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RE: [IP] Re: glucowatch

Kerri [mailto:email @ redacted] wrote:

> (There may be something about this on their website, but...) I
> *think* it is because they have not yet tested it on anyone under
> 18, therefore they can't legally recommend/approve it for anyone
> under 18 yet. However, there is such a thing as "off label"
> prescribing which I believe drs did with humalog (and probably
> many other things) ever since it first came out (it was not
> approved for use in children or pumps for a while either but
> everyone was using it.) So you could still get one anyway. [Happy
> Dance!] :)

I don't know what stage of testing they are in, but FDA approval is the
license to *market* and *sell* the device.  Once it is on the market, FDA
approval has nothing to do with how it is actually prescribed -- that is a
physician's prerogative.  So, for example, while Humalog is still not FDA
approved for use in a pump, there's nothing illegal or otherwise improper
about *using* Humalog in a pump (otherwise, Walsh and ? would be remiss in
discussing Humalog in _Pumping Insulin_).  It's just that manufacturers
cannot advertise and/or promote it that way.

The ultimate reason for all the delay in getting the GlucoWatch on the
market versus their early claims is that when they first applied for FDA
approval, they did so attempting to claim equivalence with finger stick
testing.  Had they been successful, the device would have been available a
year ago.  But the FDA (rightly, IMHO) refused to accept equivalence between
blood glucose levels and interstitial fluid glucose (which is what the
GlucoWatch measures) as there was no research and no data to validate the
association.  So Cygnus had to go back to the clinical process to determine
that 1) interstitial fluid does fluctuate with blood glucose in a
predictable way; 2) the lag time; 3) that control would not be compromised
by using the GlucoWatch.

Jim Handsfield
mailto:email @ redacted OR
mailto:email @ redacted

The opinions expressed are my own and do not necessarily represent those of
my wife who runs this house and makes more important decisions than I do.
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