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Philosys Gmate Smart (PG-101)

Device Name:Gmate Smart
Device Model:PG-101
Manufacturer:Philosys Inc., Suite 218, 304 Park Avenue, NY 10010, UNITED STATES.
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
Description: The Philosys Gmate Smart (PG-101) is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:

The technology used in the Philosys Gmate Smart (PG-101), 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhile a clinical validation is claimed, it cannot be checked properly.
Institute of Health Economics (CA)General useNo evidence provided

Validation Publications

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