Diabetes mellitus in Russian Federation: prevalence, morbidity, mortality, parameters of glycaemic control and structure of glucose lowering therapy according to the Federal Diabetes Register, status 2017

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

Dynamic monitoring of HbA1c in Russian regions: data comparison of mobile medical center (Diamodul) and national diabetes register of Russian Federation

BACKGROUND: Glikogemoglobin (HbA1c) is a key clinical marker for evaluating the effectiveness of glucose-lowering therapy for patients with diabetes mellitus (DM) and the quality of diabetic care. AIMS: to conduct dynamic monitoring of the quality of glycemic control in DM patients based on a comprehensive examination in mobile medical center (Diamodul) during repeated visits to the regions in 2019 compared with visits of Based Federal program “Diabetes Mellitus” (2005–2010) and data of the National diabetes register (NDR). MATERIALS AND METHODS: The object of the study: patients with T1DM and T2DM examined in Diamodul in 2019 in Voronezh region (Vr), Krasnodar region (Kr) (n = 600), there were “dynamic” group of re-examined (Vr n = 224; Kr n = 113), “random” group of new patients (Vr n = 72; Kr n = 191); group of adult patients from NDR with indicated HbA1c in 2019 (n = 2410067). RESULTS: According to Diamodul, the HbA1c levels are significantly worse than they were reported to NDR: the proportion of patients achieved HbA1c <7% for T1DM is 13.3% and 11.7%; T2DM – 25.1% and 28.6%, in Kr and Vr, respectively; in NDR: T1DM – 37.4%, T2DM – 52.2%. The average HbA1c values in the Diamodul are higher than in NDR by 0.95% for T1DM, 1.41% for T2DM patients. The proportion of patients with HbA1c≥9% decrease in dynamic of examinations through years in T1: in Vr from 53.1% in 2005 and 55.8% in 2010 to 42.9% in 2019, in Kr from 53.2% in 2006 to 43.8% in 2019; also there were decreases in the average HbA1c values in Vr from 9.3% in 2005 and 9.4% in 2010 to 8.8% in 2019; in Kr from 9.1% in 2006 to 8.7% in 2019. In T2DM patients with the best parameters of DM control in a whole, the positive trends were less pronounced and are assessed as non-deterioration: the proportion of HbA1c≥9 % in Vr: 34.7%–34.7%–36.4%, in Kr 40.1%–28.4%; average values of HbA1c: 8.2%–8.4%–8.5% and 8.6%–8.4%, respectively. CONCLUSIONS: The data of the research clearly indicates the need for 100% inclusion of HbA1c in the examination standards in all DM patients at the primary level at least 1 time per year, in order to monitor the real clinical situation, the effectiveness of glucose-lowering therapy and its timely intensification to prevent development of complications

Trends in the epidemiology of chronic kidney disease in Russian Federation according to the Federal Diabetes Register (2013–2016)

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 201316. 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%, 0.623.5%, respectively. The CKD prevalence in dynamics 20132016 was 2171.42303.0 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) - 12.046.8% in T1; 10.050.4% in T2. The proportion of patients with a very high risk (stages C4/5 C3aA3 and C3bA2-3) progressively decreases: 13.46.7% in T1, 11.34.4% in T2. We observed relation between the CKD prevalence and DM duration. CKD develops in 5.1% patients if T15 years and in 48.0% if T130years; in T2 3.5% and 20.3%, respectively. The average age of CKD onset in T1 increased for 4,3yr (36,140,2), in T2 for 2,4yr (64,466,8), DM duration until CKD development increased in T1 11.814.2yr, in T2 7.68.2yr. 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

Epidemiology of cardiovascular diseases among patients with diabetes mellitus according to the federal diabetes register of the Russian Federation (2013–2016)

BACKGROUND: Cardiovascular diseases (CVD) are the main cause of death for patients with diabetes mellitus (DM). AIMS: To evaluate the CVD epidemiology: coronary heart disease (CHD), myocardial infarction (MI) and cerebrovascular diseases in adult patients with type 1 (T1DM) and type 2 (T2DM) diabetes, compare dynamics with data of implementation of the Federal Program «Diabetes mellitus» in 2007–2012 and over the online period 2013–2016. MATERIALS AND METHODS: The database of the Federal Diabetes register (81 regions at 12.2017). We estimated prevalence and incidence rates/10 thousand (th) adult DM patients over 18 years. RESULTS: The prevalence of CVD for the period 2007 – 2016 significant decreased in CHD for T1DM from 14,9% to 3,5%, for T2DM from 20,1% to 11,7%; MI for T1DM from 5,7% to 1,3%, for T2DM from 7,6% to 3,5%; cerebrovascular diseases for T1DM from 4,9% to 1,7%, for T2DM from 7,6% to 4,3%, respectively. In 2013→2016 positive trends continued: MI for T1DM 8,2→5,9/10th patients, for T2DM 19,2→14,7/10th patients, respectively; CVD for T1DM 11,3→10,5, for T2DM 29,4→25,4/10th patients, respectively. There was a large heterogeneity of the prevalence of CVD in the regions. MI varied in patients for T1DM from 319/10 th patients to absence, for T2DM from 800 to 7/10 th patients; the development of cerebrovascular diseases for T2DM from 900 to less than 100/10 th patients, which is largely due to differences in their registration. A small number of cases may be due to insufficient filling of the database, the facts of a huge number require further analysis. The average age of development of MI had increased: for T1DM 51,2→53 years, for T2DM 63,5→65 years, cerebrovascular diseases for T1DM 52,3→52.5 years, for T2DM 65,2→66,5, respectively. CONCLUSIONS: The prevalence of CVD significantly decreased in the Russian Federation compared to 2007–2012, as well as for the period 2013–2016: the prevalence of CHD and cerebrovascular diseases declined, the number of new cases of MI decreased, the average age and duration of DM before the development of CVD significantly increased. These data reflect the results of the program for improvement medical care and prevention measures for patients with diabetes

Trends in the epidemiology of diabetic retinopathy in Russian Federation according to the Federal Diabetes Register (2013–2016)

Background: Diabetic retinopathy (DR) is one of the most common causes of blindness in patients with diabetes mellitus (DM) that is why its necessary to study the epidemiological characteristics of this complication. Aims: The aim of the study was to evaluate the epidemiological characteristics of DR and blindness in adult patients with type 1 (T1) and 2 (T2) diabetes in Russian Federation (RF) for period 201316years. Materials and methods: Database of Federal Diabetes register, 81st regions included in the online register. Indicators were estimated per 10,000 adult DM patients (18years). Results: In 2016 the DR prevalence in RF was T1 38,3%, T2 15,0%, with marked interregional differences: 2,666,1%, 1,146,4%, respectively. The DR prevalence within 20132016 years was: T1 3830,93805,6; T2 1586,01497,0. Trend of new DR cases/per year increased: T1 153,2187,8; T2 99,7114,9. The structure of new cases of DR in 2016: non-proliferative stage (T1 71,4%, T2 80,3%), pre-proliferative stage 16,4%, 13,8%, proliferative 12,1%, 5,8%, terminal 0,2%, 0,1%, respectively, these data indicated the earlier detection of DR. The mean age of DR diagnosis increased: T1 by 1,2 years, T2 by 2,6. The average DM duration of DR determine increased T1 9,613,1 years, T2 6,09,1. The prevalence of blindness tends to decrease: T1 92,390,8; T2 15,415,2/10.000 DM adults. The amount of new cases of blindness/per year increased: T1 4,34,6; T2 1,21,4. The mean age of blindness increased: T1 39,141,6 years, T2 64,467,4; the mean duration of diabetes before blindness occur (from the time of DM diagnosis) increased: T1 20,221,2 years, in T2 10,711,3. We observed growth of DR treatment (laser surgery, vitrectomy, anti-VEGF medication) but the frequency of use in T2 patients is about 2 times less than in T1. Conclusions: There was a decrease in the overall incidence of eye damage in diabetes (DR and blindness) in the analyzed period in RF. DR and blindness develops at advanced age and with a longer duration of diabetes. As the main directions of eye care development in diabetes it is necessary to standardize primary care in the regions, to unify the examination algorithms and methods of early diagnostic, to increase the continuity and interaction of endocrinologists and ophthalmologists in managing patients with diabetes in order to prevent the development of new cases of vision loss

Epidemiology of acute diabetes complications (coma) according to the Federal Diabetes register of the Russian Federation (2013–2016)

Background: Despite the improvement in the quality of diabetes care in the Russian Federation (RF), coma remain one of the causes of death in patients with diabetes. Aim: To assess dynamic of epidemiological characteristic of acute complications in adult patients with T1D and T2D in 2013–16. Materials and methods: The database of the Russian Federal Diabetes register (81 regions). The indicators of coma for 2013–16 were estimated for 10000 adult patients with diabetes (>18 years). Results: In 2016, the prevalence of coma in RF was 225.9 with T1D and 11.6/10000 adults with T2D. For the period from 2007 the prevalence of ketoacidotic coma decrease three times in T1D, 4 times for T2D.Totally in 2016, 165 new cases of coma for both types of diabetes were registered, an average of 0.4/10000 adults. Interregional differences in the prevalence of coma were observed 0–4.2/10000 adults. The frequency of new cases of coma has a tendency to decrease: 0,9→0,4/10000 adults: T1D 5.7→3.4, T2D 0.6→0.2/10000 adults. When evaluating the structure of coma, redistribution is evident in their form. So in 2016 the proportion of hypoglycemic coma increased to 40.7%, and ketoacidotic coma decreased to 56.6% in T1D. With T2D, the difference expressed in a lesser degree. The mean duration of diabetes at the time of coma development increased with T1D from 3.8→9.1 years, with T2D 3.5→7.0 years. The maximum frequency of development of coma is recorded with the diabetes duration more than 30 years, regardless of the type. The patients’ age at the time of coma development in T1D increased to 27.5 years old, and in T2D it was 60.4 years, it didn’t change significantly. The assessment of glycemic control showed a significant improvement: a decrease in the proportion of patients with HbA1c≥ 9.0% (23% with T1D, 8.8% with T2D), an increase with HbA1c <7% (32.4% and 51.7%, respectively). The average value of HbA1c in 2016 with T1D – 8.21%, with T2D – 7.48%. Conclusions: It is established that the dynamics of the frequency of development of coma in 2013–16 in adult patients with diabetes in the RF has a stable tendency to decrease: 1.5 times with T1D and more than 3 times with T2D. It can be assumed that this is due to the improvement in the quality of diabetes care and glycemic control in general, as well as the use of modern medicines. Attention is required to draw to the high frequency of coma in T1D, the development of coma with a longer duration of diabetes, an increase in the proportion of patients with hypoglycemic coma. Significant interregional differences in the frequency of coma registration require additional analysis

Trends in the epidemiology of diabetic foot and lower limb amputations in Russian Federation according to the Federal Diabetes Register (2013–2016)

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 201316years. 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: 0,1519,9%, 0,0710,3%, respectively. The DF prevalence in RF decreased: T1 506,3473,6, T2 214,60194,8. The incidence of new DF cases/per year was stable in adults with T1: 20,820,4/; increased in T2 13.214.2. The mean age of DF diagnosis increased by 2years for both DM types. The average DM duration of DF determine increased T1 15.419.0years, T2 7.410.1years. 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 10,512,4, T2 9,610,9, with marked interregional differences 0.132.9% in T1, 0.04-6.0% in T2. The mean DM duration before amputation increased in T1 18.421.3years, in T2 9.19.9. The average amputation age: T1 51.7years, T2 66.2years. There was marked decrease in proportion of major amputations: T1 43,637,0%, T2 52.245.5 by redistribution in one toe amputations T14,010.0%, in T22,89.1%. 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

Genetic and expression studies of SMN2 gene in Russian patients with spinal muscular atrophy type II and III

<p>Abstract</p> <p>Background</p> <p>Spinal muscular atrophy (SMA type I, II and III) is an autosomal recessive neuromuscular disorder caused by mutations in the survival motor neuron gene (<it>SMN1</it>). <it>SMN2 </it>is a centromeric copy gene that has been characterized as a major modifier of SMA severity. SMA type I patients have one or two <it>SMN2 </it>copies while most SMA type II patients carry three <it>SMN2 </it>copies and SMA III patients have three or four <it>SMN2 </it>copies. The <it>SMN1 </it>gene produces a full-length transcript (FL-SMN) while <it>SMN2 </it>is only able to produce a small portion of the FL-SMN because of a splice mutation which results in the production of abnormal SMNΔ7 mRNA.</p> <p>Methods</p> <p>In this study we performed quantification of the <it>SMN2 </it>gene copy number in Russian patients affected by SMA type II and III (42 and 19 patients, respectively) by means of real-time PCR. Moreover, we present two families consisting of asymptomatic carriers of a homozygous absence of the <it>SMN1 </it>gene. We also developed a novel RT-qPCR-based assay to determine the FL-SMN/SMNΔ7 mRNA ratio as SMA biomarker.</p> <p>Results</p> <p>Comparison of the <it>SMN2 </it>copy number and clinical features revealed a significant correlation between mild clinical phenotype (SMA type III) and presence of four copies of the <it>SMN2 </it>gene. In both asymptomatic cases we found an increased number of <it>SMN2 </it>copies in the healthy carriers and a biallelic <it>SMN1 </it>absence. Furthermore, the novel assay revealed a difference between SMA patients and healthy controls.</p> <p>Conclusions</p> <p>We suggest that the <it>SMN2 </it>gene copy quantification in SMA patients could be used as a prognostic tool for discrimination between the SMA type II and SMA type III diagnoses, whereas the FL-SMN/SMNΔ7 mRNA ratio could be a useful biomarker for detecting changes during SMA pharmacotherapy.</p

Atlas of Diabetes Register in Russian Federation, status 2018

The Federal Diabetes Register (FDR) has been conducting clinical and epidemiological monitoring of diabetes in the Russian Federation (RF) since 1996. Its methodological and organizational reference centre is Endocrinology Research Centre. FRD was created by Order of the Ministry of Health of RF №404 of December 10, 1996 as part of implementation of the Federal target program "Diabetes Mellitus". Over the 20-year period, the registry has played a key role in assessing the prevalence of diabetes and diabetic complications in the RF. Since 2014, the register has been transformed into online system as a unified federal database with an authorized code access. Personal data protection is carried out in accordance with the laws and regulations of the Russian Federation

Diabetes mellitus in children and adolescents according to the Federal diabetes registry in the Russian Federation: dynamics of major epidemiological characteristics for 2013–2016

Background: The data of the register is the main source of up-to-date information about patients with diabetes mellitus (DM). Its very important for improving the quality of medical care organization. Aims: to analyze the main epidemiological DM characteristics in Russian Federation (RF) (prevalence, incidence, mortality) in children and adolescents, to assess the dynamics of these parameters for the period 2013 2016, to analyze the status of compensation for carbohydrate metabolism, therapy of DM1, prevalence of diabetic complications and the reasons for hospitalizations in these age groups. Materials and methods: The database of Federal DM registry of 81 regions was included in the online system. Results: The total number of patients under the age of 18 with DM in RF on 31.12.2016 was 33081 people, there were 95,9% (31727 people) with DM1 and 4,1% (1354 patients) with DM2. The prevalence of DM1 in 20132016 in children: 81.0 91.4 / 100 ths., in adolescents 212,8209,5 / 100 ths. The DM1 incidence/100 thousand population in 2016 in children was 14,2/100 ths., in adolescents 10,0/100 ths. HbA1c levels in DM1 was in children: 7,5% in 32%, 7,69,0% in 33%, 9% in 35% of the patients; in adolescents 7,5% in 25%, 7,69,0% in 30%, 9% in 45% of the patients. Among complications in children and adolescents with DM1, diabetic neuropathy is the most often recorded (in 10,9% of cases and 40,8%, respectively); among DM2 patients, diabetic neuropathy is registered in 4,7% and 8,8% in children and adolescents, respectively. There are associated diseases in DM2 patients arterial hypertension and dyslipidemia. 43,8% of children and 49,2% of adolescents were hospitalized in the anamnesis, most hospitalizations in 2016 (children 71,9%, adolescents 67,1%) were due to diabetes. Conclusions: It is established that in the dynamics of 20132016 the prevalence of DM1 in children continues to increase, with relatively stable indicators in adolescents. According to the register, during last two years there has been a decrease in the incidence of DM1 and, on the contrary, an increase in the prevalence/incidence of DM2 in children. Significant interregional differences in the level of incidence/prevalence have been established, especially in regions located in various geographic regions of the RF. The frequency of diabetic complications in children and adolescents with diabetes varies. There is an association of hospitalizations with higher HbA1c level. In the structure of therapy of this age group the ratio of insulin therapy in syringes-pens and pump therapy is 80.9% / 15.1% according to the register