Table 2 Safety, efficacy and clinical study outcomes

Study period (days)

3.2 (2-5)

2.8 (1-5)

0.18

Incidence severe hypoglycemia (<2.2 mmol/L)¹

None

None

Detected by CGM

 Number of subjects

3 (4%)

4 (5%)

1.0

 Episodes < 2.2 mmol/L

3

4

% of time for the reference glucose level (SD)³

In target range (5.0-9.0 mmol/L)

69 (26)

66 (26)

0.47

Below target range (2.2-5.0 mmol/L)

5 (7)

3 (5)

0.21

 Mild/moderate hypoglycemia (2.2-3.9)

1 (3)

0 (1)

0.03

Above target range (>9.0 mmol/L)

28 (26)

34 (27)

0.06

 Mild/moderate hyperglycemia (9.0-11.1)

17 (16)

26 (23)

0.01

 Hyperglycemia (>11.1)

11(19)

7(14)

0.19

% of time for the sensor glucose levels (SD)³

In target range (5.0-9.0 mmol/L)

75 (18)

71 (20)

0.18

Below target range (2.2-5.0 mmol/L)

11 (13)

9 (12)

0.44

 Mild/moderate hypoglycemia (2.2-3.9)

2 (7)

1 (2)

0.14

Above target range (>9.0 mmol/L)

15 (16)

20 (21)

0.06

 Mild/moderate hyperglycemia (9.0-11.1)

12 (11)

16 (16)

0.03

 Hyperglycemia (>11.1)

3 (7)

4 (9)

0.35

Mean reference blood glucose (mmol/L)

8.2 (1.6)

8.3 (1.3)

0.53

Mean sensor glucose (mmol/L)

7.1 (1.1)

7.5 (1.3)

0.07

MAG change (mmol/L/h)²

0.33 (0.2-0.5)

0.32(0.2-0.4)

0.31

LOS ICU (hours)

137 (71-250)

95 (51-157)

0.04

LOS hospital (days)

15 (8-270)

14 (8-31)

0.91

Mortality ICU

15 (19%)

12 (15%)

0.67

Mortality hospital

22 (28%)

17 (22%)

0.46