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!
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.
> 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
> > 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
> > have some early doubts and suspect a play on words/ numbers.
> > On initial inspection, the 98% claim seems to imply that MM has
> > leap in technology over the competition, especially when diabetics
> > quote BG accuracy as "plus/ minus 20%".
> > I still remember my college chemistry professor saying, "your measurement
> > only as good as your standard". With this in mind, I fail to understand
> > the MM sensor can claim 98% accuracy when it is calibrated with BG meters
> > strips that only claim plus/ minus 20% accuracy??? To me this would be
> > calibrating a micrometer with a yard stick. The claim would make more
> > MM introduced BG strip technology thato;? had equivalent accuracy to the
> > claim.Even the gold standard YSI glucose measurement only claims plus/
> > - 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
> > being 98% accurate. There is nothing wrong with the logic except that
> > 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.
> > ers/accuracycomparison_fslite.pdf
> > Another interpretation of the claim is through the use of zone A and B of
> > Consensus, Parkes or Clark error grid that some manufacturers quote. As
> > on the following charts (page 4) of the first link, most BG meter
> > manufacturers can quote 100% accuracy when using this method and the
> > link shows that the Navigator CGM claims 98.4% accuracy on the Clark
> > grid (Dexcom uses a different scale to rate accuracy)
> > 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)
"There are 10 types of people in the world. Those who understand binary, and
those that don't"
for HELP or to subscribe/unsubscribe/change list versions,