Table 4.

Comparison of HCL System Pivotal Trial Outcomes and Real-World HCL System Use Analyses.

	HCL system pivotal trial a (N = 124)			First real-world HCL system use analysis a (n = 3141)			Present study real-world HCL system use analysis (n = 19 929)
	Before Auto Mode initiation (Run-in)	After Auto Mode initiation (Study)	P b	Before Auto Mode initiation	3 months after Auto Mode initiation	P b	Before Auto Mode initiation	3 months after Auto Mode initiation	P b
Auto Mode, %	—	82.2	—	—	80.8	—	—	89.4	—
SG, mg/dL	150	151	.267	159	152	<.001	167	158	<.001
<54 mg/dL	1.3	0.8	<.001	0.6	0.5	<.001	0.5	0.6	<.017
<70 mg/dL	5.5	3.0	<.001	2.7	2.1	<.001	2.1	2.1	.117
70-180 mg/dL	67.1	72.4	<.001	66.0	73.3	<.001	62.4	69.3	<.001
>180 mg/dL	27.4	24.5	<.001	31.4	24.6	<.001	35.6	28.7	<.001
>250 mg/dL	6.9	5.6	.007	8.1	5.4	<.001	10.2	7.2	<.001
TDD, units	47.5	50.9	<.001	49.8	51.9	<.001	50.1	51.1	<.001

Data are shown as mean. The pivotal trial Run-in period (before Auto Mode initiation) was ~2 weeks and the Study period was 3 months. The mean percentage of time in Auto Mode, sensor glucose, percentage of time in sensor glucose ranges, and total daily insulin dose delivered before and 3 months after Auto Mode initiation are shown for the HCL system pivotal trial, the first real-world HCL system use analysis and the present real-world HCL system use analysis.

Abbreviations: HCL, hybrid closed-loop; SG, sensor glucose; TDD, total daily insulin dose.

^aAs reported in Stone et al. ⁹

^bComparison of before versus after Auto Mode initiation.