Table 2:
Glucose control, insulin delivery, and usage endpoints in the intention-to-treat analysis population
| Closed-loop group (n=36) | Sensor-augmented pump therapy group (n=37) | Treatment difference (95% CI) | p value* | |
|---|---|---|---|---|
|
| ||||
| Primary endpoint † | ||||
| Time with glucose 3·9 to 10·0 mmol/L, % | 79·9% (7·9) | 71·4% (13·2) | 8·6 (6·3 to 11·0) | <0·0001 |
| Key secondary endpoints† | ||||
| Time with glucose >10·0 mmol/L, % | 16·7% (11·4 to 23·9) | 21·4% (16·9 to 36·5) | −8·5% (−10·9 to −6·1) | <0·0001 |
| Mean glucose, mmol/L | 7·8 (0·7) | 8·5 (1·1) | −0·7 (−0·9 to −0·5) | <0·0001 |
| HbA1c, mmol/mol | 49·3 (7·9) | 52·1 (9·2) | −2·7 (−4·2 to −1·2) | 0·0008 |
| HbA1c, % | 6·7% (0·7%) | 6·9% (0·9%) | −0·2% (−0·4 to −0·1) | 0·0008 |
| Time with glucose <3·9 mmol/L, % | 1·7 (1·3 to 2·4) | 1·7 (0·9 to 2·7) | −0·1 (−0·3 to 0·2) | 0·54 |
| Other secondary endpoints ‡ | ||||
| Time with glucose | ||||
| <3·5 mmol/L, % | 0·7% (0·5 to 1·1) | 0·7% (0·4 to 1·2) | 0·0% (−0·2 to 0·1) | 0·69 |
| <3·0 mmol/L, % | 0·2% (0·1 to 0·3) | 0·2% (0·1 to 0·3) | 0·0% (−0·1 to 0·1) | 0·69 |
| >l6·7 mmol/L, % | 0·5% (0·2 to 0·8) | 0·8% (0·2 to 2·8) | −0·7% (−1·0 to −0·3) | <0·0001 |
| Glucose, mmol/L | 2·6 (0·5) | 2·8 (0·6) | −0·2 (−0·3 to −0·1) | <0·0001 |
| Glucose coefficient of variation, % | 32·5 (4·2) | 32·7 (4·5) | −0·3 (−1·2 to 0·6) | 0·49 |
| Total daily insulin, units per day | 46·3 (36·9 to 53·5) | 42·9 (36·6 to 53·0) | 1·2 (−0·6 to 3·0) | 0·20 |
| Total daily basal insulin, units per day | 27·7 (18·9 to 32·0) | 21·5 (15·9 to 27·0) | 4·7 (3·2 to 6·1) | <0·0001 |
| Total daily bolus insulin, units per day | 20·2 (13·5 to 26·1) | 23·4 (17·0 to 29·6) | −3·5 (−4·9 to −2·0) | <0·0001 |
| Total daily dose, units per kg/day | 0·5 (0·5 to 0·6) | 0·5 (0·4 to 0·6) | 0·0 (0·0 to 0·0) | 0·35 |
| Time using continuous glucose monitoring, % | 99·7 (99·3–99·9) | 99·4 (98·8–99·9) | 0·45 (0·06–0·85) | 0·026 |
| Time using closed-loop, % | 96·7% (95·1–98·0) | .. | .. | .. |
Data are mean (SD) or median (IQR). Endpoints calculated from all randomised subjects with at least 168 h of CGM data in at least one period. Glucose data are based on sensor glucose measurements. Treatment difference is calculated as closed loop minus sensor augmented pump therapy. One participant randomised to initial use of sensor-augmented pump therapy did not cross over to closed-loop insulin delivery.
Based on a linear mixed model adjusting for period as a fixed effect and site as a random effect.
Tested in hierarchy as listed to control the type 1 error using the fixed-sequence method.
Adjusted for multiple comparisons using Benjamini-Hochberg procedure to control false discovery rate. HbA1c=glycated haemoglobin