Table 1.
Primary and secondary endpoints.
| Endpoint | Artificial pancreas period | Control period | p value* |
|---|---|---|---|
| Day and night | |||
| Median glucose, mmol/l | 7.3 (7.0–7.6) | 7.7 (7.0–9.0) | 0.123 |
| Mean glucose, mmol/l | 7.4 (7.3–8.1) | 8.1 (7.4–9.3) | 0.059 |
| Time spent in euglycaemia, % | 84.7 (82.2–87.8) | 68.5 (57.9–83.6) | 0.007 |
| Time spent in hypoglycaemia (blood glucose <3.9 mmol/l), % | 1.3 (0.2–3.2) | 2.4 (0.4–10.3) | 0.139 |
| Time spent in hypoglycaemia (blood glucose <3.3 mmol/l), % | 0.0 (0.0–0.8) | 0.5 (0.0–4.8) | 0.069 |
| Time spent in hyperglycaemia (blood glucose >10 mmol/l), % | 11.9 (10.6–17.6) | 24.3 (15.5–39.3) | 0.022 |
| Time spent in hyperglycaemia (blood glucose >13.9 mmol/l), % | 1.8 (0.9–3.7) | 5.2 (0.6–9.9) | 0.059 |
| Glycaemic variability (IQR), mmol/l | 2.8 (2.6–2.9) | 3.7 (3.1–5.3) | 0.011 |
| Glycaemic variability (BGRI), score | 6.6 (5.9–7.2) | 10.8 (7.4–15.9) | 0.005 |
| Daytime (07:00–24:00 hours) | |||
| Median glucose, mmol/l | 7.5 (7.2–8.2) | 7.8 (6.8–8.9) | 0.799 |
| Mean glucose, mmol/l | 7.8 (7.5–8.3) | 8.1 (7.4–9.6) | 0.508 |
| Time spent in euglycaemia, % | 79.9 (76.4–82.8) | 69.7 (53.5–83.1) | 0.074 |
| Time spent in hypoglycaemia (blood glucose <3.9 mmol/l), % | 1.8 (0.0–4.5) | 1.3 (0.4–12.9) | 0.285 |
| Time spent in hyperglycaemia (blood glucose >10 mmol/l), % | 16.9 (13.6–22.0) | 24.3 (16.2–40.8) | 0.169 |
| Glycaemic variability (IQR), mmol/l | 3.3 (3.1–3.4) | 3.7 (2.9–5.0) | 0.074 |
| Glycaemic variability (BGRI), score | 8.1 (6.7–8.5) | 10.2 (7.2–15.5) | 0.093 |
| Night‐time (24:00–07:00 hours) | |||
| Median glucose, mmol/l | 7.0 (6.4–7.4) | 7.7 (6.8–8.0) | 0.028 |
| Mean glucose, mmol/l | 6.8 (6.6–7.5) | 7.8 (7.4–8.7) | 0.007 |
| Time spent in euglycaemia, % | 97.7 (94.7–100.0) | 71.2 (60.3–85.9) | 0.005 |
| Time spent in hypoglycaemia (blood glucose <3.9 mmol/l), % | 0.0 (0.0–0.6) | 1.7 (0.0–10.3) | 0.069 |
| Time spent in hyperglycaemia (blood glucose >10 mmol/l), % | 0.0 (0.0–4.9) | 18.7 (11.9–36.0) | 0.007 |
| Glycaemic variability (IQR), mmol/l | 1.6 (1.4–1.8) | 3.3 (2.6–5.7) | 0.005 |
| Glycaemic variability (BGRI), score | 2.4 (2.0–4.5) | 12.3 (7.6–15.7) | 0.005 |
| Postprandial median glucose, mmol/l | |||
| Breakfast | 8.9 (7.8–10.1) | 7.7 (7.2–10.2) | 0.139 |
| Lunch | 7.3 (6.8–8.6) | 8.5 (7.5–11.0) | 0.153 |
| Dinner | 7.9 (7.3–8.3) | 7.4 (6.8–9.4) | 0.594 |
| Postprandial mean glucose, mmol/l | |||
| Breakfast | 8.9 (8.2–10.5) | 7.8 (7.2–10.8) | 0.333 |
| Lunch | 7.5 (6.9–8.7) | 8.5 (8.0–11.2) | 0.028 |
| Dinner | 8.0 (7.0–8.4) | 7.4 (7.0–9.0) | 0.646 |
| Postprandial time spent in hyperglycaemia (blood glucose >10 mmol/l), % | |||
| Breakfast | 30.6 (15.0–50.8) | 21.8 (3.8–53.2) | 0.241 |
| Lunch | 9.0 (7.4–30.2) | 30.8 (19.8–59.7) | 0.037 |
| Dinner | 17.5 (2.8–26.0) | 18.5 (4.0–40.1) | 0.374 |
Data are median (interquartile range).
Euglycaemia: 3.9–10 mmol/l. Postprandial control during the 3 h from start of the meal.
*
Wilcoxon signed rank tests.