Abbott FreeStyle Freedom Lite

Device Name:FreeStyle Freedom Lite
Manufacturer:Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Abbott FreeStyle Freedom Lite, to measure blood glucose, has passed in three validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Pass General population

15197:2013 - Pass General population

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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

15197:2003 - Fail Using insufficient blood samples (n=31)

Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876374/pdf/dst-07-1294.pdf.

Ad Hoc protocol General population

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Pass General population

Relevant Publications

Fournier PA. Analysis of "Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial". J Diabetes Sci Technol. 2013 Sep 1;7(5):1305-7. doi: 10.1177/193229681300700521. PMID: 24124958. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876375/pdf/dst-07-1305.pdf.

The publication is a letter or correspondence in which the Abbott FreeStyle Freedom Lite is referenced.