Information:
Error:
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
Link
https://clinicaltrials.gov/show/NCT01999322
Keywords
Versions (1)
- 1/16/19 1/16/19 -
Copyright Holder
see on clinicaltrials.gov
Uploaded on
January 16, 2019
DOI
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License
Creative Commons BY 4.0
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Eligibility Diabetes NCT01999322
Eligibility Diabetes NCT01999322
- StudyEvent: Eligibility
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Eligibility Diabetes NCT01999322
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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
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