Table 3 Results based on reference glucose and insulin-infusion data
| Â | Local protocol (n= 12) | Automated closed-loop (n= 12) | P |
|---|---|---|---|
Primary end point | Â | Â | Â |
Time glucose in target (%) (6.0-8.0 mM) | 18.5 (0.1-39.9) | 54.3 (44.1-72.8) | 0.001 |
Secondary end points | Â | Â | Â |
Starting glucose (mM) | 10.8 (9.9-12.0) | 10.0 (8.9-11.1) | 0.21 |
Mean glucose (mM) | 9.1 (8.3-13.0) | 7.9 (7.4-8.2) | 0.001 |
Standard deviation of glucose (mM) | 1.9 (0.8) | 1.3 (0.5) | 0.089 |
Time spent at glucose levels (%) | |||
  4.0-10.0 mM | 73.2 (21.2-89.4) | 93.3 (86.5-100.0) | 0.002 |
  5.6-10.0 mM | 73.2 (21.2-82.4) | 92.2 (83.4-99.2) | 0.001 |
  >8.0 mM | 78.4 (57.6-99.9) | 39.0 (23.5-51.4) | 0.001 |
  >10.0 mM | 26.8 (10.5-78.8) | 6.7 (0-13.5) | 0.002 |
  <6.0 mM | 0 (0-3.0) | 4.6 (3.1-8.3) | 0.028 |
  <5.6 mM | 0 (0-0) | 0.7 (0-2.7) | 0.128 |
  <4.0 mM | 0 (0-0) | 0 (0-0) | NA |
Hypoglycemia | Â | Â | Â |
  Episodes <4.0 mM | None | None |  |
  Hypoglycemia treatments | None | None |  |
Hyperglycemia | Â | Â | Â |
  Number of subjects ≥15 mM | 5 (42%) | 1 (8%) |  |
  Number of subjects ≥17 mM | 4 (33%) | 1 (8%) |  |
  Episodes ≥15 mM | 11 | 1 |  |
  Episodes ≥17 mM | 13 | 1 |  |
Insulin-infusion data | Â | Â | Â |
  Total units for 24 hours | 40.9 (34.9-101.4) | 57.4 (40.0-112.2) | 0.478 |
  Hourly infusion rate | 1.7 (1.5-4.2) | 2.4 (1.7-4.7) | 0.478 |
Total dextrose infusion for 48 hours (g) | 0.21 (0.0-5.2) | NA | NA |