Bayer HealthCare is reporting that its diabetes portfolio “now includes a innovative device for self-testing of HbA1c– the gold standard indicator of ongoing blood sugar control…”
A1CNow+®, device, designed for at-home monitoring of HbA1c–a glycosylated hemoglobin–was acquired by Bayer when it bought Metrika Inc., a company based in Sunnyvale, CA.
From the press release:
According to the American Diabetes Association (ADA), tight glycemic control sustained over time, as measured through HbA1c scores, slows the development of diabetic complications including heart, eye, kidney and nerve diseases and even a small reduction in HbA1c is important. The HbA1c value is an index of mean blood glucose levels over the past two to three months with significant changes in the HbA1c levels due to blood sugar variability over the last 30-40 days being detectable.
The newly-released, improved A1CNow+ is a portable, easy-to-use and reliable system that provides immediate access to lab-quality NGSP* certified HbA1c results in just five minutes. This helps to improve the overall efficiency of diabetes care by reporting HbA1c values directly to the patient or during the patients’ office visit eliminating absent or delayed lab results. Utilizing the integration of micro-optical technology and solid state chemistry into a proprietary monitor with disposable cartridges, AICNow+ provides rapid HbA1c results with precision and accuracy equivalent to certified laboratories.
The test can be performed with a simple three-step procedure using finger-stick or venous blood. Fast, easy measurement of HbA1c enables people with diabetes and their healthcare providers to make immediate diabetes management decisions and to help optimize and calibrate therapy with the goal of improved outcomes…
HbA1c is formed when glucose in the blood binds irreversibly to hemoglobin to form a stable glycated hemoglobin HbA1c complex. Since the normal life span of red blood cells averages about 120 days, the HbA1c level will change as new red cells are made. HbA1c values are directly proportional to the average concentration of glucose in the blood over the past two to three months. HbA1c values are not subject to the daily fluctuations that are seen with blood sugar monitoring…
The ADA recommends that the test be performed every three months for patients who have HbA1c values at or above 7% and every six months for patients with HbA1c values below 7% as well as during treatment changes or after periods of elevated blood glucose levels. The ADA also added a recommendation for point-of-care HbA1c monitoring to their 2006 professional practice guidelines emphasizing the importance of routine real-time HbA1c monitoring of persons with diabetes.
The Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) studies showed that lower HbA1c values are associated with prevention of, or significant decreases in, the development of serious eye, kidney and nerve disease.
The ADA clinical practice guidelines indicate diabetes is under control when the HbA1c result is 7% percent or less.