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Eligibility Diabetes NCT01074268

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01074268
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus for at least 12 months
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
current treatment with any basal bolus insulin for at least 12 months
Description

Basal insulin Bolus

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
hba1c below or equal to 10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 35.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
for japan only: minimum age is 20 years
Description

Japan | Age Minimum

Data type

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1524031
for the extension trial only: completed the six-month treatment period in trial nn1250-3585 (nct01074268)
Description

Extension Trial | Treatment completed Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0580352
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any other antidiabetic drug than insulin within the last 3 months
Description

Antidiabetics | Exception Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
cardiovascular disease within the last 6 months
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled treated/untreated severe hypertension
Description

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0011880
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer
Description

Malignant Neoplasms | History of cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0455471
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Similar models

Eligibility Diabetes NCT01074268

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01074268
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus
Item
current treatment with any basal bolus insulin for at least 12 months
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c below or equal to 10.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Japan | Age Minimum
Item
for japan only: minimum age is 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Extension Trial | Treatment completed Clinical Trial Specified
Item
for the extension trial only: completed the six-month treatment period in trial nn1250-3585 (nct01074268)
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Exception Insulin
Item
use of any other antidiabetic drug than insulin within the last 3 months
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
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