ID

35749

Description

GLUCOME USABILITY STUDY; ODM derived from: https://clinicaltrials.gov/show/NCT02488278

Link

https://clinicaltrials.gov/show/NCT02488278

Keywords

Versions (1)
  1. 3/20/19 3/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT02488278

English

Eligibility Diabetes Mellitus, Type 1 NCT02488278

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is male or female equal to or greater than 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject is a potential candidate for purchasing the glucome device (e.g., subjects diagnosed with diabetes type 1 or 2).
Description

Patient Appropriate Glucose measurement device | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0202048
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
3. subject has facility with both hands.
Description

Handedness Both hands

Data type

boolean

Alias
UMLS CUI [1,1]
C0023114
UMLS CUI [1,2]
C0230377
4. subject monitors himself.
Description

Self Monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0588436
5. subject knows how to download and install apps.
Description

Computer Application Experience

Data type

boolean

Alias
UMLS CUI [1,1]
C0870325
UMLS CUI [1,2]
C0596545
6. subject is capable of understanding and is willing to sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has dementia.
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
2. subject has mental disorders.
Description

Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
3. subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
Description

Diabetes | Exception Insulin-Dependent Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus | Gestational Diabetes | Congenital diabetes | Drug-induced diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011854
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011860
UMLS CUI [4]
C0085207
UMLS CUI [5]
C1393628
UMLS CUI [6]
C0271646
4. subject does not monitor himself.
Description

Self Monitoring Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0588436
UMLS CUI [1,2]
C0332197
5. subject is visually impaired.
Description

Visual Impairment

Data type

boolean

Alias
UMLS CUI [1]
C3665347
6. subject cannot draw blood samples from fingertip.
Description

Blood draw Fingertip Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0729895
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT02488278

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is male or female equal to or greater than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Patient Appropriate Glucose measurement device | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
2. subject is a potential candidate for purchasing the glucome device (e.g., subjects diagnosed with diabetes type 1 or 2).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0202048 (UMLS CUI [1,3])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Handedness Both hands
Item
3. subject has facility with both hands.
boolean
C0023114 (UMLS CUI [1,1])
C0230377 (UMLS CUI [1,2])
Self Monitoring
Item
4. subject monitors himself.
boolean
C0588436 (UMLS CUI [1])
Computer Application Experience
Item
5. subject knows how to download and install apps.
boolean
C0870325 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
Informed Consent
Item
6. subject is capable of understanding and is willing to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Dementia
Item
1. subject has dementia.
boolean
C0497327 (UMLS CUI [1])
Mental disorders
Item
2. subject has mental disorders.
boolean
C0004936 (UMLS CUI [1])
Diabetes | Exception Insulin-Dependent Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus | Gestational Diabetes | Congenital diabetes | Drug-induced diabetes mellitus
Item
3. subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
boolean
C0011847 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
C0085207 (UMLS CUI [4])
C1393628 (UMLS CUI [5])
C0271646 (UMLS CUI [6])
Self Monitoring Absent
Item
4. subject does not monitor himself.
boolean
C0588436 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Visual Impairment
Item
5. subject is visually impaired.
boolean
C3665347 (UMLS CUI [1])
Blood draw Fingertip Unable
Item
6. subject cannot draw blood samples from fingertip.
boolean
C0005834 (UMLS CUI [1,1])
C0729895 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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