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

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.