TABLE IV:
Protocol C | Day 1 | Day 2 | Day 3 | ||||||
---|---|---|---|---|---|---|---|---|---|
Metrics | Control | Proposed | p value | Control | Proposed | p value | Control | Proposed | p value |
Day & night | |||||||||
% time <54 mg/dL | 0.0 (0.0) | 0.0 (0.0) | 0.064 | 0.0 (0.0) | 0.0 (0.0) | 1.000 | 0.0 (0.0) | 0.0 (0.0) | 0.500 |
% time <70 mg/dL | 0.0 (0.0) | 0.0 (0.0) | 0.397 | 0.0 (0.0) | 0.0 (0.0) | 0.096 | 0.0 (0.0) | 0.0 (0.0) | 0.001* |
% time 70–180 mg/dL | 66.3 (14.3) | 70.5 (11.5) | <0.001* | 84.7 (13.6) | 85.8 (12.6) | <0.001* | 56.1 (21.1) | 64.8 (18.0) | <0.001* |
% time >250 mg/dL | 3.6 (10.8) | 1.9 (7.1) | <0.001* | 0.0 (0.0) | 0.0 (0.0) | <0.001* | 12.2 (17.2) | 5.9 (13.4) | <0.001* |
Mean BG (mg/dL) | 159.0 (18.1) | 153.8 (13.5) | <0.001* | 148.9 (10.3) | 146.1 (9.6) | <0.001* | 180.6 (31.6) | 166.4 (21.9) | <0.001* |
SD BG (mg/dL) | 47.7 (13.8) | 45.6 (12.7) | <0.001* | 27.7 (10.5) | 28.4 (10.6) | <0.001* | 49.6 (14.5) | 45.3 (13.3) | <0.001* |
Night time (0–6 AM) | |||||||||
% time <54 mg/dL | 0.0 (0.0) | 0.0 (0.0) | 0.219 | 0.0 (0.0) | 0.0 (0.0) | 1.000 | 0.0 (0.0) | 0.0 (0.0) | 1.000 |
% time <70 mg/dL | 0.0 (0.0) | 0.0 (0.0) | 0.010* | 0.0 (0.0) | 0.0 (0.0) | 1.000 | 0.0 (0.0) | 0.0 (0.0) | 0.008* |
% time 70–180 mg/dL | 100.0 (0.0) | 100.0 (0.0) | <0.001* | 100.0 (0.0) | 100.0 (0.0) | <0.001* | 100.0 (7.5) | 100.0 (0.0) | <0.001* |
% time >250 mg/dL | 0.0 (0.0) | 0.0 (0.0) | 1.000 | 0.0 (0.0) | 0.0 (0.0) | 1.000 | 0.0 (0.0) | 0.0 (0.0) | 0.143 |
Mean BG (mg/dL) | 120.6 (9.0) | 119.7 (8.2) | <0.001* | 133.1 (10.8) | 131.0 (9.8) | <0.001* | 138.0 (17.8) | 134.3 (12.6) | <0.001* |
SD BG (mg/dL) | 13.5 (7.3) | 13.0 (7.3) | <0.001* | 12.5 (5.7) | 12.9 (6.2) | <0.001* | 14.6 (8.3) | 13.9 (6.9) | <0.001* |
Mean BG at 7 AM (mg/dL) | 122.0 (15.0) | 121.0 (14.0) | <0.001* | 140.5 (19.0) | 136.0 (21.0) | <0.001* | 140.5 (25.0) | 135.0 (26.0) | <0.001* |
Data in this table are shown as median (inter quartile range). Statistical significance is assessed by Wilcoxon signed-rank test. Statistically significant (p < 0.05) changes are highlighted in bold with asterisks.