A team of researchers sponsored by three major international diabetes organizations has definitively established that the GlycoMark® test (1,5-AG), a simple blood test used to measure glucose control in patients with diabetes, accurately reveals potentially dangerous fluctuations in blood sugar that are undetectable by other means.

The findings support a need for a new paradigm that includes testing patients with the GlycoMark test for glucose variability in addition to the "hemoglobin A1C" test, which measures average glucose levels. A1C had long been considered the "gold standard" in determining whether patients' diabetes is under control.

The study confirms earlier data and establishes the GlycoMark test as the only blood test proven to detect glycemic variability and hyperglycemic episodes in moderately controlled patients who have Type 1 or Type 2 diabetes mellitus-- which affect a total of more than 246 million adults and children worldwide.

The findings were announced on June 6, 2009, at the annual Scientific Sessions of the American Diabetes Association (ADA).

"These results show that the GlycoMark test provides a much-needed tool to ensure that patients whose blood glucose levels appear to be well-controlled are not experiencing hypo- or hyperglycemia (or blood sugar swings) especially after meals," said Eric Button, President of GlycoMark Inc., the New York/North Carolina company that has developed the test, and who is a member of the research team.

"Chronic hyperglycemia in patients with diabetes has been associated with increased risk of vascular complications that can lead to stroke, heart attack, and blindness. Severe hypoglycemia can lead to hospitalization. Better testing of glucose control is expected to decrease such risks."

The widely-used hemoglobin AIC test measures average glucose levels over a two-to-three-month period. GlycoMark provides a much more sensitive measure of variation over a one-to-two-week period, thus indicating if blood glucose "peaks and valleys" that comprise the average are minimal or extreme and whether treatment changes are indicated.

The GlycoMark test was proven particularly effective in patients with A1C values of less than 8%-that is, those whose blood sugars were previously thought to be nearing or in control. Studies have found that as many as 40% of type 2 diabetes patients with A1C levels in the moderately controlled range are experiencing dangerous glucose swings and need medical intervention, Button said.

According to diabetes expert Irl Hirsch, Professor of Medicine at the University of Washington School of Medicine: "A1C is helpful in tracking broad glucose targets, but it only tells part of the story because it masks short term glycemic variability."

"I would become concerned if a patient has an A1C level that is within target, but a GlycoMark score that is abnormal; there may be a risk for life-threatening hypoglycemia and I can immediately explore where therapy changes need to occur. GlycoMark is a critical adjunct to A1C testing and presents a new paradigm for effective diabetes management."

The study was conducted as a follow on to the 2006-2008 international A1C- Derived Average Glucose (ADAG) study of more than 600 patients from ten research centers worldwide. ADAG is sponsored by the American Diabetes Association (ADA), International Diabetes Federation (IDF) and the European Association for the Study of Diabetes (EASD).

The 2009 study, entitled "Anhydroglucitol concentrations and measures of glucose control and glucose variability" was carried out by: Judith C. Kuenen, MD, of the Department of Endocrinology/Diabetes Center, VU University Medical Center, Amsterdam, the Netherlands; Rikke Borg, MD, of the Steno Diabetes Center, in Copenhagen, Eric A. Button, MS, MBA, of GlycoMark, Inc., Winston-Salem, NC; David M. Nathan, MD, PhD, of the Diabetes Center, Massachusetts General Hospital and Harvard Medical School, Boston; Hui Zheng , PhD, of Harvard Medical School and the Diabetes Center and Department of Biostatistics at MGH; Piet J. Kostense of the Department of Biostatistics, VU University Medical Center and Michaela Diamant, MD, PhD, of the Eli Lilly Company, Inc., in Minneapolis.

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