Table 1.

Study assessments

	Baseline	13 weeks	26 weeks	39 weeks	52 weeks
HbA1c	X	X	X	X	X
Glycemic metricsa	X	X	X	X	X
Psychosocial metricsb	X	X
Sleepc	X	X
Platform performanced	X	X	X	X	X
Safetye	X	X	X	X	X
Qualitative studyf		X

^aTime in range 70–180 mg/dL (3.9–10 mmol/L); time in tight range 70–140 mg/dL (3.9–7.8 mmol/L); time < 70 mg/dL (3.9 mmol/L); time > 180 mg/dL (10 mmol/L); hypoglycemic events; day-time (0600–2359 h) and night-time (0000–0559 h) TIR. ^bHypoglycemia Fear Survey; Diabetes Treatment Satisfaction Questionnaires; Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations. ^cPittsburgh Sleep Quality Index; Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep Impairment questionnaires; habitual sleep patterns via accelerometery. ^dAlarm frequency; percentage time of SmartGuard™ use/sensor wear; SmartGuard™ exits. ^eDiabetic ketoacidosis; severe hypoglycaemia; hospitalizations; any issues related to device use. ^fInterviews will commence following completion of the 13-week RCT phase.