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RE: [IP] GlucoWatch

Patrick G. Jobe [mailto:email @ redacted] wrote:

> Does it really manner if IF measurements are the same as 
> capillary blood or 
> not. It seems to me that is a completely extraneous issue. The real 
> question is if IF measurements are useful to the diabetic in 
> controlling 
> his/her disease.

In one sense, you are correct.  However, Cygnus attempted to fast track the
GlucoWatch through the approval process by claiming equivalence between IF
glucose and blood glucose.  If Cygnus had wanted to say, as you have, that
it is helpful for diabetics in controlling the disease, then it would have
required an entirely different set of studies, beginning with demonstrating
that IF glucose testing would be helpful.  That, so far, is an assumption,
and not tested per se.  Now the FDA is requiring that evidence, along with
the evidence that IF glucose does, in fact, track blood glucose, and that
the lag time is not too great.

Jim Handsfield
email @ redacted OR
email @ redacted

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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