Beurer GL 40 mg/dl

Description:

The Beurer GL 40 mg/dl is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Beurer GL 40 mg/dl, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	MDR Criteria	Self-measurement	Published evidence

Device Family:

Beurer GL 40 mg/dlZ, Beurer GL 40 mmol/LZ
Legend: Z Almost Certain

Validation Publications:

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Pass General population

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

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