ID

17304

Beschreibung

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

Stichworte

  1. 06.09.16 06.09.16 -
Hochgeladen am

6. September 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Diabetes NCT00604656

Eligibility Diabetes NCT00604656

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

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 1 diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

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

Diabetes disease length

Datentyp

boolean

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

Insulin Aspart

Datentyp

boolean

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

Body mass index

Datentyp

boolean

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

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Insulin Dosage Total U/kg/day

Datentyp

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)
Beschreibung

Recurrent severe hypoglycemia Interferes with Study Subject Participation Status

Datentyp

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
Beschreibung

Loss of hypoglycemic warning

Datentyp

boolean

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

Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517

Ähnliche Modelle

Eligibility Diabetes NCT00604656

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604656
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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