LifeScan OneTouch Select Simple

Description:

The LifeScan OneTouch Select Simple is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the LifeScan OneTouch Select Simple, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Legacy approval	Older clinical validation; older protocol
BG	MDR Criteria	Possibly	Confirmation required - Results not in abstract

Validation Publications:

Philis-Tsimikas A, Chang A, Miller L. Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system. J Diabetes Sci Technol. 2011 Nov 1;5(6):1602-9. doi: 10.1177/193229681100500638. PMID: 22226284.

15197:2003 - Pass General population

Freckmann G, Baumstark A, Jendrike N, Rittmeyer D, Pleus S, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements. Diabetes Technol Ther. 2017 Apr;19(4):246-54. Epub: 2017 Feb 22. doi: 10.1089/dia.2016.0341. PMID: 28225633.

15197:2013 General population (Note: Results not in Abstract)

Relevant Publications:

Krouwer JS. Analysis of the performance of the OneTouch SelectSimple blood glucose monitoring system: why ease of use studies need to be part of accuracy studies. J Diabetes Sci Technol. 2011 Nov 1;5(6):1610-1. PMID: 22226285.

The publication is a letter or correspondence in which the LifeScan OneTouch Select Simple is referenced.