Table 1.

Comparison of glucose control and insulin delivery during closed-loop and control period over 21 days

	Closed loop (n = 12)	Control (n = 12)	Paired difference*	P
Day-and-night glucose control
Time spent at glucose level (%)
3.9 to 10.0 mmol/L†	66.6 ± 7.9	47.7 ± 14.4	18.8 ± 9.8	<0.001
>10.0 mmol/L	29.7 ± 9.2	49.1 ± 16.5	−19.3 ± 11.3	<0.001
>16.7 mmol/L	5.1 (0.8–5.6)	8.0 (1.9–17.4)	−3.6 (−11.9 to −0.65)	<0.001
<3.9 mmol/L	4.3 (1.4–5.2)	2.4 (0.3–5.7)	0.4 (−2.2 to 1.3)	0.33
<2.8 mmol/L	0.3 (0.0–0.5)	0.1 (0.0–0.7)	−0.1 (−0.4 to 0.2)	0.49
AUCday <3.5 mmol/L (mmol/L × min)‡	11.1 (1.2–17.4)	2.7 (0.2–20.4)	0.0 (−10.5 to 6.8)	0.21
Mean glucose (mmol/L)	8.7 ± 0.9	10.5 ± 1.8	−1.8 ± 1.3	0.001
Within day SD of glucose (mmol/L)	3.7 ± 0.7	4.2 ± 0.8	−0.5 ± 0.7	0.013
CV of glucose within day (%)	40.5 (38.1–47.7)	38.3 (36.7–43.7)	1.2 (−2.6 to 6.7)	0.18
CV of glucose between days (%)	19.0 (13.8–23.7)	17.4 (14.9–24.0)	−0.5 (−3.9 to 6.0)	0.94
Day-and-night insulin delivery
Total daily insulin (units/day)	53.5 (39.5–72.1)	51.5 (37.6–64.3)	4.5 (1.6–6.5)	0.006
Total bolus insulin (units/day)	28.3 (16.7–32.6)	29.4 (23.6–37.6)	−4.4 (−8.1 to −1.4)	0.009
Total basal insulin (units/day)	25.8 (23.0–41.2)	19.9 (14.8–26.3)	7.6 (3.8–14.4)	0.001
SD of basal insulin delivery (units/h)	1.2 (1.0–1.9)	0.3 (0.1–0.3)	1.1 (0.8–1.6)	<0.001
CV of basal insulin delivery	106.7 (97.2–111.1)	23.9 (12.8–35.2)	79.2 (77.1–91.3)	<0.001
Bolus administrations (n/day)	4.9 (4.8–6.3)	6.3 (5.1–7.6)	−1.1 (−1.5 to −0.2)	0.015

Data are presented as mean ± SD or as median (interquartile range). P values are adjusted for period effect.

*Closed-loop minus control. A positive value indicates the value was higher on the closed-loop compared with control.

†Primary end point.

‡AUC_day indicates glucose area under curve <3.5 mmol/L per day.