High quality blood glucose monitoring systems are required for adequate self-monitoring of blood glucose (SMBG). In this study, system accuracy of 18 current-generation SMBG systems from different manufacturers was evaluated based on the international standard ISO 15197:2013 with 1 lot each against 2 comparison methods. Manufacturers were selected by their respective market share in Europe.
Each lot was tested on 100 capillary blood samples from different subjects and compliance with accuracy criterion A stipulated in ISO 15197 (at least 95% of results within ±15% or ±15 mg/dL of the comparison method’s results for BG concentrations above or below 100 mg/dL, respectively) was assessed. Glucose oxidase (GOD) and hexokinase (HK) were used as comparison methods (GOD: YSI 2300 STAT Plus, YSI Incorporated, OH, U.S.A.; HK: Cobas Integra® 400 plus, Roche Instrument Center, Switzerland).
In total, 14 of 18 systems had ≥95% of results within ±15% or ±15 mg/dL of the result obtained with the respective manufacturer’s measurement method. Individual systems showed 89 to 100% of results within these limits. Results within ±10% or ±10 mg/dL of the respective comparison method results ranged from 71 to 99.5% with 3 systems showing ≥95% of results within these more stringent limits.
In this evaluation, 14 out of 18 systems met the minimum system accuracy criterion A of ISO 15197 with the tested lot. Although only current-generation systems available on the market were used, more than 20% of systems did not meet ISO 15197 accuracy criteria.
S. Pleus: None. A. Baumstark: None. N.R. Jendrike: None. J. Mende: None. C. Haug: None. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker’s Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG.
AgaMatrix Europe Limited; Ascensia Diabetes Care GmbH; Beurer GmbH: i-SENS GmbH; LifeScan Scotland Limited; Roche Diabetes Care GmbH