Wellion Galileo Glu-Ket
Device Name:
Galileo Glu-Ket
Manufacturer:
MED TRUST Handelsgesellschaft m.b.H. (Wellion), Gewerbepark 10, A-7221 Marz, AUSTRIA.
Measuring functions:
Blood glucose, β-Ketones
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Wellion Galileo Glu-Ket is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Wellion Galileo Glu-Ket, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | MDR Criteria | Self-measurement | Published evidence |
Validation Publications:
Weissenbacher S, Yang CY, Kuan TC, Demircik F, Hanna M, Pfützner A. System accuracy assessments with a blood glucose meter with combined glucose and ß-hydroxybutyrate measurement capabilities. Expert Rev Mol Diagn. 2019 Nov;19(11):1043-1048. Epub: 2019 Sep 4. doi: 10.1080/1473715920191662300. PMID: 31482753.
15197:2013 - Pass General population