ID

44639

Descrição

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

Link

http://clinicaltrials.gov/show/NCT01134107

Palavras-chave

Versões (4)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 06/12/2013 06/12/2013 - Martin Dugas
  3. 17/04/2014 17/04/2014 - Julian Varghese
  4. 27/09/2021 27/09/2021 -
Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT01134107 Diabetes Mellitus, Type 1

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 13 Years
Descrição

age at least 13 Years

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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%
Descrição

Baseline HbA1c 5% to 9%

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Exclusion Criteria
Descrição

Exclusion Criteria

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

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

Tipo de dados

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)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
Legal Blindness
Descrição

Legal blindness

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Infection due to Staphylococcus aureus
Descrição

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

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Abnormal sleep-wake cycles
Descrição

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

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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

Tipo de dados

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 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 13 Years
Item
age at least 13 Years
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
Exclusion Criteria
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
Legal Blindness
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
Infection due to Staphylococcus aureus
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
Abnormal sleep-wake cycles
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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