference
    C0455829 (UMLS CUI-1)
    C0562350 (UMLS CUI-3)
    Waist circumference
    Item
    Waist circumference
    float
    C0455829 (UMLS CUI [1])
    Hip circumference
    Item
    Hip circumference
    float
    C0562350 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Item
    Select "Not done" if urine sample was not taken.
    integer
    Code List
    Select "Not done" if urine sample was not taken.
    CL Item
    Not done (Not done)
    Pregnancy Test: Date
    Item
    Date of Sample Taken
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    integer
    C0427777 (UMLS CUI [1])
    Code List
    Pregnancy test result
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    EQ-5D
    C2733251 (UMLS CUI-1)
    Item Group
    ADDQol
    Item Group
    Diab-MedSat
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Item
    Over the past two weeks how bothered have you been by the amount of home monitoring (blood sugar testing) required as part of using your medication(s)?
    integer
    C3174324 (UMLS CUI [1,1])
    C0005803 (UMLS CUI [1,2])
    Code List
    Over the past two weeks how bothered have you been by the amount of home monitoring (blood sugar testing) required as part of using your medication(s)?
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks how bothered have you been by the number of times you need to take your medication(s) daily?
    integer
    C3174324 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Code List
    Over the past two weeks how bothered have you been by the number of times you need to take your medication(s) daily?
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks how bothered have you been by the need to adjust the dosing (amount) of your medication(s)?
    integer
    C3174324 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Code List
    Over the past two weeks how bothered have you been by the need to adjust the dosing (amount) of your medication(s)?
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks how bothered have you been by how your medication(s) interferes with your daily life?
    integer
    C3174324 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Code List
    Over the past two weeks how bothered have you been by how your medication(s) interferes with your daily life?
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks how bothered have you been by any of the following due to your diabetes medication(s)? Unwanted weight gain
    integer
    C0043094 (UMLS CUI [1,1])
    C3174324 (UMLS CUI [1,2])
    Code List
    Over the past two weeks how bothered have you been by any of the following due to your diabetes medication(s)? Unwanted weight gain
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Pain or discomfort
    integer
    C3639378 (UMLS CUI [1,1])
    C3174324 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Pain or discomfort
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Gas and bloating
    integer
    C0946092 (UMLS CUI [1,1])
    C3174324 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Gas and bloating
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Diarrhea
    integer
    C0011991 (UMLS CUI [1,1])
    C3174324 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Diarrhea
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Symptoms of low blood sugar (trembling, sweating, dizziness or blurred vision)
    integer
    C1457887 (UMLS CUI [1,1])
    C0020615 (UMLS CUI [1,2])
    C3174324 (UMLS CUI [1,3])
    Code List
    Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)? - Symptoms of low blood sugar (trembling, sweating, dizziness or blurred vision)
    CL Item
    Not at all bothered  (1)
    C3828778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Slightly bothered  (2)
    C3831310 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Somewhat bothered  (3)
    C3831293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Very bothered  (4)
    C3831292 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Extremely bothered (5)
    C3830278 (UMLS CUI-1)
    (Comment:en)
    Item
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... keep your blood sugar levels stable (avoids highs and lows)?
    integer
    C0392201 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [1,3])
    C0242428 (UMLS CUI [1,4])
    Code List
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... keep your blood sugar levels stable (avoids highs and lows)?
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... help you from feeling tired and lacking energy?
    integer
    C0015672 (UMLS CUI [1,1])
    C0242428 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how DISSATISFIED or SATISFIED have you been with the ability of your diabetes medication(s) to ... help you from feeling tired and lacking energy?
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the ease and convenience of your diabetes medications
    integer
    C3831015 (UMLS CUI [1,1])
    C0242428 (UMLS CUI [1,2])
    Code List
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the ease and convenience of your diabetes medications
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your physical well being?
    integer
    C0018684 (UMLS CUI [1,1])
    C0242428 (UMLS CUI [1,2])
    Code List
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your physical well being?
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your emotional well being?
    integer
    C0025353 (UMLS CUI [1,1])
    C0242428 (UMLS CUI [1,2])
    Code List
    Overall over the past two weeks, how DISSATISFIED or SATISFIED have you been with ... the impact of your diabetes medication(s) on your emotional well being?
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Thinking about your diabetes medication(s) over the past two weeks ... how difficult has it been for your to plan your daily activities around your medication(s)?
    integer
    C0001288 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Code List
    Thinking about your diabetes medication(s) over the past two weeks ... how difficult has it been for your to plan your daily activities around your medication(s)?
    CL Item
    Not at all (1)
    CL Item
    Slightly (2)
    CL Item
    Somewhat (3)
    CL Item
    Very (4)
    CL Item
    Extremely (5)
    Item
    Thinking about your diabetes medication(s) over the past two weeks ... how much burden has it been for you to take your medication(s) as prescribed?
    integer
    C2828008 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Code List
    Thinking about your diabetes medication(s) over the past two weeks ... how much burden has it been for you to take your medication(s) as prescribed?
    CL Item
    Not at all (1)
    CL Item
    Slightly (2)
    CL Item
    Somewhat (3)
    CL Item
    Very (4)
    CL Item
    Extremely (5)
    Item
    Thinking about your diabetes medication(s) over the past two weeks ... how embarrassed or awkward have you felt of taking your medication(s) as prescribed?
    integer
    C3174033 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Code List
    Thinking about your diabetes medication(s) over the past two weeks ... how embarrassed or awkward have you felt of taking your medication(s) as prescribed?
    CL Item
    Not at all (1)
    CL Item
    Slightly (2)
    CL Item
    Somewhat (3)
    CL Item
    Very (4)
    CL Item
    Extremely (5)
    Item
    Thinking about your diabetes medication(s) over the past two weeks ... how worries have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
    integer
    C0850735 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Code List
    Thinking about your diabetes medication(s) over the past two weeks ... how worries have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
    CL Item
    Not at all (1)
    CL Item
    Slightly (2)
    CL Item
    Somewhat (3)
    CL Item
    Very (4)
    CL Item
    Extremely (5)
    Item
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... be flexible with planning meals (when you eat and what you are able to eat)?
    integer
    C0013216 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... be flexible with planning meals (when you eat and what you are able to eat)?
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    All the time (5)
    Item
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... do your recommended physical activity or exercise?
    integer
    C0013216 (UMLS CUI [1,1])
    C0015259 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITH your ability to... do your recommended physical activity or exercise?
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    All the time (5)
    Item
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITh your ability to... follow your recommended diet?
    integer
    C0013216 (UMLS CUI [1,1])
    C0012155 (UMLS CUI [1,2])
    Code List
    Over the past two weeks, how often has taking your diabetes medication(s) as prescribed INTERFERED WITh your ability to... follow your recommended diet?
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    All the time (5)
    Item
    Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how DISSATISFIED or SATISFIED have you been with your current diabetes medication(s)?
    integer
    C0242428 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Code List
    Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how DISSATISFIED or SATISFIED have you been with your current diabetes medication(s)?
    CL Item
    Extremely dissatisfied  (1)
    CL Item
    Very dissatisfied (2)
    CL Item
    Slightly dissatisfied (3)
    CL Item
    Neither dissatisfied or satisfied (4)
    CL Item
    Slightly satisfied (5)
    CL Item
    Very satisfied (6)
    CL Item
    Extremely satisfied (7)
    Item
    Overall, based on your current experiences with your diabetes medication(s), how INTERESTED would you be to change the type of medication(s) you take or the way you take it, if it was possible?
    integer
    C0013216 (UMLS CUI [1,1])
    C0580105 (UMLS CUI [1,2])
    Code List
    Overall, based on your current experiences with your diabetes medication(s), how INTERESTED would you be to change the type of medication(s) you take or the way you take it, if it was possible?
    CL Item
    Not at all interested (1)
    CL Item
    Slightly interested (2)
    CL Item
    Somewhat interested (3)
    CL Item
    Very interested (4)
    CL Item
    Extremely interested (5)

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