The IFCC Global Campaign of Diabetes Mellitus Campaign Diabetes.pdfdiagnosing and monitoring of...
Transcript of The IFCC Global Campaign of Diabetes Mellitus Campaign Diabetes.pdfdiagnosing and monitoring of...
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The IFCC Global Campaign of
Diabetes Mellitus
IFCC General Conference, Antalya, April 13-15th 2008 Sverre Sandberg, Howard Morris, Matthew McQueen
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Content
- to give an overview of what has been
done last 5 years
- to discuss future tasks
- to discuss limitations of the present
work
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WHY IFCC Global Campaign of Diabetes
Mellitus?
- prevalence is increasing
- major health care problem
- generates enormous economical problems
15% of health care budget will be spent on
Diabetes Mellitus related diseases!!
- disease where laboratory medicine is very
important.
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But also because it is a opportunity to
show that laboratory medicine is active
from standardization and reference
materials to interaction with
physicians and patients
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IFCC Task Force
Global Campaign of
Diabetes Mellitus.
Members
M. McQueen
(K. Miedema)
H. Morris
S. Sandberg
(chair)
Corresponding
S. Manley
R. Little
D. Sacks
P. Gillary
26 country
representatives
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(a) Examine the best diagnostic strategy for diagnosing diabetes mellitus.
(b) Review and study the current use of laboratory test, and educate doctors and patients in interpretation of laboratory tests used in diagnosing and monitoring of diabetes mellitus.
(c) Provide quality specifications for analytes used to diagnose and monitor diabetes mellitus.
(d) Give recommendations on self-monitoring of blood glucose
(e) Try to associate with other groups or persons (including manufacturers) who will co-operate on the work to be done.
Global Campaign, Terms of references
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(a) Examine the best diagnostic strategy for diagnosing diabetes mellitus.
(b) Review and study the current use of laboratory test, and educate doctors and patients in interpretation of laboratory tests used in diagnosing and monitoring of diabetes mellitus.
(c) Provide quality specifications for analytes used to diagnose and monitor diabetes mellitus.
(d) Give recommendations on self-monitoring og blood glucose
(e) Try to associate with other groups or persons (including manufacturers) who will co-operate on the work to be done.
Global Campaign, Terms of references
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• Questionnaire to national societies of
IFCC
• International external quality assessment
of use and interpretation of Glucose,
HbA1c and Urine - albumin
• Evaluation of guidelines for DM
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Questionnaire
circulated to all member
societies
Global Campaign of Diabetes Mellitus
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Latvia
Lithuania
Malaysia
Morocco
Norway
Serbia and Montenegro
Singapore
Slovakia
Slovenia
Sweden
Syria
Taiwan
The Netherlands
Tunisia
Turkey
USA
Vietnam
Australia
Austria
China
Croatia
Cuba
England
Estonia
France
Germany
Hong Kong
India
Indonesia
Israel
Italy
Japan
Kenya
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Questons dealing with
• Units for HbA1c
• How to diagnose DM
• How to monitor DM
• Quality spec. for analytes used in DM
• Use of SMBG
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Conclusions
• Most countries use “DCCT” numbers for HbA1c
• Diagnosis: WHO or ADA; 6 countries used HbA1c
• Monitoring: HbA1c 4 times a year type I / variable
for type II
• SMBG for type 1 > 90% in 50% of the countries, for
type 2 less than 15% in 50% of the countries
• No specific analytical quality specifications
Global Campaign of Diabetes Mellitus
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Post - analytical external
quality assurance of
interpretation of glucose and
HbA1c results Case histories distributed in
Argentina Hungary*
Australia* Spain*
Norway* South-Africa
Netherlands* Sweden*
Circulated to about 6000 GPs
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Physicians: HbA1c
A 45 year-old, considerably overweight
woman with 5 children. She was diagnosed
with type II diabetes 4 years ago and you are
her physician. Her diabetes treatment was a
total daily dose of 7 mg glibenclamide and
500 mg metformine. She has a tight every-
day schedule paying little attention to her
diet and without time for exercise.
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HbA1c By consultation now the HbA1c is 9.1 %
You do what you find appropriate.
What do you mean the HbA1c test -result should be at the next consultation for the value to indicate:
A. Better diabetes control: HbA1c value must have decreased to at least ……%
B. Poorer diabetes control: HbA1c value must have increased to at least …….%
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Feedback report to the
participants
• Information on
–Own results compared to others
–Corresponding analytical quality
– Information on analytical and
biological variation
–Guidelines for use of glucose and
HbA1c
Clin Chem, 2005; 51:1143-51
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Microalbuminuria –
Standardization Working Group
and Clinical Assessment
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Assessment of
interpretation by reviewing
a case history Spain
Croatia
Denmark
Sweden
France
The Netherlands
Hungary
Estonia
Australia
Austria
Norway
Sent to about 10 000 GPs
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Questions in the case history
- how important the physician think it is
to analyse u-albumin in this patient
- analytical methods used
- what samples are used
- critical differences
- how the finding of microalbuminuria
influences treatment of the patient
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Receive - translate
-distribute - register -
-translate feedback report
- distribute
Letter to organizers Case History
Letter to participants
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Registration of questionnaires
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Feedback Clinical Update Translate -
adjust -
return -
distribute
(from
Web)
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Examples of results from
country specific feed-back
reports (each participant is
compared with others in the
country)
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A. How important is it to test if this
patient has MA now?
- please specify importance on a
scale of 1 (totally unnecessary) to
10 (very important): 8 1 2 3 4 5 6 7 8 9 10
Importance of testing for MA
0
10
20
30
40
Part
icip
an
ts (
%)
your value 8,0 mean 7,8
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Months until re-testing (no MA)
0
10
20
30
40
50
Part
icip
an
ts (
%)
your value 3,0 mean 9,2
B. If he does not have MA now, when should his urine be retested?
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Feedback report to each
individual clinician
• All own responses compared to others
• FROM GUIDELINES
• Who should have a u-albumin test
• How to diagnose Microalbuminuria
• How to interpret differences between
consecutive u-albumin results
• How to treat Microalbuminuria
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Summary U-albumin
1. There is confusion about the type of sample and type of units that should be used.
2. There is not adherence to guidelines when it comes to diagnosis of MA
3. Can the diagnosis be made in PHC?
4. Impact of biological variation is not known
5. Diagnosing MA has a varying impact on how to deal with the patients (i.e. drug treatment).
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Recommendations
1. Methods for sample collection and results
reporting for UA analysis should be as simple
as possible to promote uniform practice
among GPs.
2. The need for repeat analyses to diagnose MA
may be difficult to incorporate into everyday
practice, and the evidence for this
recommendation should be weighed against
the practicability.
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3. The more UA analysis is emphasized in clinical care, the more guidelines should be concerned with recommendations on laboratory aspects of UA measurement
4. IFCC should be encouraged to develop concerted actions with clinical societies, where IFCC could have the responsibility for the detailed laboratory part, in order to establish common recommendations for diagnosing MA.
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Evaluation of 26 guidelines
for DM - with C-EBLM
Horvath, A.R.1; Nagy, E.1; Watine, J.2; Bunting, P.3; Onody, R.1; Oosterhuis, W.4; Rogic, D.5; Sandberg, S.6; Boda, K.
Conclusions: The poor quality of GLs on the diagnosis and monitoring of DM question the internal and external validity of recommendations which may affect their implementation in practice. Our results call for systematically developed, explicit recommendations, based on evidence-based guideline development and reporting standards in laboratory medicine. (Submitted Clin Chem)
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(a) Examine the best diagnostic strategy for diagnosing diabetes mellitus.
(b) Review and study the current use of laboratory test, and educate doctors and patients in interpretation of laboratory tests used in diagnosing and monitoring of diabetes mellitus.
(c) Provide quality specifications for analytes used to diagnose and monitor diabetes mellitus.
(d) Give recommendations on self-monitoring of blood glucose
(e) Try to associate with other groups or persons (including manufacturers) who will co-operate on the work to be done.
Global Campaign, Terms of references
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By giving the critical differences needed physicians indirectly suggest QS for HbA1c, glucose and U-Alb
And by questioning the patients they indirectly set QS for glucose in SMBG and HbA1c
QS has still to be set for u-albumin
3 publ Clin Chem
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(a) Examine the best diagnostic strategy for diagnosing diabetes mellitus.
(b) Review and study the current use of laboratory test, and educate doctors and patients in interpretation of laboratory tests used in diagnosing and monitoring of diabetes mellitus.
(c) Provide quality specifications for analytes used to diagnose and monitor diabetes mellitus.
(d) Give recommendations on self-monitoring of blood glucose
(e) Try to associate with other groups or persons (including manufacturers) who will co-operate on the work to be done.
Global Campaign, Terms of references
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Standardized evaluation of SMBG
instruments / EQAS for SMBG /
Control at GPs office
•Developing a model for how these instruments should be evaluated in a standardized way.
•Establish principles for EQAS for patients
•Establish principles for how instruments and patients can control their practice at GPs offices or at pharmacies
1.Clin Chem. 2002;48:994-1003
2.Clin Chem 2004;50:1068-71.
3.Clin Chem 2005;51:1632-6.
4.Point of Care 2006;5:100-4.
5.Clin Chem 2006;52:1311-7.
6.Submitted 2008;
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CHAPTER 6:
DIAGNOSIS AND MANAGEMENT OF
DIABETES MELLITUS
SMBG chapter and
glucose chapter
written together with
IFCC representatives
Also as sep. paper i
Point of Care 2007
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Developing practice
guidelines for the use of
SMBG
Possible joint project with IDF and
IFCC
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(a) Examine the best diagnostic strategy for diagnosing diabetes mellitus.
(b) Review and study the current use of laboratory test, and educate doctors and patients in interpretation of laboratory tests used in diagnosing and monitoring of diabetes mellitus.
(c) Provide quality specifications for analytes used to diagnose and monitor diabetes mellitus.
(d) Give recommendations on self-monitoring of blood glucose
(e) Try to associate with other groups or persons (including manufacturers) who will co-operate on the work to be done.
Global Campaign, Terms of references
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Panteghini, McQueen and Sandberg
U-albumin
Standardization, measurement and reporting
- meeting in Washington 2007 -
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Agenda - Review of current status of measurement and reporting (clinical reporting and EQAS)
- Measurement issues for albumin in urine
- Quality specifications
- Sample collection and pre-analytical considerations,
- Urine albumin measurement procedures,
- IDMS candidate reference measurement procedure,
- Urine albumin as a measurand,
- Impact of change in calibration of urine creatinine on the albumin/creatinine ratio
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Current Issues in Measurement and
Reporting of
Urinary Albumin Excretion - a review article -
W. Greg Miller, Andrew Narva, David E Bruns, Glen L Hortin , Sverre Sandberg,
Kristin M Aakre, Graham Jones, Matthew McQueen David Seccombe Yoshihisa Itoh, David Bunk, John C.
Lieske, Gary C. Curhan
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Symposiae / courses
On every major conference
and a lot of national and regional
Conferences since 2003.
Visiting lecturer:
Mexico
Russia
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Clinical aspects of kidney disease
The role of laboratory medicine in the
evaluation of kidney function
Kidney and non-renal diseases
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Cooperation
NACB
NKDEP
IDF
Within IFCC
C - POCT
C - EBLM
C - NPU
WG HbA1c
C - AQ
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(own) Evaluation
Some work has been done
HOWEVER - more is to be done:
Especially:
IFCC should be more active in the
clinical “diabetes world”.
All work in IFCC has not been
integrated, e.g. Standardization /
nomenclature HbA1c
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Thank you