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Re: [IPk] GlucoWatch

I reproduce here an article given to me by Jenny Hirst
<email @ redacted>, who runs the Insulin Dependent Diabetes
Trust <http://www.iddt.org>. This article is due to be published in their
July newsletter:

>The GlucoWatch has been launched in the UK the device that we have all
>been waiting for! It is a sensor that continuously measures blood glucose
>levels and sounds an alarm when they reach dangerously low levels. It
>extracts fluid through the skin and glucose levels are measured using this
>fluid every 20 minutes for 12 hours.
>But before you get too excited, the press launch did not make clear that
>this development is yet far from a safe replacement for conventional
>finger pricking blood glucose testing. On March 22nd the FDA in the US
>announced approval of the GlucoWatch. However this approval is, rightly,
>strictly limited. It will be only be available on prescription to people
>18 and over and because of the potential for error the FDA advises that
>the GlucoWatch should be used in conjunction with conventional finger
>prick tests. However, the FDA have not yet given approval to the
>manufacturing facililites and so it is not yet on sale in the US!
>Trials have shown that up to 25% of the time the results different from
>traditional finger prick blood tests by 30%. They also showed that
>sometimes there were erroneous readings, the GlucoWatch was less effective
>at very low glucose levels [the ones we really want!] than very high ones
>and would not measure at all if the arm was too sweaty. It also caused
>mild skin irritations in at least half the people that used it.
>When I contacted the company on the advertised phone line, they could not
>confirm that the GlucoWatch had been approved by the Medical Devices
>Agency [MDA] in the UK or that the MDA had issued similar advice to that
>of the FDA. [We have written to the MDA and are awaiting a response.]
>Indeed, I could have purchased a GlucoWatch on the telephone without a
>doctor's prescription.
>While this device is a very welcome step forward for people with diabetes,
>especially to people who have lost their hypo warnings symptoms, it is
>important that an overzealous approach to the advantages does not obscure
>the necessary warnings and precautions associated with it.

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