Thomas LE, Kane MP, Bakst G, Busch RS, Hamilton RA, Abelseth JM. A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic. Diabetes Technol Ther. 2008 Apr;10(2):102-110. doi: 10.1089/dia.2007.0244. PMID: 18260773.

Ad Hoc protocol General population

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

Harrison B, Leazenby C, Halldorsdottir S. Accuracy of the CONTOUR® blood glucose monitoring system. J Diabetes Sci Technol. 2011 Jul 1;5(4):1009-13. doi: 10.1177/193229681100500425. PMID: 21880245. Available from: PMC3192609.

15197:2003 - Pass General population

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Fail General population

15197:2013 - Fail General population

Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.

15197:2003 - Pass General population

Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012 Jul 12;142:w13631. doi: 10.4414/smw.2012.13631. PMID: 22791566. eCollection 2012.

15197:2003 - Pass General population (Note: Reference device: HemoCue Glucose 201+)

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Fail General population

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Fail General population

Pleus S, Baumstark A, Rittmeyer D, Jendrike N, Haug C, Freckmann G. Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013. Curr Med Res Opin. 2016 May;32(5):847-55. Epub: 2016 Feb 23. doi: 10.1185/03007995.2016.1146666. PMID: 26809001.

15197:2013 - Pass General population

Andriankaja OM, Muñoz-Torres FJ, Vergara JL, Pérez CM, Joshipura K. Utility of point-of-care vs reference laboratory testing for the evaluation of glucose levels. Diabet Med. 2019 May;36(5):626-632. Epub: 2019 Mar 1. doi: 10.1111/dme13922. PMID: 30710457. Available from: PMC6599708.

ADA:1996 - Pass Obesity + Diabetes Mellitus (n=62)

ADA:1996 - Fail Obesity + Pre-diabetes (n=301)

ADA:1996 - Fail Obesity + Normoglycaemia (n=929)

Point-of-care blood glucose measurement may be useful to screen people with diabetes, and to assess glucose among individuals with diabetes where blood can be drawn, but laboratory tests are unavailable or untimely.

SKUP. Report from the evaluation SKUP/2004/30: Contour (Bayer Healthcare), a system for blood glucose measurement. Bergen, Norway: SKUP; 2004. 48 p. Available from: skup.org.

ADA:1996 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements when the meter is new (less than 3 weeks of use) only.)

SKUP. Report from the evaluation SKUP/2009/75: Contour (Bayer Healthcare), a system for blood glucose measurement. Bergen, Norway: SKUP; 2009. 50 p. Available from: skup.org.

15197:2003 - Pass General population

Simmons DA. Comments on evaluation of five glucose meters by Thomas et al. Diabetes Technol Ther. 2008 Oct;10(5):415. Epub: 2008 Aug 21. doi: 10.1089/dia.2008.0056. PMID: 18715220.

The publication is a letter or correspondence in which the Ascensia (Bayer) Contour is referenced.

Kane MP, Hamilton RA. Response to Simmons. Diabetes Technol Ther. 2008 Oct;10(5):417. Epub: 2008 Aug 21. doi: 10.1089/dia.2008.0059.

The publication is a letter or correspondence in which the Ascensia (Bayer) Contour is referenced.

Roth-Kleiner M, Stadelmann Diaw C, Urfer J, Ruffieux C, Werner D. Evaluation of different POCT devices for glucose measurement in a clinical neonatal setting. Eur J Pediatr. 2010 Nov;169(11):1387-95. Epub: 2010 Jun 24. doi: 10.1007/s00431-010-1243-2. PMID: 20574734.

Retrospective study with ISO 15197:2003 criteria applied to results, on neonates, recorded over 1 year. The authors claim that the device tended to overestimate glycaemia values; however the application of protocol criteria is dependent on the protocol procedure being followed precisely.

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.

Herrington SJ, Gee DL, Dow SD, Monosky KA, Davis E, Pritchett KL. Comparison of glucose monitoring methods during steady-state exercise in women. Nutrients. 2012 Sep;4(9):1282-92. Epub: 2012 Sep 14. doi: 10.3390/nu4091282. PMID: 23112916.

The publication describes the Ascensia (Bayer) Contour being used as a reference device for comparison with the Dexcom Seven Plus.

Comparisons, in 12 non-diabetic women during intensity cycling and recovery, to the Dexcom Seven Plus. Authors conclude inconsistent results with further research required.

Lv H, Zhang GJ, Kang XX, Yuan H, Lv YW, Wang WW, Randall R. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal. 2013 Sep;27(5):354-66. doi: 10.1002/jcla.21611. PMID: 24038220.

The publication evaluates the performance of the Ascensia (Bayer) Contour, though not in a formal validation.