posted 01/20/03

Date of approval: Dec. 17, 2002

What is approved: The FDA has approved Metrika's A1c Now test for monitoring glucose control. This is the first test for glycated hemoglobin to be available over the counter. The device measures the levels of glycated hemoglobin -- or A1c -- in the blood of diabetics.

Glycated hemoglobin is a substance created by the interaction between hemoglobin and blood sugars; diabetes is caused by too high levels of blood sugars. Levels of glycated hemoglobin provide a good measure of how well diabetes is being controlled. High levels are associated with higher risk of long-term diabetes complications such as eye disease, kidney disease, and nerve damage.

Experts say glycated hemoglobin levels should be measured every three months -- although most diabetes patients don't undergo this procedure at all. The test provides information about the average sugar level over a 2-3 month period and can complement information from daily blood glucose monitoring.

How it is used: The patient places a drop of blood into the device's monitor, which displays results in eight minutes.

Basis of approval: A clinical study compared test results obtained by patients who used the device with test results obtained by medical professionals. The patients' results were comparable to those obtained by medical professionals.

Manufacturer: Metrika

Source: WebMD Medical News: FDA web site • News release, Metrika.

January 2003 News Article Index