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The Glycomark® Test

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The Glycomark® Test Enhance detection of hyperglycemia with a simple blood test. The GlycoMark® Test The only blood test specific to detecting recent hyperglycemia. Detects changes in glycemic control within two weeks. Independently associated with increased rates of diabetes complications. Identifies patients that may benefit from closer diabetes management. Complimentary test to A1C, non-fasting, and FDA-cleared. Nearly 40% of patients in “good control” may have significant postprandial hyperglycemia or glycemic variability.1,2 A1C reflects an individual’s average blood glucose over the prior two to three months. High and low glucose values are NOT represented with A1C. In fact, the estimated blood glucose range for an A1C of 7% is 123 - 185 mg/dL.3 Detect recent hyperglycemia with the GlycoMark test. The GlycoMark test measures 1,5-Anhydroglucitol (1,5-AG), a glucose-like sugar found in most foods.4,5 Glycemic Control Hyperglycemia When blood glucose is well-controlled, When glucose exceeds the renal threshold (>180 mg/dL†), glucose and 1,5-AG circulate in the bloodstream, glycosuria occurs. Glycosuria blocks reabsorption are filtered in the kidneys and reabsorbed by the body. of 1,5-AG. 1,5-AG is excreted in the urine, Urinary 1,5-AG is equal to the ingested 1,5-AG. depleting the serum level. 1,5-AG1,5-AG 1,5-AG1,5-AG ood ood ood ood B B B B L L L L O O O O O O 1,5-AG1,5-AG O O GeGe he he 1,5-AG1,5-AG tribute tribute D D 1,5-AG1,5-AG tribute tribute D D reeree ee all allorgans organs and and tissues tissues S S allall organs organs and and tissues tissues S S T T b bhe he ey ey T T 1,5-AG1,5-AG reabsorptionreabsorption R R Gcosuria Gcosuria R R E E E LoLo E A A A A M M 1,5-AG1,5-AG Excretion Excretion M M GcosuriaGcosuria hh 1,5-AG1,5-AG Excretion Excretion Circulating 1,5-AG maintained/ Circulating 1,5-AG depleted/ higher serum concentrations of 1,5-AG lower serum concentrations of 1,5-AG GlycoMark Test: Normal GlycoMark Test: Abnormal †The ADA recommends a postprandial blood glucose goal of 180 mg/dL and an A1C of <7%.6 The GlycoMark test is a specific and more rapid indicator of recent hyperglycemia than A1C. The body quickly removes and restores 1,5-AG. Changes that improve or worsen glycemic control can be detected within two weeks with the GycoMark test. A1C takes at least four weeks to show significant change.7,8 Change in Test Values from Baseline in Response to Improved Glycemic Control8 Baseline 9.5% A1C 180 *p<0.05 6 * 4 120 100 * 80 6 * 4 e he ee he e * 20 * * * * * * * 0 0 2 4 8 Wee 1,5-AG A1C Fructe Ge The GlycoMark test reveals hyperglycemic excursions that are not evident with A1C.9 4 4 Patient Case #1 350 350 Infrequent spikes. 52 year old female 3 3 250 A1C 7.4% 250 Re 200 Re GlycoMark 12.4 µg/mL 200 Thehd 150 150 Glucose mg/dLGlucose Glucose mg/dLGlucose 100 100 50 50 0 0 2/15 6 7 2/18 2/19 2/20 2/21 2/22 2/15 6 7 2/18 2/19 2/20 2/21 2/22 Time days 4 Patient Case #2 4 3 Repeated, lengthy spikes. 3 49 year old male 3 3 250 A1C 7.4% 250 Re 200 Re GlycoMark 4.5 µg/mL 200 Thehd 150 150 Glucose mg/dLGlucose Glucose mg/dLGlucose 100 100 50 50 0 0 2/8 2/9 2/10 2/11 2/12 3 4 2/15 2/8 2/9 2/10 2/11 2/12 3 4 2/15 Time days GLCOMA eference ange10 GlycoMark results identify recent hyperglycemic excursions that may go Result Interpretation undetected and untreated. 3 µg/mL‡ GLYCOMARK < µg/mL‡ GLYCOMARK ‡Normal GlycoMark results are lower in females than in males. Hyperglycemia and low GlycoMark are independently associated with significant health risks. GlycoMark correlates with hyperglycemia and glycemic variability as confirmed by continuous glucose monitoring (CGM).9 Abnormal Hyperglycemia GlycoMark Hyperglycemia is independently Diabetes Low GlycoMark results are associated with diabetes strongly associated with higher ** related complications, which Complications rates of diabetes related increase patient mortality, complications, even after adjusting Glycemic variability/hypoglycemia, 11-15 morbidity and healthcare costs. Cardiovascular disease/mortality, for A1C and other risk factors. Nephropathy, Cognitive decline, Macrosomia/high birth weight, Retinopathy, Kidney disease **GlycoMark is not intended to diagnose, prevent, treat, cure or mitigate these complications. Clinical interpretation of GlycoMark test results. G����M��� result Yes within reference range? No Example: G����M��� 12 Example: G����M��� 5 Normal Abnormal • No evidence of significant recent hyperglycemia and/or glycemic • Consistent with significant recent hyperglycemia/glycemic variability. variability. • Consider fasting glucose, structured SMBG and/or CGM to determine hyperglycemic patterns. G����M��� re Higher compared to prior? Lower Example: G����M��� 3 11 Example: G����M��� 12 5 mproing Glycemic ontrol Worsening Glycemic ontrol • Future A1C may trend lower. • Future A1C may trend higher. • Suggests recent good behavior/compliance with treatment program. • Suggests non-compliance with treatment program or other factors. A1C compared to G����M��� re G����M��� Normal G����M��� Abnormal 10 – 31 μg/mL <10 μg/mL Discordant A1 At Goal oncordant Prior good control, recent worsening. Experiencing Good control. % hyperglycemic excursions, most likely postprandial.3 A1 Above Goal Discordant oncordant Prior poor control, recent improvement. ≥7% Poor control. Fewer hyperglycemic excursions. The lower the GlycoMark result, the more severe the hyperglycemia. The GlycoMark Test Nonfasting, FDA-cleared blood test No limits on test frequency Reimbursed by federal, state and private payors - Collect one (1) SST or EDTA plasma tube CPT Code 84378 GlycoMark is easy to order and available through most reference labs. Contact your local representative or visit our website, www.GlycoMark.com Baseline or monitor GlycoMark between Order Code: A1C measurements The information contained herein is not medical, diagnostic or treatment advice for any particular patient. Physicians should use GlycoMark With A1C Order Code: their clinical judgment and experience when deciding how to diagnose and treat patients and in the use of the GlycoMark test in the treatment of the patient. Please refer to the GlycoMark product insert for more information. A1C with reflex to GlycoMark Order Code: The GlycoMark test is FDA cleared for professional use to provide quantitative measurement of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The GlycoMark test is intended for intermediate-term monitoring of glycemic control in patients with diabetes. It is not intended to be used to identify patients that will experience complications of diabetes or reduce the likelihood of experiencing complications. The information above contains general reimbursement information only and is not legal advice, nor is it advice about how to code, complete, or submit any claim for payment. Providers have the ultimate responsibility for all aspects of coding and billing. 1Erlinger TP, Brancati FL. Diabetes Care. 2001 Oct;24(10):1734-8. 2Bonora E, et al. Diabetologia. 2006 May;49(5):846-54. 3Nathan DM, et al. Diabetes Care 31:1473–1478, 2008. 4Yamanouchi T, et al. Diabetes 1989 Jun; 38(6): 723-729. 5Buse JB, et al. Diabetes Technol Ther. 2003;5(3):355-63. 6American Diabetes Association. Diabetes Care 2015 Jan; 38(Supplement 1): S33-S40. 7Yamanouchi T, et al. Lancet. 1996 Jun 1;347(9014):1514-8. 8McGill, et al. Diabetes Care 2004 Aug; 27(8): 1859-1865. American Diabetes Association Circulating 1,5-Anhydroglucitol Levels in Adult Patients With Diabetes Reflect Longitudinal Changes of Glycemia, American Diabetes Association, 2004. Copyright and all rights reserved. Material from this publication has been used with the permission of American Diabetes 805 Third Avenue, 17th Floor 9 10 Association. Dungan KM, et al. Diabetes Care 2006 Jun; 29(6): 1214-1219. GlycoMark Test Product Package Insert, Revision G, 2017. New York, NY 10022 11Selvin E, et al. Clin Chem. 2014 Nov; 60(11): 1409–1418. 12Selvin E, et al. Diabetes 2016;65:201–208. 13Lee AK, et al. Diabetes Care 2017 Dec; 40(12): 1661-1667. 14Rawlings AM, et al. Diabetes Care 2017 Jul; 40(7): 879-886. 15Nowak N, et al. Diabetologia 2013 Apr; 1-888-744-0221 56(4): 709–713. [email protected] GlycoMark is a registered trademark of GlycoMark, Inc. © 2018 GlycoMark, Inc. All Rights Reserved. M-54-1B www.glycomark.com.
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