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ID

17159

Descrizione

Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children; ODM derived from: https://clinicaltrials.gov/show/NCT00069615

collegamento

https://clinicaltrials.gov/show/NCT00069615

Keywords

  1. 29/08/16 29/08/16 -
Caricato su

29 agosto 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of type 1 diabetes
    Descrizione

    Diabetes Mellitus, Insulin-Dependent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    duration of diabetes > 1 year
    Descrizione

    Diabetes disease length

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0011847
    UMLS CUI [1,2]
    C0872146
    daily insulin therapy (pump or at least 2 injections/day)
    Descrizione

    Insulin regime Daily | Insulin pump | Insulin injection Quantity Daily

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0557978
    UMLS CUI [1,2]
    C0332173
    UMLS CUI [2]
    C1140609
    UMLS CUI [3,1]
    C0199782
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0332173
    stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)
    Descrizione

    Insulin regime Stable status | Administration of insulin Modality Change | injection of insulin | Insulin pump

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0557978
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [2,1]
    C0199782
    UMLS CUI [2,2]
    C0695347
    UMLS CUI [2,3]
    C0392747
    UMLS CUI [3]
    C0586328
    UMLS CUI [4]
    C1140609
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    the presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
    Descrizione

    Skin Abnormalities Affecting Protocol Compliance | Disease Significant Affecting Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0037268
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0750502
    UMLS CUI [2,3]
    C0392760
    UMLS CUI [2,4]
    C0525058
    prior use of a gwb prescribed for home use (prior use of a gwb as part of a research study is allowable)
    Descrizione

    Blood glucose measurement Investigational Medical Device Use of

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0392201
    UMLS CUI [1,2]
    C2346570
    UMLS CUI [1,3]
    C1524063
    the presence of any of the following diseases:
    Descrizione

    Disease Presence

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0150312
    asthma if treated with systemic or inhaled corticosteroids in the last 6 months
    Descrizione

    Asthma | systemic steroids | inhaled steroids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    UMLS CUI [2]
    C2825233
    UMLS CUI [3]
    C2065041
    cystic fibrosis
    Descrizione

    Cystic Fibrosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0010674
    other major illness that in the judgment of the investigator might interfere with the completion of the protocol
    Descrizione

    Illness Major Interferes with Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C0525058
    adequately treated thyroid disease and celiac disease do not exclude
    Descrizione

    Therapeutic procedure Adequate Thyroid Diseases | Therapeutic procedure Adequate Celiac Disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0205411
    UMLS CUI [1,3]
    C0040128
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0205411
    UMLS CUI [2,3]
    C0007570
    inpatient psychiatric treatment in the past 6 months for either the subject or the subject’s primary care giver (i.e., parent or guardian).
    Descrizione

    inpatient psychiatric therapy | inpatient psychiatric therapy Caregiver Primary | inpatient psychiatric therapy parent | inpatient psychiatric therapy Guardian

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2142969
    UMLS CUI [2,1]
    C2142969
    UMLS CUI [2,2]
    C0085537
    UMLS CUI [2,3]
    C0205225
    UMLS CUI [3,1]
    C2142969
    UMLS CUI [3,2]
    C0030551
    UMLS CUI [4,1]
    C2142969
    UMLS CUI [4,2]
    C1274041
    current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
    Descrizione

    Pharmaceutical Preparations Medical contraindication Study Subject Participation Status | Glucocorticoids Oral | Glucocorticoids Inhalation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1301624
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [2,1]
    C0017710
    UMLS CUI [2,2]
    C1527415
    UMLS CUI [3,1]
    C0017710
    UMLS CUI [3,2]
    C0205535

    Similar models

    Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    diagnosis of type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    Diabetes disease length
    Item
    duration of diabetes > 1 year
    boolean
    C0011847 (UMLS CUI [1,1])
    C0872146 (UMLS CUI [1,2])
    Insulin regime Daily | Insulin pump | Insulin injection Quantity Daily
    Item
    daily insulin therapy (pump or at least 2 injections/day)
    boolean
    C0557978 (UMLS CUI [1,1])
    C0332173 (UMLS CUI [1,2])
    C1140609 (UMLS CUI [2])
    C0199782 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0332173 (UMLS CUI [3,3])
    Insulin regime Stable status | Administration of insulin Modality Change | injection of insulin | Insulin pump
    Item
    stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)
    boolean
    C0557978 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0199782 (UMLS CUI [2,1])
    C0695347 (UMLS CUI [2,2])
    C0392747 (UMLS CUI [2,3])
    C0586328 (UMLS CUI [3])
    C1140609 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Skin Abnormalities Affecting Protocol Compliance | Disease Significant Affecting Protocol Compliance
    Item
    the presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
    boolean
    C0037268 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C0392760 (UMLS CUI [2,3])
    C0525058 (UMLS CUI [2,4])
    Blood glucose measurement Investigational Medical Device Use of
    Item
    prior use of a gwb prescribed for home use (prior use of a gwb as part of a research study is allowable)
    boolean
    C0392201 (UMLS CUI [1,1])
    C2346570 (UMLS CUI [1,2])
    C1524063 (UMLS CUI [1,3])
    Disease Presence
    Item
    the presence of any of the following diseases:
    boolean
    C0012634 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    Asthma | systemic steroids | inhaled steroids
    Item
    asthma if treated with systemic or inhaled corticosteroids in the last 6 months
    boolean
    C0004096 (UMLS CUI [1])
    C2825233 (UMLS CUI [2])
    C2065041 (UMLS CUI [3])
    Cystic Fibrosis
    Item
    cystic fibrosis
    boolean
    C0010674 (UMLS CUI [1])
    Illness Major Interferes with Protocol Compliance
    Item
    other major illness that in the judgment of the investigator might interfere with the completion of the protocol
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0521102 (UMLS CUI [1,3])
    C0525058 (UMLS CUI [1,4])
    Therapeutic procedure Adequate Thyroid Diseases | Therapeutic procedure Adequate Celiac Disease
    Item
    adequately treated thyroid disease and celiac disease do not exclude
    boolean
    C0087111 (UMLS CUI [1,1])
    C0205411 (UMLS CUI [1,2])
    C0040128 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C0205411 (UMLS CUI [2,2])
    C0007570 (UMLS CUI [2,3])
    inpatient psychiatric therapy | inpatient psychiatric therapy Caregiver Primary | inpatient psychiatric therapy parent | inpatient psychiatric therapy Guardian
    Item
    inpatient psychiatric treatment in the past 6 months for either the subject or the subject’s primary care giver (i.e., parent or guardian).
    boolean
    C2142969 (UMLS CUI [1])
    C2142969 (UMLS CUI [2,1])
    C0085537 (UMLS CUI [2,2])
    C0205225 (UMLS CUI [2,3])
    C2142969 (UMLS CUI [3,1])
    C0030551 (UMLS CUI [3,2])
    C2142969 (UMLS CUI [4,1])
    C1274041 (UMLS CUI [4,2])
    Pharmaceutical Preparations Medical contraindication Study Subject Participation Status | Glucocorticoids Oral | Glucocorticoids Inhalation
    Item
    current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
    boolean
    C0013227 (UMLS CUI [1,1])
    C1301624 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C0017710 (UMLS CUI [2,1])
    C1527415 (UMLS CUI [2,2])
    C0017710 (UMLS CUI [3,1])
    C0205535 (UMLS CUI [3,2])

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