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Enhance Detection of Recent Hyperglycemia with a Simple Blood Test

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Enhance Detection of Recent Hyperglycemia with a Simple Blood Test Enhance detection of recent hyperglycemia with a simple blood test. The GlycoMark® Test Detects recent hyperglycemia and hyperglycemic excursions. Reveals improving or worsening glycemic control for the prior one to two weeks. Is independently associated with increased rates of diabetes complications. Identifies patients that may benefit from closer diabetes management. Is a non-fasting, FDA cleared blood test that complements A1C. 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 glucose and 1,5-AG circulate in the bloodstream, (>180 mg/dL†), glycosuria occurs. Glycosuria blocks are filtered in the kidneys and reabsorbed by the body. reabsorption 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 cosuria, cosuria, R R E E E lolo E A A A A M M 1,5-AG1,5-AG excretion excretion M M Gcosuria,Gcosuria, hhhh 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 A specific and more rapid indicator of recent changes in glycemic control 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 eek 1,5-AG A1C Fructe Ge 4 The350 GlycoMark test reveals hyperglycemic excursions that are not evident with A1C.9 3 4 250 4 Patient Case #1 Re 200 350 350 Infrequent spikes. Thehd 52 150year old female, type 1 diabetes 3 Glucose mgdGlucose 3 100 250 A1C 7.4% 250 50 Re 200 Re GlycoMark 12.4 µg/mL 200 Thehd 0 Thehd 2/15 6 7 2/18 1502/19 2/20 2/21 2/22 150 Time days mgdGlucose Glucose mgdGlucose 100 100 4 50 3 50 3 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 2/22 250 Time days Re Time days 200 Thehd 4 150 4 Glucose mgdGlucose Patient Case #2 3 Repeated, lengthy spikes. 100 3 49 year old male, type 2 diabetes 3 50 3 0 250 2/8 2/9 2/10A1C 7.3% 2/11 250 2/12 3 4 2/15 Re Time days 200 Re GlycoMark 4.5 µg/mL 200 Thehd 150 150 Glucose mgdGlucose Glucose mgdGlucose 100 100 50 Paire ete e e 50 0 e es 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 GLYCOMAR Reference Range0 GlycoMark results identify recent hyperglycemic excursions that may go Result Interpretation undetected and untreated. 3 µg/mL‡ GLYCOMARK ‡ Paire ete e e < µg/mL GLYCOMARK Paire ete e e‡Normal GlycoMark results are lower in females than in males. e es 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 Complications** strongly associated with higher related complications, which rates of diabetes related increase patient mortality, Glycemic variability/hypoglycemia, complications, even after adjusting morbidity and healthcare costs. Cardiovascular disease/mortality, for A1C and other risk factors.11-15 Nephropathy/kidney disease, Macrosomia/high birth weight, Cognitive decline, Retinopathy **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? ower Example: G����M��� 3 11 Example: G����M��� 12 5 Improing 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 A At Goal oncordant Prior good control, recent worsening. Experiencing Good control. % hyperglycemic excursions, most likely postprandial.17 A 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. Test Specifications Patients to Test: Patients diagnosed with diabetes Instrument: Most major chemistry platforms Test Performed: GlycoMark Test / 1,5-Anhydroglucitol Send-Out: National and regional laboratories Regulatory: FDA cleared, CE Marked Reimbursement: Reimbursed by most federal, state and Patient Prep: Non-fasting private payors, CPT Code 84378 Specimen: SST or EDTA plasma, 7 days, refrigerated GlycoMark is easy to order and available through most reference labs. Contact your local representative or visit our website, www.GlycoMark.com The information contained herein is not medical, diagnostic or treatment advice for any particular patient. Physicians should use 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. 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 diagnose disease or identify patients that will experience complications of diabetes or 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 2018 Jan; 41(Supplement 1): S1-S159. 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 Association. 805 Third Avenue, 17th Floor 9Dungan KM, et al. Diabetes Care 2006 Jun; 29(6): 1214-1219. 10GlycoMark Test Product Package Insert, Revision G, 2017. 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; New York, NY 10022 40(12): 1661-1667. 14Rawlings AM, et al. Diabetes Care 2017 Jul; 40(7): 879-886. 15Nowak N, et al. Diabetologia 2013 Apr; 56(4): 709–713. 1-888-744-0221 16Monnier L, et al. Diabetes Care 2003 Mar; 26(3): 881-885. [email protected] GlycoMark, Inc. is the exclusive licensee of the GlycoMark test, trademark and logo. © 2019 GlycoMark, Inc. All Rights Reserved. M-54-1C www.glycomark.com.
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