Outcome | Closed loop with standard insulin (n=11) | Closed loop with diluted insulin (n=11) | p Value |
---|---|---|---|
Primary outcome | |||
Time in target 70–145 mg/dL (%) | 72 (54, 81) | 83 (70, 100) | 0.328 |
Secondary outcomes | |||
Mean glucose (mg/dL) | 122 (23) | 122 (24) | 0.993 |
Time in target 70–180 mg/dL (%) | 85 (72, 97) | 98 (79, 100) | 0.328 |
Hypoglycemia | |||
Less than 70 mg/dL (%) | 1.4 (0.0, 11.6) | 0.0 (0.0, 1.4) | 0.161 |
Less than 63 mg/dL (%) | 0.0 (0.0, 7.9) | 0.0 (0.0, 0.0) | 0.249 |
Low blood glucose index (unitless) | 2.0 (0.6, 2.2) | 0.7 (0.2, 1.0) | 0.050 |
Hyperglycemia | |||
Greater than 145 mg/dL (%) | 18.8 (9.5, 44.9) | 13.0 (0.0, 26.9) | 0.477 |
Greater than 180 mg/dL (%) | 5.1 (0.0, 26.8) | 0.0 (0.0, 15.3) | 0.953 |
Glucose variability | |||
SD of glucose (mg/dL) | 35 (26, 53) | 26 (14, 39) | 0.091 |
CV of glucose (%) | 32 (24, 42) | 20 (13, 31) | 0.075 |
MAGE (mg/dL) | 80 (0, 112) | 32 (0, 63) | 0.074 |
Insulin infusion (U/h) | 0.2 (0.2, 0.3) | 0.2 (0.1, 0.3) | 0.328 |
Insulin concentration (pmol/L) | 141 (35, 262) | 112 (50, 144) | 0.213 |
Data are mean (SD) or median (IQR).
Outcomes calculated between 21:00 and 8:00 and based on plasma glucose levels.
CV, coefficient of variation; MAGE, mean amplitude of glucose excursions.