Table 4.
Secondary comparisons in eating out scenario based on plasma glucose concentrations. Data are medians (interquartile ranges) unless stated otherwise
| Period and outcome | Insulin delivery system | Paired difference* (n=12) | P value | |
|---|---|---|---|---|
| Closed loop (n=12) | Insulin pump (n=12) | |||
| From start of closed loop delivery† | ||||
| Mean (SD) plasma glucose level at start (mmol/L) | 8.1 (3.5) | 9.5 (3.8) | −1.4 (4.5) | — |
| Mean (SD) overnight plasma glucose level (mmol/L) | 6.8 (0.8) | 6.9 (1.6) | −0.1 (1.3) | 0.68 |
| SD of overnight plasma glucose level (mmol/L) | 1.7 (1.3 to 2.0) | 2.2 (1.8 to 2.8) | −0.5 (−0.9 to 0.1) | 0.06 |
| Mean amplitude of glucose excursions (mmol/L) | 3.8 (3.5 to 5.4) | 6.6 (4.3 to 8.8) | −1.2 (−5.2 to 0.0) | 0.16 |
| Time spent at plasma glucose level (%): | ||||
| ≤3.5 mmol/L | 1 (0 to 6) | 8 (0 to 18) | −3 (−14 to 2) | 0.13 |
| ≤3.90 mmol/L | 4 (0 to 10) | 14 (0 to 26) | −5 (−22 to 4) | 0.21 |
| >8.0 mmol/L | 23 (10 to 36) | 31 (12 to 57) | −21 (−31 to 6) | 0.12 |
| Low blood glucose index | 1.2 (0.7 to 1.8) | 2.8 (0.6 to 4.7) | −0.9 (−3.2 to 0.5) | 0.37 |
| Insulin infusion (U/h) | 0.8 (0.6 to 1.1) | 0.9 (0.6 to 1.1) | 0.1 (−0.1 to 0.2) | 0.65 |
| Insulin concentration (pmol/L) | 139 (102 to 174) | 129 (105 to 208) | −8 (−17 to 7) | 0.59 |
| After midnight‡ | ||||
| Mean (SD) overnight plasma glucose level (mmol/L) | 6.7 (0.6) | 6.8 (2.1) | −0.1 (1.8) | 0.61 |
| SD of overnight plasma glucose level (mmol/L) | 1.5 (1.3 to 1.9) | 1.8 (1.0 to 2.3) | −0.3 (−0.7 to 0.6) | 0.46 |
| Mean amplitude of glucose excursions (mmol/L) | 3.8 (2.9 to 5.1) | 4.3 (3.5 to 7.2) | −0.4 (−3.5 to 1.2) | 0.34 |
| Time plasma glucose level spent in target (%) | 74 (63 to 87) | 53 (27 to 67) | 33 (4 to 41) | 0.005 |
| Time spent at plasma glucose level (%): | ||||
| ≤3.5 mmol/L | 0 (0 to 2) | 5 (0 to 19) | −1 (−19 to 0) | 0.12 |
| ≤3.90 mmol/L | 0 (0 to 4) | 9 (0 to 27) | −1 (−26 to 0) | 0.25 |
| >8.0 mmol/L | 20 (9 to 35) | 31 (0 to 64) | −16 (−41 to 12) | 0.37 |
| Low blood glucose index | 0.6 (0.5 to 1.3) | 2.0 (0.3 to 4.9) | −0.7 (−4.0 to 0.1) | 0.55 |
| Insulin infusion (U/h) | 0.9 (0.7 to 1.1) | 0.9 (0.6 to 1.1) | 0.1 (0.0 to 0.3) | 0.36 |
| Insulin concentration (pmol/L) | 118 (77 to 135) | 100 (75 to 149) | 3 (−13 to 19) | 0.80 |
*Closed loop delivery minus pump therapy. Positive value indicates measurement was higher on night of closed loop delivery compared with night of pump therapy.
†From start of closed loop control at 2200 to 1200 in eating out scenario.
‡From midnight to 1200 in eating out scenario.
§Target range 3.91-8.0 mmol/L.