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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, age at least 18 years at the time of signing inform consent
Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1)
Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
Using an external CSII system for the previous 6 months prior to screening (Visit 1)
HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
Body Mass Index (BMI) 20.0-35.0 kg/m\^2
You may not be if
History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
History of abscess at the infusion site within 6 months prior to screening (Visit 1)
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)
