Table 3.
Primary and Secondary Efficacy Analysis of Accuracy Evaluations (Intention-to-Treat Population)
| Mean (SD) Median (Min; Max) (Bootstrapped (10,000 replicates) 95% CI for mean) P value within group | |||||
|---|---|---|---|---|---|
| Variable | MARD (%) ([|FGM − HemoCue|]/HemoCue) × 100 | MAD (mg/dL) (|FGM − HemoCue|) | MD (mg/dL) (FGM − HemoCue) | MRD (%) ([FGM − HemoCue]/HemoCue) × 100 | Pearson correlation coefficient FGM vs. HemoCue |
| Overall (n = 50) | 13.2 (4.4) | 19.8 (7.3) | −9.20 (13.98) | −5.24 (9.01) | 0.957 (0.033) |
| 12.4 (6.2; 28.0) | 18.0 (8.6; 36.8) | −8.41 (−34.72; 18.54) | −6.10 (−22.47; 12.80) | 0.966 (0.838; 0.991) | |
| (12.0; 14.4) | (17.8; 21.8) | (−13.00; −5.41) | (−7.69; −2.77) | (0.947; 0.966) | |
| P < 0.0001 | |||||
| For HemoCue <72 (n = 42) | 20.3 (9.0) | 12.3 (5.7) | 0.047 (11.277) | 1.34 (17.98) | |
| 17.7 (7.1; 50.0) | 10.8 (4.5; 34.2) | −0.225 (−21.622; 34.235) | 0.17 (−31.25; 50.00) | ||
| (17.7; 23.1) | (10.7; 14.2) | (−3.271; 3.443) | (−3.99; 6.73) | ||
| P = 0.81 | |||||
| For HemoCue 72–180 (n = 50) | 14.7 (4.8) | 17.8 (6.0) | −7.86 (12.37) | −6.50 (10.10) | |
| 13.6 (6.1; 28.1) | 17.1 (8.0; 32.5) | −7.68 (−30.85; 15.98) | −6.66 (−24.84; 12.20) | ||
| (13.4; 16.0) | (16.1; 19.4) | (−11.20; −4.43) | (−9.21; −3.68) | ||
| P < 0.0001 | |||||
| For HemoCue >180 (n = 50) | 9.62 (4.10) | 23.6 (10.8) | −11.7 (17.8) | −4.56 (7.13) | |
| 8.40 (3.76; 24.63) | 20.1 (8.1; 60.8) | −8.9 (−46.5; 31.9) | −3.16 (−17.96; 13.19) | ||
| (8.54; 10.81) | (20.8; 26.8) | (−16.5; −6.8) | (−6.48; −2.61) | ||
| P < 0.0001 | |||||
| Week 1 (n = 45) | 13.6 (5.7) | 20.5 (9.3) | |||
| 12.2 (6.6; 33.9) | 17.2 (9.5; 43.5) | ||||
| (12.1; 15.4) | (18.0; 23.3) | ||||
| Week 2 (n = 45) | 12.7 (4.1) | 19.0 (7.7) | |||
| 11.7 (5.4; 22.0) | 17.7 (7.7; 41.7) | ||||
| (11.5; 13.9) | (16.9; 21.3) | ||||
| Difference week 1 to week 2 (n = 45) | −0.940 (5.053) | −1.53 (7.66) | |||
| −0.985 (−17.762; 9.916) | −1.63 (−20.29; 27.53) | ||||
| (−2.443; 0.497) | (−3.64; 0.76) | ||||
| P = 0.14 | P = 0.058 | ||||
For continuous variables mean (SD)/median (Min; Max)/(Bootstrapped (10,000 replicates) 95% CI for mean)/P is presented.
For comparison within groups the Wilcoxon signed rank test was used.
Patients 01–018, 01–031, 01–032, 01–037, and 02–005 are deleted from the MARD and the MAD week analyses because of change of censor during the study.
MAD, mean absolute difference; MARD, mean absolute relative difference.