Informatie:
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ID
33729
Beschrijving
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01682902
Link
https://clinicaltrials.gov/show/NCT01682902
Trefwoorden
Versies (1)
- 21-12-18 21-12-18 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
21 december 2018
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Diabetes NCT01682902
Eligibility Diabetes NCT01682902
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT01682902
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (visit 1)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Insulin Analogue | Continuous subcutaneous infusion of insulin
Item
treatment with the same insulin analogue by csii (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (visit 1)
boolean
C2825028 (UMLS CUI [1])
C0393124 (UMLS CUI [2])
C0393124 (UMLS CUI [2])
Insulin pump Specified
Item
using a minimed paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (visit 1)
boolean
C1140609 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) below or equal to 9.0% by central laboratory
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])
Diabetic Ketoacidosis Episodes Hospitalization Required
Item
history of diabetic ketoacidsosis (dka) episodes requiring hospitalization within 6 months prior to the screening visit (visit 1)
boolean
C0011880 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
Infusion site abscess
Item
history of abscess at the infusion site within 6 months prior to the screening visit (visit 1)
boolean
C1142012 (UMLS CUI [1])
Loss of hypoglycemic warning | Hypoglycaemic episodes Severe Hospitalization Required
Item
hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (visit 1)
boolean
C0342317 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])