Standards of specialized diabetes care. Edited by Dedov I.I., Shestakova M.V., Mayorov A.Yu. 10th edition

Dear Colleagues!

We are glad to present the 10th Edition (revised) of the Standards of Specialized Diabetes Care. These evidence-based guidelines were designed to standardize and facilitate diabetes care in all regions of the Russian Federation.

The Standards are updated on the regular basis to incorporate new data and relevant recommendations from national and international clinical societies, including World Health Organization Guidelines (WHO, 2011, 2013), International Diabetes Federation (IDF, 2011, 2012, 2013), European Association for the Study of Diabetes (EASD 2018, 2019), American Diabetes Association (ADA, 2018, 2019, 2021), American Association of Clinical Endocrinologists (AACE, 2020, 2021), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2018) and Russian Association of Endocrinologists (RAE, 2019). Current edition of the “Standards” also integrates results of completed randomized clinical trials (ADVANCE, ACCORD, VADT, UKPDS, SAVOR, TECOS, LEADER, EXAMINE, ELIXA, SUSTAIN, DEVOTE, EMPA-REG OUTCOME, CANVAS, DECLARE, CARMELINA, REWIND, CREDENCE, CAROLINA, DAPA-CKD, DAPA-HF, EMPEROR-Reduced trial, VERIFY, VERTIS CV, PIONEER, etc.), as well as findings from the national studies of diabetes mellitus (DM), conducted in close partnership with a number of Russian hospitals.

Latest data indicates that prevalence of DM in the world increased during the last decade more than two-fold, reaching some 537 million patients by the end of 2021. According to the current estimation by the International Diabetes Federation, 643 million patients will be suffering from DM by 2030 and 784 million by 2045.

Like many other countries, Russian Federation experiences a sharp rise in the prevalence of DM. According to Russian Federal Diabetes Register, there are at least 4 871 863 patients with DM in this country on 01.01.2021 (3,34% of population) with 92,3% (4 498 826)–Type 2 DM, 5,6% (271 468)–Type 1 DM and 2,1% (101 569)–other types of DM, including 9 729 women with gestational DM. However, these results underestimates real quantity of patients, because they consider only registered cases. Results of Russian epidemiological study (NATION) confirmed that only 54% of Type 2 DM are diagnosed. So real number of patients with DM in Russia is 10 million patients (about 7% of population). This is a great long-term problem, because a lot of patients are not diagnosed, so they don’t receive any treatment and have high risk of vascular complications.

Severe consequences of the global pandemic of DM include its vascular complications: nephropathy, retinopathy, coronary, cerebral and peripheral vascular disease. These conditions are responsible for the majority of cases of diabetes-related disability and death.

In сurrent edition of the “Standards”:

• New goals of glycemic control for continuous glucose monitoring (time in range, below range and above range, glucose variability) are given.
• It also features updated guidelines on stratification of treatment in newly diagnosed Type 2 diabetes.
• In the recommendations for the personalization of the choice of antidiabetic agents, it is taken into account that in certain clinical situations (the presence of atherosclerotic cardiovascular diseases and their risk factors, chronic heart failure, chronic kidney disease, obesity, the risk of hypoglycemia) certain classes of hypoglycemic agents (or individual drugs) have proven advantages.
• Indications for the use of antidiabetic agents in chronic kidney disease are expanded.
• Information about insulin pump therapy is added.
• Recommendations on vaccination are added.
• An algorithm for replacing some insulin preparations with others is given.

This text represents a consensus by the absolute majority of national experts, achieved through a number of fruitful discussions held at national meetings and forums. These guidelines are intended for endocrinologists, primary care physicians, pediatricians and other medical professionals involved in the treatment of DM.

Compared with previous edition of the Standards of Specialized Diabetes Care edited by Dedov I.I., Shestakova M.V., ­Mayorov A.Yu., 10th edition, Moscow, 2021 (signed for printing on 10.09.2021) a number of changes have been made.

On behalf of the Working Group

1. Галстян Г.Р., Токмакова А.Ю., Егорова Д.Н., и др. Клинические рекомендации по диагностике и лечению синдрома диабетической стопы. // Раны и раневые инфекции. Журнал имени проф. Б.М. Костючёнка.–2015.–Т. 2.–№ 3.–С. 63-83. [Galstyan GR, Tokmakova AY, Egorova DN, et al. Clinical guidelines for diagnosis and treatment of diabetic foot syndrome. Wounds and wound infections. The prof. B.M. Kostyuchenok journal. 2015;2(3):63-83.] doi: 10.17650/2408-9613-2015-2-3-63-83

2. Дедов И.И., Краснопольский В.И., Сухих Г.Т., от имени рабочей группы. Российский национальный консенсус «Гестационный сахарный диабет: диагностика, лечение, послеродовое наблюдение». // Cахарный диабет.–2012.–Т. 15.–№ 4.–С. 4–10. [Dedov I, Krasnopol’skiy V, Sukhikh G. Russian National Consensus Statement on gestational diabetes: diagnostics, treatment and postnatal care. Diabetes mellitus.–2012.–Т.15.–№4.–С.4-10.] doi: 10.14341/2072-0351-5531

3. Дедов И.И., Мельниченко Г.А., Шестакова М.В., и др. Национальные клинические рекомендации по лечению морбидного ожирения у взрослых. 3-ий пересмотр (лечение морбидного ожирения у взрослых). // Ожирение и метаболизм. — 2018. — Т.15. — № 1 — С.53-70. [Dedov II, Mel’nichenko GA, Shestakova MV, et al. Russian national clinical recommendations for morbid obesity treatment in adults. 3rd revision (Morbid obesity treatment in adults). Obesity and metabolism. 2018;15(1):53-70.] doi: 10.14341/OMET2018153-70

4. Дедов И.И., Петеркова В.А., Кураева Т.Л. Российский консенсус по терапии сахарного диабета у детей и подростков. // Cахарный диабет.–2010.–Т.13. – №5.–С. 1-8. [Dedov I, Peterkova V, Kuraeva T. Rossiyskiy andomize po terapii sakharnogo diabeta u detey i podrostkov. Diabetes mellitus. 2010;13(5):1-8.] doi: 10.14341/2072-0351-6048

5. Дедов И.И., Шестакова М.В., Александров А.А., и др. Алгоритмы специализированной медицинской помощи больным сахарным диабетом (5-й выпуск). Под редакцией И.И. Дедова, М.В. Шестаковой. // Cахарный диабет.–2011.–Т.14.–№ 3 (приложение)–С. 2-72. [Dedov II, Shestakova MV, Aleksandrov AA, et al. Algorithms of Specialized Medical Care for Diabetes Mellitus Patients. Edited by Dedov II, Shestakova MV (5th edition). Diabetes mellitus. 2011;14(3s):2-72.] doi: 10.14341/2072-0351-5612

6. Дедов И.И., Шестакова М.В., Александров А.А., и др. Клинические рекомендации «Алгоритмы специализированной медицинской помощи больным сахарным диабетом» (6-й выпуск). Под редакцией И.И. Дедова, М.В. Шестаковой. // Cахарный диабет.–2013.–Т.16.–№1S–C. 1-121. [Dedov II, Shestakova MV, Aleksandrov AA, et al. Standards of specialized diabetes care. Edited by Dedov II, Shestakova MV. (6th edition). Diabetes mellitus. 2013;16(1S):1-121.] doi: 10.14341/DM20131S1-121

7. Дедов И.И., Шестакова М.В., Аметов А.С., и др. Инициация и интенсификация сахароснижающей терапии у больных сахарным диабетом 2 типа: обновление консенсуса совета экспертов Российской ассоциации эндокринологов (2015 г.). // Сахарный диабет.–2015.–Т. 18.–№1.–С.4-22. [Dedov I, Shestakova M, Ametov A, et al. Initiation and intensification of antihyperglycemic therapy in type 2 diabetes mellitus: Update of Russian Association of Endocrinologists expert consensus document (2015). Diabetes mellitus. 2015;18(1):4-22.] doi: 10.14341/DM201515-23

8. Дедов И.И., Шестакова М.В., Аметов А.С., и др. Консенсус совета экспертов Российской ассоциации эндокринологов по инициации и интенсификации сахароснижающей терапии у больных сахарным диабетом 2 типа. // Cахарный диабет.–2011.–Т. 14.–№4.–С.6-17. [Dedov I, Shestakova M, Ametov A, et al. Russian Association of Endocrinologists expert consensus document on initiation and intensification of antyhiperglycaemic therapy in type 2 diabetes mellitus. Diabetes mellitus. 2011;14(4):6-17.] doi: 10.14341/2072-0351-5810

9. Дедов И.И., Шестакова М.В., Викулова О.К., и др. Клинические рекомендации «Алгоритмы специализированной медицинской помощи больным сахарным диабетом» (7-й выпуск). Под редакцией И.И. Дедова, М.В. Шестаковой. // Cахарный диабет.–2015. –№1S–C. 1-112. [Dedov II, Shestakova MV, Vikulova OK, et al. Standards of specialized diabetes care. Edited by Dedov II, Shestakova MV (7th edition). Diabetes mellitus. 2015;18(1S):1-112.] doi: 10.14341/DM20151S1-112

10. Дедов И.И., Шестакова М.В., и др. Оптимизация и интенсификация инсулинотерапии при СД 2 типа (клинические рекомендации). // Cахарный диабет.–2010.–Т.13.–№5.–С.9-16. [Dedov I, Shestakova M, et al. Optimizatsiya i intensifikatsiya insulinoterapii pri sakharnom diabete 2 tipa (klinicheskie rekomendatsii). Diabetes mellitus. 2010;13(5):9-16.] doi: 10.14341/2072-0351-6049

11. Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации «Алгоритмы специализированной медицинской помощи больным сахарным диабетом» (8-й выпуск). Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. // Cахарный диабет.–2017. –№1S–C. 1-112. [Dedov II, Shestakova MV, Mayorov AY, et al. Standards of specialized diabetes care. Edited by Dedov II, Shestakova MV, Mayorov AY (8th edition). Diabetes mellitus. 2017;20(1S):1-112.] doi: 10.14341/DM20171S8

12. Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации «Алгоритмы специализированной медицинской помощи больным сахарным диабетом» (9-й выпуск). Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. // Cахарный диабет.–2019. –№1S–C. 1-112. [Dedov II, Shestakova MV, Mayorov AY, et al. Standards of specialized diabetes care. Edited by Dedov II, Shestakova MV, Mayorov AY (9th edition). Diabetes mellitus. 2019;22(1S):1-144.] doi: 10.14341/DM221S1

13. Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации. Сахарный диабет 1 типа у взрослых. Сахарный диабет. 2020;23(1S):42-114. [Dedov I.I., Shestakova M.V., Mayorov A.Yu., et al. Clinical guidelines. Diabetes mellitus type 1 in adults. Diabetes mellitus. 2020;23(1S):42-114. (In Russ.)] doi: 10.14341/DM12505

14. Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации. Сахарный диабет 2 типа у взрослых. Сахарный диабет. 2020;23(2S):4-102. [Dedov I.I., Shestakova M.V., Mayorov A.Yu., et al. Clinical guidelines. Diabetes mellitus type 2 in adults. Diabetes mellitus. 2020;23(2S):4-102. (In Russ.)] doi: 10.14341/DM12507

15. Майоров А.Ю., Мельникова О.Г., Котешкова О.М., Мисникова И.В., Черникова Н.А. Техника инъекций и инфузии при лечении сахарного диабета. Методическое руководство. ООО «АРТИНФО», Москва, 2018–64 с. [Mayorov AY, Melnikova OG, Koteshkova OM, Misnikoba IV, Chernikova NA. Tekhnika in’ektsiy I infuzii pri lechenii sakharnogo diabeta. Metodicheskoe rukovodstvo. OOO “ARTINFO”, Moscow, 2018 -64 p.].

16. Общероссийская общественная организация «Российская ассоциация геронтологов и гериатров». Клинические рекомендации «Старческая астения». 2020. [Obshcherossiiskaya obshchestvennaya organizatsiya “Rossiiskaya assotsiatsiya gerontologov i geriatrov”. Klinicheskie rekomendatsii “Starcheskaya asteniya”. 2020.]

17. Осложнения сахарного диабета: лечение и профилактика/Под ред. И.И. Дедова, М.В. Шестаковой.–М.: ООО «Издательство «Медицинское информационное агентство», 2017. [Dedov II, Shestakova MV, eds. Complications of diabetes mellitus: treatment and prevention. Moscow: Meditsinskoe informatsionnoe agentstvo; 2017].

18. Петеркова В.А., Безлепкина О.Б., Кураева Т.Л. и др. Клинические рекомендации. Сахарный диабет 2 типа у детей. [Peterkova V.A., Bezlepkina O.B., Kuraeva T.L., et al. Clinical guidelines. Diabetes mellitus type 2 in childhood. (In Russ.)] https://cr.minzdrav.gov.ru/schema/622_4

19. Петеркова В.А., Шестакова М.В., Безлепкина О.Б., и др. Клинические рекомендации. Сахарный диабет 1 типа у детей. Сахарный диабет. 2020;23(1S):4-40. [Peterkova V.A., Shestakova M.V., Bezlepkina O.B., et al. Clinical guidelines. Diabetes mellitus type 1 in childhood. Diabetes mellitus. 2020;23(1S):4-40. (In Russ.)] doi: https://doi.org/10.14341/DM12504

20. Потемкин В.В., Старостина Е.Г. Руководство по неотложной эндокринологии.–М: Медицинское информационное агентство, 2008. 393 с. [Potemkin VV, Starostina EG. Rukovodstvo po neotlozhnoy endokrinologii. Moscow: Meditsinskoe informatsionnoe agentstvo; 2008. 393p.].

21. Cахарный диабет типа 1: реалии и перспективы/Под ред. И.И. Дедова, М.В. Шестаковой.–М.: ООО «Издательство «Медицинское информационное агентство», 2016. [Dedov II, Shestakova MV, eds. Diabetes mellitus Type 1: reality and perspectives. Moscow: Meditsinskoe informatsionnoe agentstvo; 2016].

22. Cахарный диабет типа 2: от теории к практике/Под ред. И.И. Дедова, М.В. Шестаковой.–М.: ООО «Издательство «Медицинское информационное агентство», 2016. [Dedov II, Shestakova MV, eds. Diabetes mellitus Type 2: from theory to practice. Moscow: Meditsinskoe informatsionnoe agentstvo; 2016].

23. Cахарный диабет: многообразие клинических форм/Под ред. И.И. Дедова, М.В. Шестаковой.–М.: ООО «Издательство «Медицинское информационное агентство», 2016. [Dedov II, Shestakova MV, eds. Diabetes mellitus: andomizedy of clinical forms. Moscow: Meditsinskoe informatsionnoe agentstvo; 2016].

24. Сахарный диабет и репродуктивная система/Под ред. И.И. Дедова, М.В. Шестаковой.–М.: ООО «Издательство «Медицинское информационное агентство», 2016. [Dedov II, Shestakova MV, eds. Diabetes mellitus and reproductive system. Moscow: Meditsinskoe informatsionnoe agentstvo; 2016].

25. Шестакова М.В., Дедов И.И. Сахарный диабет и хроническая болезнь почек.–М.: Медицинское информационное агентство, 2009. 500 с. [Shestakova MV, Dedov II. Diabetes mellitus and chronic kidney disease. Moscow: Meditsinskoe informatsionnoe agentstvo; 2009. 500 p.].

26. Aboyans V, Ricco JB, Bartelink MEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Eur Heart J. 2018;39(9):763-816. Doi: 10.1093/eurheartj/ehx095

27. American Diabetes Association. Standards of medical care in diabetes–2021. Diabetes Care. 2021;44(Suppl 1):S1-232.

28. de Boer IH, Caramori ML, Chan JCN, et al. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int 2020; 98: S1–S115.

29. Busetto L et al. Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management. Obes Facts. 2017;10:597–632.

30. Buse JB, Wexler DJ, Tsapas A, et al. 2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2020;43: 487-493. Doi: 10.2337/dci19-0066

31. Classification of diabetes mellitus. World Health Organization. 2019.

32. Collet J-P, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42(14):1289–1367. Doi: 10.1093/eurheartj/ehaa575

33. Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255-323. Doi:10.1093/eurheartj/ehz486

34. Cummings DE, Rubino F. Metabolic surgery for the treatment of type 2 diabetes in obese individuals. Diabetologia. 2018;61:257–264.

35. Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40(12):1631–1640.

36. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41:2669–2701. Doi:10.2337/dci18-0033

37. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia. Report of WHO/IDF Consultation. 2006.

38. Definition, Diagnosis, and Classification of Diabetes Mellitus and Its Complications: Report of a WHO consultation. Part 1: Diagnosis and Classification of Diabetes Mellitus (WHO/NCD/NCS/99.2). Geneva: World Health Organization; 1999.

39. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy. WHO Guideline. 2013.

40. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm–2020 Executive Summary. Endocr Pract. 2020;26(1):107-139. Doi: 10.4158/CS-2019-0472

41. Gough SC. A review of human and analogue insulin trials. Diabetes research and clinical practice. 2007;77(1):1-15. Doi: 10.1016/j.diabres.2006.10.015

42. Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus. Endocr Pract. 2021;27(6):505-537. Doi: 10.1016/j.eprac.2021.04.008

43. Holt RIG, DeVries JH, Hess-Fischl A, et al. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2021; 44(11):2589-2625. Doi.org/10.2337/dci21-0043

44. International Diabetes Federation. IDF Diabetes Atlas, 10th edn. Brussels, Belgium: International Diabetes Federation, 2021.

45. International Diabetes Federation. Global Guideline for Type 2 diabetes. 2012.

46. International Diabetes Federation. Guideline for management of postmeal glucose. 2011.

47. International Diabetes Federation. Managing older people with Type 2 Diabetes. Global Guideline. 2013.

48. ISPAD Clinical Practice Consensus Guidelines 2018. Pediatric Diabetes. 2018;19:1-338.

49. Kaul S. Mitigating Cardiovascular Risk in Type 2 Diabetes With Antidiabetes Drugs: A Review of Principal Cardiovascular Outcome Results of EMPA-REG OUTCOME, LEADER, and SUSTAIN-6 Trials. Diabetes Care. 2017;40(7):821-831. Doi: 10.2337/dc17-0291

50. Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017;377(9):839-848. Doi: 10.1056/NEJMoa1616011

51. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844.

52. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311-322. Doi: 10.1056/NEJMoa1603827

53. Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabøl R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)–DEVOTE-1. Am Heart J. 2016;179:175-83. Doi: 10.1016/j.ahj.2016.06.004

54. Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®). Diab Vasc Dis Res. 2015;12(3):164-74.

55. Matthews DR, Paldánius PM, Proot P, Chiang Y, Stumvoll M, Del Prato S; VERIFY study group. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicenter, randomized, double-blind trial. Lancet. 2019;394(10208):1519-1529. Doi: 10.1016/S0140-6736(19)32131-2

56. McDonagh T, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-3726. Doi:10.1093/eurheartj/ehab368

57. Mills JL Sr, Conte MS, Armstrong DG, et al. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014;59(1):220-34.e1-2. Doi: 10.1016/j.jvs.2013.08.003

58. Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR. CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017;377(7):644-657. Doi: 10.1056/NEJMoa1611925

59. Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015;373(23):2247-2257. Doi: 10.1056/NEJMoa1509225

60. Rubino F, Nathan DM, Eckel RH et al. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by international diabetes organizations. Diabetes Care 2016;39:861–877.

61. Schaper NC, Van Netten JJ, Apelqvist J, et al. Prevention and management of foot problems in diabetes: a Summary Guidance for Daily Practice 2015, based on the IWGDF Guidance Documents. Diabetes Metab Res Rev. 2016;(Suppl 1):7-15. Doi: 10.1002/dmrr.2695

62. Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009;32(1):187-192. Doi: 10.2337/dc08-9026

63. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus. Abbreviated Report of a WHO Consultation (WHO/NMH/CHP/CPM/11.1). World Health Organization; 2011.

64. Visseren FLJ, Mach F, Smulders YM, et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021;42(34):3227-3337. Doi:10.1093/eurheartj/ehab484

65. Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. Doi: 10.1161/CIRCULATIONAHA.117.028268

66. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021–3104. Doi: 10.1093/eurheartj/ehy339

67. Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380(4):347-357. Doi: 10.1056/NEJMoa1812389

68. World Union of Wound Healing Societies (WUWHS), Florence Congress, Position Document. Local management of diabetic foot ulcers. Wounds International, 2016.

69. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-2128. Doi: 10.1056/NEJMoa1504720