ID

44883

Description

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 Mellitus Visit 4

Keywords

Versions (4)
  1. 9/1/16 9/1/16 -
  2. 9/28/16 9/28/16 -
  3. 9/28/16 9/28/16 -
  4. 2/19/22 2/19/22 - Martin Dugas
Copyright Holder

Astellas Pharma Inc

Uploaded on

February 19, 2022

DOI

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License

Creative Commons BY-NC 4.0
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Visit 4 iabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

English

Visit 4 iabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Physical Examination
Description

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.
Description

Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0031809
Assessment Date
Description

Assessment Date

Data type

date

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

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Not Done:
Description

Assessment

Data type

boolean

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

Assessment Date

Data type

date

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

Assessment Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
Position
Description

Vital Signs

Data type

integer

Alias
UMLS CUI [1]
C0518766
Location of blood pressure measurement
Description

Location of blood pressure measurement

Data type

integer

Alias
UMLS CUI [1]
C1651662
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Data type

text

Measurement units
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
12 Lead ECG 1
Description

12 Lead ECG 1

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

ECG Date

Data type

date

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

ECG time

Data type

time

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

ECG Interpretation

Data type

integer

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

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Description

Assessment Date

Data type

date

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist and Hip Circumference
Description

Waist and Hip Circumference

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

Waist circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip circumference
Description

Hip circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Pregnancy Test
Description

Pregnancy Test

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

Urine Sample

Data type

integer

Date of Sample Taken
Description

Pregnancy Test: Date

Data type

date

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

Pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
Randomization
Description

Randomization

Alias
UMLS CUI-1
C0034656
Was Randomized Study Drug Dispensed
Description

Randomized Study Drug Dispensed

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Date of Randomization
Description

Date of Randomization

Data type

date

Alias
UMLS CUI [1]
C0034656
Date of First Study Drug Taken
Description

Date of First Study Drug Taken

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C3899436
dd/MMM/yyyy
EQ-5D
Description

EQ-5D

Alias
UMLS CUI-1
C2733251
Anxiety / Depression
Description

Anxiety / Depression

Data type

text

Alias
UMLS CUI [1]
C0003467
UMLS CUI [2]
C0011581
ADDQol
Description

ADDQol

Diab-MedSat
Description

Diab-MedSat

Assessment Date
Description

Assessment Date

Data type

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)?
Description

Bothered, Blood sugar testing

Data type

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?
Description

bothered, medication

Data type

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)?
Description

bothered, adjusting medication

Data type

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?
Description

bothered medication interference

Data type

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
Description

weight gain bothered

Data type

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
Description

pain or discomfort

Data type

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
Description

gas and bloating

Data type

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
Description

diarrhea

Data type

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)
Description

low blood sugar

Data type

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)?
Description

blood glucose stable

Data type

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?
Description

lack of energy

Data type

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
Description

convenience

Data type

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?
Description

physical well being

Data type

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?
Description

emotional well being

Data type

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)?
Description

daily activities

Data type

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?
Description

burden to take medication

Data type

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?
Description

embarrassed to take medication

Data type

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?
Description

worry med not show/prevent complication

Data type

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)?
Description

Medication Interferes with meals

Data type

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?
Description

Medication Interferes with exercise

Data type

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... be flexible with planning meals (when you eat and what you are able to eat)?
Description

Medication Interferes with meals

Data type

integer

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1998602
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)?
Description

Satisfaction with medication

Data type

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?
Description

Overall Insterest to change medication

Data type

integer

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

Visit 4 iabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Position
integer
C0518766 (UMLS CUI [1])
Vital Signs
Code List
Position
CL Item
Sitting (1)
CL Item
Standing (2)
Item
Location of blood pressure measurement
integer
C1651662 (UMLS CUI [1])
Location of blood pressure measurement
Code List
Location of blood pressure measurement
CL Item
Right Arm (1)
CL Item
Left Arm (2)
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
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])
ECG Interpretation
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
Urine Sample
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])
Pregnancy test
Code List
Pregnancy test result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Randomization
C0034656 (UMLS CUI-1)
Randomized Study Drug Dispensed
Item
Was Randomized Study Drug Dispensed
boolean
C0034656 (UMLS CUI [1])
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1])
Date of First Study Drug Taken
Item
Date of First Study Drug Taken
date
C3899436 (UMLS CUI [1])
Item Group
EQ-5D
C2733251 (UMLS CUI-1)
Anxiety / Depression
Item
text
C0003467 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
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])
Bothered, Blood sugar testing
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
bothered, medication
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
bothered, adjusting medication
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
bothered medication interference
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
weight gain bothered
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
pain or discomfort
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
gas and bloating
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
diarrhea
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
low blood sugar
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)
CL Item
Slightly bothered  (2)
CL Item
Somewhat bothered  (3)
CL Item
Very bothered  (4)
CL Item
Extremely bothered (5)
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])
blood glucose stable
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])
lack of energy
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])
convenience
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])
physical well being
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])
emotional well being
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])
daily activities
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])
burden to take medication
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])
embarrassed to take medication
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])
worry med not show/prevent complication
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])
Medication Interferes with meals
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])
Medication Interferes with exercise
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... 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])
Medication Interferes with meals
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
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])
Satisfaction with medication
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])
Overall Insterest to change medication
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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