0 Ratings
ID

17304

Description

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

Keywords

Versions (1)
  1. 9/6/16 9/6/16 -
Uploaded on

September 6, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Diabetes NCT00604656

    English

    Eligibility Diabetes NCT00604656

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects with type 1 diabetes
    Description

    Diabetes Mellitus, Insulin-Dependent

    Data type

    boolean

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

    Diabetes disease length

    Data type

    boolean

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

    Insulin Aspart

    Data type

    boolean

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

    Body mass index

    Data type

    boolean

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

    Glycosylated hemoglobin A

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Insulin Dosage Total U/kg/day

    Data type

    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)
    Description

    Recurrent severe hypoglycemia Interferes with Study Subject Participation Status

    Data type

    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
    Description

    Loss of hypoglycemic warning

    Data type

    boolean

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

    Hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020517
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    Similar models

    Eligibility Diabetes NCT00604656

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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