Consensus meeting on reporting glycated haemoglobin and estimated average glucose in the UK: report to the National Director for Diabetes, Department of Health

Ann Clin Biochem 2008;45:343-344
doi:10.1258/acb.2008.200815
© 2008 Association for Clinical Biochemistry

 

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Consensus Report


Julian H Barth1,
Sally M Marshall2 and
Ian D Watson1


1 Association for Clinical Biochemistry;
2 School of Clinical Medical Sciences, University of Newcastle-upon-Tyne Medical School, UK


A consensus paper1 on worldwide standardization of measurement and reporting of glycated haemoglobin (HbA1c) has been published recently by the American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), International Federation of Clinical Chemistry (IFCC) and Laboratory Medicine and the International Diabetes Federation (IDF). This proposal has accepted that the IFCC Reference Measurement procedure2 should be the international method for calibrating all assays used for the measurement of glycated haemoglobin. The consensus proposed five points, which are reproduced in Box 1.



Box 1 ADA, EASD, IFCC, IDF 2007 Consensus1

  1. HbA1c test results should be standardized worldwide, including the reference system and results reporting.
  2. The new IFCC reference system is the only valid anchor to implement standardization of the HbA1c measurement.
  3. HbA1c test results should be standardized worldwide, including the reference system and results reporting. The new IFCC reference system is the only valid anchor to implement standardization of the HbA1c measurement. HbA1c results are to be reported worldwide in IFCC units (mmol/mol) and derived NGSP units (%), using the IFCC-NGSP master equation.
  4. If the ongoing ‘average plasma glucose study’ fulfils its a priori specified criteria, an ADAG value calculated from the HbA1c result will also be reported as an interpretation of the HbA1c results.
  5. Glycaemic goals appearing in clinical guidelines should be expressed as IFCC units, derived NGSP units and as ADAG.

 

A meeting convened at the request of Dr Sue Roberts, National Director for Diabetes, was held in London on 23 January 2008. Representatives of 18 professional organizations and representatives of the diagnostic industry involved in the management of people with diabetes as well as patients with diabetes (Box 2) attended to discuss these proposals and how they should be incorporated into clinical practice in the UK.

  1. HbA1c test results should be standardized worldwide, including the reference system and results reporting.
  2. The new IFCC reference system is the only valid anchor to implement standardization of the HbA1c measurement.

These two points were universally accepted and, indeed, they were first proposed at an earlier consensus held in London in 2000.3

(3) HbA1c results are to be reported worldwide in IFCC units (mmol/mol) and derived National Glycohemoglobin Standardization Program (NGSP) units (%), using the IFCC-NGSP master equation.

 



Box 2 Professional organizations represented at the London meeting

  • Association for Clinical Biochemistry
  • Association of Clinical Pathologists
  • Association of British Clinical Diabetologists
  • Australian Association of Clinical Biochemists
  • British In-Vitro Diagnostics Association
  • Department of Health of England
  • Diabetes UK
  • European Federation of Clinical Chemistry
  • International Diabetes Foundation
  • International Federation of Clinical Chemistry and Laboratory Medicine
  • Primary Care Diabetes Society
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Obstetricians and Gynaecologists
  • Royal College of Pathologists
  • Royal College of Physicians
  • UK National External Quality Assessment Scheme (UK NEQAS)
  • Wales External Quality Assessment Scheme (WEQAS)

 

There was an agreement that it was necessary for glycated haemoglobin to be standardized to the IFCC Reference Measurement procedure but there was a concern regarding the introduction of a dual reporting system including new units with which patients and clinicians were unfamiliar. It was felt that there was a real risk that patient control would deteriorate due to lack of understanding, particularly with an unheralded change to IFCC units. It was agreed that dual reporting would be necessary for a considerable period until both unitary systems were understood. However, this should only occur after extensive educational programmes had been performed. Moreover, it must be ensured that these programmes will reach all the appropriate health-care professionals as well as patients.

(4) If the ongoing ‘average plasma glucose study’ fulfils its a priori specified criteria, an HbA1c-derived average glucose (ADAG) value calculated from the HbA1c result will also be reported as an interpretation of the HbA1c results.

A report of the preliminary findings of the ADAG study was presented by one of the study investigators.4Data were presented on approximately two-thirds of the subjects,although it was stated that it was anticipated at this stagethat the final results would not be different. The group attendinguniformly felt that there was insufficient information regardingentry criteria, study design and data analysis on which to acceptany conclusions at this stage and that further studies validatingthe findings from the ADAG study would be required before implementationcould be considered.

The conceptual benefits of reporting glycated haemoglobin interms that patients understand was accepted for patients whomeasure their own blood glucose concentrations, despite thefact that no patient survey had been performed to study thisaspect. However, there was a concern that it would not be beneficialfor the vast majority of patients with diabetes who have type2 disease and who do not routinely measure capillary glucose.

Moreover, there was a concern that the formula for calculating estimated average glucose (eAG) would give a different value than the capillary (finger-prick) samples used for daily monitoring. Overall, it was felt that due to issues raised about the study design and the clinical applicability of the eAG measurement in practice, it was not possible to consider implementing this recommendation in the UK.

(5) Glycaemic goals appearing in clinical guidelines should be expressed as IFCC units, derived NGSP units and as ADAG.

There was a general agreement that reportinga single measurement in three different formats was consideredto be unacceptably complicated.

There was a mention of the need for a consistent internationalmeasurement for the monitoring of diabetes in a world with hugepopulation mobility to ensure that all patients would have optimalcare.

It was felt that eAG was an interesting concept that had thepotential to help patients with diabetes improve their understandingof diabetes and therefore improve their health. Participantsrecommended that studies of eAG should be performed in the UKand that these studies should include patient populations whohave been excluded from ADAG. These include children, pregnantwomen, the elderly and ethnic populations.





Summary recommendations for the UK

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 Summary recommendations for the…
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  • HbA1c test results should be standardized using the new IFCC Reference Measurement procedure.
  • An extensive education programme should be developed urgently for all health-care professionals and people with diabetes to help the understanding and interpretation of the new IFCC units. Provision of this programme will require considerable resources.
  • HbA1c results should be reported in both IFCC units (mmol/mol) and derived NGSP units (%) (synonymous with Diabetes Control and Complications Trial [DCCT]), using the IFCC-NGSP master equation for the time being
  • There is currently insufficient experimental evidence to support the introduction of eAG.
  • Further research into the individual utility of eAG and of its use in all groups of individuals with diabetes is required in order to determine what role reporting of eAG has in clinical practice.

 




REFERENCES

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Go to previous sectionSummary recommendations for the…

 REFERENCES


  1. ADA, EASD, IFCC Consensus Committee. Consensus statement on the worldwide standardisation of the HbA1c measurement. Diabetologia 2007;50:2042–3[Medline]
  2. Finke A Kobold U Hoelzel W Weycamp C Jeppsson JO Miedema K. Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations. Clin Chem Lab Med 1998;36:299–308[Medline]
  3. Marshall SM Barth JH. Standardisation of HbA1c measurements – a consensus statement. Ann Clin Biochem 2000;37:45–56; Diabet Med 2000;17:5–6[Free Full Text]
  4. See http://www.easd-lectures.org/amsterdam/index.php?menu=view&id=201 (accessed 24 February 2008)


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