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RE: [IP] More Glucowatch info.
Sylvia [mailto:email @ redacted] wrote:
> based on that fact alone. Jim H- what is YOUR knowledgeable
> opinion on this
I haven't studied the protocol, so I won't claim my opinion is that
knowledgeable other than in a very general sense. The FDA review process
takes a careful look at the protocol to check for potential bias and
appropriateness of the sampling frame as well as appropriateness of the
statistical analysis and subsequent conclusions.
I don't know that it makes a lot of difference if one uses type 1 or type 2
diabetics for this sort of clinical trial. Both diseases cause elevated
blood sugar, which is what is being monitored. The fact is that
approximately 90% of diabetics are type 2, not type 1, so it makes sense to
make sure that products like GlucoWatch will be suitable for them.
We pump users in many ways are a whole different cohort as frequent testing
(at least 4 times a day) is more or less a prerequisite to getting a pump.
I suspect that most diabetics, including type 1s, seldom test more than
twice a day, if that. Certainly the bulk of the health care system seems to
think that is sufficient, but then again, I think most health care providers
not familiar with the studies (DCCT and UKPDS) pretty much resign themselves
(and patients) to eventual complications. This attitude, too often, gets
passed on to their patients. The concept (and necessity!) of testing often
is foreign to them.
All of this is sort of background (I suspect) for *MARKETING* to convince
health care professionals, patients, and *INSURANCE* companies of the value
of the kind of monitoring the GlucoWatch is capable of. In this context,
BTW, marketing is a good thing as it will help us all to continue to have
state of the art resources in controlling our disease, whether type 1 or
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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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