Table 2 Summary of primary and secondary outcomes dealing with glycaemic variability

Glucometer

 GLI over 48 h, ITT analysis* ^† mean (95% CI)

86

5.37 (5.21; 5.53)

86

5.46 (5.27; 5.64)

−0.09 (−0.34; 0.16)

0.49^ǂ

 GLI over 48 h, complete case analysis* mean (95% CI)

79

5.35 (5.21; 5.49)

80

5.44 (5.26; 5.62)

−0.09 (−0.32; 0.13)

0.40^ǂ

 Capillary blood glucose average over 48 h, mg dl⁻¹

79

134.8 ± 21.0

132.0 (117.0–149.0)

80

138.7 ± 26.2

133.5 (123.0–146.0)

–

0.58^#

 Capillary standard deviation over 48 h, mg dl⁻¹

79

31.0 ± 13.3

29.0 (25.0–36.0)

80

32.5 ± 18.3

29.0 (22.5–37.5)

–

0.93^#

 MAGE over 48 h, mg dl⁻¹

79

9.8 ± 6.2

9.0 (6.0–12.0)

80

10.1 ± 7.4

9.0 (5.0–12.0)

–

0.98^#

 At least one hypoglycaemia, n (%)

79

11 (13.9)

80

8 (10.0)

–

0.45^Ɨ

 At least one hyperglycaemia, n (%)

79

51 (64.6)

80

48 (60.0)

–

0.55^Ɨ

CGM

 iPro2 glucose average over 48 h, mg dl⁻¹

74

128.0 ± 21.3

124.5 (111.0–142.0)

70

133.5 ± 25.3

129.0 (117.4–139.0)

–

0.26^#

 iPro2 glucose standard deviation over 48 h, mg dl⁻¹

74

23.3 ± 8.9

21.0 (18.0–25.0)

70

25.1 ± 12.3

21.0 (17.0–29.0)

–

0.75^#

 At least one hypoglycaemia detected by iPro2, n (%)

74

19 (25.7)

70

9 (12.9)

–

0.052^Ɨ

 Time spent in hypoglycaemia for 1000 h recorded with iPro2 (h)

74

9.7 ± 25.0

0.0 (0.0–1.74)

70

4.4 ± 14.8

0.0 (0.0–0.0)

–

0.059^#

 At least one hyperglycaemia detected by iPro2, n (%)

74

45 (60.8)

70

46 (65.7)

–

0.54^Ɨ

 Time spent in hyperglycaemia for 1000 h recorded with iPro2

74

64.3 ± 97.3

15.6 (0.0–97.2)

70

92.7 ± 181.1

13.9 (0.0–104.17)

–

0.78^#

 Time in target range recorded with iPro2

74

71 ± 26

80 (54–92)

70

72 ± 25

80 (64–78)

–

0.82^#