Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus

Table 1 Trial procedures

Visits/months	VS	V1	V2	V3	V4	V5	V6	V7	V8	V9	End
Visits/months	VS	0	3	6	9	12	15	18	21	24	End
Informed consent	+
Selection/exclusion criteria	+
Randomisation		+
Inclusion/exclusion criteria		+
Demographic data	+
Medical history	+
Physical examination	+	+	+	+	+	+	+	+	+	+	+
Concomitant illness and medication	+	+	+	+	+	+	+	+	+	+	+
Blood glucose profile			+	+	+	+	+	+	+	+	+
HbA_1c		+	+	+	+	+	+	+	+	+	+
Pulmonary function		+	+	+	+	+	+	+	+	+	+
IV therapy (antibiotics)		+	+	+	+	+	+	+	+	+	+
Adverse events		+	+	+	+	+	+	+	+	+	+
Hypoglycaemic episodes			+	+	+	+	+	+	+	+	+
Drug dispensation		+	+	+	+	+	+	+	+

ISSN: 1471-2431