Abbott FreeStyle Lite

Device Name:FreeStyle 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 Lite, to measure blood glucose, has passed in five validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

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

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: http://clinchem.aaccjnls.org/content/clinchem/61/5/772.full.pdf.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluations 2007/64 and 2010/89

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen MP, Bailey TS, Nichols JH, Kohn MA. Blood Glucose Monitoring System Surveillance Program. https://www.diabetestechnology.org/surveillance.shtml [Internet] Burlingame, CA: Diabetes Technology Society; 2017 Jun 23.

DTS:2016 - Pass General population

Relevant Publications

Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. Epub: 2014 Jan 1. doi: 10.1177/1932296813511747. PMID: 24876543. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4454101/pdf/10.1177_1932296813511747.pdf.

Measurements from the Abbott FreeStyle Lite are compared to those from the Abbott FreeStyle Navigator, though not in a formal validation.

Fingerstick and wired-enzyme technologies are compared.

Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.

Measurements from the Abbott FreeStyle Lite are compared to those from the Bayer Contour Next and, indirectly, the Roche Accu-Chek Aviva Nano, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.