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44639

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01134107

Länk

http://clinicaltrials.gov/show/NCT01134107

Nyckelord

Versioner (4)
  1. 2013-12-06 2013-12-06 - Martin Dugas
  2. 2013-12-06 2013-12-06 - Martin Dugas
  3. 2014-04-17 2014-04-17 - Julian Varghese
  4. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

DOI

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Creative Commons BY 4.0
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    Eligibility NCT01134107 Diabetes Mellitus, Type 1

    Tysk Engelsk

    Eligibility

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beskrivning

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 13 Jahre
    Beskrivning

    age at least 13 Years

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
    Beskrivning

    Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0011854
    SNOMED CT 2011_0131
    46635009
    MedDRA 14.1
    10067584
    LOINC Version 232
    MTHU020217
    ICD-10-CM Version 2010
    E10
    UMLS CUI 2011AA
    C0451584
    SNOMED CT 2011_0131
    273931002
    Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
    Beskrivning

    Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL415147
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C0586328
    SNOMED CT 2011_0131
    308755006
    Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir
    Beskrivning

    Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0444504
    SNOMED CT 2011_0131
    255586005
    UMLS CUI 2011AA
    C2348070
    UMLS CUI 2011AA
    C0021641
    SNOMED CT 2011_0131
    67866001
    LOINC Version 232
    MTHU019392
    UMLS CUI 2011AA
    C1519795
    UMLS CUI 2011AA
    C1289877
    Baseline body mass index (BMI) <= 35.0 kg/m2
    Beskrivning

    Baseline body mass index (BMI) <= 35.0 kg/m2

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1305855
    SNOMED CT 2011_0131
    140075008
    MedDRA 14.1
    10005894
    LOINC Version 232
    LP35925-4
    Baseline HbA1c 5% to 9%
    Beskrivning

    Baseline HbA1c 5% to 9%

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1442488
    UMLS CUI 2011AA
    C0019018
    SNOMED CT 2011_0131
    33601001
    LOINC Version 232
    MTHU018890
    Ausschlusskriterien
    Beskrivning

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
    Beskrivning

    Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C0005803
    SNOMED CT 2011_0131
    308113006
    Impaired renal function (serum creatinine >= 2.0 mg/dl)
    Beskrivning

    Impaired renal function (serum creatinine >= 2.0 mg/dl)

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1565489
    SNOMED CT 2011_0131
    236423003
    MedDRA 14.1
    10062237
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    gesetzliche Blindheit
    Beskrivning

    Legal blindness

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0271215
    SNOMED CT 2011_0131
    65956007
    Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
    Beskrivning

    Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0332189
    SNOMED CT 2011_0131
    272128006
    UMLS CUI 2011AA
    C0020617
    SNOMED CT 2011_0131
    267384006
    MedDRA 14.1
    10021000
    ICD-10-CM Version 2010
    E15
    ICD-9-CM Version 2011
    251.0
    UMLS CUI 2011AA
    C0036572
    SNOMED CT 2011_0131
    91175000
    MedDRA 14.1
    10039910
    ICD-9-CM Version 2011
    780.39
    UMLS CUI 2011AA
    C0233407
    SNOMED CT 2011_0131
    62476001
    MedDRA 14.1
    10013395
    LOINC Version 232
    MTHU013516
    ICD-10-CM Version 2010
    R41.0
    Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
    Beskrivning

    Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0342317
    MedDRA 14.1
    10020997
    UMLS CUI 2011AA
    C0205547
    SNOMED CT 2011_0131
    50811001
    UMLS CUI 2011AA
    C0231221
    SNOMED CT 2011_0131
    84387000
    UMLS CUI 2011AA
    C0005802
    Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
    Beskrivning

    Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1546435
    HL7 V3 2006_05
    ER
    UMLS CUI 2011AA
    C1512346
    HL7 V3 2006_05
    ENC
    UMLS CUI 2011AA
    C0019993
    SNOMED CT 2011_0131
    394656005
    MedDRA 14.1
    10054112
    UMLS CUI 2011AA
    CL420107
    UMLS CUI 2011AA
    C0205169
    SNOMED CT 2011_0131
    556001
    UMLS CUI 2011AA
    C0726398
    Have had a pump-related infusion site abscess in the 12 months prior to screening.
    Beskrivning

    Have had a pump-related infusion site abscess in the 12 months prior to screening.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0182537
    SNOMED CT 2011_0131
    44668000
    UMLS CUI 2011AA
    C0699792
    SNOMED CT 2011_0131
    263498003
    UMLS CUI 2011AA
    C1142012
    MedDRA 14.1
    10058464
    Have had multiple, clinically significant occlusions as judged by the investigator.
    Beskrivning

    Have had multiple, clinically significant occlusions as judged by the investigator.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0439064
    SNOMED CT 2011_0131
    255204007
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    CL354751
    SNOMED CT 2011_0131
    26036001
    MedDRA 14.1
    10029990
    Staphylococcus aureus-Infektion
    Beskrivning

    Have had any infection with Staph aureus in the past 5 years

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1318973
    SNOMED CT 2011_0131
    406602003
    Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
    Beskrivning

    Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0243087
    UMLS CUI 2011AA
    C0018939
    SNOMED CT 2011_0131
    191124002
    MedDRA 14.1
    10061590
    ICD-10-CM Version 2010
    D75.9
    ICD-9-CM Version 2011
    289.9
    UMLS CUI 2011AA
    C2242489
    MedDRA 14.1
    10067777
    UMLS CUI 2011AA
    C0022658
    SNOMED CT 2011_0131
    90708001
    MedDRA 14.1
    10029151
    ICD-10-CM Version 2010
    N18.9
    UMLS CUI 2011AA
    C0018799
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    UMLS CUI 2011AA
    C0023895
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    UMLS CUI 2011AA
    C0017178
    SNOMED CT 2011_0131
    119292006
    MedDRA 14.1
    10017944
    Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
    Beskrivning

    Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0007117
    SNOMED CT 2011_0131
    1338007
    MedDRA 14.1
    10004146
    UMLS CUI 2011AA
    C0553723
    SNOMED CT 2011_0131
    254651007
    MedDRA 14.1
    10041834
    Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
    Beskrivning

    Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0005841
    SNOMED CT 2011_0131
    116859006
    MedDRA 14.1
    10005835
    LOINC Version 232
    MTHU020992
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0019080
    SNOMED CT 2011_0131
    50960005
    MedDRA 14.1
    10055798
    ICD-10-CM Version 2010
    R58
    ICD-9-CM Version 2011
    459.0
    UMLS CUI 2011AA
    C0019045
    SNOMED CT 2011_0131
    80141007
    MedDRA 14.1
    10060892
    LOINC Version 232
    MTHU029621
    ICD-10-CM Version 2010
    D58.2
    UMLS CUI 2011AA
    C0002878
    SNOMED CT 2011_0131
    61261009
    MedDRA 14.1
    10018916
    ICD-10-CM Version 2010
    D55-D59
    UMLS CUI 2011AA
    C0002895
    SNOMED CT 2011_0131
    127040003
    MedDRA 14.1
    10040641
    LOINC Version 232
    MTHU021603
    ICD-10-CM Version 2010
    D57.1
    ICD-9-CM Version 2011
    282.6
    UMLS CUI 2011AA
    C0349705
    MedDRA 14.1
    10018879
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0019018
    SNOMED CT 2011_0131
    33601001
    LOINC Version 232
    MTHU018890
    UMLS CUI 2011AA
    C0969625
    Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
    Beskrivning

    Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205191
    SNOMED CT 2011_0131
    90734009
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    CL428886
    MedDRA 14.1
    10071104
    irregulärer Schlaf-Wach-Rhythmus
    Beskrivning

    Have an irregular sleep/wake cycle in the investigator's opinion.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1862910
    Have a known hypersensitivity or allergy to any of the study insulins or their excipients
    Beskrivning

    Have a known hypersensitivity or allergy to any of the study insulins or their excipients

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    257550005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0021641
    SNOMED CT 2011_0131
    67866001
    LOINC Version 232
    MTHU019392
    UMLS CUI 2011AA
    C0015237
    SNOMED CT 2011_0131
    360215002
    Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
    Beskrivning

    Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0032992
    SNOMED CT 2011_0131
    169565003
    UMLS CUI 2011AA
    C0241028
    SNOMED CT 2011_0131
    228453005
    MedDRA 14.1
    10066098
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0420844
    SNOMED CT 2011_0131
    169450001
    Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
    Beskrivning

    Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1516879
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    UMLS CUI 2011AA
    C1096117
    MedDRA 14.1
    10053762
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C2346570
    Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
    Beskrivning

    Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0457432
    SNOMED CT 2011_0131
    258143003
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0010995
    UMLS CUI 2011AA
    C0699733
    SNOMED CT 2011_0131
    49062001
    LOINC Version 232
    MTHU020022
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    Similar models

    Eligibility

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 13 Years
    Item
    Alter mindestens 13 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
    Item
    Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    C0451584 (UMLS CUI 2011AA)
    273931002 (SNOMED CT 2011_0131)
    Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
    Item
    Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
    boolean
    CL415147 (UMLS CUI 2011AA)
    C0549178 (UMLS CUI 2011AA)
    C0586328 (UMLS CUI 2011AA)
    308755006 (SNOMED CT 2011_0131)
    Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir
    Item
    Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir
    boolean
    C0444504 (UMLS CUI 2011AA)
    255586005 (SNOMED CT 2011_0131)
    C2348070 (UMLS CUI 2011AA)
    C0021641 (UMLS CUI 2011AA)
    67866001 (SNOMED CT 2011_0131)
    MTHU019392 (LOINC Version 232)
    C1519795 (UMLS CUI 2011AA)
    C1289877 (UMLS CUI 2011AA)
    Baseline body mass index (BMI) <= 35.0 kg/m2
    Item
    Baseline body mass index (BMI) <= 35.0 kg/m2
    boolean
    C1305855 (UMLS CUI 2011AA)
    140075008 (SNOMED CT 2011_0131)
    10005894 (MedDRA 14.1)
    LP35925-4 (LOINC Version 232)
    Baseline HbA1c 5% to 9%
    Item
    Baseline HbA1c 5% to 9%
    boolean
    C1442488 (UMLS CUI 2011AA)
    C0019018 (UMLS CUI 2011AA)
    33601001 (SNOMED CT 2011_0131)
    MTHU018890 (LOINC Version 232)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
    Item
    Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0549178 (UMLS CUI 2011AA)
    C0005803 (UMLS CUI 2011AA)
    308113006 (SNOMED CT 2011_0131)
    Impaired renal function (serum creatinine >= 2.0 mg/dl)
    Item
    Impaired renal function (serum creatinine >= 2.0 mg/dl)
    boolean
    C1565489 (UMLS CUI 2011AA)
    236423003 (SNOMED CT 2011_0131)
    10062237 (MedDRA 14.1)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    Legal blindness
    Item
    gesetzliche Blindheit
    boolean
    C0271215 (UMLS CUI 2011AA)
    65956007 (SNOMED CT 2011_0131)
    Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
    Item
    Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
    boolean
    C0332189 (UMLS CUI 2011AA)
    272128006 (SNOMED CT 2011_0131)
    C0020617 (UMLS CUI 2011AA)
    267384006 (SNOMED CT 2011_0131)
    10021000 (MedDRA 14.1)
    E15 (ICD-10-CM Version 2010)
    251.0 (ICD-9-CM Version 2011)
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    C0233407 (UMLS CUI 2011AA)
    62476001 (SNOMED CT 2011_0131)
    10013395 (MedDRA 14.1)
    MTHU013516 (LOINC Version 232)
    R41.0 (ICD-10-CM Version 2010)
    Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
    Item
    Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
    boolean
    C0342317 (UMLS CUI 2011AA)
    10020997 (MedDRA 14.1)
    C0205547 (UMLS CUI 2011AA)
    50811001 (SNOMED CT 2011_0131)
    C0231221 (UMLS CUI 2011AA)
    84387000 (SNOMED CT 2011_0131)
    C0005802 (UMLS CUI 2011AA)
    Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
    Item
    Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
    boolean
    C1546435 (UMLS CUI 2011AA)
    ER (HL7 V3 2006_05)
    C1512346 (UMLS CUI 2011AA)
    ENC (HL7 V3 2006_05)
    C0019993 (UMLS CUI 2011AA)
    394656005 (SNOMED CT 2011_0131)
    10054112 (MedDRA 14.1)
    CL420107 (UMLS CUI 2011AA)
    C0205169 (UMLS CUI 2011AA)
    556001 (SNOMED CT 2011_0131)
    C0726398 (UMLS CUI 2011AA)
    Have had a pump-related infusion site abscess in the 12 months prior to screening.
    Item
    Have had a pump-related infusion site abscess in the 12 months prior to screening.
    boolean
    C0182537 (UMLS CUI 2011AA)
    44668000 (SNOMED CT 2011_0131)
    C0699792 (UMLS CUI 2011AA)
    263498003 (SNOMED CT 2011_0131)
    C1142012 (UMLS CUI 2011AA)
    10058464 (MedDRA 14.1)
    Have had multiple, clinically significant occlusions as judged by the investigator.
    Item
    Have had multiple, clinically significant occlusions as judged by the investigator.
    boolean
    C0439064 (UMLS CUI 2011AA)
    255204007 (SNOMED CT 2011_0131)
    C0205210 (UMLS CUI 2011AA)
    58147004 (SNOMED CT 2011_0131)
    C0750502 (UMLS CUI 2011AA)
    386134007 (SNOMED CT 2011_0131)
    CL354751 (UMLS CUI 2011AA)
    26036001 (SNOMED CT 2011_0131)
    10029990 (MedDRA 14.1)
    Have had any infection with Staph aureus in the past 5 years
    Item
    Staphylococcus aureus-Infektion
    boolean
    C1318973 (UMLS CUI 2011AA)
    406602003 (SNOMED CT 2011_0131)
    Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
    Item
    Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
    boolean
    C0243087 (UMLS CUI 2011AA)
    C0018939 (UMLS CUI 2011AA)
    191124002 (SNOMED CT 2011_0131)
    10061590 (MedDRA 14.1)
    D75.9 (ICD-10-CM Version 2010)
    289.9 (ICD-9-CM Version 2011)
    C2242489 (UMLS CUI 2011AA)
    10067777 (MedDRA 14.1)
    C0022658 (UMLS CUI 2011AA)
    90708001 (SNOMED CT 2011_0131)
    10029151 (MedDRA 14.1)
    N18.9 (ICD-10-CM Version 2010)
    C0018799 (UMLS CUI 2011AA)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    C0023895 (UMLS CUI 2011AA)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    C0017178 (UMLS CUI 2011AA)
    119292006 (SNOMED CT 2011_0131)
    10017944 (MedDRA 14.1)
    Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
    Item
    Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
    boolean
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    CL411789 (UMLS CUI 2011AA)
    C0007117 (UMLS CUI 2011AA)
    1338007 (SNOMED CT 2011_0131)
    10004146 (MedDRA 14.1)
    C0553723 (UMLS CUI 2011AA)
    254651007 (SNOMED CT 2011_0131)
    10041834 (MedDRA 14.1)
    Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
    Item
    Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
    boolean
    C0005841 (UMLS CUI 2011AA)
    116859006 (SNOMED CT 2011_0131)
    10005835 (MedDRA 14.1)
    MTHU020992 (LOINC Version 232)
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0019080 (UMLS CUI 2011AA)
    50960005 (SNOMED CT 2011_0131)
    10055798 (MedDRA 14.1)
    R58 (ICD-10-CM Version 2010)
    459.0 (ICD-9-CM Version 2011)
    C0019045 (UMLS CUI 2011AA)
    80141007 (SNOMED CT 2011_0131)
    10060892 (MedDRA 14.1)
    MTHU029621 (LOINC Version 232)
    D58.2 (ICD-10-CM Version 2010)
    C0002878 (UMLS CUI 2011AA)
    61261009 (SNOMED CT 2011_0131)
    10018916 (MedDRA 14.1)
    D55-D59 (ICD-10-CM Version 2010)
    C0002895 (UMLS CUI 2011AA)
    127040003 (SNOMED CT 2011_0131)
    10040641 (MedDRA 14.1)
    MTHU021603 (LOINC Version 232)
    D57.1 (ICD-10-CM Version 2010)
    282.6 (ICD-9-CM Version 2011)
    C0349705 (UMLS CUI 2011AA)
    10018879 (MedDRA 14.1)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0019018 (UMLS CUI 2011AA)
    33601001 (SNOMED CT 2011_0131)
    MTHU018890 (LOINC Version 232)
    C0969625 (UMLS CUI 2011AA)
    Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
    Item
    Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
    boolean
    C0205191 (UMLS CUI 2011AA)
    90734009 (SNOMED CT 2011_0131)
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    CL428886 (UMLS CUI 2011AA)
    10071104 (MedDRA 14.1)
    Have an irregular sleep/wake cycle in the investigator's opinion.
    Item
    irregulärer Schlaf-Wach-Rhythmus
    boolean
    C1862910 (UMLS CUI 2011AA)
    Have a known hypersensitivity or allergy to any of the study insulins or their excipients
    Item
    Have a known hypersensitivity or allergy to any of the study insulins or their excipients
    boolean
    C0020517 (UMLS CUI 2011AA)
    257550005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0021641 (UMLS CUI 2011AA)
    67866001 (SNOMED CT 2011_0131)
    MTHU019392 (LOINC Version 232)
    C0015237 (UMLS CUI 2011AA)
    360215002 (SNOMED CT 2011_0131)
    Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
    Item
    Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
    boolean
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0032992 (UMLS CUI 2011AA)
    169565003 (SNOMED CT 2011_0131)
    C0241028 (UMLS CUI 2011AA)
    228453005 (SNOMED CT 2011_0131)
    10066098 (MedDRA 14.1)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0420844 (UMLS CUI 2011AA)
    169450001 (SNOMED CT 2011_0131)
    Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
    Item
    Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
    boolean
    C1516879 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    C1096117 (UMLS CUI 2011AA)
    10053762 (MedDRA 14.1)
    C0013230 (UMLS CUI 2011AA)
    C2346570 (UMLS CUI 2011AA)
    Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
    Item
    Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
    boolean
    C0457432 (UMLS CUI 2011AA)
    258143003 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0010995 (UMLS CUI 2011AA)
    C0699733 (UMLS CUI 2011AA)
    49062001 (SNOMED CT 2011_0131)
    MTHU020022 (LOINC Version 232)
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