Backgraund: The total number of patients with type 2 diabetes mellitus (T2DM) in the Russian Federation as of 01.01.2019 is 4.24 million. The majority of patients with T2DM are elderly people and older, forming groups with high comorbidity and the risk of severe hypoglycemia, including those associated with excess hypoglycemic therapy. Foreign studies indicate that a significant proportion of older adults with diabetes are potentially exposed to excessive sugar-lowering therapy.

Aims: to study the frequency of excessive decrease in HbA1c in a group of patients with T2DM according to a sample from the regional diabetes register.

Materials and methods: A content analysis of the regional register of diabetes mellitus was carried out as of ­December 31, 2019. Based on the register data, an individual target level of HbA_1c was calculated and the compliance of the achieved HbA1c level with the target level was assessed.

Results: The analysis included data from 1202 patients with T2DM, which amounted to 2.35% of the total number of patients with T2DM in the region (n = 51,163). The age of the included individuals was 66 years (LQ 60.0; UQ 72), 360 men (29.95%). The duration of T2DM 8.0 years. The HbA_1c level in the general group was 7.1%. Persons over 60 years of age accounted for 75.21% (n = 904). When analyzing HbA1c in the age groups, there were no statistically significant differences (p> 0.05). HbA1c was above the target level in 43.34% of cases (n = 521). The level of HbA_1c <6.5% was noted in a quarter of cases (24.62%), including HbA_1c <6.0% was recorded in 97 cases, which accounted for a third of all cases of tight glycemic control. At the same time, the majority of observations of HbA_1c <6.5% were in patients 60 years and older (79.73%). Among young and middle-aged patients with HbA_1c <6.5%, 8.33% of cases had risk factors for severe hypoglycemia in the presence of SU and / or insulin therapy. In the older age group (in comparison with young and middle-aged patients), HbA_1c <7% (p <0.05) was significantly more often detected, there was a tendency for a higher frequency of HbA_1c <6.5% (p = 0.067). Among elderly and senile patients with HbA_1c <6.5%, in 41.53% of cases there were risk factors for severe hypoglycemia, in a quarter of cases in T2DM therapy SU and / or insulin were used (24.58%), almost every fifth patient (19.07%), risk factors for severe hypoglycemia, received SU and / or insulin.

Conclusion: According to our data, at least a quarter of patients in the older age group (24.58%) had overtreatment and need de-intensification of therapy. Perhaps that in this group of patients, the risks associated with treatment may outweigh the benefits of tight glycemic control, and these patients require planned de-intensification of glucose-lowering therapy. Taking into account the position of some expert communities on determining the target range of HbA_1c in the older age group, the need for de-intensification of antihyperglycaemic therapy may be even higher. Further research is required in order to develop a full-fledged domestic concept of de-intensification of hypoglycemic therapy.

Background: Myocardial infarction (MI) is one of the leading causes of mortality in patients with type 2 diabetes mellitus (DM), therefore it is essential to give preference to a glucose-lowering drug having optimal cardioprotective properties. A comparative study of the various sodium-glucose co-transporter inhibitors representatives’ protective effects in experimental MI was not carried out within the framework of one study.

Aim: To evaluate the influence of empagliflozin (EMPA) and canagliflozin (CANA), in comparison with sitagliptin (SITA), on hemodynamic parameters and myocardial damage area in rats with diabetes type 2 model in experimental MI.

Materials and methods: Type 2 DM was modelled in Wistar rats by means of 4-week high-fat diet followed by nicotinamide 230 mg/kg and streptozotocin 60 mg/kg administration. 4 weeks after DM induction the following groups were made: «DM+SITA» — treatment with SITA 50 mg/kg, «DM+EMPA» — treatment with EMPA 2 mg/kg, «DM+CANA» — treatment with CANA 25 mg/kg per os once daily for 8 weeks. Animals in «DM» group remained untreated for the following 8 weeks. Rats in control group were fed with standard chow. 16 weeks after the experiment beginning transient global myocardial ischemia was modelled in all rats. Hemodynamic parameters and myocardium necrosis area were evaluated.

Results: The necrosis area was larger in «DM» group, than in control one (p=0.018). Infarction size in «DM+SITA» did not differ from that in «DM» group (62.92(41.29;75.84) and 57.26(45.51;70.08)%, р=0.554). Necrosis area in «DM+EMPA» and «DM+CANA» groups was smaller than in «DM» group (37.90(20.76;54.66)%, 46.15(29.77;50.55) vs 57.26(45.51;70.08)%, р=0.008 and р=0.009, respectively). Necrosis size did not differ between «DM+EMPA» and «DM+CANA» groups (p=0.630). Ischemic contracture in «DM+CANA» group was less prominent than under the use of all other glucose-lowering drugs. We observed increase of coronary blood flow in «DM+EMPA» group, in comparison with «DM», «DM+CANA» and «DM+SITA» groups.

Conclusions: SITA does not have cardioprotective effect in ischemia-reperfusion injury in diabetic rats. EMPA and CANA have similarly prominent infarct-limiting properties. EMPA is able to increase coronary blood flow, whereas cardioprotective action of CANA is associated with ischemic contracture diminishing.

Background: In recent years, pump-based insulin therapy, also known as continuous subcutaneous insulin infusion (CSII), has become a common treatment for children with type 1 diabetes mellitus (T1DM). Despite the fact that, in general, children with type 1 diabetes achieve the best glycemic control indices during pump therapy, while there is a significant heterogeneity of metabolic outcomes among individual patients, many children with CSII do not reach the target level of HbA1c.

Objective: To assess the level of glycemic control and factors associated by withdrawal of use, the response to treatment with prolonged use of CSII in children with type 1 diabetes.

Materials and methods: The study included 458 children aged 1 to 18 years, treated to pump therapy at least 3 years before the study, the presence of the analyzed data in the register.

Results: The level of HbA_1c decreased by -0.7% compared with the primary endpoint, which was accompanied by an increase in the number of patients who reached the target level of HbA_1c (<7.5%) from 17% to 36%. The best response was observed for patients under 6 years of age with HbA_1c over 9% for pump insulin therapy, as well as in patients who regularly use additional bolus and basal functions and CGM. The main reason for stopping the use of the insulin pump is the inconvenience of using and wearing — 47.7%. Risk factors for pump abandonment: later age of start treatment on CSII and frequent episodes of severe hypoglycemia.

Conclusion: According to the results of the study, it was shown that pump therapy is an effective method of insulin therapy, which allows to achieve a lower level of HbA_1c compared to the initial values.

Most young patients with hyperglycemia have type 1 diabetes and type 2 diabetes but up to 10% of all cases of the disease occur in MODY (Maturity Onset Diabetes of the Young). Published abstracts show features of the debut, laboratory and genetic characteristics of MODY in the Russian population. However there is a small amount of data on the clinical course of this nosology in the Russian Federation.

Aim: To investigate the characteristics of the 3-year course of GCK-MODY diagnosed after 18 years.

Materials and methods: 85 probands and 46 relatives of the first and second degrees of kinship with a clinical diagnosis of GCK-MODY were examined: biochemical and hormonal blood tests, ultrasound, molecular genetic studies. Patients were invited for a follow-up visit 3 years after verification of the pathogenic mutations associated with GCK-MODY. Examination, biochemical and hormonalanalyzes , ultrasound were done in second visit.

Results: The diagnosis GCK-MODY was verified by a molecular genetic study in 25 probands (29.4%). In 33 of 46 (71.7%) relatives of patients with GCK-MODY were diagnosed identical mutations. In 31 patients with GCK-MODY diagnosed after 18 years, a dynamic observation was performed for three years. Most patients over 18 years of age did not have clinical manifestations of carbohydrate metabolism disorders when diagnosing GCK-MODY and follow up visit. Skin rashes and allergic reactions prevailed among concomitant pathologies. Patients with GCK-MODY had preserved β-cell secretion, HbA1c targets were achieved. Low fasting hyperglycemia prevailed which persisted even after treatment correction. Among the characteristics of carbohydrate metabolism, biochemical, lipid and hormonal parameters during GCK-MODY verification and after three years of observation no significant differences were obtained, which indicates a stable course of the disease. Half of the patients achieved normoglycemia by rational nutrition, two people with GCK-MODY within three years after determining the diagnosis were transferred from insulin therapy to oral glucose-lowering drugs. Among oral glucose-lowering drugs prior to GCK-MODY verification most patients used metformin, 3 years later — dipeptidyl peptidase-4 inhibitors.

Conclusion. The results of a three-year follow-up of a group of patients with GCK-MODY demonstrate a non-progressive course of this type of diabetes with stable indicators of carbohydrate metabolism and low fasting hyperglycemia that persists after 3 years of observation. With the verification of GCK-MODY and the achievement of the target values of glycated hemoglobin and postprandial glycaemia by rational nutrition, even if a low level of fasting hyperglycemia is determined, the prescription of oral glucose-lowering drugs is not indicated in most cases.

STELLA-LONG TERM, a 3-year post-marketing surveillance study, evaluated the safety and effectiveness of the sodiumglucose cotransporter 2 inhibitor ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients. Final results in the safety (n = 6697) and effectiveness populations (n = 5625) were analyzed by stratifying patients by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) into four subgroups (≥90, 60 to <90, 45 to <60, and <45) and two subgroups (≥60 and <60). Adverse drug reaction (ADR) incidence, and changes from baseline in glycosylated hemoglobin (HbA_1c), bodyweight, and eGFR were assessed. The percentage of patients experiencing ADRs and serious ADRs was similar across most eGFR subgroups. Polyuria/pollakiuria was the most common ADR. Renal disorders and volume depletion ADRs were more frequent in the subgroups with more severe renal impairment at baseline than in those with an eGFR of 60 to <90 or ≥90 mL/min/1.73 m². Bodyweight and HbA1c decreased in all subgroups, the latter by − 0.91% to − 0.40% (P <0.05 vs. baseline). eGFR increased in the 45 to <60 mL/min/1.73 m² subgroup (+ 1.42 ± 8.77 mL/min/1.73 m²; P = 0.006). It decreased in the ≥90 and 60 to <90 mL/min/1.73 m² subgroups (− 8.27 ± 13.73 and − 1.22 ± 10.34 mL/min/1.73 m²; P <0.001), but not to <60 mL/min/1.73 m². In conclusion, there were no new or unexpected safety findings in Japanese patients treated with ipragliflozin for T2DM, and long-term sustained improvements in HbA_1c and bodyweight were observed regardless of the presence of renal impairment.

This review presents the applications of artificial intelligence for the study of the mechanisms of diabetes development and generation of new technologies of its prevention, monitoring and treatment. In recent years, a huge amount of molecular data has been accumulated, revealing the pathogenic mechanisms of diabetes and its complications. Data mining and text mining open up new possibilities for processing this information. Analysis of gene networks makes it possible to identify molecular interactions that are important for the development of diabetes and its complications, as well as to identify new targeted molecules. Based on the big data analysis and machine learning, new platforms have been created for prediction and screening of diabetes, diabetic retinopathy, chronic kidney disease, and cardiovascular disease. Machine learning algorithms are applied for personalized prediction of glucose trends, in the closed-loop insulin delivery systems and decision support systems for lifestyle modification and diabetes treatment. The use of artificial intelligence for the analysis of large databases, registers, and real-world evidence studies seems to be promising. The introduction of artificial intelligence systems is in line with global trends in modern medicine, including the transition to digital and distant technologies, personification of treatment, high-precision forecasting and patient-centered care. There is an urgent need for further research in this field, with an assessment of the clinical effectiveness and economic feasibility.

Background: Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disease characterized by insulin deficiency due β-cell destruction and following hyperglycaemia. Specific markers of T1DM are pancreatic islet-targeting autoantibodies that are found months to years before symptom onset, and can be used to identify individuals who are at risk of developing T1DM.

Aim: The study is aimed at the review of current knowledge of diabetes-related autoantibodies as biomarkers of T1DM.

Materials and methods: Foreign and national clinical studies on this topic were included. PubMed, Medline and ­eLibrary were searched.

Results: Modern ideas about known diabetes-specific autoantibodies as markers of autoimmune inflammation of β-cells of the pancreas were discussed. The analysis of their independent diagnostic value in predicting the occurrence of T1DM were carried out.

Conclusion: There is no unified concept in the literature on this issue. Current data on autoantibodies in T1DM show a ­significant individual variability in the timing, dynamic changes and autoantibody composition in T1DM progression.

Insulin therapy for diabetes mellitus is the most effective way to control glycemia with the progression of the disease and the ineffectiveness of other sugar-lowering drugs. At the same time, the existing limitations of traditional insulin preparations, along with increasing attention to the individualized treatment of this disease, are pushing developers to create drugs that most closely reproduce the effect of natural human insulin. In this regard, the appearance of a combination of insulin analogs, the action profile of which practically imitates insulin secretion by a healthy pancreas, presents new possibilities in the treatment of diabetes mellitus. Insulin degludec / insulin aspart (IDegAsp, Ryzodeg®, Novo Nordisk, Denmark) is the first and only soluble combination preparation containing 70% of the ultra-long-acting insulin analogue degludec and 30% of the ultra-short-acting insulin analogue aspart in one injection, which meets the need for both basal and prandial insulin. The combined drug has nothing in common with traditional mixed insulin preparations (both human and analog) and provides doctors and patients with significant advantages over the latter. The article presents the position of Russian experts-diabetologists with extensive experience in the use of IDegAsp regarding the role and place of the drug in real clinical practice. Data from real clinical practice confirm that IDegAsp is a reasonable choice for starting and intensifying insulin therapy for type 2 diabetes mellitus when basal and prandial glycemic control is required. The use of the drug is most appropriate in patients who are on basal, biphasic, basal-plus/basal-bolus regimens and who do not achieve the goals of glycemic control during prior therapy. One of the leading reasons for choosing IDegAsp may also be a lower risk of developing hypoglycemia compared to insulin analogues of previous generations — biphasic insulin aspart and basal insulin glargine 100 U/ml. In addition, IDegAsp is a simple, flexible and safe insulin therapy for patients on premix therapy and basal-plus/basis-bolus regimens who require basal and prandial glycemic control. IDegAsp is a simple, flexible and safe insulin therapy. The greatest benefit of this drug use can be obtained by patients for whom adherence to a complex therapy regimen is difficult (the elderly, with cognitive impairment, after a stroke, with dementia), as well as patients who have an active lifestyle, accompanied by irregular food intake. It is important to note that since January 1, 2021, there is no need for a decision by a special medical commission to prescribe (IDegAsp) Ryzodeg®. This fact, as well as a significant price reduction at the end of 2020, opens up broader prospects for using the drug in the routine practice of a Russian endocrinologist.

The Scientific Advisory Board chaired by Academician of the Russian Academy of Sciences, Peterkova V.A. was held 26 of November in Moscow to discuss the possibilities of continuous glucose monitoring technology (CGM) implementation into routine clinical practice in Russia in order to improve glycemic control in patients with diabetes mellitus (DM).

The main aims for Advisory board were to determine the most significant indicators and parameters for CGM to be implemented in practice from a practical point of view of LMWH, necessary for implementation in clinical practice, for different patients groups with diabetes.

The following questions and topics were raised within the discussion: the importance of additional indicators beyond glycated hemoglobin (HbA1c) for glycemic control assessment in diabetes patients, CGM positioning in International and Russian clinical guidelines, the accuracy of CGM devises and approaches to its assessment, the role of education programs for diabetic patients, including trainings in correct use and data interpretation and analysis of CGM data obtained, clinical evidence analysis for CGM in randomized trials and real world evidence.

Hyperglycemia in T2DM is based on three main mechanisms: insulin resistance, progressive β-cell dysfunction, and excess glucose production by the liver.

The onset of T2DM is usually preceded by a long period of insulin resistance. Prescribing sugar drugs that affect different links of pathogenesis, reducing a steady decrease in glycemia. To date, in clinical practice, various combinations of hypoglycemic drugs are used, the choice of which is determined by the characteristics of the course of diabetes in the patient, the presence of concomitant diseases and complications of diabetes, as well as the dominant clinical problem. This resolution provides an expert council opinion on the feasibility of using a combination of alogliptin and pioglitazone in patients with type 2 diabetes.