Table 2.

Statistical results for the investigated test strip lot compared against the manufacturer’s reference measurement procedure: percentage of results within ISO 15197 accuracy criteria, minimal deviation from the reference measurement procedure’s results containing at least 95% of values and relative bias according to Bland and Altman (systems are ranked alphabetically)

#	BGMS	Reference measurement procedure	±15 mg/dL/±15%	±10 mg/dL/±10%	±5 mg/dL/±5%	Minimal deviation containing at least 95% of values	Relative bias	N
			%	%	%	mg/dL/%	%
a	ABRA	GOD	91.0	71.0	36.5	±16.8	−2.9	200
b	Accu-Chek Guide	HK	100.0	97.5	82.0	±8.4	−1.6	200
c	AURUM	GOD	97.5	88.0	55.5	±13.5	2.6	200
d	CareSens Dual	GOD	96.5	84.5	48.0	±13.8	0.8	200
e	CERA-CHEK 1CODE	GOD	94.5	82.0	51.0	±15.2	−1.3	200
f	ContourNext One	GOD	100.0	99.5	77.0	±7.7	3.3	200
g	eBsensor	GOD	89.0	73.5	45.5	±19.7	3.9	200
h	FreeStyle Freedom Lite	GOD	99.5	91.5	46.5	±11.1	−6.6	200
i	GL50 evo	GOD	97.5	86.5	59.5	±13.4	1.7	200
j	GlucoCheck GOLD	GOD	100.0	92.0	54.5	±11.2	−4.5	200
k	GlucoMen areo 2K	GOD	98.0	86.0	49.0	±13.3	5.7	200
l	GluNEO	HK*	93.0	77.5	35.0	±16.2	−0.6	200
m	MyStar DoseCoach	GOD	95.0	85.0	56.0	±14.4	4.3	200
n	OneTouch Verio Flex	GOD	99.0	93.5	58.5	±11.9	4.2	200
o	Pic Gluco Test	GOD	98.0	87.5	54.5	±12.2	3.3	200
p	Rightest GM700S	GOD	99.5	96.0	67.0	±9.4	2.1	200
q	TRUEyou	GOD	99.0	85.5	56.0	±13.6	0.9	200
r	WaveSense JAZZ Wireless	GOD	95.0	84.0	55.0	±14.4	4.2	200

*No information about the manufacturer’s reference measurement procedure was available at the time of manuscript submission. Based on literature research¹⁹ and the investigator’s experience regarding reliability of measurement results, the HK-based procedure was assigned as primary reference measurement procedure for system accuracy evaluation.

GOD, glucose oxidase; HK, hexokinase.