Bailey T. et al. Diabetes Technology Ther. 2015, 17(11), 1-8

is provided in Table 2. The variation in MARD against BG reference for different sensors is shown in Figure 2, with the linear mixed model estimating the between-subjects variance component to be 44% of the total variation. There was no significant difference between left and right arm insertion sites (11.2% and 11.4%; P = 0.5950). The System’s sensor results were highly correlated to capillary BG. Regression analysis produced a slope of 1.02, an intercept of -6.4 mg/dL, and a correlation coefficient of 0.95 (range, 23–498 mg/dL). The coefficient of variation of sensitivity (as measured by slope) between sensors was 8.5%, 8.6%, and 8.9% for each sensor lot. This variation was Table 2. Difference Analysis Compared with Capillary and Venous Reference Under Various Conditions Reference, glucose Days 1–14 Days 2–14 Day (7 a.m.– Night (11 p.m. Without hypoglycemia/ rapid changea range, parameter All Home Clinic All Home Clinic 11 p.m.) –7 a.m.) All Clinic Capillary, BG < 100 mg/dL MAD (mg/dL) 11.3 11.3 11.8 11.0 11.0 10.6 11.5 10.4 10.3 8.4 n 2,153 1,946 207 1,985 1,813 172 1,787 366 905 97 ‡ 100 mg/dL MARD (%) 10.7 10.5 11.8 10.2 10.2 10.4 10.8 9.9 10.2 11.1 n 11,042 9,642 1,400 9,987 8,878 1,109 9,717 1,325 9,341 1,236 All % 11.4 11.3 12.1 11.0 11.0 10.7 11.5 10.8 10.4 11.0 n 13,195 11,588 1,607 11,972 1,0691 1,281 11,504 1,691 10,246 1,333 Venous, YSI < 100 mg/dL MAD (mg/dL) — — 13.4 — — 12.6 — — — 10.2 n — — 1,475 — — 1,327 — — — 620 ‡ 100 mg/dL MARD (%) — — 11.4 — — 10.3 — — — 10.9 n — — 10,697 — — 8,789 — — — 9,722 All % — — 12.0 — — 11.0 — — — 11.0 n — — 12,172 — — 10,116 — — — 1,0342 a Excluding rapidly changing/hypoglycemia (80 mg/dL) and impending hypoglycemia. BG, blood glucose; MAD, mean absolute difference, MARD, mean absolute relative difference. FIG. 2. Histogram of the mean absolute relative difference (MARD) per sensor. 4 BAILEY ET AL. MAD (mg/dL) 11.311.311.811.011.010.611.510.410.38.4 n 2,1531,9462071,9851,8131721,78736690597 MARD (%) 10.710.511.810.210.210.410.89.910.211.1 n 11,0429,6421,4009,9878,8781,1099,7171,3259,3411,236 % 11.411.312.111.011.010.711.510.810.411.0 n 13,19511,5881,60711,9721,06911,28111,5041,69110,2461,333

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