Table 1.
Comparison of primary and secondary outcomes between closed-loop and control periods
| Closed-loop (n = 26) | Control (n = 26) | P value | |
|---|---|---|---|
| Proportion of time spent at glucose level (%) | |||
| 5.6–10.0 mmol l−1 a | 52.8 (12.5) | 37.7 (20.5) | <0.001 |
| 3.9–10.0 mmol l−1 | 57.1 (14.3) | 42.5 (24.7) | 0.002 |
| >10.0 mmol l−1 | 42.6 (14.3) | 56.6 (25.1) | 0.003 |
| >20.0 mmol l−1 | 1.8 (2.4) | 6.7 (10.7) | 0.012 |
| <5.6 mmol l−1 | 3.2 (2.0, 7.0) | 4.0 (0.9, 9.5) | 0.87 |
| <3.9 mmol l−1 | 0.12 (0.02, 0.44) | 0.17 (0.00, 1.11) | 0.040 |
| <3.0 mmol l−1 | 0.00 (0.00, 0.03) | 0.00 (0.00, 0.22) | 0.047 |
| Mean glucose (mmol l−1) | 10.1 (1.3) | 11.6 (2.8) | 0.003 |
| Standard deviation of glucose (mmol l−1) | 3.2 (0.7) | 3.6 (0.9) | 0.021 |
| CV of glucose (%) | 31.7 (4.8) | 31.5 (5.4) | 0.87 |
| Between days CV of glucose (%) | 30.8 (3.4) | 31.2 (5.8) | 0.72 |
| Total daily insulin dose (U kg−1) | 0.34 (0.15, 0.54) | 0.36 (0.19, 0.58) | 0.37 |
| Total daily insulin dose (U) | 20.4 (9.2, 50.3) | 32.2 (12.1, 54.4) | 0.38 |
| Sensor glucose data (h) | 454 (450, 460) | 452 (425, 454) | 0.062 |
| Time using sensor glucose (%) | 95 (94, 96) | 94 (90, 95) | 0.062 |
| Time using closed-loop (%) | 93 (89, 94) | – | – |
aPrimary endpoint.
Data presented as mean (s.d.) or median (interquartile range).
CV, coefficient of variation.
A two-sample t-test on paired differences was used to compare normally distributed variables and the Mann–Whitney–Wilcoxon rank-sum test was used for data that are not normally distributed. No allowance was made for multiplicity.