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17304

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.09.16 06.09.16 -
Hochgeladen am

6. September 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Diabetes NCT00604656

    Englisch

    Eligibility Diabetes NCT00604656

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects with type 1 diabetes
    Beschreibung

    Diabetes Mellitus, Insulin-Dependent

    Datentyp

    boolean

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

    Diabetes disease length

    Datentyp

    boolean

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

    Insulin Aspart

    Datentyp

    boolean

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

    Body mass index

    Datentyp

    boolean

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

    Glycosylated hemoglobin A

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

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

    Insulin Dosage Total U/kg/day

    Datentyp

    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)
    Beschreibung

    Recurrent severe hypoglycemia Interferes with Study Subject Participation Status

    Datentyp

    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
    Beschreibung

    Loss of hypoglycemic warning

    Datentyp

    boolean

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

    Hypersensitivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Diabetes NCT00604656

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00604656
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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