Table 2.
Blinded first month | Unblinded sixth month | *P value for CSII vs. MDI | ‡P value for month 6 unblinded vs. blinded | |||
---|---|---|---|---|---|---|
MDI | CSII | MDI | CSII | |||
ITT population* | ||||||
Glucose average | 9.8 mmol/L (176.4 mg/dL) | 9.9 mmol/L (178.3 mg/dL) | 9.69 mmol/L (174.0 mg/dL) | 9.3 mmol/L (166.7 mg/dL) | 0.304 | 0.001 |
Glucose SD | 4.3 mmol/L (77.0 mg/dL) | 4.2 mmol/L (75.1 mg/dL) | 3.7 mmol/L (67.4 mg/dL | 3.8 mmol/L (68.0 mg/dL) | 0.089 | <0.001 |
Hours/day in hypoglycemia (<3.9 mmol/L [70 mg/dL]) | 1.3 | 1.3 | 1.0 | 1.0 | 0.728 | <0.001 |
Hours/day in hyperglycemia (>10.0 mmol/L [180 mg/dL]) | 8.2 | 8.9 | 8.0 | 6.9 | 0.421 | <0.001 |
Hours/day within target range (70–180 mg/dL) | 9.7 | 9.8 | 10.4 | 11.2 | 0.297 | 0.009 |
MAGE | 10.6 mmol/L (190.2 mg/dL) | 10.1 mmol/L (182.8 mg/dL) | 9.3 mmol/L (166.8 mg/dL) | 9.4 mmol/L (168.5 mg/dL) | 0.133 | <0.001 |
GRADE | 11.5 | 11.7 | 10.8 | 9.9 | 0.890 | <0.001 |
Per-protocol population† | ||||||
Glucose average | 9.8 mmol/L (177.3 mg/dL) | 9.5 mmol/L (171.2 mg/dL) | 9.5 mmol/L (170.7 mg/dL) | 8.8 mmol/L (158.2 mg/dL) | 0.001 | <0.001 |
Glucose SD | 4.3 mmol/L (78.0 mg/dL) | 4.1 mmol/L (73.5 mg/dL) | 3.8 mmol/L (67.7 mg/dL) | 3.6 mmol/L (64.2 mg/dL) | 0.055 | <0.001 |
Hours/day in hypoglycemia (<70 mg/dL) | 1.4 | 1.5 | 1.1 | 1.1 | 0.599 | 0.008 |
Hours/day in hyperglycemia (>180 mg/dL) | 8.8 | 8.6 | 8.4 | 6.8 | 0.038 | 0.004 |
Hours/day within target range (70–180 mg/dL) | 9.8 | 10.7 | 11.3 | 13.5 | 0.017 | <0.001 |
MAGE | 10.8 mmol/L (194.4 mg/dL) | 9.9 mmol/L (178.1 mg/dL) | 9.4 mmol/L (169.8 mg/dL) | 8.7 mmol/L (155.9 mg/dL) | 0.007 | <0.001 |
GRADE | 11.7 | 10.9 | 10.5 | 8.9 | 0.013 | <0.001 |
*ITT analysis showed no difference in mean glucose value or glucose variability indexes in the two groups.
†There was a significant reduction in mean glucose, MAGE, GRADE, and time spent in hyperglycemia in the CSII group when compared with MDI group.
‡However, there were similar but significant reductions in all parameters in the unblinded phase.