Dmitriy Nikitich Laptev

Objective. Cost-effectiveness analysis of screening for type 1 diabetes (T1D) in 6-year-old children by measuring autoantibodies to beta-cell and pancreatic islet antigens followed by longitudinal monitoring of individuals with positive results. Material and methods. The Markov model was used to predict efficacy, direct and indirect costs for three screening scenarios in 6-year-old children after testing for autoantibodies to beta-cell and pancreatic islet antigens: 1) general population; 2) first-degree relatives (FDR); 3) children with autoimmune diseases (AID). For each scenario, two cohorts (screening vs no screening) were simulated over a 50-year time horizon, and incremental cost-effectiveness ratios (ICER) were calculated using quality-adjusted life year (QALY). Results. Across all three scenarios, T1D screening reduced mortality and incidence of long-term complications by preventing diabetic ketoacidosis (DKA) at disease onset and increased QALY. The largest numbers of prevented long-term complications were observed in FDR and AID scenarios: by 18 years for diabetic neuropathy and by 56 years for lower extremity amputation and end-stage chronic kidney disease. In FDR and AID scenarios, ICER fell below 2.3 million rubbles after 7 years. After 16 years, ICER became negative that indicated cost savings alongside higher clinical benefit. In general population, ICER fell below 2.3 million rubbles after 28-year modelling and amounted to 2.287.652.27 RUB per QALY gained. Conclusion. In high-risk groups (FDR and children with AID), T1D screening followed by monitoring of autoantibody-positive individuals is economically justified for Russian healthcare system. In general population, cost-effectiveness emerges only over a long-term horizon (after 28 years). This highlights the need for long-term planning and confirming key clinical effects of screening in routine practice during program scale-up (reduced proportion of DKA at onset and early-disease HbA1c trajectories).

BACKGROUND. Continuous glucose monitoring (CGM) is becoming the standard of care for children with type 1 diabetes (T1D), yet data on its use in children under 4 years old remain limited. FreeStyle Libre 2 (FSL2) is approved for use from the age of 4, but there is a clinical need for use in younger age groups. OBJECTIVE. To evaluate the accuracy and safety of the FSL2 system when used off-label in children aged 1–4 years with T1D. MATERIALS AND METHODS. The study included 20 children with T1D (mean age 2.8±0.7 years, diabetes duration 1.2±0.8 years, HbA1c 7.1±1.4%). Participants consecutively used two FSL2 sensors over a 28-day period. Accuracy was assessed by comparing FSL2 data to reference capillary blood glucose measurements (≥6 times daily). Analyses included mean absolute relative difference (MARD), agreement rates, and distribution across zones of the Parkes consensus error grid. RESULTS. A total of 2,554 paired measurements were analyzed. Overall MARD was 11.5% (95% CI: 10.6–12.3%). Agreement rates: 74.6% of readings were within ±15%/15 mg/dL, and 84.2% within ±20%/20 mg/dL. A total of 99.9% of readings fell within Zones A+B of the consensus error grid. MARD remained stable over the 14-day sensor wear period (11.9%, 11.1%, 11.7% in the initial, middle and final periods of use). The average sensor wear time was 285.7±95.9 hours. No serious adverse events were reported; local skin reactions were mild and resolved fully without any treatment. CONCLUSION. FSL2 demonstrated clinically acceptable accuracy and a high safety profile in children aged 1–4 years with T1D. The findings support potential extension of FSL2 use in this age group to improve glycemic control and family quality of life.

Type 1 diabetes is an autoimmune disease that causes damage and destruction of the pancreatic islet beta cells, leading to insufficient insulin production, followed by metabolic disturbances and clinically overt hyperglycemia, which requires lifelong insulin therapy. Currently, it is possible to detect the disease at preclinical stages, when pancreatic islet beta-cell function is sufficient to prevent hyperglycemia and the need for insulin therapy, by determining antibodies to islet cells (ICA, IA-2, GAD, IAA, Zn8T). Due to the high relevance and growing demands from the medical community regarding the problem of early diagnosis of T1D and the need to standardize approaches, several international guidelines on screening and monitoring individuals with positive autoantibodies (AAb) at preclinical stages of T1D were published during 2024. Monitoring these patients will reduce the risk of DKA, give them and their families more time to acquire knowledge and skills for diabetes management, and may also reduce anxiety and stress associated with the onset of the clinical stage of T1D. This review analyzes and compares international approaches to screening and monitoring the preclinical stages of T1D.

BACKGROUND : Fast-acting insulin aspart has superior pharmacokinetic properties compared to traditional rapid-acting insulin analogs, but data on its real-world clinical effectiveness in children and adolescents are limited AIM : To evaluate the effectiveness of fast-acting insulin aspart compared to rapid-acting insulin analogs in children and adolescents with type 1 diabetes (T1D) under real-world clinical practice conditions. MATERIALS AND METHODS : A cross-sectional study of 2,188 children and adolescents with T1D aged 1–18 years was conducted. Primary outcomes included glycated hemoglobin (HbA1c) level and time in range (TIR, 3.9–10.0 mmol/L). Statistical analysis involved the Mann-Whitney U test for between-group comparisons and multivariate linear regression to assess independent predictors of outcomes. RESULTS : The median age of participants was 12.0 [9.0; 15.0] years, with diabetes duration of 4.3 [2.3; 7.1] years. Multivariate analysis confirmed an independent association of fast-acting insulin with 0.182% lower HbA1c (95% CI: -0.292; -0.071, p=0.001) and 2.663% higher TIR (95% CI: 1.031; 4.294, p=0.001) after adjustment for age, diabetes duration, and insulin delivery method. The most pronounced benefits were observed in adolescents aged 13–18 years and patients with diabetes duration exceeding 7 years. CONCLUSION : Fast-acting insulin aspart demonstrates statistically significant and clinically relevant advantages in glycemic control among children and adolescents with T1D in real-world clinical practice, supporting its broader use in pediatric populations.

BACKGROUND : Type 1 diabetes mellitus (DM1) is a chronic disease, the main causes of disability, mortality and decreased quality of life in which are acute and chronic complications. The onset of T1DM in childhood is associated with a significant reduction in life expectancy and a higher risk of cardiovascular complications. In addition, the chronic course of T1DM is often accompanied by other autoimmune diseases (autoimmune thyroiditis (AIT), celiac disease), as well as concomitant conditions (growth retardation, dyslipidemia, etc.), which have independent significance. AIM : To assess the frequency and provide clinical characteristics of complications, concomitant diseases and conditions in children with T1DM who fell ill during preschool age. MATERIALS AND METHODS : A single-center, cross-sectional study including data from 396 children aged 4 to 18 years with previously diagnosed T1DM, according to generally accepted criteria, for a duration of at least 3 and no more than 10 years on intensified insulintherapy. Depending on the age of diagnosis of T1DM, study participants were divided into two groups: group with manifestation of T1DM RESULTS : Median age was 11.9 [9.3; 14.9] years, disease duration 5.2 [3.9; 6.9] years, glycated hemoglobin level 7.9 [7.2; 9.2] %. Study groups did not differ in gender, disease duration or SDS BMI. The level of glycated hemoglobin (p=0.011) and height SDS (p=0.041) were higher in children with onset of T1DM over 7 years of age. According to the results of regression analysis, taking into account the correction for the age of children at the time of examination, a direct relationship was established between the manifestation of T1DM in preschool age and retinopathy (β=4.95), MAU (β=2.64) and growth retardation (height SDS less than 2 ) (β=1.22). In contrast, a decrease in GFR was associated with an older age at onset of T1DM (p=0.012). After adjustment for age, the incidence of AIT, celiac disease and dyslipidemia did not differ significantly depending on the age of diagnosis of T1DM. CONCLUSION : The data obtained indicate the importance of the manifestation of T1DM in preschool age as an independent risk factor for vascular complications in children and slower linear growth. Although the exact causes are not fully understood today, these data indicatethe need for more careful and strict monitoring of T1DM in young children, starting from the very onset of the disease.

Continuous glucose monitoring (CGM) has been established as a method for self-assessment glucose levels in individuals with diabetes mellitus in the Russian Federation for more than 15 years. The main characteristics of CGM sensors are its’ accuracy and performance that ensure their effectiveness and safety. Currently, there are no standardized guidelines that outline the minimum accuracy standards for CGM systems.This review is aimed to codify the current methods for evaluating CGMs accuracy and performance across the different countries, as well as to propose local Russian guidelines on CGM device accuracy evaluation. This involves guidelines for the design of clinical trials to assess sensors accuracy and the minimum acceptable performance requirements for CGM devices to be utilized in clinical settings.

Дистанционное управление гликемией с применением устройств для беспроводной передачи данных у детей с сахарным диабетом 1 типа: промежуточные результаты клинической апробации

Modern pediatric endocrinology represents the dawn of a new era in diagnosis and treatment, based on scientific research in molecular genetics and the development of advanced diagnostic and therapeutic tools. At the Pediatric Clinic of the En docrinology Research Centre (ERC), later the Institute of Pediatric Endocrinology, molecular genetic research began in 1990 in collaboration with the N.P. Bochkov Research Centre for Medical Genetics and the Institute of Immunology. The ERC’s Laboratory of Molecular Genetics has been operational since 2001, conducting research in partnership with foreign clinics and institutions.

Type 1 diabetes mellitus (T1DM) in childhood is one of the most important social and medical problems, given the growing incidence and negative impact on the duration and quality of life. The onset of the disease in childhood associated with significantly reduced life expectancy, largely due to micro- and macrovascular complications, and background pathological processes may occur from the T1DM onset due to suboptimal glucose control. Large registers data indicate that less than half of children with T1DM achieve target glycemic control, and adolescence is characterized by the worst glycemic control among all age groups. In recent years, modern treatment tools have been widely adopted in children with T1DM: insulin pumps, continuous glucose monitoring and automatic insulin delivery systems, which has become possible due to their increased availability, convenience and proven effectiveness. These technologies not only reduce the burden of the disease, but also improve the effectiveness of treatment of T1DM in children, consequently reducing the risks of diabetic complications protecting the health for the upcoming adult life.

BACKGROUND: Despite existing recommendations for the initial calculation of insulin pump settings, the process is largely subjective and depends on the physician’s personal experience.AIM: Development of a clinical decision support system (CDSS) that determines the initial settings of the insulin pump, which would have satisfactory agreement with the expert opinion of physicians.MATERIALS AND METHODS: Neural network model developed using data (continuous subcutaneous insulin infusion (CSII) settings, age, weight, total daily dose, and HbA1c) from 2850 children with T1D who were switched to CSII and achieved optimal glycemic control according to glucose levels. CDSS utilizing the model implemented as a computer program in Python.A prospective assessment of the agreement between the recommendations of the CDSS and the physician conducted on 35 data sets of children with T1D (median age 9.3 years [6.4, 11.5]), and 840 points for decisions were analyzed. 4 degrees of agreement were used: complete consistency, when the physicians agreed with the CDSS recommendations; partial consistency, when the physicians didn’t agree with the CDSS recommendations, but the difference was in the range of ±15%; complete inconsistency — the difference more than ±15%; acceptable consistency is the sum of full and partial consistency (± 15% error is clinically acceptable). The null hypothesis of the study was the absence of difference in consistency/inconsistency between physicians and the CDSS.RESULTS: The frequency of full consistency between CDSS and physician recommendations for initiating insulin pump therapy is 29.8-43.8%, and inconsistency is 33.7-41.1%. Acceptable consistency is 58.9–66.3%. There were no significant differences in mean insulin pump parameters between CDSS and physicians.CONCLUSION: The results obtained are consistent with previous studies. Proposed model demonstrates acceptable performance regarding initial CSII settings, without significant deviations between various parameters.