ID

34291

Description

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

Lien

https://clinicaltrials.gov/show/NCT01999322

Mots-clés

  1. 16/01/2019 16/01/2019 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

16 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility Diabetes NCT01999322

Eligibility Diabetes NCT01999322

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

Inclusion Criteria

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

ID.1

Type de données

boolean

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

ID.2

Type de données

boolean

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

ID.3

Type de données

boolean

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

ID.4

Type de données

boolean

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

ID.5

Type de données

boolean

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

ID.6

Type de données

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

ID.7

Type de données

boolean

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

ID.8

Type de données

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)
Description

ID.9

Type de données

boolean

Similar models

Eligibility Diabetes NCT01999322

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01999322
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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