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Part 3 Interpretation and Clinical Use of 1,5-Anhydroglucitol Values

An Educational Service from GLYCOMARK

GLYCOMARK is a registered trademark of GlycoMark, Inc.© GlycoMark, Inc. All rights reserved

NOTE: Please see slide notes below each page for study and slide details

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GLYCOMARK 1,5-AG Value Correlation toEstimated Average Peak Glucose (eAPG)

• When A1C > 8%, 1,5-AG will almost always be <10 µg/mL due to 1,5-AG tissue depletion from constant hyperglycemic state

• When A1C < 8%, 1,5-AG reveals differences in postprandial glucose

Dungan, K., Buse, J. et al. Diabetes Care, June 2006Patent No. US 8,178,312 B2 May 15, 2012

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Actual Clinical Data

A1Cs <7.0%Meet ADA Guidelines

Similar A1Cs can have very different postmeal glucoses

Actual patient results from Diabetes Care Center, Hudson, FL and other paired lab results

A1C

1,5-AG Paired Value

Estimated Average Peak Glucose

(eAPG)

8.3 %8.17.97.87.77.5

2.7 µg/mL5.14.43.56.5

19.6

258 mg/dL211219235199171

7.47.4

15.13.4

175237

7.27.2

19.25.7

171205

7.07.0

18.12.0

172294

6.86.86.7

20.85.84.4

170204219

6.46.46.4

16.86.32.3

173200276

6.36.36.3

10.29.24.3

184187221

5.75.7

23.24.9

169213

1,5-AG identifies patients at higher risk so you can make needed

therapy changes

Low 1,5-AG values with low A1Cs may reveal

undetected hypoglycemia

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Glycemic Blood Marker Comparison

• 1,5-Anhydroglucitol reflects recent glycemic variability not detected by A1C – Measures therapy change effectiveness in 2-4 weeks– Detects glycemic deterioration or improvement earlier

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1,5-AG

Fructosamine orGlycated Albumin

HbA1C

Weeks Prior to Measurement

FBG or SMBG

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When patients have low 1,5-AG values, consider further assessment…

• Anything unusual in the past 2 weeks?– Vacation/holiday – unusual food intake– Stopped taking diabetes medication – Steroid injection– Illness or unusual stress

• Consider…– Structured postmeal fingerstick glucose testing – 24 hour glucose profile – 3-day continuous glucose monitor

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Limitations of 1,5-Anhydroglucitol Test

• Low values have been observed in– Advanced kidney disease Stage 4 or 5; < 30 GFR; Dialysis– Cirrhosis of the liver Reduced 1,5-AG liver biosynthesis– Pregnancy Due to low and varying renal thresholds– Drugs

• Acarbose Reduces absorption of carbs including 1,5-AG• SGLT2 inhibitors Effect unknown (1,5-AG is transported via SGLT4)

• High values have been observed in– Some IV hyperalimentation solutions– Some Chinese medicines (Polygala, Tenuifolia, Senega Syrup)

Suggested Personalized Therapy Algorithm

Modified from Dungan.Expert Rev Mol Diagn 8(1), 2008Patent No. US 8,178,312 B2 May 15 2012

Identify hidden PPH Monitor therapy changes

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1,5-AG Assay Summary

• Clinically proven two week measure of glucose spikes1,2,3 – Detects recent deterioration in glucose control missed by A1C – Assesses therapy effectiveness after change4

– Reinforces positive adherence to therapy and lifestyle changes4

• Guides selection of the right medication to improve A1Cs while potentially reducing risk of hypoglycemia– Fasting vs. prandial glucose– Identify patients who need more frequent SBGM or CGM – Appropriate selection of more costly prandial or injectable drugs

1 Wang, et al., Diabetes Metab Res Rev 2012; 28: 357–362.2 Dungan, K., Buse, J. et al. Diabetes Care, June 20063 Yamanouchi, et al. Clin Sci (Lond) 2001 Sep;101(3):227-33.4 McGill, et al, Diabetes Care, Vol 27, No. 8, August 2004

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The Glycemic Triad Diabetes Panel

1,5-AnhydroglucitolPostprandial hyperglycemia marker

(Last 14 days)

Average glucose marker(Last 60-90 days)

Fasting GlucoseBaseline glucose marker(Current point in time)

HbA1C

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For more information

• For a listing of postprandial hyperglycemia outcome studies, please visit www.glycomark.com/postprandialhyperglycemia

• For a listing of studies about the 1,5-anhydroglucitol biomarker for postprandial hyperglycemia, please visit www.glycomark.com/product/studies

• For a 3-minute overview about the 1,5-anhydroglucitol biomarker, please visit www.glycomark.com/movie