FDA Clears First Instant Home A1c Test For Diabetes

by Anonymous

FDA Clears First Instant Home A1c Test For Diabetes

In 8 minutes you have your average blood glucose every second of the day for the last 90 days.

Contacts
Stephen Freed
President
www.A1cnow.net
800/798-6972

Media Contact
Stephen Freed
800/798-6972
steve@a1cnow.net

SUNNYVALE, Calif., December 30, 2002 — The Food and Drug Administration (FDA) has cleared the first over-the-counter instant test that measures the average blood glucose over 90 days (glycated hemoglobin) in people with diabetes to help monitor how well they are managing their disease (glycemic control).

The test, called A1c Now, manufactured by Metrika Inc, of Suunnyvale Calforniia, can now be purchased without a prescription and, used at home, with results on the spot, making it readily available to people with pre-diabetes & 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 (A1c) 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. This tells you what your average blood glucose is over a 90 day period, every second of the day. There are over 7 million seconds in 90 days, so testing 3 or 4 times a day will not be as accurate to determine your average blood glucose as using the A1cNow test.

The A1c (glycated hemoglobin) test should be performed two to four times a year to monitor long-term control over blood glucose levels. A1c 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 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 and then disposes the monitor.

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. The A1c Now test has been certified by the National Glycohemoglobin Standardization Program, an independent certification body.

A result of below 6% would be for a normal person without diabetes. If the result is greater than 7% then action must be taken immediately to prevent the complications of diabetes, as blindness, limb amputation, kidney failure and heart disease.

About 17 million Americans have been diagnosed with diabetes. Another 7-10 million have diabetes and don’t even know they have it. It is estimated that more than 16 million people have PreDiabetes..