Dear Colleagues! We are glad to present the 9th Edition (revised) of Standards of 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), American Diabetes Association (ADA, 2018, 2019), American Association of Clinical Endocrinologists (AACE, 2019), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2014, 2018) and Russian Association of Endocrinologists (RAE, 2011, 2012, 2015). 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, 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 463 million patients by the end of 2019. According to the current estimation by the International Diabetes Federation, 578 million patients will be suffering from diabetes mellitus by by 2030 and 700 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 4 584 575 patients with DM in this country by the end of 2018 (3,1% of population) with 92% (4 238 503) Type 2 DM, 6% (256 202) Type 1 DM and 2% (89 870) other types of DM, including 8 006 women with gestational DM. However, these results underestimates real quantity of patients, because they consider only registered cases. Results of Russian epidemiological study (NATION) con- firmed that only 54% of Type 2 DM are diagnosed. So real number of patients with DM in Russia is 9 million patients (about 6% of population). This is a great long-term problem, because a lot of patients are not diagnosed, so they dont receive any treatment ant have high risk of vascular complications. Severe consequences of the global pandemics of DM include its vascular complications: nephropathy, retinopathy, coronary, cerebral, coronary 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 the elderly, based on the presence of functional dependence, as well as for pregnant women, children and adolescents, are given. Added a snippet that describes the continuous glucose monitoring. Only low-density lipoprotein cholesterol level is used as a target for lipid metabolism. Proposes more stringent target levels of blood pressure. It also features updated guidelines on stratification of treatment in newly diagnosed Type 2 diabetes: the excess of the initial level of HbA1c over the target level was used as a criterion. 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. Recommendations for psychosocial support are added. The position of metabolic surgery as a method of treatment of DM with morbid obesity is updated. Recommendations for diagnostic and treatment of hypogonadism syndrome in men with DM are added. For the first time, evidence levels of confidence and credibility levels of recommendations for diagnostic, therapeutic, rehabilitative and preventive interventions based on a systematic review of the literature are given in accordance with the recommendations of the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. This text represents a consensus by the absolute majority of national experts, achieved through a number of fruitful discus- sions held at national meetings and forums. These guidelines are intended for endocrinologists, primary care physicians and other medical professionals involved in the treatment of DM. On behalf of the Working Group

Dear Colleagues! We are glad to present the 9th Edition (revised) of Standards of 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), American Diabetes Association (ADA, 2018, 2019), American Association of Clinical Endocrinologists (AACE, 2019), International Society for Pediatric and Adolescent Diabetes (ISPAD, 2014, 2018) and Russian Association of Endocrinologists (RAE, 2011, 2012, 2015). 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, 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 463 million patients by the end of 2019. According to the current estimation by the International Diabetes Federation, 578 million patients will be suffering from diabetes mellitus by by 2030 and 700 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 4 584 575 patients with DM in this country by the end of 2018 (3,1% of population) with 92% (4 238 503) Type 2 DM, 6% (256 202) Type 1 DM and 2% (89 870) other types of DM, including 8 006 women with gestational DM. However, these results underestimates real quantity of patients, because they consider only registered cases. Results of Russian epidemiological study (NATION) con- firmed that only 54% of Type 2 DM are diagnosed. So real number of patients with DM in Russia is 9 million patients (about 6% of population). This is a great long-term problem, because a lot of patients are not diagnosed, so they dont receive any treatment ant have high risk of vascular complications. Severe consequences of the global pandemics of DM include its vascular complications: nephropathy, retinopathy, coronary, cerebral, coronary 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 the elderly, based on the presence of functional dependence, as well as for pregnant women, children and adolescents, are given. Added a snippet that describes the continuous glucose monitoring. Only low-density lipoprotein cholesterol level is used as a target for lipid metabolism. Proposes more stringent target levels of blood pressure. It also features updated guidelines on stratification of treatment in newly diagnosed Type 2 diabetes: the excess of the initial level of HbA1c over the target level was used as a criterion. 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. Recommendations for psychosocial support are added. The position of metabolic surgery as a method of treatment of DM with morbid obesity is updated. Recommendations for diagnostic and treatment of hypogonadism syndrome in men with DM are added. For the first time, evidence levels of confidence and credibility levels of recommendations for diagnostic, therapeutic, rehabilitative and preventive interventions based on a systematic review of the literature are given in accordance with the recommendations of the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. This text represents a consensus by the absolute majority of national experts, achieved through a number of fruitful discus- sions held at national meetings and forums. These guidelines are intended for endocrinologists, primary care physicians and other medical professionals involved in the treatment of DM. On behalf of the Working Group

ФГБУ Национальный медицинский исследовательский центр эндокринологии Минздрава России, Москва ОБОСНОВАНИЕ. Изучение эпидемиологических характеристик синдрома диабетической стопы (СДС) представляет особую актуальность в связи с высоким риском ампутаций нижних конечностей у больных сахарным диабетом (СД).ЦЕЛЬ. Оценить эпидемиологические характеристики развития СДС и ампутаций нижних конечностей у взрослых па-циентов с СД 1 и 2 типа (СД1 и СД2) в РФ за период 2013-2016 гг.МЕТОДЫ. Объектом исследования является база данных Федерального регистра СД -81 региона РФ, включенных в систему онлайн-регистра. Оценивались показатели на 10 тыс. взрослых пациентов с СД (>18 лет).РЕЗУЛЬТАТЫ. В 2016 г. распространенность СДС в РФ составила: СД1 -4,7%, СД2 -1,9%, с выраженными межре-гиональными различиями -0,15-19,9%, 0,07-10,3% соответственно. Распространенность СДС в РФ в динамике 2013→2016 гг. имеет тенденцию к снижению: СД1 -506,3→473,6; СД2 -214,60→194,8/10 тыс. взрослых. Динамика но-вых случаев СДС/год стабильна при СД1 -20,8→20,4, отмечается рост при СД2 -13,2→14,2. Средний возраст разви-тия СДС увеличился на 2 года при обоих типах СД. Средняя длительность СД до манифестации СДС увеличилась: при СД1 -15,4→19,0 лет, СД2 -7,4→10,1 года. Соотношение различных форм СДС при СД1: нейропатическая с трофиче-ской язвой -41,6%, нейропатическая (стопа Шарко) -17,9%, нейроишемическая -28,3%, ишемическая -12,2%; СД2: 41,6%, 7,4%, 32,4%, 18,5% соответственно. Количество новых случаев ампутаций/год в динамике: СД1 -10,5→12,4, СД2 -9,6→10,9, с выраженной межрегиональной вариабельностью 0,13-2,9% при СД1, 0,04-6,0% при СД2. Средняя длительность СД до ампутации увеличилась: СД1 -18,4→21,3 года, СД2 -9,1→9,9 года. Средний возраст развития ам-путаций: СД1 -51,7 года, СД2 -66,2 года. Отмечается уменьшение доли высоких ампутаций: СД1 -43,6→37,0%, СД2 -52,2→45,5% за счет перераспределения в пользу ампутаций в пределах одного пальца стопы: при СД1 -4,0→10,0%, при СД2 -2,8→ 9,1%. ЗАКЛЮЧЕНИЕ.Динамика частоты новых случаев СДС у взрослых пациентов в РФ стабильна при СД1, при СД2 имеет тенденцию к повышению. Выраженные межрегиональные различия в частоте СДС и ампутаций между регионами могут быть обусловлены различиями в качестве оказания специализированной помощи, отсутствием или нехваткой кабинетов диабетической стопы, лечением пациентов с СДС в условиях общей хирургической практики в ряде реги-онов, что признано менее эффективной стратегией. Отмечается отчетливая положительная динамика уменьшения доли высоких ампутаций, развития СДС в более старшем возрасте и при большей длительности СД, что отражает повышение эффективности мер профилактики поражения нижних конечностей при СД. BACKGROUND:The epidemiological study of diabetic foot (DF) is very important because of high risk lower limbs amputations in patients with diabetes mellitus (DM).

ОБЗОРЫДиабетическая полинейропатия (ДПН) являет-ся одним из наиболее распространенных поздних осложнений сахарного диабета (СД), а также глав-ной причиной язвенных дефектов стоп [1]. В связи с неуклонным ростом заболеваемости СД 2-го типа проблема приобретает все большие масштабы [2]. По современным представлениям, распространен-ность нейропатии на стадии явных клинических симптомов может достигать 21,9% [3], тогда как не-врологический дефицит уже имеют около 50% па-циентов с СД [4]. Недавно показано, что распро-страненность нейропатии среди лиц с СД составля-ет около 28%, однако начальные признаки повреж-дения периферической нервной системы обнаружи-вались уже у 13% пациентов с нарушением толе-рантности к глюкозе (НТГ) [5]. Различия в частоте встречаемости ДПН обусловлены отсутствием на-дежных методов диагностики, а также использова-нием различных критериев оценки степени тяжести нейропатии. Вероятно, повреждение нервных воло-кон может предшествовать развитию других ослож-нений СД и в ряде случаев быть первым клиниче-ским признаком нарушения углеводного обмена. There are presently no reliable methods for diagnostics of the early manifestations of the lesions in the peripheral nervous system. Only puncture biopsy of the skin and the nerves can be used at the preclinical stage. However, the application of these invasive methods is fraught with the risk of infectious complications. Confocal retinal microscopy is the new non-invasive morphometric technique that permits to reveal the early signs of the lesions in the peripheral nervous system and to study dynamics of the associated changes that can be used as a valid surrogate end point for the evaluation of the effectiveness of pharmacotherapy.

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