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Kdigo Clinical Practice Guideline on Diabetes Mangement in Chronic Kidney Disease

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Kdigo Clinical Practice Guideline on Diabetes Mangement in Chronic Kidney Disease KDIGO CLINICAL PRACTICE GUIDELINE ON DIABETES MANGEMENT IN CHRONIC KIDNEY DISEASE CONFIDENTIAL: DO NOT DISTRIBUTE PUBLIC REVIEW DRAFT DECEMBER 2019 TABLE OF CONTENTS KDIGO Executive Committee………………………………………………....................................................... vii Reference Keys…………………………………………………………………………..................................... ix CKD Nomenclature…………………………………………………………………….………………………. x Conversion Factors……………………………………………………………………..……………………..... xi Abbreviations and Acronyms………………………………………………………….…………….................. xii Notice…………………………………………………………………………………..………………………. xii Foreword………………………………………………………………..……………..……………………….. xiv Update to Guideline Format………………………………………………………………………………......... xvi Work Group Membership ………………..……………………………………….....………………………… xx Abstract……………………………………….……………………………………..………………….. …….. xxii Introduction from the Guideline Co-Chairs………………………………………..…….…………………….. xxiii Summary of Recommendation Statements and Practice Points.....…………………………………………….. xxvi Chapter 1. Comprehensive Care in Patients with Diabetes and CKD.................................................................. 1 Chapter 2. Glycemic Monitoring and Targets in Patients with Diabetes and CKD............................................. 17 Chapter 3. Lifestyle Interventions in Patients with Diabetes and CKD....………….……….……………. …... 30 Chapter 4. Anti-hyperglycemic Therapies in Patients with Diabetes and CKD…..……………..…………….. 51 Chapter 5. Approaches to Management of Patients with Diabetes and CKD………………..……..….………. 89 Methods for Guideline Development…………...………………………………....………………….………... 104 Disclosure Information………………………………………………………………………………..………... 127 References……………………………………………………………………………………………................ 129 . ii TABLES Table 1. Different formulations of ACEi and ARBs……………………………………………………………..... 6 Table 2. Frequency of HbA1c and use of CGMI in CKD…………………………………………………………. 22 Table 3. Relationship of anti-hyperglycemic drug choice to risk of hypoglycemia and rationale for SMBG or CGM……………………………………………………………………………………………………….............. 23 Table 4. Protein guideline for adults with diabetes and CKD ND………………………………………………… 35 Table 5. Examples of various levels of physical activity and their associated metabolic equivalent…………....... 46 Table 6. Overview of selected large, placebo-controlled clinical outcomes trials assessing the benefits and harms of SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors…………………………….……….. 52 Table 7. Different formulations of metformin…………………………………………………………………….. 59 Table 8. Cardiovascular and kidney Outcome Trials for SGLT2 inhibitors………………………….…………… 68 Table 9. SGLT2i with established kidney and cardiovascular benefits and doses adjustments as approved by FDA (be aware of country-to-country variation)………………………………………………………………...... 74 Table 10. Cardiovascular and kidney outcome trials for GLP1RA………..……………………………………… 83 Table 11. Dosing for available GLP-1 RA agents and dose modification for CKD…………….………………… 87 Table 12. Key objectives of effective diabetes self-management education programs…………………………… 89 Table 13. Hierarchy of outcomes……………………………………………………………………….................. 105 Table 14. Clinical questions and systematic review topics in PICOM format…………………………................. 107 Table 15. Classification for certainty and quality of the evidence………………………………............................ 122 Table 16. GRADE system for grading quality of evidence…………………………………………….................. 122 Table 17. KDIGO nomenclature and description for grading recommendations………………………................. 123 Table 18. Determinants of the strength of recommendation………………………………………………………. 124 iii FIGURES Figure 1. Cardio-kidney risk factor management………………………………………………………….……….. 2 Figure 2. Approach to ACEi or ARB treatment………………………………………………………….……....... 9 Figure 3. Effects of CKD-related factors on advanced glycation end-products and glycemic biomarkers….......... 20 Figure 4. Factors potentially guiding decisions on individual HbA1c targets……………….………………......... 26 Figure 5. What does a kidney healthy diet look like?............................................................................................... 31 Figure 6. Average protein content of foods in grams………………………………...………………………......... 35 Figure 7. Decreased sodium intake, quality of evidence…………………………………………………………... 38 Figure 8. Ten ways to cut out salt……………………………………………………………………………........ 40 Figure 9. Physical activity levels in people with CKD in the United States……………………………………... 47 Figure 10. Suggested approach to address physical inactivity and sedentary behavior in CKD……...…………. 49 Figure 11. Glycemic treatment algorithm for patients with T2D and CKD…………………………………........ 51 Figure 12. Patient factors influencing selection of glucose-lowering drugs other than SGLT2i and metformin in T2D and CKD………………………………………………………………………………….......................... 56 Figure 13. Suggested approach in dosing metformin…………………………………………………………...... 61 Figure 14. Algorithm for initiation of SGLT2i therapy for patients with T2D, CKD, and eGFR ≥ 30 ml/min/1.73m2, who are already treated with anti-hyperglycemic medications…………………………………... 73 Figure 15. Meta-analysis showing effect of different intervention components on a) systolic blood pressure, b) diastolic blood pressure, c) eGFR, d) HbA1c (%), e) self-management activity, and f) health related quality of life…………….......................................................................................................................................................... 92 Figure 16. Forest plots showing outcomes for people with diabetes and CKD undergoing self-management education programs for a) systolic BP, b) diastolic BP, c) eGFR, d) HbA1c, e) self-management activities and f) health-related quality of life…………………………………………………………………………………….. 93 Figure 17. A schematic diagram showing the use of physician and non-physician personnel to provide regular assessments, assisted by information technology, to facilitate individualized management and patient self- management with ongoing support in order to detect, monitor and treat risk factors and complications early to reduce hospitalizations, multiple morbidities and premature death………………….............................................. 97 Figure 18. The chronic care model emphasizes the additive benefits of different components at the system, policies, providers and patient levels in improving clinical outcomes……………………………………………. 101 Figure 19. Team-based integrated care delivered by physicians and non-physician personnel supported by decision makers……………………………………………………………………………………………………. 102 Figure 20. Search yield and study flow diagram…………………………………………………………………... 119 iv SUPPLEMENTARY MATERIAL Table S1: Search strategies for systematic review topics - Search dates – RCTs October 2018, Systematic reviews October 2018, Observational studies February 2019……………………………………………………. S1 Table S2: Guideline development checklist - IOM standards for development of trustworthy clinical practice guidelines…………………………………………………………………...…………………………………….. S27 Table S3: Adapted systematic review reporting standards checklist - IOM standards for systematic reviews ….. S28 Table S4: Summary of findings table: ACEi versus placebo or standard of care………………………………… S29 Table S5: Summary of findings table: ARB versus placebo or standard of care…………………………………. S34 Table S6: Summary of findings table: Smoking cessation versus no smoking cessation………………………… S38 Table S7: Summary of findings table: Tight glycemic control (HbA1c ≤7% or fasting glucose levels ≤120 mg/dl (6.7 mmol/L) versus non-tight glycemic control…………………………………………………………... S40 Table S8: Summary of findings table: Tight glycemic control (HbA1c ≤6.5%) versus non-tight glycemic control…………………………………………………………………………………………………………….. S44 Table S9: Summary of findings table: Tight glycemic control (HbA1c ≤6%) versus non-tight glycemic control…………………………………………………………………………………………………………….. S47 Table S10: Summary of findings table: Alternative biomarkers versus measure blood glucose or HbA1c…………………………………………………………………………………………………………….. S50 Table S11: Summary of findings table: Continuous glucose monitoring or self-monitoring of blood glucose versus measure blood glucose or HbA1c…………………………………………................................................. S52 Table S12: Summary of findings table: Low protein diet versus usual protein diet……………….......…............. S54 Table S13: Summary of findings table: Patients with type 1 diabetes - Low salt diet versus normal salt diet…... S58 Table S14: Summary of findings table: Patients with type 2 diabetes - Low salt diet versus normal salt diet…... S62 Table S15: Summary of findings table: Adults with habitual low salt intake – Higher dietary salt intake (through NaCl supplement) versus regular salt intake……………………………………………………………. S65 Table S16: Summary of findings table: Adults with habitual high salt intake – Higher dietary salt intake (through NaCl supplement) versus regular salt intake………………………………………………………......... S67 Table S17: Summary of findings table: Obese patients – Exercise (12-week program of aerobic and resistance training, followed by 40 weeks of home exercise) + diet versus diet alone……………………………………… S69 Table S18: Summary of findings table: Obese patients – Aerobic exercise and medical management versus medical management only………………………………………………………………………………………... S72 Table S19: Summary of findings table: SGLT2 inhibitors versus placebo………………………......................... S74 Table
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