Table 2.
Summary results of all 11-day experiments
| Bionic pancreas | Comparator | Difference (95% CI) | p value | |
|---|---|---|---|---|
|
Day and night CGM glucose concentration on days 2–11 | ||||
| Overall mean* | 7·8 (0·6, 6·3–9·2) | 9·0 (1·6, 5·2–13·6) | 1·1 (0·7–1·6) | <0·0001 |
| <3·3 mmol/L (% of time)* | 0·6% (0·6, 0·0–2·8) | 1·9% (1·7, 0·0–7·7) | 1·3% (0·8–1·8) | <0·0001 |
| 3·9–10·0 mmol/L (% of time) | 78·4% (6·0, 66·3–98·6) | 61·9% (14·4, 19·6–88·3) | 16·5% (12·5–20·6) | <0·0001 |
| >10·0 mmol/L (% of time) | 19·8% (6·1, 1·2–33·3) | 33·6% (16·4, 0·8–80·3) | 13·8% (9·3–18·3) | <0·0001 |
| Participant-level SD (mmol/L) | 2·8 (0·5, 1·4–3·6) | 3·5 (0·8, 1·6–5·9) | 0·6 (0·4–0·9) | <0·0001 |
| Coefficient of variation (%) | 35·9% (5·1, 22–45) | 38·8% (6·0, 26–53) | 2·9% (0·7–5·0) | 0·013 |
| Daily differences (mmol/L) | 0·9 (0·4, 0·2–2·1) | 1·6 (0·7, 0·6–4·1) | 0·7 (0·5–0·9) | <0·0001 |
| Number of carbohydrate interventions per day | 0·4 (0·3, 0·0–1·3) | 0·9 (0·7, 0·0–2·8) | 0·5 (0·3–0·8) | <0·0001 |
| Night-time CGM glucose concentration on nights 2–11 | ||||
| Overall mean (mmol/L) | 7·4 (0·8, 5·9–9·9) | 9·2 (2·1, 4·9–15·3) | 1·7 (1·2–2·3) | <0·0001 |
| <3·3 mmol/L (% of time) | 0·3% (0·4, 0·0–1·7) | 1·9% (2·7, 0·0–13·3) | 1·6% (0·8–2·5) | 0·0008 |
| 3·9–10·0 mmol/L (% of time) | 84·8% (8·6, 60·1–99·3) | 60·3% (16·9, 14·6–97·7) | 24·6% (20·0–29·1) | <0·0001 |
| >10·0 mmol/L (% of time) | 14·1% (8·4, 0·5–39·6) | 34·8% (19·0, 0·0–85) | 20·7% (15·6–25·8) | <0·0001 |
| Participant-level SD (mmol/L) | 2·4 (0·6, 1·2–3·8) | 3·5 (0·9, 1·6–5·9) | 0·6 (0·4–0·9) | <0·0001 |
| Coefficient of variation (%) | 32·1% (7·1, 20–51) | 37·0% (8·8, 23–57) | 4·9% (1·4–8·3) | 0·0092 |
Data are mean (SD, range), unless otherwise specified. CGM=continuous glucose monitoring.
*
Coprimary outcomes.