Prospective study of efficacy and safety of insulin pump therapy in children and adolescents

2014

The primary objective of the present study was to analyse the advantages of insulin pump therapy and real time glucose monitoring systems as the tools for reducing the frequency of hypoglycemic episodes. The study included 190 children and adolescents at the age varying from 1 to 18 years suffering from type 1 diabetes mellitus. All the patients were hospitalized at the Endocrinological Research Centre for the treatment the disease using different modalities of insulin therapy, such as multiple injections of insulin (MII) and its continuous subcutaneous infusion (CSII). The blood glucose level was monitored during 72 hours making use of the continuous blind and real time monitoring protocols (blind-CGM and RT-CGM respectively). All the patients were divided into 4 groups depending on the therapeutic modality and the mode of blood glucose monitoring. Group 1 was comprised of the patients given multiple insulin injections in combination with blind glucose monitoring ("blind-CGM + MII"), group 2 included the patients undergoing blind glucose monitoring in conjunction with continuous insulin infusion ("blind-CGM + CSII"), group 3 contained the patients treated by multiple insulin injections followed by real-time blood glucose monitoring ("RT-CGM + MII"), and group 4 was composed of the patients undergoing continuous subcutaneous infusion of insulin combined with real-time blood glucose monitoring ("RT-CGM + CSII"). In all the cases, the blood glucose levels were measured and the occurrence of hypoglycemia during the period of monitoring time was evaluated. It was shown that the highest frequency of hypoglycemia during 72 hours was recorded in the "blind-CGM" group and the lowest one in the RT-CGM groups. Despite adequate self-control, almost half of the patients in the "blind-CGM + MII" group reported at least one hypoglycemic episode either at the daytime or at night ; the duration of such episode was more than 1 hour on the average. In the "blind-CGM" group, CSII resulted in the decrease of the number of hypoglycemic episodes both at night and daytime (p<0.05). In the "RT-CGM + CSII" group, continuous insulin infusion reduced the mean duration of nocturnal hypoglycemic episodes (p<0.05) whereas this parameter was not significantly different between the other groups. It is concluded that hypoglycemia especially nocturnal one is rather a common problem facing children and adolescents suffering from type 1 diabetes mellitus. The use of insulin pump

Section: Discussionunclassified

Section: проблемы эндокринологии 2 2014unclassified

The advantages of insulin pump therapy and real time glucose monitoring systems as the tools for reducing the frequency of hypoglycemic episodes in the children and adolescents with type 1 diabetes mellitus

2014

“…ORIGINAL STUDY Проблемы эндокринологии / Problems of Endocrinology | 51 ОБОСНОВАНИЕ Непрерывная подкожная инфузия инсулина (НПИИ), или помповая инсулинотерапия, является эффективным методом улучшения и поддержания гликемического контроля у детей с сахарным диабетом 1 типа (СД1) [1][2][3][4][5][6][7]. Однако использование НПИИ требует от специалиста-эндокринолога соответствующей квалификации и достаточного опыта, непосредственного участия и контакта врача с пациентом и не всегда сопровождается удовлетворительным гликемическим контролем.…”

unclassified

Remote monitoring and treatment of children and adolescents with type 1 diabetes

Emel'yanov

Самойлова

et al. 2020

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.

“…Значительному росту использования ППИИ у детей способствовало технологическое совершенствование помп и понимание необходимости достижения целевого уровня гликемического контроля для снижения риска развития осложнений СД1. Результаты многих исследований показывают, что ППИИ в педиатрической популяции является безопасным и эффективным методом лечения СД1, обеспечивающим лучший гликемический контроль, значительное снижение частоты гипогликемий и улучшение качества жизни по сравнению с режимом множественных инъекций инсулина [1][2][3][4][5][6].…”

unclassified

Monitoring of insulin pump therapy in children, adolescents, and young adults with type 1 diabetes mellitus in the Russian Federation

Никитич²,

Pereverzeva

et al. 2018

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.