Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.

Detailed description:

Arms:
arm 1: The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period arm 2: The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period

Interventions: intervention 1: Faster-acting insulin aspart intervention 2: insulin aspart
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 2: Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Protocol document: