J&J OneTouch Select Simple
The technology used in the J&J 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.
|Medaval||★ Recommendation||Recent clinical validation; older protocol|
|MDR Criteria||Possibly||Confirmation required - Results not in abstract|
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)
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 J&J OneTouch Select Simple is referenced.