Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)

BMC Endocrine Disorders

Table 1 Visit schedule

Study period	4 week wash in period						24 week primary RCT															18 month RT-CGM RCT continuation
Visit number	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24	25	26	27
informed consent	x
eligibility criteria	x
given information sheet on clamp study	x																		x
hypoglycaemia screening questionnaire	x		x
HbA1c	x		x							x		x		x		x		x		x			x		x		x
C-peptide and plasma glucose	x
retinal photographs		x
urine albumin:creatinine ratio		x
demographic info			x
concomitant medication			x							x		x		x		x		x		x			x		x		x
full physical examination			x																	x
history of glycaemic control										x		x		x		x		x
full medical history including glycaemic control			x																	x			x		x		x
vital signs			x							x		x		x		x		x		x			x		x		x
height			x
weight			x							x		x		x		x		x		x			x		x		x
TFTs					x
Coeliac antibody					x
short synacthen test					x
detailed SH history			x							x		x		x		x		x		x			x		x		x
Modified Clarke/Edinburgh			x																	x			x		x		x
QoL questionnaires			x																	x			x		x		x
week 4 short questionnaire pack										x
4 week Blood Glucose / hypo diary	x		x							x		x		x		x		x		x
7 day CGMS placement		x							x		x		x		x		x		x			x		x		x
Autonomic function tests				x																	x
clamp study			x																x
education programme						x
Insulin administration education session							x
Home glucose monitoring/RT education session								x

ISSN: 1472-6823