1. Journal Club 亀田メディカルセンター 糖尿病内分泌内科 Diabetes and Endocrine Department, Kameda Medical Center 松田 昌文 Matsuda, Masafumi 2007 年８月 30 日 8:20-8:50 B 棟８階 カンファレンス室

6. In Clinical Guidelines In Japan HbA 1C <6.5% ADA A1C<7% EASD HbA 1C (DCCT standard) ≦ 6.5%

7. What is the issue? 4 different A1C exists in the world NGSP-HbA 1C JDS/JSCC HbA 1C Swedish-HbA 1C & DOF (N-[1 deoxyfructos-1-yl] hemoglobin beta chain)

8. The decision was made to define HbA1c as haemoglobin molecules having a special hexapeptide in common, which is the stable adduct of glucose to the N-terminal valine of the haemoglobin b-chain (bN-1 deoxyfructosylhaemoglobin). The rationale was that this quantity is biochemically well characterised, is the major form of HbA1c in human blood, and most of the commercial HbA1c tests claim to measure only this form. HPLC-MS or the HPLC-CE a combination of high-pressure liquid chromatography (HPLC) and electron-spray mass spectrometry (MS) or, alternatively, a two-dimensional approach using HPLC and capillary electrophoresis (CE) with UV detection

9. A1C test results should be standardized worldwide, including the reference system and results reporting. The new IFCC reference system for A1C represents the only valid anchor to implement standardization of the measurement. A1C results are to be reported worldwide in IFCC units (mmol/mol) and derived NGSP units (%), using the IFCC-NGSP master equation. If the ongoing "average plasma glucose study" fulfills its a priori–specified criteria, an A1C-derived average glucose (ADAG) value calculated from the A1C result will also be reported as an interpretation of the A1C results. Glycemic goals appearing in clinical guidelines should be expressed in IFCC units, derived NGSP units, and as ADAG. CONSENSUS

10. 4 different A1C exists in the world NGSP-HbA 1C JDS/JSCC HbA 1C Swedish-HbA 1C & DOF (N-[1 deoxyfructos-1-yl] hemoglobin beta chain) Winner? & ADAG

11. COMMENT Be implemented globally as soon as possible. Expressing test results in scientifically correct units along with a clinically relevant interpretation of those results is not an uncommon practice (e.g., creatinine and estimated glomerular filtration rate).

12. Who decided? At a meeting held in Milan, Italy, on 4 May 2007 For IFCC Prof. Jocelyn Hicks, IFCC President Prof. Mathias Mueller, IFCC Past President Prof. Mauro Panteghini, IFCC Scientific Division Chair Dr. Garry John, IFCC SD WG-HbA1c Chair For ADA Dr. Richard Kahn, ADA Chief Scientific and Medical Officer Dr. John Buse, President-Elect, ADA Prof. David Nathan, Harvard Medical School For EASD Prof. Ele Ferrannini, EASD President Prof. Robert Heine, President-Elect, EASD For the International Diabetes Federation: Prof. Martin Silink, MD, President, IDF Paediatric Endocrinology, University of Sydney, Australia Prof. Jean-Claude Mbanya, MD. Vice-President, IDF Endocrinology at the Faculty of Medicine & Biomedical Sciences in Yaounde, Cameroon

13. What we will see! Clin Chem Lab Med 2007;45(8):942–944

19. The HbA1c values of JDS Lot 2 were transferred from those assigned to Lot 1 using KO500, a high-resolution HPLC method, at three laboratories approved by the JDS committee. Vials of JDS Lot 2 were shipped to and assayed by the NGSP in the USA and 10 IFCC reference laboratories. Methods

26. HbA1c values in several largescale studies, including the DCCT and UKPDS, have been reported using the NGSP values. As seen in the present study, the conversion of HbA1c values based on the NGSP method and reported in European and USA papers to JDS values can be done by the simple subtraction of 0.3%. COMMENTS