0 Ratings

ID

17162

Description

Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer; ODM derived from: https://clinicaltrials.gov/show/NCT00069628

Link

https://clinicaltrials.gov/show/NCT00069628

Keywords

  1. 8/29/16 8/29/16 -
Uploaded on

August 29, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    clinical diagnosis of type 1 diabetes
    Description

    Diabetes Mellitus, Insulin-Dependent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
    Description

    Insulin regime | Insulin pump | Administration of insulin Quantity Daily

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0557978
    UMLS CUI [2]
    C1140609
    UMLS CUI [3,1]
    C0199782
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0332173
    hba1c between 7.0 and 11.0%
    Description

    Glycosylated hemoglobin A

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    stable insulin regimen for the 2 months prior to study entry and no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of lantus [glargine] insulin)
    Description

    Insulin regime Stable | Administration of insulin Change Planned | Injection | Insulin pump | Insulin Glargine [Lantus] Additive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0557978
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [2,1]
    C0199782
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [2,3]
    C1301732
    UMLS CUI [3]
    C1828121
    UMLS CUI [4]
    C1140609
    UMLS CUI [5,1]
    C1236501
    UMLS CUI [5,2]
    C0442796
    agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
    Description

    Protocol Compliance | blood glucose determination by fingerstick Quantity per day | Home blood glucose monitor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2,1]
    C2022094
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0439505
    UMLS CUI [3]
    C0917953
    comprehend written english
    Description

    Comprehension English Language Written

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0233733
    UMLS CUI [1,2]
    C0376245
    UMLS CUI [1,3]
    C0681288
    female participants must not intend to become pregnant during the next 6 months
    Description

    Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032992
    plan to remain in the area of the clinical center during the next 6 months
    Description

    Home Remaining Clinic Region

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0442519
    UMLS CUI [1,2]
    C1527428
    UMLS CUI [1,3]
    C0442592
    UMLS CUI [1,4]
    C0017446

    Similar models

    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    clinical diagnosis of type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    Insulin regime | Insulin pump | Administration of insulin Quantity Daily
    Item
    insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
    boolean
    C0557978 (UMLS CUI [1])
    C1140609 (UMLS CUI [2])
    C0199782 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0332173 (UMLS CUI [3,3])
    Glycosylated hemoglobin A
    Item
    hba1c between 7.0 and 11.0%
    boolean
    C0019018 (UMLS CUI [1])
    Insulin regime Stable | Administration of insulin Change Planned | Injection | Insulin pump | Insulin Glargine [Lantus] Additive
    Item
    stable insulin regimen for the 2 months prior to study entry and no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of lantus [glargine] insulin)
    boolean
    C0557978 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0199782 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C1301732 (UMLS CUI [2,3])
    C1828121 (UMLS CUI [3])
    C1140609 (UMLS CUI [4])
    C1236501 (UMLS CUI [5,1])
    C0442796 (UMLS CUI [5,2])
    Protocol Compliance | blood glucose determination by fingerstick Quantity per day | Home blood glucose monitor
    Item
    agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
    boolean
    C0525058 (UMLS CUI [1])
    C2022094 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0439505 (UMLS CUI [2,3])
    C0917953 (UMLS CUI [3])
    Comprehension English Language Written
    Item
    comprehend written english
    boolean
    C0233733 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    C0681288 (UMLS CUI [1,3])
    Pregnancy, Planned
    Item
    female participants must not intend to become pregnant during the next 6 months
    boolean
    C0032992 (UMLS CUI [1])
    Home Remaining Clinic Region
    Item
    plan to remain in the area of the clinical center during the next 6 months
    boolean
    C0442519 (UMLS CUI [1,1])
    C1527428 (UMLS CUI [1,2])
    C0442592 (UMLS CUI [1,3])
    C0017446 (UMLS CUI [1,4])

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