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)

#BGMSReference measurement procedure±15 mg/dL/±15%±10 mg/dL/±10%±5 mg/dL/±5%Minimal deviation containing at least 95% of valuesRelative biasN
bAccu-Chek GuideHK100.097.582.0±8.4−1.6200
dCareSens DualGOD96.584.548.0±13.80.8200
eCERA-CHEK 1CODEGOD94.582.051.0±15.2−1.3200
fContourNext OneGOD100.099.577.0±7.73.3200
hFreeStyle Freedom LiteGOD99.591.546.5±11.1−6.6200
iGL50 evoGOD97.586.559.5±13.41.7200
jGlucoCheck GOLDGOD100.092.054.5±11.2−4.5200
kGlucoMen areo 2KGOD98.086.049.0±13.35.7200
mMyStar DoseCoachGOD95.085.056.0±14.44.3200
nOneTouch Verio FlexGOD99.093.558.5±11.94.2200
oPic Gluco TestGOD98.087.554.5±12.23.3200
pRightest GM700SGOD99.596.067.0±9.42.1200
rWaveSense JAZZ WirelessGOD95.084.055.0±14.44.2200
  • *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.