Table 1.
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.
‡AUCday indicates glucose area under curve <3.5 mmol/L per day.