Table 5

Participant timeline

	Screening visit	Baseline visit	Randomisation (t=0)	HARPdoc /BGAT week 1	HARPdoc /BGAT week 2	HARPdoc /BGAT week 3	HARPdoc week 4 and week 5	HARPdoc /BGAT week 6	F/U 1 03/12	F/U2 06/12	F/U 3 12/12	F/U 4 18/12	F/U 5 24/12
Visit no.	1	2	N/A	3	4	5	6	7	8	9	10	11	12
Week	0 to −26	−4 to −1	−1 to 0	1	2	3	4 and 5	6	12	26	52	78	104
One to one or group
Duration	2 hour	2 hour	N/A	Day	Day	Day	1 hour	Day	2 hour	2 hour	2 hour	2 hour	2 hour
Patient information and informed consent	X
Diabetes and other medical history	X
Physical examination	X
Gold Score	X	X							X	X	X	X	X
Modified Clarke score	X	X							X	X	X	X	X
DAFNE hypo awareness tool	X	X							X	X	X	X	X
Severe and moderate hypoglycaemia rate	X	X							X	X	X	X	X
Documentation of treatment regimen	X	X							X	X	X	X	X
2 week SMBG download	X	X							X	X	X	X	X
Blood sample for local HbA1c	X	X							X	X	X	X	X
Blood sample for central HbA1c		X									X		X
Blood sample for liver, renal, thyroid function, coeliac screen, cortisol, growth hormone and IGF-1	X
Questionnaire pack on hypoglycaemia, diabetes behaviours and QoL		X									X		X
Online blinded CGM		X									X		X
Randomisation			X
Notes	May occur in one visit if screening is within 1 month of start of course (ie, within the baseline window).		Occurs within 1 month of the course start date.						For each visit, 6-week window on either said of the due date except visit 12 where an 8-week window period on either side is acceptable.

BGAT, Blood Glucose Awareness Training; DAFNE, Dose Adjustment for Normal Eating; F/U, follow up; HARPdoc, Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care; IGF1, Insulin like growth factor 1; QoL, Quality of life; SMBG, Self Monitoring of Blood Glucose