Nipro TRUEyou

Device Name:

TRUEyou

Manufacturer:

Distributer: Nipro Medical Europe, Blokhuisstraat 42, 2800 Mechelen, BELGIUM.

Other: 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:

Discontinued but still available

Description:

The Nipro TRUEyou is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Nipro TRUEyou, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Jendrike N, Rittmeyer D, Pleus S, Baumstark A, Haug C, Freckmann G. ISO 15197:2013 Accuracy Evaluation of Two CE-Marked Systems for Self-Monitoring of Blood Glucose. J Diabetes Sci Technol. 2015 Jul;9(4):934-5. Epub: 2015 Apr 21. doi: 10.1177/1932296815582223. PMID: 25901021. Available from: PMC4525667. No abstract available.

15197:2013 - Pass General population

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)