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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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