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Re: [IP] Enlite news



I have looked for FDA items that are waiting to be approved, but have only
found already approved devices. Maybe someone else had better luck.

I would ASSUME Medtronic has submitted it to FDA, especially if it is better
than the stuff they have now!

---A

On Thu, Apr 7, 2011 at 10:35 AM, Sue Ann Bowling
<email @ redacted>wrote:

>  Plus ANY sensor that measures interstitial fluid glucose is going to be
> affected by the lag time between blood glucose and interstitial glucose.
> (But
> I'm still looking forward to the Enlite. Anybody know if the FDA is even
> starting to look at it?)
> On Apr 7, 2011, at 8:18 AM, Ricardo wrote:
>
> > 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
> > .
>
> Sue Ann Bowling, Author of Homecoming (Reader Views Literary Awards Winner)
> http://www.sueannbowling.com
> .
>



-- 


Alan Segal
"There are 10 types of people in the world. Those who understand binary, and
those that don't"
.
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