Device Name:
GlucoMen GM
Manufacturer:
A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.
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
Device Manual:
Description:
The Menarini GlucoMen GM is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Menarini GlucoMen GM, to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BG |
Medaval |
Not recommended |
This device has failed a clinical validation. |
Validation Publications:
Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.
15197:2003 - Fail Using insufficient blood samples (n=31)
Relevant Publications:
Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.
Performance with haematocrit variation unstable.
