Run in | Phase 1 intervention | Phase 2 intervention | P value Phase 2 vs. Phase 1 | |
---|---|---|---|---|
Mean glucose, mmol/L | 8.4 ± 0.8 | 8.3 ± 0.6 | 8.5 ± 0.7 | 0.5 |
Glucose management indicator, %b | 6.9 ± 0.4 | 6.9 ± 0.2 | 7 ± 0.3 | 0.5 |
Coefficient of variation, % | 35.8% ± 5 | 36.3 ± 4.7 | 34.2 ± 5 | 0.08 |
%time in severe hypoglycemia (< 3 mmol/L/54mg/dl), | 0.40 ± 0.40 | 0.40 ± 0.40 | 0.10 ± 0.10 | 0.01 |
%Time below range (< 3.9 mmol/L/70mg/dl)b | 2.1 ± 1.70 | 2.10 ± 1.30 | 1.40 ± 1.20 | 0.04 |
% Time in tight range (3.9–7.8mmol/70-140mg/dl) | 49.7 ± 10.4 | 50.2 ± 7.2 | 49.2 ± 7.7 | 0.55 |
%Time in range (3.9–10 mmol/L/70-180mg/dl)c | 72.2 ± 9.9 | 72.9 ± 7.8 | 73.5 ± 8.6 | 0.84 |
%Time above range (>10mmol/180mg/dl) | 25.7 ± 10.0 | 25 ± 7.3 | 25.2 ± 8.5 | 0.87 |
%Time in severe hyperglycemia (> 13.9 mmol/L/ > 250mg/dl) | 6.4 ± 5.8 | 6.2 ± 3.9 | 6.1 ± 4.4 | 0.91 |
Total Daily dose, units | 51.6 ± 30.4 | 51.3 ± 29.2 | 47.1 ± 19.3 | 0.46 |
Meal Bolus, units | 19.6 (12.4) | 19.3 ± 10.9 | 14.8 ± 8 | 0.06 |
Basal insulin, units | 23.1 (11.9) | 20.1 ± 11.2 | 16.7 ± 7.8 | 0.13 |
Autocorrection, units | 8.2 (7.1) | 9.7 ± 7.2 | 10.7 ± 6.3 | 0.58 |
Meals per day | 5.2 ± 2 | 5.1 ± 1.8 | 4.6 ± 1.8 | 0.32 |
Carbs per day(g) | 174.3 ± 70.7 | 169.8 ± 71.4 | 156.8 ± 71.8 | 0.51 |
Sensors use % | 89.8 ± 11.8 | 87.6 ± 9.9 | 88.6 ± 15.6 | 0.73 |
% Time in Automodec | 94.1 ± 5.7 | 95.8 ± 6.3 | 98.1 ± 3.9 | 0.07 |
AHCL exits, weekd | 1.2 ± 1 | 1.1 ± 0.90 | 0.7 ± 0.40 | 0.05 |
% of Subjects Automode < 70% | 3.8% | 1.9% | 0% | 0.07 |