Visit 1 | Visit 2 | Visit 3 - 9 | Visit 10 | Visit 11 -12 | Visit 13 | Visit 14 | Visit 15 | |
---|---|---|---|---|---|---|---|---|
up to one month and a reference period1 of 2 h before Visit 2 | 0 h2 | 1–7 h (every hour) ± 5 min | 8 h ± 5 min | 9 and 10 h ± 5 min | 16 h ± 30 min | 24 h ± 30 min | 72 h ± 1 h | |
Informed consent | ● | |||||||
Eligibility criteria | ● | ● | ||||||
Medical history | ● | |||||||
Concomitant medication | ● | ● | ● | ● | ● | ● | ● | ● |
Physical examination | ● | ● | ||||||
Vital signs3 | ● | ● | ● | ● | ● | ● | ● | ● |
Pregnancy test4 | ● | |||||||
Placement of the CGM | ● | |||||||
CGM calibration | ● | |||||||
Continuous glucose and lactate monitoring | ● | ● | ● | ● | ● | ● | up to every 2 h | |
Recalibration | ● | |||||||
Central venous blood sampling for the BGA5 | ● | ● | ● | ● | ● | |||
Central venous blood sampling for central laboratory measurement6 | ● | ● | ● | ● | ||||
Removal of CGM | ● | |||||||
Assessment of unwanted events/effects | ● | ● | ● | ● | ● | ● | ● |