ID

15283

Beskrivning

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01697657

Länk

https://clinicaltrials.gov/show/NCT01697657

Nyckelord

  1. 2016-05-24 2016-05-24 -
Uppladdad den

24 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Diabetes NCT01697657

    Eligibility Diabetes NCT01697657

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01697657
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 1 diabetes
    Beskrivning

    type 1 diabetes

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    fasting c-peptide below lower limit of normal fasting range
    Beskrivning

    fasting c-peptide

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2208720
    duration of type 1 diabetes for at least 12 months
    Beskrivning

    duration of diabetes

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0872146
    UMLS CUI [1,2]
    C0011854
    current treatment: basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
    Beskrivning

    current treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    hba1c maximum 9.0% (using biorad variant method)
    Beskrivning

    hba1c

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    able and willing to perform self-monitoring of blood glucose
    Beskrivning

    blood glucose

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0202042
    basal insulin requirement at least 30% of the total daily insulin dose
    Beskrivning

    basal insulin requirement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0650607
    bmi (body mass index) maximum 35 kg/m^2
    Beskrivning

    BMI

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    proliferative retinopathy or maculopathy requiring acute treatment
    Beskrivning

    retinopathy or maculopathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0035309
    UMLS CUI [2]
    C0730362
    total daily insulin dose above 1.4 iu/kg/day
    Beskrivning

    insulin dose

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021641
    known unawareness of hypoglycaemia
    Beskrivning

    unawareness of hypoglycaemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0342317
    impaired hepatic function
    Beskrivning

    impaired hepatic function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    impaired renal function
    Beskrivning

    impaired renal function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    cardiac problems
    Beskrivning

    cardiac problems

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0262402
    uncontrolled, treated/untreated hypertension
    Beskrivning

    hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    known or suspected allergy to trial product or related products
    Beskrivning

    allergy to trial product

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C3854006

    Similar models

    Eligibility Diabetes NCT01697657

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01697657
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    type 1 diabetes
    Item
    type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    fasting c-peptide
    Item
    fasting c-peptide below lower limit of normal fasting range
    boolean
    C2208720 (UMLS CUI [1])
    duration of diabetes
    Item
    duration of type 1 diabetes for at least 12 months
    boolean
    C0872146 (UMLS CUI [1,1])
    C0011854 (UMLS CUI [1,2])
    current treatment
    Item
    current treatment: basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
    boolean
    C0087111 (UMLS CUI [1])
    hba1c
    Item
    hba1c maximum 9.0% (using biorad variant method)
    boolean
    C0019018 (UMLS CUI [1])
    blood glucose
    Item
    able and willing to perform self-monitoring of blood glucose
    boolean
    C0202042 (UMLS CUI [1])
    basal insulin requirement
    Item
    basal insulin requirement at least 30% of the total daily insulin dose
    boolean
    C0650607 (UMLS CUI [1])
    BMI
    Item
    bmi (body mass index) maximum 35 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    retinopathy or maculopathy
    Item
    proliferative retinopathy or maculopathy requiring acute treatment
    boolean
    C0035309 (UMLS CUI [1])
    C0730362 (UMLS CUI [2])
    insulin dose
    Item
    total daily insulin dose above 1.4 iu/kg/day
    boolean
    C0021641 (UMLS CUI [1])
    unawareness of hypoglycaemia
    Item
    known unawareness of hypoglycaemia
    boolean
    C0342317 (UMLS CUI [1])
    impaired hepatic function
    Item
    impaired hepatic function
    boolean
    C0232741 (UMLS CUI [1])
    impaired renal function
    Item
    impaired renal function
    boolean
    C0232804 (UMLS CUI [1])
    cardiac problems
    Item
    cardiac problems
    boolean
    C0262402 (UMLS CUI [1])
    hypertension
    Item
    uncontrolled, treated/untreated hypertension
    boolean
    C0020538 (UMLS CUI [1])
    allergy to trial product
    Item
    known or suspected allergy to trial product or related products
    boolean
    C0020517 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])

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