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RE: [IP] Glucowatch - My Feelings
Kathy Greifzu [mailto:email @ redacted] wrote:
> This is by no means a flame. You shared your feelings about
> the Glucowatch.
> I'm sure your concerns are very valid. But you have to
> remember that this
> is the first attempt at something of this nature.
These are all good observations, Brian's included. The GlucoWatch is a step
in the right direction, and actually a pretty significant step. Perhaps its
biggest significance is that it's the first device approved by the FDA that
uses interstitial fluid (IF) rather than blood or urine to estimate serum
glucose levels in a waived* test. It's the first commercial volley in the
race to produce non-invasive blood glucose testing. BTW, the GlucoWatch is
*not* a non-invasive technology. The mild electric current the device uses
to draw IF into the patch is considered invasive, and it's this current that
causes the irritation in some people (note: I was a little surprised at the
50% estimate - earlier reports from Cygnus were in the neighborhood of 10%).
But the success of GlucoWatch itself will probably be very limited because
of its relatively high cost both for the device and for the testing supplies
(including a new AAA battery every day). It's possible that most of its use
will be as a poor person's CMBG system.
*Waived refers to the categorization of laboratory tests (yes, our personal
meters are considered laboratory tests for regulation purposes) in which the
devices and operators are not required to participate in regular proficiency
testing processes (i.e. they are waived from the requirement) unlike
moderate and high complexity test methodologies.
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The opinions expressed are mine and may not represent those of my wife who
runs our house and makes more important decisions than I do.
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