ID

17304

Descripción

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00604656

Link

https://clinicaltrials.gov/show/NCT00604656

Palabras clave

  1. 6/9/16 6/9/16 -
Subido en

6 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diabetes NCT00604656

Eligibility Diabetes NCT00604656

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604656
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
duration of diabetes for at least 12 months
Descripción

Diabetes disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0872146
treatment with insulin aspart for at least 3 months before trial start
Descripción

Insulin Aspart

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708521
body mass index (bmi) below 35.0 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c below 12.0%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
total insulin dosage more than 1.4 iu/kg/day
Descripción

Insulin Dosage Total U/kg/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439810
UMLS CUI [1,4]
C1532634
recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
Descripción

Recurrent severe hypoglycemia Interferes with Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342316
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
known hypoglycaemia unawareness as judged by the investigator
Descripción

Loss of hypoglycemic warning

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
known hypersensitivity or allergy
Descripción

Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517

Similar models

Eligibility Diabetes NCT00604656

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604656
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
subjects with type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetes disease length
Item
duration of diabetes for at least 12 months
boolean
C0011847 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Aspart
Item
treatment with insulin aspart for at least 3 months before trial start
boolean
C1708521 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c below 12.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin Dosage Total U/kg/day
Item
total insulin dosage more than 1.4 iu/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1532634 (UMLS CUI [1,4])
Recurrent severe hypoglycemia Interferes with Study Subject Participation Status
Item
recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
boolean
C0342316 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Loss of hypoglycemic warning
Item
known hypoglycaemia unawareness as judged by the investigator
boolean
C0342317 (UMLS CUI [1])
Hypersensitivity
Item
known hypersensitivity or allergy
boolean
C0020517 (UMLS CUI [1])

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