Clinical Trials Study
Copyright ©The Author(s) 2022.
World J Clin Cases. Aug 6, 2022; 10(22): 7794-7807
Published online Aug 6, 2022. doi: 10.12998/wjcc.v10.i22.7794
Table 1 Baseline characteristics
Variable
All, n = 40
FAS population, n = 33
Age in yr64.1 (9.2)63.2 (9.2)
66 (41; 77)65.5 (41; 77)
n = 39n = 32
HbA1c in mmol/mol53.1 (11.0)53.9 (11.5)
53 (31; 75)54 (31; 75)
n = 40n = 33
HbA1c %7 (3.2)7.1 (3.2)
53 (5; 9)7.1 (5; 9)
n = 40n = 33
Dialysis
Not in dialysis 20 (50.0%)17 (51.5%)
Hemodialysis 11 (27.5%)7 (21.2%)
Peritoneal dialysis9 (22.5%)9 (27.3%)
Diabetes duration28.5 (14.7)29.2 (15.4)
27.5 (5.3; 64.5)28.5 (5.3; 64.5)
n = 32n = 26
Sex
Man 29 (74.4%)22 (68.8%)
Woman10 (25.6%)10 (31.3%)
Smoking
No 25 (71.4%)19 (67.9%)
Yes 3 (8.6%)3 (10.7%)
Do not know7 (20.0%)6 (21.4%)
Systolic blood pressure in mmHg145.6 (24.2)146.5 (24.7)
145 (95; 213)142.5 (95; 213)
n = 37n = 30
Diastolic blood pressure in mmHg77.4 (13.7)78.6 (13.8)
80 (52; 103)80 (52; 103)
n = 37n = 30
Insulin delivery
Basal insulin only 12 (32.4%)10 (33.3%)
Mix insulin 2 (5.4%)2 (6.7%)
MDI 24 (64.9%)20 (66.7%)
Other glucose lowering treatment5 (13.5%)3 (10.0%)
Total insulin dose per day73.0 (60.3)65.7 (63.8)
45 (8; 277)41 (8; 277)
n = 25n = 20
Type of diabetes
Type 111 (30.6%)10 (33.3%)
Type 225 (69.4%)20 (66.7%)
Table 2 Mean absolute relative difference, mean absolute difference and mean difference for Dexcom G5 and FreeStyle Libre
Variable
FreeStyle Libre (isCGM)
Dexcom G5 CGM
Difference (isCGM-CGM)
P value1
Mean MARD20.9 (8.6)15.2 (12.2)5.72 (10.17)0.0036
19.8 (8.5; 43.1)11.9 (2.2; 60.5)6.5 (-26.75; 24.68)
n = 33n = 33(2.11; 9.32)
n = 33
Mean MAD1.76 (0.78)1.21 (0.78)0.548 (0.795)0.0004
1.65 (0.48; 4.48)0.95 (0.23; 3.12)0.679 (-1.662; 2.11)
n = 33n = 33(0.267; 0.830)
n = 33
Mean MD-1.10 (1.24)-0.107 (0.937)-0.998 (1.278)0.0002
-1.46 (-4.48; 1.63)-0.229 (-2.47; 3.007)-1.1 (-3.586; 2.431)
n = 33n = 33(-1.451; -0.545)
n = 33
Persons in dialysis
Mean MARD19.3 (7.4)15.5 (14.8)3.80 (11.09)0.19
17.7 (8.5; 33.7)8.6 (4.1; 60.5)6.51 (-26.75; 15.75)
n = 16n = 16(-2.11; 9.71)
n = 16
Mean MAD1.74 (0.91)1.26 (0.85)0.489 (0.828)0.035
1.65 (0.77; 4.48)0.99 (0.43; 3.12)0.611 (-1.236; 1.65)
n = 16n = 16(0.048; 0.931)
n = 16
Mean MD-1.29 (1.29)0.056 (1.232)-1.34 (1.30)0.0019
-1.32 (-4.48; 0.96)-0.252 (-2.47; 3.007)-1.46 (-3.59; 1.07)
n = 16n = 16(-2.03; -0.65)
n = 16
People not in dialysis
Mean MARD22.5 (9.5)15.0 (9.6)7.53 (9.19)0.0033
19.8 (8.8; 43.1)12.5 (2.2; 38.5)6 (-15.59; 24.68)
n = 17n = 17(2.80; 12.25)
n = 17
Mean MAD1.77 (0.65)1.16 (0.72)0.604 (0.784)0.0057
1.67 (0.48; 3.22)0.95 (0.23; 2.77)0.679 (-1.662; 2.11)
n = 17n = 17(0.201; 1.007)
n = 17
Mean MD-0.934 (1.211)-0.260 (0.529)-0.673 (1.209)0.037
-1.482 (-2.586; 1.632)-0.223 (-1.323; 0.932)-0.855 (-2.348; 2.431)
n = 17n = 17(-1.295; -0.052)
n = 17
Glucose values < 3.9 mmol/L
Mean MARD53.0 (37.1)89.8 (66.8)-36.9 (42.0)0.027
35.3 (12.8; 115.2)66.7 (7.7; 197.4)-44.7 (-127.2; 7.1)
n = 9n = 9(-69.2; -4.5)
n = 9
Mean MAD1.81 (1.33)3.10 (2.47)-1.29 (1.52)0.027
1.2 (0.47; 3.9)1.8 (0.27; 7.2)-1.3 (-4.65; 0.2)
n = 9n = 9(-2.46; -0.12)
n = 9
Mean MD1.18 (1.96)3.03 (2.54)-1.85 (1.42)0.0078
1.2 (-1.2; 3.9)1.8 (0.27; 7.2)-1.8 (-4.65; 0.2)
(-2.94; -0.76)
n = 9n = 9n = 99
Glucose values 3.9-10.0 mmol/L
Mean MARD22.6 (8.9)14.8 (10.6)7.83 (9.88)< 0.0001
21 (8.7; 44.1)11.9 (1.5; 40.5)8.05 (-13.18; 28.95)
n = 33n = 33(4.32; 11.33)
n = 33
Mean MAD1.60 (0.62)1.03 (0.71)0.568 (0.689)< 0.0001
1.45 (0.5; 2.98)0.82 (0.13; 2.59)0.633 (-0.918; 2.045)
n = 33n = 33(0.323; 0.812)
n = 33
Mean MD-0.868 (1.183)0.136 (0.859)-1.00 (1.19)< 0.0001
-1.067 (-2.9; 2.508)-0.017 (-2.1; 2.445)-1.07 (-3.57; 1.38)
n = 33n = 33(-1.43; -0.58)
n = 33
Glucose values > 10.0 mmol/L
Mean MARD16.6 (11.1)12.3 (11.6)4.22 (8.63)0.010
15.3 (1.9; 59)7.9 (1.9; 50.4)4.69 (-25.08; 16.94)
n = 31n = 31(1.06; 7.39)
n = 31
Mean MAD2.06 (1.29)1.54 (1.31)0.520 (1.139)0.016
1.9 (0.2; 6.45)1.04 (0.2; 5.5)0.533 (-3.4; 2.18)
n = 31n = 31(0.102; 0.938)
n = 31
Mean MD-1.82 (1.56)-0.944 (1.633)-0.875 (1.777)0.0087
-1.89 (-6.45; 1.16)-0.563 (-5.5; 2.7)-0.95 (-4.1; 5.72)
n = 31n = 31(-1.527; -0.223)
n = 31
Hemodialysis
Mean MARD21.4 (9.1)20.3 (18.9)1.13 (14.27)0.86
20.7 (8.5; 33.7)17 (5.6; 60.5)2.88 (-26.75; 15.75)
n = 7n = 7(-12.07; 14.33)
n = 7
Mean MAD1.79 (0.69)1.44 (0.87)0.354 (1.012)0.38
1.89 (0.77; 2.73)1.28 (0.56; 3.12)0.211 (-1.236; 1.614)
n = 7n = 7(-0.582; 1.290)
n = 7
Mean MD-0.905 (1.451)0.378 (1.185)-1.28 (1.47)0.063
-1.606 (-2.733; 0.96)0.056 (-0.433; 3.007)-1.99 (-2.54; 1.07)
n = 7n = 7(-2.65; 0.08)
n = 7
Peritoneal dialysis
Mean MARD17.6 (5.9)11.7 (10.4)5.88 (8.16)0.078
14.9 (12.1; 28.8)6.9 (4.1; 36.7)7.18 (-14.64; 13.35)
n = 9n = 9(-0.39; 12.15)
n = 9
Mean MAD1.71 (1.09)1.11 (0.86)0.595 (0.700)0.043
1.4 (0.96; 4.48)0.77 (0.43; 2.83)0.736 (-0.89; 1.65)
n = 9n = 9(0.057; 1.132)
n = 9
Mean MD-1.58 (1.15)-0.193 (1.278)-1.39 (1.23)0.0039
-1.25 (-4.48; -0.8)-0.442 (-2.47; 2.195)-1 (-3.59; -0.33)
n = 9n = 9(-2.34; -0.44)
n = 9
Table 3 Patient experience of FreeStyle Libre and Dexcom G5 measured on a visual analogue scale
VariableFreeStyle Libre isCGM, n = 31Dexcom G5 CGM, n = 31Change from FreeStyle Libre isCGM to Dexcom G5 CGM

P value
My experience of the system was very positive8.35 (2.03)6.84 (2.70)-1.52 (3.41)0.023
9.00 (3.00; 10.00)8.00 (2.00; 10.00)-2.00 (-7.00; 7.00)
(7.61; 9.10)(5.85; 7.83)(-2.77; -0.26)
n = 31n = 31n = 31
The insertion of the sensor was easy9.03 (1.71)8.27 (2.29)-0.767 (1.455)0.0084
10.00 (2.00; 10.00)9.00 (1.00; 10.00)0.000 (-5.000; 2.000)
(8.39; 9.67)(7.41; 9.12)(-1.310; -0.223)
n = 30n = 30n = 30
I felt safe during my time using the system7.94 (2.67)7.19 (2.46)-0.742 (3.916)0.32
9.00 (0.00; 10.00)8.00 (3.00; 10.00)-1.000 (-7.000; 9.000)
(6.96; 8.91)(6.29; 8.09)(-2.178; 0.694)
n = 31n = 31n = 31
It was easy to use the system9.52 (0.96)7.60 (2.62)-1.93 (2.21)< 0.0001
10.00 (6.00; 10.00)9.00 (2.00; 10.00)-1.00 (-7.00; 0.00)
(9.16; 9.87)(6.62; 8.58)(-2.76; -1.11)
n = 31n = 30n = 30
It was easy to interpret the information on the receiver screen9.42 (0.99)7.97 (2.46)-1.45 (1.98)< 0.0001
10.00 (7.00; 10.00)9.00 (1.00; 10.00)-1.00 (-7.00; 1.00)
(9.06; 9.78)(7.07; 8.87)(-2.18; -0.73)
n = 31n = 31n = 31
I was not in pain or had discomfort in connection to my use of the system9.74 (0.73)8.48 (2.78)-1.26 (2.68)0.0078
10.00 (7.00; 10.00)10.00 (0.00; 10.00)0.00 (-10.00; 0.00)
(9.47; 10.01)(7.46; 9.50)(-2.24; -0.27)
n = 31n = 31n = 31
I experienced no problem scanning/contact with the system9.55 (0.93)7.19 (3.29)-2.35 (3.23)< 0.0001
10.00 (7.00; 10.00)9.00 (0.00; 10.00)-1.00 (-10.00; 2.00)
(9.21; 9.89)(5.99; 8.40)(-3.54; -1.17)
n = 31n = 31n = 31
The sensor was comfortable to have on my body in my daily life9.20 (1.40)7.23 (2.69)-1.90 (2.34)< 0.0001
10.00 (4.00; 10.00)8.00 (1.00; 10.00)-1.00 (-8.00; 1.00)
(8.68; 9.72)(6.24; 8.21)(-2.77; -1.03)
n = 30n = 31n = 30
The system did not disturb my daily life9.33 (1.09)7.74 (2.62)-1.50 (2.43)0.0024
10.00 (6.00; 10.00)9.00 (3.00; 10.00)0.00 (-7.00; 4.00)
(8.93; 9.74)(6.78; 8.70)(-2.41; -0.59)
n = 30n = 31n = 30
I would like to use the system in my daily life8.45 (2.86)5.42 (3.49)-2.66 (4.98)0.0096
10.00 (0.00; 10.00)6.00 (0.00; 10.00)-3.00 (-10.00; 9.00)
(7.36; 9.54)(4.14; 6.70)(-4.55; -0.76)
n = 29n = 31n = 29
It was easy to calibrate the Dexcom G58.40 (2.21)
10.00 (3.00; 10.00)
(7.58; 9.22)
n = 30
The alarms did not disturb my daily life7.97 (2.74)
9.00 (0.00; 10.00)
(6.95; 8.99)
n = 30