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Nipro TRUEtrack

Device Name:TRUEtrack
Manufacturer:

Distributer: Trividia Health Inc. (Nipro/HDI [Home Diagnostics Inc.]), 2400 NW 55th Court, Fort Lauderdale, FL 33309, UNITED STATES.

Sole: Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Nipro TRUEtrack, to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a general population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

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: PMC3876374.

Ad Hoc protocol General population

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.

DTS:2016 - Fail 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: PMC3876375.

The publication is a letter or correspondence in which the Nipro TRUEtrack is referenced.

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