Mafauzy Mohamad Health Campus University Sains Malaysia. Declared no potential conflict of interest

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1 International guidelines for the management of diabetes: evidence based medicine vs personalized medicine Mafauzy Mohamad Health Campus University Sains Malaysia Declared no potential conflict of interest

2 International guidelines for the management of diabetes: evidence-based medicine vs personalised medicine Mafauzy Mohamed Professor of Medicine/ Senior Consultant Endocrinologist Health Campus, Universiti Sains Malaysia

3 Conflict of interest Mafauzy Mohamed has declared no potential conflicts of interest.

4 Learning objectives To understand that complications of diabetes can be prevented or delayed To know that there is a broad range of guidelines for management of diabetes and that these are regularly updated To appreciate that guidelines need to be sensitive to cost-effectiveness and available resources To understand that there is a move towards patientcentred care

5 Introduction/background There is good evidence that diabetes complications can be prevented or delayed Cost-effectiveness of interventions to improve diabetes care has been well established by many studies (e.g., UKPDS) Optimal management, however, is not reaching many of the people who could benefit Reasons include size and complexity of evidence base and the complexity of diabetes care itself International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

6 Introduction/background continued There is a lack of proven cost-effective resources for diabetes care In clinical practice, there is a diversity of standards and methods in diabetes care, both within countries and between countries Guidelines are an essential component of achieving good-quality diabetes care for all Guideline recommendations define standards for care and use evidence-based interventions to achieve them International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

7 IDF Global Guideline for Type 2 Diabetes International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

8 Preface Goals and indicators of healthcare do not differ between people with diabetes living in developed and in developing countries What is different is availability of resources, hence the need to use different approaches, methods and therapeutic strategies to achieve these goals Funding and expertise available for healthcare vary widely between countries and even between localities The Guideline is sensitive to resource and cost-effectiveness issues International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

9 Levels of care From the Guideline All people with diabetes should have access to the broad range of diabetes services and therapies and no person should be denied any element of effective diabetes care. It is recognised that in many parts of the developing world the implementation of particular standards of care is limited by lack of resources. This guideline provides a practical approach to promote the implementation of cost-effective evidence-based care in settings between which resources vary widely. The approach adopted has been to advise on three levels of care. International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

10 Summary of the levels of care structure Recommended care: Evidence-based care, cost-effective in most nations with a well-developed service base and with healthcare funding systems consuming a significant part of their national wealth Limited care: Care that seeks to achieve the major objectives of diabetes management, but is provided in healthcare settings with very limited resources drugs, personnel, technologies and procedures Comprehensive care: Care with some evidence base that is provided in healthcare settings with considerable resources International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

11 Glucose control levels Normal Target HbA1c <6.0% / 42 mmol/mol <7.0% / 53 mmol/mol Fasting/pre-meal capillary plasma glucose 5.5 mmol/l (100 mg/dl) 6.5 mmol/l (115 mg/dl) Post-meal capillary plasma glucose 7.8 mmol/l (140 mg/dl) 9.0 mmol/l (160 mg/dl) International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

12 Glucose control levels Recommended care Advise people with diabetes that maintaining an HbA1c below 7.0% / 53 mmol/mol minimises the risk of developing complications A lower HbA1c target may be considered if it is easily and safely achieved A higher HbA1c target may be considered for people with comorbidities or when previous attempts to optimise control have been associated with unacceptable hypoglycaemia International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

13 Glucose control levels Comprehensive care The principles are as for Recommended care but may be possible to devote more resources to achieving lower target levels without adverse impact on health Limited care: The principles are as for Recommended care including assessment of diabetes and control by HbA1c measurement. In very limited settings diabetes control may need to be based on measurement of plasma glucose levels alone International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

14 International Diabetes Federation: Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes, 2012.

15 ADA: Standards of Medical Care In Diabetes 2015 American Diabetes Association. Diabetes Care 2015;38(Suppl 1).

16 ADA evidence grading system for clinical practice recommendations Level of evidence A B C E Description Clear or supportive evidence from adequately powered wellconducted, generalisable, randomised controlled trials Compelling non-experimental evidence Supportive evidence from well-conducted cohort studies or case-control study Supportive evidence from poorly controlled or uncontrolled studies Conflicting evidence with the weight of evidence supporting the recommendation Expert consensus or clinical experience American Diabetes Association. Diabetes Care 2015;38(Suppl 1):S2 - Table 1. ADA. Diabetes Care 2015;38(suppl 1):S2; Table 1

17 Trends in the number and proportion of higher and lower level recommendations Higher level recommendations defined as A or B evidence grades Lower level recommendations defined as C or E evidence grades Grant RW, Kirkman MS. Diabetes Care 2015;38:6-8.

18 Trends in the proportion of higher level recommendations by category Grant RW, Kirkman MS. Diabetes Care 2015;38:6-8.

19 Glycaemic recommendations for non-pregnant adults with diabetes A1C <7.0% * Preprandial capillary plasma glucose mg/dl * ( mmol/l) Peak postprandial capillary plasma glucose <180 mg/dl * (<10.0 mmol/l) *Goals should be individualised. Postprandial glucose measurements should be made 1 2 h after the beginning of the meal generally peak levels in patients with diabetes. American Diabetes Association. Diabetes Care 2015;38(Suppl 1):S37 - Table 6.2.

20 Approach to the management of hyperglycaemia American Diabetes Association. Diabetes Care 2015;38(Suppl 1):S37 - Figure 6.1. Adapted with permission from Inzucchi SE et al. Diabetes Care 2015;38:140-9.

21 Antihyperglycaemic therapy in type 2 diabetes American Diabetes Association. Diabetes Care 2015;38(Suppl 1):S43 - Figure 7.1. Adapted with permission from Inzucchi SE et al. Diabetes Care 2015;38: ADA. 7. Approaches to Glycemic Treatment. Diabetes Care 2015;38(suppl 1):S43. Figure 7.1; adapted with permission from Inzucchi SE, et al. Diabetes Care, 2015;38:

22 Diabetes care concepts The American Diabetes Association highlights three themes that are woven throughout the Standards of Medical Care in Diabetes that clinicians, policymakers and advocates should keep in mind: Patient-centredness: The science and art of medicine come together when the clinician is faced with making treatment recommendations for patients who would not have met eligibility criteria for the studies on which guidelines were based Diabetes across the lifespan: There is a need to improve co-ordination between clinical teams as patients pass through different stages of the lifespan or the stages of pregnancy (preconception, pregnancy and postpartum) Advocacy for patients with diabetes: Given the tremendous toll that lifestyle factors such as obesity, physical inactivity and smoking have on the health of patients with diabetes, ongoing and energetic efforts are needed to address and change the societal determinants at the root of these problems American Diabetes Association. Diabetes Care 2015;38(Suppl 1):S5. ADA. 1. Strategies for Improving Diabetes Care. Diabetes Care 2015;38(suppl 1):S5

23 Conclusions Guidelines are developed based on evidence and cost-effectiveness However, evidence is not available in some patient conditions and so guidelines may not be applicable in certain situations (e.g., elderly, advance complications) Treatment decisions should be based on evidence-based guidelines tailored to individual patient preferences, prognoses and comorbidities

24 4-5 July 2015, Mumbai, India 2015 Asia Pacific Conference on Cardiometabolic Diseases Management IMPROVING THE PATIENT S LIFE THROUGH MEDICAL EDUCATION