Trividia TRUEbalance
Device Name:
TRUEbalance
Manufacturer:
Distributer: Trividia Health Inc. (Formerly Nipro/HDI [Home Diagnostics Inc.]), 2400 NW 55th Court, Fort Lauderdale, FL 33309, UNITED STATES.
Other: Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.
Other: Nipro Medical Europe, Blokhuisstraat 42, 2800 Mechelen, BELGIUM.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Trividia TRUEbalance is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
The technology used in the Trividia TRUEbalance, 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. However, it was also assessed in another study, but the results have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |
Validation Publications:
Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013 Jan 1;7(1):144-52. doi: 10.1177/193229681300700117. PMID: 23439170. Available from: PMC3692226.
15197:2003 - Fail General population