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[IP] Enlite news



Nikos Wrote:
I'm looking forward to see tree things on it:

1. If Enlite is more accurate at readings, especially at hypoglycemia where MM
claims that it will have 98% accuracy...

Ricardo Responds:
Hi Nikos,

I am going to reserve judgment on MM's 98% claim until I learn more, but I
have some early doubts and suspect a play on words/ numbers.

On initial inspection, the 98% claim seems to imply that MM has accomplished a
leap in technology over the competition, especially when diabetics commonly
quote BG accuracy as "plus/ minus 20%".

I still remember my college chemistry professor saying, "your measurement is
only as good as your standard". With this in mind, I fail to understand how
the MM sensor can claim 98% accuracy when it is calibrated with BG meters and
strips that only claim plus/ minus 20% accuracy??? To me this would be like
calibrating a micrometer with a yard stick. The claim would make more sense if
MM introduced BG strip technology thato;? had equivalent accuracy to the 98%
claim.Even the gold standard YSI glucose measurement only claims plus/ minus 3
- 4% accuracy.

What I think may explain the claim is if ISO 15197 defines BG measurement
accuracy as being within plus/ minus 20% and a manufacturer can get 98% of a
group of samples to be within this range, then they can market the sensor as
being 98% accurate. There is nothing wrong with the logic except that some may
misinterpret the claim as there being a breakthrough in BG measurement.

As seen in the following link, bottom of page 3, using current BG meter
technology, nearly all BG meter manufacturers could make similar claims.

http://www.abbottdiabetescare.ie/_resources/media/documents/hcps/clinical_pap
ers/accuracycomparison_fslite.pdf

Another interpretation of the claim is through the use of zone A and B of the
Consensus, Parkes or Clark error grid that some manufacturers quote.  As seen
on the following charts (page 4) of the first link, most BG meter
manufacturers can quote 100% accuracy when using this method and the second
link shows that the Navigator CGM claims 98.4% accuracy on the Clark error
grid (Dexcom uses a different scale to rate accuracy)

http://www.niprodiagnostics.com/our_products/downloads/bgm_true_balance/TB_Cl
inicalStudy.pdf

http://www.diabeteshealth.com/media/pdfs/CGM-Chart_0609.pdf

I am sure MM has improved their sensor, but I am not as sure about the
accuracy claims.

Ricardo
.
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