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Non invasive bgl and hb1ac device

Hmmmm, just had a look and an invasive BG has to be taken for a bolus! So not really that accurate??
Missed that I just saw invasive whilst calibrating. I guess like a libre in it’s early days then without the filament but more hassle than swiping a phone/reader.
 
Does not seem to be as good as current bgl meters for accuracy. Although the ISO standards would not apply to this meter, it would not meet the current one that is mandated for sale or use in the UK and EU and so NHS would not support it. Probably not CE marked either but that may irrelevant post Brexit. There is no FCC declaration of conformance for EMI as should apply in US and Canada, but which the CE testing would also cover for the UK

There have been several attempts to used transmitted light for a non invasive solution before, but which did not make it to market.. Same technology as is used in the oxygen sats monitors and Fitbit type devices, but not glucose sampling.

Since this is calibrating against current invasive technology which can already have an allowed error value of (ARD) of +/- 15% to start with then this is probably not suitable for use in life maintaining situations,
 
Hmmmm, just had a look and an invasive BG has to be taken for a bolus! So not really that accurate??

That may just be their for legal reasons, as otherwise it needs to be aproved as a medical device in some countries.
 
I wondrt hoe many skin types they tested it on. Scenaio - what if the calibrations are done in a nice warm room, but then tries to take a measurement wheter tje fonger is cold. i.e. the bcapilliaries are being restricted to preserve bosy heat so skin changes colour and becomes more transparent, Will this affect calibration?

The invasive meters nowadays measure the phusical interstitial fluid glucose level, but are caibrated to give reading as if for plasma blood. The HbA1c is using whole blood, so is a different calibration. I wonder whether they used different types of YSI measurement when testing. Few test laboratories carry the different adaptors and control solutions etc for doing dual testing at plasma or whole blood. At least with the ISO submission there will be a test and validation report we could read to check, but this lot seem very secretive.

invasive meters are susceptible to corruption by contaminants such as maltos, dextrose malitol etx being in the blood, so this could affect the calibrations, aeven if the new meter is immune to this intererence. However, it would be very sensitive to variations in haematocrit levels, and aslo to red blood cell count in the blood. May also be affected by lipid content as well, so agin what testing with deliberate induction of these types of interference. Will having a mobile phone in the pocket nearby affect readings?

As an engineer, these are just a few of the problem areas that could trip it up, and some of which did trip up previous competitors. We have no indicaion of what robustness testing they have done.
 
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