ID

34291

Descrizione

A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01999322

collegamento

https://clinicaltrials.gov/show/NCT01999322

Keywords

  1. 16/01/19 16/01/19 -
Titolare del copyright

see on clinicaltrials.gov

Caricato su

16 gennaio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Diabetes NCT01999322

Eligibility Diabetes NCT01999322

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01999322
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing inform consent
Descrizione

ID.1

Tipo di dati

boolean

type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (visit 1)
Descrizione

ID.2

Tipo di dati

boolean

currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (visit 1)
Descrizione

ID.3

Tipo di dati

boolean

using an external csii system for the previous 6 months prior to screening (visit 1)
Descrizione

ID.4

Tipo di dati

boolean

hba1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
Descrizione

ID.5

Tipo di dati

boolean

body mass index (bmi) 20.0-35.0 kg/m^2
Descrizione

ID.6

Tipo di dati

boolean

Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetic ketoacidosis (dka) episodes requiring hospitalization within 6 months prior to screening (visit 1)
Descrizione

ID.7

Tipo di dati

boolean

history of abscess at the infusion site within 6 months prior to screening (visit 1)
Descrizione

ID.8

Tipo di dati

boolean

hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (visit 1)
Descrizione

ID.9

Tipo di dati

boolean

Similar models

Eligibility Diabetes NCT01999322

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01999322
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female, age at least 18 years at the time of signing inform consent
boolean
ID.2
Item
type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (visit 1)
boolean
ID.3
Item
currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (visit 1)
boolean
ID.4
Item
using an external csii system for the previous 6 months prior to screening (visit 1)
boolean
ID.5
Item
hba1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
boolean
ID.6
Item
body mass index (bmi) 20.0-35.0 kg/m^2
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
history of diabetic ketoacidosis (dka) episodes requiring hospitalization within 6 months prior to screening (visit 1)
boolean
ID.8
Item
history of abscess at the infusion site within 6 months prior to screening (visit 1)
boolean
ID.9
Item
hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (visit 1)
boolean

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