Table 2.

Glucose control and variability indexes in the two groups

	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.