FDA Clears Glucose Monitor

A single-use, quantitative test for long-term glucose monitoring has been cleared by the U.S. Food and Drug Administration (FDA) for home use. By eliminating the need for a doctor visit, the monitor will facilitate timely testing and help diabetic patients to better manage their disease.

Called the DRx HbA1c patient monitor, the test has also been cleared for professional in-office use. This means that physicians can perform a key test once available only in clinical laboratories and to obtain lab-equivalent results in just eight minutes, says Metrika Inc. (Sunnyvale, CA, USA), the marketer of the test. The test measures glucose-bound hemoglobin, or HbA1c, which studies have shown to be a key indicator of disease control for diabetes.

The American Diabetes Association recommends that an HbA1c test be performed every three to six months in all diabetes patients to determine how well glucose has been controlled over that period of time. As a percentage of total blood hemoglobin, the goal is to maintain an HbA1c level of 7% or lower.

"For diabetes patients, this should provide for more informed assessment of disease management and better prevention of serious complications,” said Richard Bergenstal, M.D., executive director of the International Diabetes Center in Minneapolis (MN, USA).



Related Links:
Metrika Inc.