BACKGROUND: The enormous social lesion caused by high prevalence of diabetes mellitus (DM) determines the state importance of clinical and epidemiological monitoring organization.

AIMS: To analyze epidemiological characteristics (prevalence, mortality, morbidity), the level of HbA1c, evaluate the therapy in Russian Federation in 2013–2017.

METHODS: We have used the database of the Russian Federal Diabetes register – 81 regions included in the online register system.

RESULTS: The total number of patients with DM was 4,498m. (3.06% RF population), including: Type 1 (T1) 5,7% (0,26 m), T2 92,1% (4,15m), other DM types 1,9% (83,8 ths). Distribution male/female: T1 53.5%/46.5%, T2 29%/71%, other DM types 24%/76%. The proportion of men decreases with aging. Number of patients >65 years was 2.293.520, including T1 21.97ths (3.6%), T2 2m271.5ths (54.7%). The prevalence 2013→2017 per 100,000 population was as follows: T1 159,8→169,6; T2 2455.3→2775.6; other DM types 51,2→65,8. Morbidity: T1 9,8→7,0; T2 226,7→185,2; other DM types 7,8→12,4. The structure of causes of death 2013→2017: T1: diabetic coma 2,0→1,5%, myocardial infarction 4,0→4,4%, cerebral circulation disorders 8,2→7,6%, cardiovascular insufficiency 18,5→16,4%, chronic renal failure 6,1→ 6,0%; T2 0,2→0,2%, 4,5→4,5%, 12,7→12,2%, 29,0→28,6%, 1,2→1,8%, respectively. Mortality: T1 2.3; T2 68.4, other DM types 0,8. Life expectancy (average age of death of patients): T1 male 50.3→50.2, female 60.2→ 57.2; T2 69.8→70.3, 75.1→75.9 respectively. The number of patients with target HbA1c level <7%: T1 22.3→34.0%, T2 38.0→52.4%; HbA1c≥9.0%: T1 29.2→21.1%, T2 12.6→8.8%. The most commonly prescribed classes of glucose lowering medications (GLM) in 2017: in monotherapy Metformin (57.3%), Sulfonilurea (SU) (41,1%); in combination of 2 GLM: Metformin+SU 92,58% Metformin+iDPP-4 5.63%; 3 or more GLM: Metformin+SU+iDPP-4 83,9%, Metformin+SU+iSGLT-2 8.98%. The proportion of patients on aGPP-1 therapy is 0.01%.

CONCLUSIONS: We observed the growth of prevalence of DM in Russian Federation and decrease in registered morbidity rate; an increase in life expectancy in T2; decrease in mortality due to diabetic coms and stable mortality rate from cardiovascular events (heart attack, stroke, cv deficiency), gangrene, chronic renal failure in both types of DM; a steady improvement in glycemic control. In the structure of T2 therapy the oral GLMs are dominated, especially Metformin and SU. In the dynamics the prescription of Metformin, insulin, iDPP-4, iSGLT-2 has increased, the proportion of SU has decreased.

BACKGROUND: Chronic kidney disease (CKD) is one of the most severe complications of diabetes mellitus (DM), this determines the importance of the study of epidemiological characteristics of the disease.

AIMS: To assess the epidemiological characteristics of CKD in adult DM patients with type 1 (T1), 2 (T2) in Russian Federation in 2013–16.

METHODS: We have used the database of the Russian Federal Diabetes register, 81st regions included in online register. Indicators were estimated per 10,000 adult DM patients (>18years).

RESULTS: In 2016, the CKD frequency registration was T1 23%, T2 6.9% with marked interregional differences 1.5-49.9%, 0.6–23.5%, respectively. The CKD prevalence in dynamics 2013→2016 was 2171.4→2303.0 in T1 and 512. →687.2 in T2. The incidence of new CKD cases increased 2 times in T1 (215.5 vs 104.2), and 3.7 times in T2 (190.4 vs 51.8). The analysis of distribution by CKD stages by KDIGO indicates the increase in the proportion of patients with low and moderate cardiovascular risk and end stage renal disease (ESRD) (with the initial stages of CKD, C1/2 A1) - 12.0→46.8% in T1; 10.0→50.4% in T2. The proportion of patients with a very high risk (stages C4/5 C3aA3 and C3bA2-3) progressively decreases: 13.4→6.7% in T1, 11.3→4.4% in T2. We observed relation between the CKD prevalence and DM duration. CKD develops in 5.1% patients if T1<5 years and in 48.0% if T1>30years; in T2 3.5% and 20.3%, respectively. The average age of CKD onset in T1 increased for 4,3yr (36,1→40,2), in T2 for 2,4yr (64,4→66,8), DM duration until CKD development increased in T1 11.8→14.2yr, in T2 7.6→8.2yr.

CONCLUSIONS: There is a significant improvement in the quality of CKD diagnostics at the earlier stages, older age and a longer DM duration before CKD onset in both types while we observed the increasing trends in CKD prevalence in Russian Federation in the dynamics of 2013-2016. Advances in the management of patients with DM in recent years do not reduce the risk of CKD, but give us a delay in its development. The marked interregional differences frequency of registration of CKD might indicate some remaining problems in verification in a number of regions where the standard for mandatory assessment of albuminuria and glomerular filtration rate not implemented.

BACKGROUND: The epidemiological study of diabetic foot (DF) is very important because of high risk lower limbs amputations in patients with diabetes mellitus (DM).

AIMS: The aim of the study was to evaluate the DF prevalence in adult patients with type 1 (T1) and 2 (T2) diabetes in Russian Federation for period 2013–16years.

METHODS: We have used the database of the Russian Federal Diabetes register, 81st regions included in the online register. Indicators were estimated per 10,000 adult DM patients (>18years).

RESULTS: In 2016, the prevalence of DF in RF was T1 4,7%, T2 1,9%, with marked interregional differences: 0,15–19,9%, 0,07–10,3%, respectively. The DF prevalence in RF decreased: T1 506,3→473,6, T2 214,60→194,8. The incidence of new DF cases/per year was stable in adults with T1: 20,8→20,4/; increased in T2 13.2→14.2. The mean age of DF diagnosis increased by 2years for both DM types. The average DM duration of DF determine increased T1 15.4→19.0years, T2 7.4→10.1years. Proportion of DF forms: neuropathic with trophic ulcer 41.6%, neuropathic form (Charcot's foot) 17.9%, the neuroischemic 28.3%, ischemic 12.2%, in T2: 41.6%, 7,4%, 32,4%, 18,5%, respectively. The amount of new cases of amputations/per year in dynamics: T1 10,5→12,4, T2 9,6→10,9, with marked interregional differences 0.13–2.9% in T1, 0.04-6.0% in T2. The mean DM duration before amputation increased in T1 18.4→21.3years, in T2 9.1→9.9. The average amputation age: T1 51.7years, T2 66.2years. There was marked decrease in proportion of major amputations: T1 43,6→37,0%, T2 52.2→45.5 by redistribution in one toe amputations T14,0→10.0%, in T22,8→ 9.1%.

CONCLUSIONS: The dynamic of new DF cases in adult patients in Russian Federation is stable at T1, in T2 tends to increase. The interregional differences in frequency of DF and amputations may be due to differences in the quality of specialized care, the lack or shortage of diabetic foot cabinets, treatment of patients with DF in general surgical practice in a number of regions, which is recognized as a less effective strategy. A positive fact that proportion of high amputations declines, DF develops in later age and longer diabetes duration, that may reflect the increasing effectiveness of preventive lower limbs in diabetes.

BACKGROUND: The study of low-grade inflammation in patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular diseases is a pressing problem. A deeper understanding of the cascade of inflammatory reactions, possibly mediating the severe atherosclerotic lesions of various vascular pools in patients with diabetes, has the potential to introduce more sophisticated diagnostic and therapeutic approaches into practice.

AIM: To study the interrelation of low-grade inflammation and atherosclerosis of peripheral arteries in patients with coronary artery disease (CAD) and T2DM.

MATERIALS AND METHODS: The study included 137 patients (77 men and 60 women) with CAD. The average age of patients was 62.0 (57.0–66.0) years. The first group included 67 patients with CAD and T2DM, and the second group included 70 patients with CAD. Low-grade inflammation was assessed by the levels of high-sensitivity C-reactive protein, interleukin (IL)-1β, IL-6, IL-8, IL-10 and TNF-α. All patients underwent duplex scanning of carotid arteries and lower extremity arteries (LEAs).

RESULTS: Patients with CAD and T2DM showed significantly greater values of stenosis of carotid arteries and LEAs. Direct correlation was revealed between markers of inflammation and the degree of stenosis of the femoral and tibial arteries, as well as the intima-media thickness of the carotid and femoral arteries. In the group of patients with T2DM, the value of IL-1β was 2.04 (0.98–2.52) pg/mL, which was significantly less than 2.43 (1.84–3.19) pg/mL for patients in the second group (p = 0.010). The values of IL-6 were also significantly lower in the first group of patients, at 1.84 (0.73–4.41) pg/mL vs. 3.73 (2.27–10.2) pg/mL in the first and second groups, respectively (p = 0.008). The dose of metformin was inversely correlated with the level of IL-6 (r = −0.314, p = 0.003).

CONCLUSIONS: Patients with CAD and T2DM compared with patients without diabetes had significantly greater values of stenosis of peripheral arteries. The levels of IL-1β and IL-6 in the group of patients with CAD and T2DM were significantly lower in comparison with patients without diabetes. The dose of metformin was inversely correlated with the level of IL-6.

BACKGROUND: The patterns of bioelectric activity of the brain in patients with type 1 diabetes mellitus are being actively studied. A recent study of changes in brain bioelectric activity during sleep in children with diabetes mellitus was done without monitoring changes in the level of glycaemia in real time. The current study was conducted with concurrent monitoring of EEG in sleep and glycaemia.

AIM: To study the results of night time EEG monitoring of sleep in children with type 1 diabetes mellitus depending on the level of glycaemia.

METHODS: This study included 20 children (10–17 years of age) with type 1 diabetes. All patients received continuous monitoring of glycaemia and night time EEG of sleep for 9 h.

RESULTS: Absence of pathological changes was more often observed in patients with optimal glycaemic indices (n = 9) compared with patients with hypoglycaemic periods (n = 0) (P = 0.011, Fisher exact test) and hyperglycaemia (n = 3) (P = 0.0011, Fisher exact test). Light paroxysmal disturbances (high-amplitude bilateral flares during theta waves in stages 1–2 of sleep) were more often recorded in patients during periods of hypoglycaemia (n = 3) compared with periods of optimal glycaemia (n = 1) (P = 0.032, Fisher exact test). The hypersynchronous rhythm was also more often detected in patients during periods of hypoglycaemia (n = 3) compared with optimal glycaemia (n = 1) (P = 0.032, Fisher exact test). ECG potentials were more often recorded in hypoglycaemia (n = 4) compared with optimal glycaemia (n = 2) (P = 0.011, Fisher exact test) and hyperglycaemia (n = 3) (P = 0.005, Fisher exact test). The interrelation of brain bioelectric activity and glycaemic indices was seen in patients with hypoglycaemia (positive correlation) and at optimal glycaemia (negative correlation). The highest correlation was seen between ECG potentials (r = +0.61, P < 0.05), hypersynchronous rhythm (r = +0.40; P < 0.05) and hypoglycaemia. Significant differences between the groups were obtained in the beta range (increase in amplitude and beta-rhythm index) by the spectral analysis.

CONCLUSIONS: Disturbance of the bioelectric activity of the brain is seen mainly in the hypoglycaemic state in patients with type 1 diabetes mellitus. This indicates the dysfunction of vegetative regulatory adaptation mechanisms, which can significantly increase the risk of severe hypoglycaemia.

Military Medical Academy of S.M. Kirov, Saint-Petersburg, Russia

Recent clinical trials about the cardiovascular safety of empagliflozin and liraglutide demonstrated a convincing lowering effect on mortality from cardiovascular causes among the patients with type 2 diabetes. These findings resulted in many questions about why this phenomenon was seen in two drugs with widely different mechanisms of functioning. It is important to note that the glucose-lowering effect was moderate, although a feature seen in both empagliflozin and liraglutide was their ability to increase insulin sensitivity. In many fundamental studies, this feature was associated with a reduction of cardiovascular risks. Insulin resistance, which has always been a pathophysiological base for the development of cardiovascular disease in patients with type 2 diabetes, is a topic for this report. Different methods to manage insulin resistance, including lifestyle changes, drug treatment and metabolic surgery, are discussed. Furthermore, the most common features of glucose-lowering drugs are analysed, including protective effects for cardiovascular outcomes in patients with type 2 diabetes presented in randomised clinical trials. Studies include the United Kingdom Prospective Diabetes Study (UKPDS), PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive), Insulin Resistance Intervention After Stroke (IRIS), Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) and the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). The current study shows that the potential to reduce the risk of cardiovascular disease is determined not only by effective lowering of glucose but also by the ability to lower insulin resistance, which causes a paradigm shift in the management of type 2 diabetes.

BACKGRAUND: A closed-loop glucose control system or ‘artificial pancreas’ consists of three components – a Continuous Glucose Monitor (CGM), infusion pumps to deliver hormone(s) and a sophisticated dosing algorithm to control hormone delivery. In the past years, numerous studies with closed-loop system devices were conducted with gradual shift to out-of-hospital environment and with lengthening study duration.

AIMS: To compare efficacy and safety of closed-loop insulin pump use in children with type 1 diabetes mellitus in compare with conventional insulin treatment (continuous subcutaneous insulin infusion (CSII) with our without CGM) based on randomized control trials data (RCT).

METHODS: In the systematic review we have include 28 randomized controlled trials results indexed in PubMed, Medline databases published till 15 June 2017. The efficacy on metabolic control in this study evaluated by the proportion of time within target range (preferably 70 to 180 mg/dl if reported) and mean (median) glucose based on sensor measurements, and the safety evaluated by time in hypoglycemia (below 70 mg/dl if reported).

RESULTS: Increased time in range in the night period was observed in all RCT. Only 3 RCT showed decrease of the time in range within 24 h evaluation period. In one RCT the significant positive differences have been shown in the time in range for dual hormone closed-loop glucose control system in compare with insulin-only artificial pancreas. Mean glycaemia and glucose variability changes were not in the same manner in different RCT, both in the night only and in 24 h estimation period. Night hypoglycemia duration decreased in most RCT with closed-loop control in compare with CSII, and increased only in 2 RCT. When all-day estimation period the time in hypoglycemia changed not in the same manner in different RCT. Valuable methodology differences of the glycaemic control estimation within observed RCT brought significant complications in the data analysis and made impossible the results quantitative estimation to prepare a metaanalysis.

CONCLUSIONS: Much work has been done to develop effective and safe artificial pancreas, but not all RCTs confirmed advantages of closed-loop glucose control in compare with CSII in children and adolescents in real life. More research with prospective randomized control design required to prove benefits of closed-loop glucose control. Further RCTs should have an uniform methodology for glycemic control assessment and long duration that will allow to use cumulative measures in a closed-loop efficacy estimation (HbA1c).