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Re: [IP] home hba1c test approved by FDA

Several things we must be concerned about: how much error is introduced in the measurement, lab test +- 5% lab, then +-2%, after all this, is the measure meaningfull? What is the real cost? How many measurements do you get at what +/-. If your H1ac does not change that much over a given period. You d'nt need a precrip as of last Thur.
BE Good.

From: "Michael" <email @ redacted>
Date: Thu, 19 Dec 2002 10:16:47 -0800
To: email @ redacted
Subject: [IP] home hba1c test approved by FDA

> email @ redacted
> ##########################
> http://www.metrika.com/
>         The Food and Drug Administration (FDA) has cleared the first
> over-the-counter test that measures glycated hemoglobin in people with
> diabetes to help monitor how well they are managing their disease
> (glycemic control).  The test, called Metrika A1c Now, is currently 
> available by prescription only.  Over-the-counter status means that 
> the test can now be purchased without a prescription and used at 
> home, with results on the spot, making it readily available to people 
> with diabetes.
>         Diabetes is a chronic disease in which blood glucose (sugar) 
> levels are too high.  Abnormally high levels of glucose can damage 
> the small and large blood vessels, leading to blindness, kidney 
> disease, amputation of limbs, stroke, and heart disease.
>          Glycated hemoglobin is a unique substance created as a result
> of interaction between hemoglobin and glucose. The level of glycated 
> hemoglobin provides information on the average level of glucose in 
> the body over a 90 to 120 day period of time. The glycated hemoglobin 
> test should be performed two to four times a year to monitor 
> long-term control over blood glucose levels.  Glycated hemoglobin 
> tests provide information to complement that obtained from daily 
> finger stick blood glucose tests that measure glucose at a single 
> point in time. To perform the Metrika A1c Now test, the patient takes 
> a blood sample from his finger with a lancet and places it in a 
> monitor.  The monitor displays test results in eight minutes.  Unlike 
> some other products, there is no need to send the sample back to the 
> physician to get results.  The patient gets the results on the spot.
>         FDA cleared the test for non-prescription use based on a
>         clinical study conducted by the manufacturer, Metrika, Inc., 
> of Sunnyvale, Calif. The study compared test results obtained by lay 
> users of the device to test results obtained by medical 
> professionals.   In the study, 286 patients-271 diabetics and 15 
> non-diabetics-used the test without physician supervision. The 
> results were comparable to those obtained by medical professionals. 
> The Metrika A1c Now test has been certified by the National 
> Glycohemoglobin Standardization Program, an independent certification 
> body.
> ----------------------------------------------------------
> for HELP or to subscribe/unsubscribe, contact:
> HELP@insulin-pumpers.org

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