Abbott FreeStyle InsuLinx

Description:

The Abbott FreeStyle InsuLinx 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 Abbott FreeStyle InsuLinx, 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BG	TÜV Rheinland Nederland	General use	Unpublished internal data
BG	Institute of Health Economics (CA)	General use	No evidence provided
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Bedini JL, Wallace JF, Pardo S, Petruschke T. Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting. J Diabetes Sci Technol. 2016 Jan;10(1):85-92. Epub: 2015 Oct 7. doi: 10.1177/1932296815609368. PMID: 26445813. Available from: PMC4738222.

15197:2013 - Pass General population

Jendrike N, Baumstark A, Pleus S, Liebing C, Beer A, Flacke F, Haug C, Freckmann G. Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence. Diabetes Technol Ther. 2018 Apr;20(4):303-13. doi: 10.1089/dia.2017.0391. PMID: 29664706.

15197:2013 - Pass General population