Roche Accu-Chek Compact Plus
Device Name:
Accu-Chek Compact Plus
Manufacturer:
Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Click here to download the Device Manual
Description:
The Roche Accu-Chek Compact Plus is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. 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 Roche Accu-Chek Compact Plus, to measure blood glucose, has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★ Recommendation Older clinical validation; recent protocol; multiple clinical validations
BG Institute of Health Economics (CA) General use No evidence provided
BG MDR Criteria Self-measurement and professional use Published evidence
Validation Publications:

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

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)

Ad Hoc protocol - Pass High Altitude (Note: Various altitudes on Mt. Kilimanjaro)

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

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 - Pass Using insufficient blood samples (n=31)

SKUP. Report from the evaluation SKUP/2005/43: Accu-Chek Compact Plus (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2005. 40 p. Available from: skup.org.

15197:2003 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)

Relevant Publications:

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 Roche Accu-Chek Compact Plus 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 Roche Accu-Chek Compact Plus is referenced.

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