HemoCue Glucose 201 Plus

Description:

The HemoCue Glucose 201 Plus is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.

Assessment:

The technology used in the HemoCue Glucose 201 Plus, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Pass High Altitude (Note: Simulated altitude in hypobarbic chamber)

Relevant Publications:

Harman-Boehm I, Gal A, Raykhman AM, Naidis E, Mayzel Y. Noninvasive glucose monitoring: increasing accuracy by combination of multi-technology and multi-sensors. J Diabetes Sci Technol. 2010 May;4(3):583-595. Epub: 2010 May 1. doi: 10.1177/193229681000400312. PMID: 20513324. Available from: PMC2901035.

The publication describes the HemoCue Glucose 201 Plus being used as a validation control device.

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.

The publication describes the HemoCue Glucose 201+ being used as a validation control device.