Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
A randomized, double-blinded (for insulin type), single centre, crossover design young adult
study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring
time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed
Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency
number EMEA/H/C/004046) or normal acting insulin Aspart.
Study duration will be about 3 weeks per subject, 5 month overall.
The objectives of this clinical investigation is:
1. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter
with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity
and unannounced meals, in a controlled in-hospital environment.
Primary endpoint is significant between-group difference (intervention Fast-CL versus control
Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl)
during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till
18:00 next day based on sensor glucose readings.