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ID

17300

Beskrivning

Efficacy and Safety of Insulin Detemir in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00595374

Länk

https://clinicaltrials.gov/show/NCT00595374

Nyckelord

Versioner (1)
  1. 2016-09-05 2016-09-05 -
Uppladdad den

5 september 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Diabetes NCT00595374

    Engelsk

    Eligibility Diabetes NCT00595374

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00595374
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    duration of type 1 diabetes for at least 12 months
    Beskrivning

    Insulin-Dependent Diabetes Mellitus disease length

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011854 (Diabetes Mellitus, Insulin-Dependent)
    SNOMED
    46635009
    UMLS CUI [1,2]
    C0872146 (disease length)
    bmi below 35 kg/m2
    Beskrivning

    Body mass index

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    hba1c between 7.0-12.0%
    Beskrivning

    Glycosylated hemoglobin A

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019018 (Glycosylated hemoglobin A)
    LOINC
    LP16413-4
    current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
    Beskrivning

    Short-Acting Insulin ante cibus U/day | insulin isophane U/day

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0356365 (Insulin, Short-Acting)
    UMLS CUI [1,2]
    C1550738 (ante cibus)
    SNOMED
    307165006
    UMLS CUI [1,3]
    C0456683 (U/day)
    SNOMED
    258950000
    UMLS CUI [2,1]
    C0021658 (insulin isophane)
    SNOMED
    412219004
    UMLS CUI [2,2]
    C0456683 (U/day)
    SNOMED
    258950000
    fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
    Beskrivning

    Childbearing Potential Contraceptive methods | Risk of Pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2]
    C4048193 (undefined)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    known or suspected allergy to trial product or related products
    Beskrivning

    Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2,3]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [2,4]
    C0013230 (Investigational New Drugs)
    previous participation in this trial
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    receipt of any investigational products within the last 2 months prior to this trial
    Beskrivning

    Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    drug or alcohol dependence
    Beskrivning

    Substance Dependence

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038580 (Substance Dependence)
    pregnancy, breast-feeding or intention of becoming pregnant
    Beskrivning

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3]
    C0032992 (Pregnancy, Planned)
    SNOMED
    169565003
    Tillbaka till toppen

    Similar models

    Eligibility Diabetes NCT00595374

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00595374
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Insulin-Dependent Diabetes Mellitus disease length
    Item
    duration of type 1 diabetes for at least 12 months
    boolean
    C0011854 (UMLS CUI [1,1])
    C0872146 (UMLS CUI [1,2])
    Body mass index
    Item
    bmi below 35 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Glycosylated hemoglobin A
    Item
    hba1c between 7.0-12.0%
    boolean
    C0019018 (UMLS CUI [1])
    Short-Acting Insulin ante cibus U/day | insulin isophane U/day
    Item
    current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
    boolean
    C0356365 (UMLS CUI [1,1])
    C1550738 (UMLS CUI [1,2])
    C0456683 (UMLS CUI [1,3])
    C0021658 (UMLS CUI [2,1])
    C0456683 (UMLS CUI [2,2])
    Childbearing Potential Contraceptive methods | Risk of Pregnancy
    Item
    fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C4048193 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
    Item
    known or suspected allergy to trial product or related products
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C0439849 (UMLS CUI [2,3])
    C0013230 (UMLS CUI [2,4])
    Study Subject Participation Status
    Item
    previous participation in this trial
    boolean
    C2348568 (UMLS CUI [1])
    Investigational New Drugs
    Item
    receipt of any investigational products within the last 2 months prior to this trial
    boolean
    C0013230 (UMLS CUI [1])
    Substance Dependence
    Item
    drug or alcohol dependence
    boolean
    C0038580 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    pregnancy, breast-feeding or intention of becoming pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Tillbaka till toppen 

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