Table 2.

Schedule of study visits/phone contacts when the participant is randomised to usual care (conventional or sensor-augmented insulin pump therapy) (control group)

	Visit/contact	Description	Start relative to previous/next visit/activity	Duration (hours)
Run-in	Visit 1	Recruitment visit: consent, HbA1c, screening bloods, urine pregnancy test, baseline surveys, blinded CGM training and insertion		1–4
	Visit 2	Review of baseline bloods, pump settings and CGM data; adjustment of treatment	2 weeks after visit 1 (+1 week); run-in could be repeated	1–2
Training period	Visit 3	Randomisation, repeat HbA1c if visit 3 and visit 1 are >28 days apart, urine pregnancy test, insulin pump refresher training, competency assessment	May coincide with visit 2, within 8 weeks of visit 1	3–4
Usual insulin pump therapy intervention (6 months)	Visit 4*	Initiation of standard therapy arm at clinic/home, glucometer download, recording of current insulin requirements, blinded CGM	4 weeks after randomisation (±1 week)	2–6
	Contact 1	Study update	Within 24–48 hours after visit 4	<1
	Visit 5†	Study update	1 week after visit 4 (±3 days)	<1
	Contact 2	Study update	2 weeks after visit 4 (±3 days)	<1
	Contact 3	Study update	1 month after visit 4 (±2 weeks)	<1
	Contact 4	Study update	2 months after visit 4 (±2 weeks)	<1
	Visit 6	3-month visit: HbA1c, urine pregnancy test, glucometer download, recording of current insulin requirements, surveys, blinded CGM	4 months after randomisation (±2 weeks)	1–3
	Contact 5	Study update	5 months after randomisation (±2 weeks)	<1
	Contact 6	Study update	6 months after randomisation (±2 weeks)	<1
	Visit 7	Blinded CGM	2–4 weeks before planned visit 8	<0.5
	Visit 8	End of standard pump therapy treatment arm (6 months): HbA1c, glucometer download, recording of current insulin requirements, surveys and focus groups, resume usual care	7 months after randomisation (±2 weeks)	1–3

*In-person clinic visit mandatory in USA only.

†Could be done via phone/email.

CGM, continuous glucose monitoring; HbA1c, glycated haemoglobin.