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Analysis of Glycated Hemoglobin by HPLC Technology
Shalini Kini Product Specialist

Diabetic EpidemiologyWhere Do we Stand!?!

World Scenario

* IDF Diabetes Atlas 5th Edition 2012 update. http://www.idf.org/diabetesatlas/5e/Update2012

Did U Know!!??!
One Adult in Ten will have diabetes by 2030!!!

Year 2012

Year 2030

63.01m
India

101.2m
India

• India Ranked Second in the world in Diabetes Prevalence, behind China.

*IDF Diabetes Atlas- Fifth Edition http://www.idf.org/atlasmap/atlasmap

Comparative Diabetes Prevalence:

HbA1c- An Indicator!!??

Hemoglobin

Hemoglobin Fractions

Glycohemoglobin - HbA1c

HbA1c as Diagnostic Tool
• HbA1c as an Indicator of glycemic control, recommended for diagnosis of Diabetes by ADA in 2010.



Test Results are not affected by - Time of the Day - Meal Intake - Exercise - Just Administered Diabetes Drugs - Emotional Stress



HbA1c level correlates well with risks of Diabetic complications.

[Reference: American Diabetes Association Clinical Practice Standards of Medical Care in Diabetes - 2010 Diabetes Care 2010;33, suppl.1: S4-5.]

Why Use HbA1c Vs OGGT/FPG!?
• • • • • The patient does not need to be fasting HbA1c is standardized and aligned to DCCT Better index of overall glycemic exposure and risk for long-term complications Substantially less biologic variability/ pre-analytic stability Relatively unaffected by acute (e.g., stress or illness related) perturbations in glucose levels

NIH Publication No 11-7816 Sept 2011. www.diabetes.niddk.nih.gov

HbA1c Standardization

Need for Standardization
• 1993: Diabetes Control & Complication trial (DCCT), correlated chronic complications of Diabetes to degree of glycemic control with HbA1c as an Index. April 1993: American Association of Clinical Chemistry (AACC) estd HbA1c Standardization Subcommitee. Goal: To relate Individual Lab HbA1c results to those of DCCT, where relationships of HbA1c values to MBG and to risks of complications has been established. 1996: National Glycohemoglobin Standardization Program (NGSP) implements recommendations of AACC.

• •



IFCC Vs NGSP
• 1995-2001: International Federation of Clinical Chemistry (IFCC) developed reference method for HbA1c standardization. Consensus Statement 2010-2011: [ ADA, EASD, IDF, IFCC, ISPAD] recommendations: HbA1c results to be reported worldwide in SI Units (mmol/mol-No decimals) and NSGP derived units (%- one decimal) using IFCC_NGSP master equation: (NGSP = [0.09148 * IFCC] + 2.152). HbA1c conversion tables including both SI (IFCC) and NGSP units should be easily accessible to the diabetes community.

• •



NGSP %A1C 4 6 8

IFCC %A1C 2.1 4.3 6.4

Diff. %A1C 1.9 1.7 1.6

HbA1c & eAG correlation:
Estimated Average Glucose HbA1c Correlation HbA1c Mg/dl 6 126 7 154 183 8 9 212 10 241 11 270 12 299 For Every 29 mg/dl Rise in Estimated Average Glucose HbA1c goes up by 1% Diabetes Care 2008: 31: 1477-8

Clinical Interpretation of HbA1c Values

HbA1c Value 4–6% 6.1 – 7 % 7.1-8 %

Interpretation Normal Value (or) Non Diabetic Well Controlled Diabetes Unsatisfactory Control Poor Control and needs treatment

>8%

Risks of Diabetic Complications!!?!Improve ur A1c number!!

Complications of Diabetes
• Microvascular disease
– Eye disease – Nephropathy – Neuropathy

• Macrovascular disease
– Cardiovascular disease – Cerebrovascular Disease – Peripheral Vascular Disease

Diabetic patients have a 2 to 6 times higher risk for development of these complications than the general population !!

*DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study http://diabetes.niddk.nih.gov/dm/pubs/control/DCCT-EDIC_508.pdf

Alc & Complications: DCCT Study

Alc & Complications: UKPDS Study

21%

Deaths related to diabetes

HbA1c
1%

37%

Microvascular complications

14%

Myocardial infarction

Στραττον ΙΜ, ετ αλ. ΒΜϑ 2000; 321:405 412....
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