An economic value of the glycated hemoglobin test in diabetes mellitus type 2 diagnosis

BACKGROUND: Diagnostic of diabetes mellitus type 2 (DM2T) in time is very actual for treatment and prevention of potential complications of illness. Fasting blood glucose test (FBG) is a widely used method of primary DM2T diagnose. Glycated hemoglobin (HbA1c) test is an alternative and used more rarely due to expensive. AIM: Modelling of comparative expenditures for DM2T control in cases of primary diagnostic by HbA1c test or FBG test usage in 20-years horizon. METHODS: Retrospective analysis of aggregated epidemiological Russian NATION study data in 810 patients with prediabetes and DM2T with both analysis performed, with sensitivity and specificity of each is detected. The simulation model of DM2T outcomes has been used for Health Technology assessment (direct and indirect costs of Diabetes control during 20 years). Three algorithms of the DM2T treatment were investigated for understanding of expenditures in case on diagnostic on-time and case of late verification with metformin, gliflozines, gliptins, Glucagon-like peptide-1 receptor agonists, basal insulin analogs and their combinations. RESULTS: FBG test has more negative results for DM2T diagnostics in compare with HbA1c analysis (77,4% and 36,5% accordingly). Amount of false negative results in FBG test in 3 times more often occurred in comparison with HbA1c. HbA1c test in 3 times more precisely than FBG test for carbon metabolism abnormalities detection. Diagnostic in time with HbA1c test in compare with late process of illness detection by FBG can cut common expenditures on 26,3-27,7% depending on treatment option due to macrovasular complications decreasing. Disability rate is expected decrease on 21% to 20-th year in case of diagnostic with HbA1c performing instead FBG test. CONCLUSION: HbA1c test has diagnostic advantages in compare with FBG test for primary investigation (dispanserization). Direct and indirect expenditures in average for one patient with DM2T on 20-years horizon including cost of drugs, analysis, complications, disabilities are less in case of diagnostic in time with HbA1c test in comparison with late diagnostics in case of FBG test execution

«DIARISK» — the first national prediabetes and diabetes mellitus type 2 risk calculator

BACKGRAUND: The need to create a national questionnaire for screening the population for disorders of carbohydrate metabolism.AIMS: Develop a highly specific and sensitive questionnaire-calculator of the risk of prediabetes (PreD) and diabetes mellitus type 2 (DM2T) based on depersonalized data of individuals who have these diagnoses confirmed in the national epidemiological study NATION.METHODS: The express method of prediabetes (PreD) and diabetes mellitus type 2 (DM2T) risks has been created, validated and proposed for clinical usage for the first time in the Russian Federation, it was based of NATION epidemiologic study database (more than 26 000 participants). The following mathematical instruments have been used: mathematic modelling, main components methodology, binary variables, correlation analysis and single-factor analysis of variance.RESULTS: Highest coefficients of logistic regression for PreD (p<0.05) were identified for age — ≥52 years old for women and ≥59 years old for men (1,48); body mass index ≥31 (0.75); waist circumference ≥100 сm for women and ≥112 cm for men (0.90). In the same time coefficients for DM2T were for for age — ≥52 years old for women and ≥59 years old for men (1,24); body mass index ≥31 (1,19), high blood fasting glucose analysis in the past (1,37); waist circumference / hip circumference ratio ≥0.85 for women and ≥0.92 for men (1,05), high blood pressure (0.69). Correlation coefficients were taken into account and score has been used for specialized questionnaire creation. Sensitivity and specificity for PreD were 83,8% and 59,3% accordingly, for DM2T — 85,4% and 73,6% accordingly. DM2T may be suspected when total score of questionnaire is 11 and higher, and PreD — when total score will be ≥7 and <11.CONCLUSIONS: The calculator based on questionnaire (DIARISK) allows to separate of potential patient for PreD and DM2T confirmation during first examination or dispanserization. A patent for innovation has been issued

Cost-of-Illness Analysis of Type 2 Diabetes Mellitus in the Russian Federation: Results from Russian multicenter observational pharmacoepidemiologic study of diabetes care for patients with type 2 diabetes mellitus (FORSIGHT-Т2DM)

Background: Cost-of-Illness Analysis (COI) constitutes the basis for the decision-making process on the budget and allocation in a modern health care system. Considering the wide prevalence of type 2 diabetes mellitus (Т2DM), it is important to perform COI in the Russian Federation (RF). Aim: The aim of the secondary objective FORSIGHT-Т2DM study was to conduct Cost-of-Illness Analysis (COI) of Т2DM in the Russian Federation in relation to taking into consideration the presence of complications and concomitant diseases. Materials and methods: COI of Т2DM was performed using the data obtained in Russian multicenter observational, pharmacoepidemiologic cross-sectional study of diabetes care for assessing routine healthcare pattern of T2DM in the Russian Federation (FORSIGHT-Т2DM). Information for each patient was collected from primary medical records and By asking patients to fill out a questionnaire. Total costs were calculated as the sum of direct medical costs (DCm), direct non-medical costs (DCn) and indirect costs (IC). Results: The final analysis included data from 2014 patients with T2DM residing in 45 cities of RF. Total direct medical costs (DCm) of treating Т2DM and its complications and comorbidities amounted to 105 337 rubles ($2742) per patient per year; direct non-medical costs (DCn) amounted to 24 518 rubles ($638) per patient per year; indirect costs (IC) amounted to 149 754 rubles ($3898) per patient per year. The total cost of T2DM in RF in 2014 year amounted to 279 609 rubles ($7278) per patient. The total cost of T2DM in RF in 2014 amounted to 279 609 rubles per patient. Conclusions: More than half (53,5%) of the total cost of T2DM is the loss of GDP due to patients disability. The DCm constitute 37,7% of the total cost of the disease, of which 57% is spent on treatment of T2DM complications and concomitant diseases, while only 10% is spent on glucose-lowering therapies

Assessing routine healthcare pattern for type 2 diabetes mellitus in Russia: the results of рharmacoepidemiological study (FORSIGHT-DM2)

Rationale. The rising incidence of type 2 diabetes mellitus (T2DM) allows researchers to conduct observational multicentre studies and obtain objective information about the epidemiology of diabetes and its complications and evaluate the efficacy of different therapies and diagnostic strategies designed to identify systemic vascular complications. Aims. To analyse epidemiological and socio-demographic parameters, the quality of glycaemic control, diagnostic monitoring and therapeutic measures typical among patients with T2DM living in Russian towns of different populations. Materials and methods. FORSIGHT-DM2 is an all-Russian multicentre observational epidemiological study that involves 2014 patients with T2DM from 45 different towns in the Russian Federation (RF). All patients have had T2DM for at least 1 year. They received glucose-lowering therapy and primary medical care from RF public outpatient health institutions between 01.01.2014 and 31.12.2014. For comparative analysis of the typical treatment for patients with T2DM, we stratified patients into groups based on the number of residents. Results. The data reveal a lack of glycaemic control (average НbА1с 7.9% ± 1.9%), with НbА1с  8% in 36% of patients. The frequency of T2DM complications was high and the prevalence of retinopathy was 63.2%, nephropathy was 34.4% (7.8% had chronic kidney disease G3a-G5), peripheral polyneuropathy was 63.3%, ‘diabetic foot’ syndrome was 13.7% and osteoarthropathy was 5%. The number of T2DM-related complications is correlated with the HbA1c level and disease duration. Moreover, simultaneous influence of these factors led to a significant increase in the number of chronic complications associated with T2DM (r = 0.338 for T2DM duration, r = 0.262 for HbA1c; р 0.001). Despite the high frequency of patient consultations with endocrinologists (83%) and a large percentage of hospitalisations in the current year (46%), the screening of chronic complications of T2DM in 2014 is insufficient. Conclusion. The results indicate insufficient glycaemic control among patients with T2DM and a higher prevalence of chronic complications compared with the national register of diabetic patients