New Study Shows GlycoMark Blood Test is Most Effective Monitor of
After-Meal Glucose Levels in Patients with Diabetes
Results Published in the Current Issue of the Journal "Diabetes Care"
&
Being Presented at American Diabetes Association Annual Meeting
Washington, DC -- June 6, 2006 – A key study in the current edition of the American Diabetes Association's Diabetes Care
journal demonstrates that the new GlycoMark blood test is a better
measure of after-meal or postprandial glucose levels compared to
standard tests for diabetes. This is a very
important finding as elevated after-meal glucose levels are associated
with cardiovascular complications – the leading cause of death in
patients with diabetes.
The
study completed by Kathleen Dungan, MD and John Buse, MD at the
University of North Carolina and Steven Wittlin, MD at the University
of Rochester shows that although the current gold standard diabetes
test, hemoglobin A1C (A1C) may indicate adequate control of glucose
levels, after-meal glucose levels may still be elevated (know as
postprandial hyperglycemia). The GlycoMark
test which measures circulating levels of 1,5-anhydroglucitol (1,5-AG),
a sugar similar to glucose, reflects after-meal glucose levels over the
previous one to two weeks.
The authors of the study conclude that "1,5-AG was reflective of varying postmeal glucose levels, despite similarities in A1Cs. Thus,
the 1,5-AG assay may facilitate achieving good glycemic control in
patients with suboptimal A1Cs by identifying patients in whom
postprandial glucose elevations predominate." The
authors go on to say, "In clinical practice, A1C and 1,5-AG may be used
sequentially, first utilizing the A1C assay to identify patients who
are moderately or well controlled, and then using the 1,5-AG assay to
determine the extent of postprandial glucose excursions."
A
growing body of scientific evidence suggests that controlling
after-meal glucose levels play a significant role in achieving optimal
glycemic control. Reducing after-meal glucose levels is also thought to be associated with a reduction in the burden of cardiovascular disease. To
that end, many pharmaceutical companies have developed and are
developing therapeutic agents to specifically target after-meal glucose
levels. The GlycoMark test is being used in several of these clinical studies.
Diabetes and Cardiovascular Disease
One of the most common risks to people with diabetes is cardiovascular disease (CVD). People with diabetes are two to four times more likely to develop CVD than are people without diabetes. Furthermore,
risk of cardiovascular death is three times as high among those with
diabetes than for people who don't have diabetes.
FDA CLEARS GLYCOMARK TEST FOR PEOPLE WITH DIABETES
GlycoMarkTM Monitors Intermediate Glycemic Control
(New York, NY) – November 6, 2003
- Tomen America Inc. and Nippon Kayaku Co. Ltd. today announced that
the U.S. Food and Drug Administration (FDA) has granted marketing
clearance for the GlycoMarkTM test. This
blood test is cleared for the intermediate term monitoring of glycemic
control (measurement of overall glucose control over time) in people
with diabetes. Data from a prospective clinical study conducted at Washington University (St. Louis, Missouri) is being presented today at the Diabetes Technology Meeting in San Francisco, California.
The
GlycoMark™ test measures the level of 1,5-anhydroglucitol (1,5-AG) in
human blood. 1,5-AG responds rapidly to increasing glucose levels
and reflects average glucose levels over a period of a few days to 2
weeks. This may allow patients to seek
medical intervention in a timely manner such as when starting or
changing therapy, empowering patients to achieve and maintain control
of their disease.
According to the American Diabetes Association, monitoring of glycemic status is a cornerstone of diabetes care. Glycemic tests such as hemoglobin A1c, fructosamine, and now GlycoMarkTM, provide measures of overall glucose control and are important in maintaining near-normal glucose levels. As an intermediate-term monitoring test of glycemic control, GlycoMarkTM
is an additional tool for the physician to measure more recent glycemic
status to monitor diabetes therapy timely and effectively.
"GlycoMarkTM
is an important new test which physicians may use to monitor glycemic
control," said Dr. Steve Edelman, Professor of Medicine at the University of California, San Diego.
"Fructosamine has been somewhat disappointing as a measure of
short-term glycemic control due to its inherent variability, and the
availability of GlycoMark™ would certainly be a welcome addition to the
tools available to monitor glycemia."
"Receiving FDA marketing clearance for the GlycoMarkTM test in the United States is an important milestone for Tomen America and Nippon Kayaku. There
is significant market potential for an accurate, consistent test that
monitors intermediate glycemic control in patients with diabetes," said
Eric Button, president of BioEmerge Partners, a life science venture
development firm based in Winston-Salem, NC.
Current research is focused on the ability of GlycoMarkTM to measure postprandial hyperglycemia (after-meal glucose levels) in diabetic patients. Control of postprandial hyperglycemia is the subject of intensive pharmaceutical/academic research and development.
