RATIONALE: Continuous subcutaneous insulin infusion (CSII) is an effective method for optimizing glycemic control in children with type 1 diabetes mellitus (DM1). However, the use of CSII does not always result in adequate glycemic control. Telehealth can be applied as one of the methods to improve the effectiveness of treatment.AIMS: To evaluate the use of remote medical support of children and adolescents with DM1 and its influence on glycemic control, quality of life, and incidence of acute complications of DM1.MATERIALS AND METHODS: We conducted a 24-week multi-institutional prospective open-label controlled clinical trial. 180 children and adolescents were included in this study and divided into the following categories: 1) age 8–18 years; 2) DM1 at least 1 year; 3) pump insulin therapy Medtronic Paradigm (Medtronic MiniMed, USA) at least 6 months; 4) self-monitoring of glycemia at least 4 times a day and replacement of the insulin pump infusion system at least once every 3 days; 5) inadequate glycemic control of DM1: the level of glycated hemoglobin (HbA1c) 7.5% or higher. Patients were assigned to a remote consultation group (RC; n=100) or a traditional control group (TC; n=80). All patients were trained on the basic principles of DM1 and CSII, and we measured initial HbA1c, then after 12 and 24 weeks, also registered and analyzed glycemic indicators and daily doses of insulin, evaluated and corrected the treatment. Patients or their parents in the RC group sent pump data via the Internet to the pump insulin therapy center at least once every 2 weeks at home and received treatment recommendations in response.RESULTS: The total number of patients included in the study in all institutions was 180 children at 8–18 years. Patients in both groups did not differ in age, gender, duration of DM1 and CSII, and HbA1c level. The total amount of remote consultations for all institutions was 949. The decrease in the level of HbA1c by the end of the study against the initial one was statistically significantly greater in the RC group: 1.17% compared to 0.59% in the TC group (p<0.05). The proportion of patients who reached the target level of HbA1c (<7.5%) was significantly higher in the RC group (32%) compared to the TC group (12.5%, p<0.05). During the study, the incidence of DKA and severe hypoglycemia in the RC group was statistically significantly lower.CONCLUSIONS: Remote monitoring in children with DM1 resulted in significant improvements in glycemic control (HbA1c, glycemic variability, and hypoglycemic frequency). The accumulation of evidence on the effectiveness and safety of telehealth in DM should contribute to implementing this approach in practical health care.

Background. Insulin pump therapy in increasingly frequently used in the Russian Federation in recent years, which requires an evaluation of the treatment in order to improve its efficacy and safety. Objective — the study was aimed at complex monitoring (long-term efficacy and safety, state of medical care, factors associated with metabolic control, and factors hindering its use) of the continuous subcutaneous insulin infusion (CSII) in children, adolescents, and young adults with type 1 diabetes mellitus (DM1) from various regions of the Russian Federation. Material and methods. Data of 395 DM1 children and adolescents from 60 regions of the Russian Federation were collected from the pediatric CSII register of the Endocrinology Research Center. The following data were analyzed in different age groups (0 to 7 years, 8 to 11 years, 12 to 17 years, and 18 to 25 years): glycemic control, the incidence of acute complications, discontinuation of CSII, characteristic features of blood glucose monitoring, and supplies coverage. Results. Initiation of CSII is accompanied by decrease in HbA1c level with the lowest values within the period from 6 to 24 months (–0.7±1.5% compared to the baseline level). However, 6 years after CSII initiation, HbA1c values do not differ significantly from the baseline values. The target HbA1c level (less than 7.5%) is observed in 43.6% of children aged 0 to 7 years, 32.7% of children aged 8 to 11 years, 24.2% of adolescents aged 12 to 17 years, and 28% of young adults aged 18 to 25 years. Regular self-monitoring of glycemia, 4 and more times per day, was performed by 83% of patients, while the frequency of continuous glucose monitoring (CGM) was low, 12.7% in the whole population. The incidence of acute complications in children and adolescents under 18 years did not differ significantly and the lowest incidence was observed in the age group 18 to 25 years. The effectiveness of CSII depended on the frequency of self-monitoring, CGM use, and supplies coverage. CSII discontinuation rate was 4.6 cases per 100 patient-years. The main reasons for discontinuation of CSII included the inconvenience of its use and the cost of supplies. Conclusions. Many children and the majority of adolescents with DM1, who use CSII, did not reach target HbA1c level despite the adequate self-monitoring. Many patients do not use CGM and refuse CSII. This necessitates the efforts to improve the efficacy and overcome barriers to the use of CGM and CSII.

Цель. Выявить особенности суточных колебаний потребности в инсулине и чувствительности к инсулину у детей и подростков с сахарным диабетом 1 типа (СД1), получающих интенсифицированную инсулинотерапию путем постоянной подкожной инфузии инсулина (ППИИ), а также закономерностей их изменения в различные возрастные периоды для оптимизации настроек инсулиновой помпы. Материалы и методы. В исследование вошли 138 детей и подростков с СД1 в возрасте 1-18 лет, получающих интенсифицированную инсулинотерапию путем ППИИ. Все пациенты были разделены на 3 возрастные группы: дошкольники младше 6 лет (n=23), дети до пубертата от 6 до 12 лет (n=39), подростки от 12 до 18 лет (n=76). В каждой группе проанализированы схемы проводимой инсулинотерапии, в том числе среднесуточная доза инсулина (СДИ), соотношение суточной дозы инсулина, вводимого в базальном и болюсном режиме, профили введения инсулина в базальном режиме за сутки, углеводные коэффициенты (УК), факторы чувствительности к инсулину (ФЧИ). Результаты. В ходе исследования обнаружены возрастные особенности изменения потребности в инсулине, вводимом в базальном режиме и болюсно в течение суток. Маленьким детям требуется более высокая скорость инфузии инсулина в базальном режиме в вечерние часы и в первую половину ночи, а минимальная-днем. Детям старшего возраста и подросткам для достижения индивидуальных целевых показателей гликемии требуется более высокая скорость инфузии инсулина в базальном режиме в ранние утренние часы. Также во всех возрастных группах обнаружена зависимость значений УК и ФЧИ от времени суток. Заключение. СДИ, соотношение дозы вводимого в базальном режиме и болюсно инсулина, а также циркадный профиль изменения потребности в инсулине и чувствительности к инсулину существенно зависят от возраста. Полученные в ходе исследования коэффициенты для расчета доз болюсов инсулина значимо отличаются от значений, получаемых с помощью наиболее известных формул. Для индивидуальной настройки инсулиновой помпы с учетом возрастных особенностей используемые формулы для расчета показателей следует модифицировать путем введения в них поправочных коэффициентов. Ключевые слова: сахарный диабет; помповая инсулинотерапия; постоянная подкожная инфузия инсулина; калькулятор болюсов; углеводный коэффициент; фактор чувствительности к инсулину, базальный режим Age-adjustment of insulin pump settings in children and adolescents with type 1 diabetes mellitus

Adequate glycemic control remains an unresolved problem for children and adolescents with type 1 diabetes mellitus. The use of new insulin analogsand intense insulinotherapy does not always permit to achieve the target levels of glycemia and HbA1c. To-day insulin pump therapy is considered tobe the most efficacious tool for the improvement of glycemic control.Aim. To estimate results of glycemic control in children and adolescents treated by insulin pump therapy. Materials and methods. The study included 173 patients aged 1.5-22 years having the disease for 0.5-20 years. MiniMed 508, MiniMed 712,MiniMed 722, Accu Check Spirit, Accu check D-Tron, Dana Care IIs pumps, ultrashort-acting insulins aspart and lispro were used. The patientsperformed self-control of glycemia 4-8 times during 24 hours. HbA1c was measured before and 12, 24, 36, 48 months after the onset of therapy. Thefrequency of DKA and severe hypoglycemia was recorded. Results. The HbA1c before the onset of therapy was 9.8 ?2.0% and dropped to 8.6; 8.7; 8.7; 8.9 and 9% 12, 24, 36, 48 months after it respectively.DKA was diagnosed in 20 (2.4%) and severe hypoglycemia in 5 patients. All patients in the CSII group were content with the use of the pumps, theabsence of injections and flexible day regimen. Conclusion. One year after the beginning of therapy the level of HbA1c significantly decreased. However, it increased again during a follow-up of5 years probably because of impaired compliance. This fact implies the necessity to regular repeat patient education for raising awareness of and motivationfor self-management.

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 HbA1c 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 HbA1c (<7.5%) from 17% to 36%. The best response was observed for patients under 6 years of age with HbA1c 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 HbA1c compared to the initial values.