FDA Clears Home Glycated Hemoglobin Test For Diabetics

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.

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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.

About 17 million Americans have diabetes. Many of them may find the new home glycated hemoglobin test helpful.

Source: FDA