Visits/months | VS | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | End |
---|---|---|---|---|---|---|---|---|---|---|---|
0 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | |||
Informed consent | + | ||||||||||
Selection/exclusion criteria | + | ||||||||||
Randomisation | + | ||||||||||
Inclusion/exclusion criteria | + | ||||||||||
Demographic data | + | ||||||||||
Medical history | + | ||||||||||
Physical examination | + | + | + | + | + | + | + | + | + | + | + |
Concomitant illness and medication | + | + | + | + | + | + | + | + | + | + | + |
Blood glucose profile | + | + | + | + | + | + | + | + | + | ||
HbA1c | + | + | + | + | + | + | + | + | + | + | |
Pulmonary function | + | + | + | + | + | + | + | + | + | + | |
IV therapy (antibiotics) | + | + | + | + | + | + | + | + | + | + | |
Adverse events | + | + | + | + | + | + | + | + | + | + | |
Hypoglycaemic episodes | + | + | + | + | + | + | + | + | + | ||
Drug dispensation | + | + | + | + | + | + | + | + |