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ID

17304

Beschrijving

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00604656

Link

https://clinicaltrials.gov/show/NCT00604656

Trefwoorden

  1. 06-09-16 06-09-16 -
Geüploaded op

6 september 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Diabetes NCT00604656

    Eligibility Diabetes NCT00604656

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects with type 1 diabetes
    Beschrijving

    Diabetes Mellitus, Insulin-Dependent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    duration of diabetes for at least 12 months
    Beschrijving

    Diabetes disease length

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0011847
    UMLS CUI [1,2]
    C0872146
    treatment with insulin aspart for at least 3 months before trial start
    Beschrijving

    Insulin Aspart

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1708521
    body mass index (bmi) below 35.0 kg/m2
    Beschrijving

    Body mass index

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    hba1c below 12.0%
    Beschrijving

    Glycosylated hemoglobin A

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    total insulin dosage more than 1.4 iu/kg/day
    Beschrijving

    Insulin Dosage Total U/kg/day

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021641
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0439810
    UMLS CUI [1,4]
    C1532634
    recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
    Beschrijving

    Recurrent severe hypoglycemia Interferes with Study Subject Participation Status

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0342316
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C2348568
    known hypoglycaemia unawareness as judged by the investigator
    Beschrijving

    Loss of hypoglycemic warning

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0342317
    known hypersensitivity or allergy
    Beschrijving

    Hypersensitivity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0020517

    Similar models

    Eligibility Diabetes NCT00604656

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    subjects with type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    Diabetes disease length
    Item
    duration of diabetes for at least 12 months
    boolean
    C0011847 (UMLS CUI [1,1])
    C0872146 (UMLS CUI [1,2])
    Insulin Aspart
    Item
    treatment with insulin aspart for at least 3 months before trial start
    boolean
    C1708521 (UMLS CUI [1])
    Body mass index
    Item
    body mass index (bmi) below 35.0 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Glycosylated hemoglobin A
    Item
    hba1c below 12.0%
    boolean
    C0019018 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Insulin Dosage Total U/kg/day
    Item
    total insulin dosage more than 1.4 iu/kg/day
    boolean
    C0021641 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    C1532634 (UMLS CUI [1,4])
    Recurrent severe hypoglycemia Interferes with Study Subject Participation Status
    Item
    recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
    boolean
    C0342316 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Loss of hypoglycemic warning
    Item
    known hypoglycaemia unawareness as judged by the investigator
    boolean
    C0342317 (UMLS CUI [1])
    Hypersensitivity
    Item
    known hypersensitivity or allergy
    boolean
    C0020517 (UMLS CUI [1])

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