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New Clinical Study Data Show the GlycoMark® Test Helps Confirm Compliance and Appropriate Response to SGLT-2 Inhibitors

GlycoMark, Inc. announced a new study “GlycoMark 1,5-Anhydroglucitol Values in Patients Taking SGLT-2 Inhibitors” presented at the American Diabetes Association (ADA) Scientific Sessions 2019 involving the GlycoMark test being used for patients with Type 2 diabetes that are being treated with an SGLT-2 inhibitor. SGLT-2 inhibitors are used to lower glucose levels in patients with diabetes by preventing glucose reabsorption by the kidneys and triggering glycosuria.

The GlycoMark test, an FDA-cleared and CE marked blood test used to monitor glycemic control in patients with diabetes, is sensitive and specific to detecting high blood glucose levels and glucose variability during the prior 1 to 2 weeks. A low GlycoMark result (generally less than 10 µg/mL) is abnormal and suggests glucose levels have exceeded dangerously high limits, including postprandial glucose variability, which can be missed in up to 40% of patients with a “good” A1C.(1) A previous study in patients taking an SGLT-2 inhibitor by Balis, et al reported extremely low GlycoMark test results that suggested drug interference and test inaccuracy, thereby negating utility in patients taking an SGLT-2 inhibitor. However, as stated in the GlycoMark test package insert, the low GlycoMark values associated with SGLT-2 inhibitor is caused by glycosuria, i.e. the effect of the drug, and is not interfering with the test itself.

In the study presented this week, clinical investigators from Aveon Health, Scottsdale, AZ, conducted a review of their patients treated with an SGLT-2 inhibitor from January 2015 to December 2018 and their corresponding GlycoMark test results, with the hypothesis that GlycoMark test results in patients taking SGLT-2 inhibitors would be extremely low due to persistent glycosuria, which may be useful for assessing patient compliance with and confirming the SGLT-2 inhibitor effect. Of the 240 patients being treated with an SGLT-2 inhibitor, 92% had a GlycoMark test result that was on the extremely low end of abnormal (less than or equal to µg/mL), and the average GlycoMark result was 1.2 µg/mL. “We have long suspected that SGLT-2 inhibitor use is associated with extremely low GlycoMark results, even lower than typically seen for moderately controlled patients with persistent hyperglycemia. We hypothesized that the extremely low GlycoMark results were not an indicator of very poor glycemic control but were rather indicating compliance with the medication as prescribed and achieving the desired effect, which is elimination of glucose in urine. These data support this hypothesis,” said Sam Fereidouni, MD, MHSA, a Family Physician and Medical Director at Aveon Health, lead investigator on the study. Using GlycoMark test results, investigators also identified 52 non-compliant patients that had an average GlycoMark result of 6.4 µg/mL.

Dr. Fereidouni, who has been using the GlycoMark test for over 8 years in his practice and who has exceeded national and private payor benchmarks aimed at reducing patient outcomes, encourages clinicians to include the GlycoMark test in their workup of patients with diabetes for its unique ability to detect glycemic variability not evident with A1C, fructosamine, or glycated albumin - tests that all report a glucose average. “GlycoMark results in addition to A1C provide a more complete assessment of glycemic control. By including the GlycoMark test, patients with glycemic control issues can be properly selected for continuous glucose monitoring, counseling, or other diabetes treatment modifications.”

“The study data support the sensitivity of the GlycoMark test to glycosuria, which is associated with hyperglycemia and hyperglycemic excursions, and may have utility in diabetes patients taking SGLT-2 inhibitors,” said Jeff Dahlen, PhD, VP Clinical Affairs at GlycoMark and co-author on the study.

Subsequent to incorporating the GlycoMark test into clinical practice, Dr. Fereidouni became a paid clinical consultant of GlycoMark.

Reference: 1. Erlinger TP, Brancati FL. Diabetes Care. 2001 Oct;24(10):1734-8.

About the GlycoMark test

The GlycoMark test provides quantitative measurement of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes. The GlycoMark Test has not been FDA cleared for monitoring SGLT-2 inhibitor effect.

About GlycoMark, Inc.

GlycoMark, Inc., based in Manhattan, New York, is dedicated to improving the management and health of patients with diabetes. The company is a joint venture among Toyota Tsusho America, Inc. (New York, NY), Toyota Tsusho Corporation (Tokyo, Japan), and Nippon Kayaku Co., Ltd. (Tokyo, Japan), and is the exclusive supplier of the GlycoMark test in the U.S., Europe, Australia, the Asia-Pacific Region and the Middle East. The GlycoMark test is an FDA cleared non-fasting blood test that detects hyperglycemia and hyperglycemic excursions occurring in the prior 1 to 2 weeks. Since its discovery, the GlycoMark Test, a quantitative test for 1,5-Anhydroglucitol (1,5-AG), has been described in more than 1,300 scientific and medical publications and is shown to be independently associated with complications of diabetes. More information is available at
GlycoMark, Inc. is the exclusive licensee of the GlycoMark test, trademark and logo.

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