RESUMO
In the article "Point-of-care blood glucose testing: post-market performance assessment of the Accu-Chek Inform II hospital-use glucose meter," published in the Terapevticheskii Arkhiv journal, Vol. 95, No.12, 2023 (DOI: 10.26442/00403660.2023.12.202522), errors were made: the term "measurements at the place of treatment" was changed, as well as the section "Conflict of interest." At the request of the authors' team, errors in the conflict of interest and the wording of the term have been corrected, and the section "Information about the authors" has been updated. The publisher replaced the original version of the published article with the corrected one; the information on the website was also corrected. Correct text of the section "Conflict of interest": Conflict of interest. All authors are not employees or consultants of Roche Diagnostics and have not received any compensation from Roche Diagnostics. Correct wording of the term in Russian: "измеÑÐµÐ½Ð¸Ñ Ð¿Ð¾ меÑÑÑ Ð»ÐµÑениÑ". Changes were made to the title of the article in Russian: "ÐзмеÑÐµÐ½Ð¸Ñ Ð³Ð»ÑÐºÐ¾Ð·Ñ Ð¿Ð¾ меÑÑÑ Ð»ÐµÑениÑ: поÑÑÑегиÑÑÑаÑионное иÑпÑÑание гоÑпиÑалÑного глÑкомеÑÑа ÐккÑ-Чек ÐнÑоÑм II", the text of the abstract, keywords, citation, in the text of the article, and abbreviations. Information of the place of work has been updated: Center for Laboratory Diagnostics of the Russian Children Clinical Hospital, a Branch of the Pirogov Russian National Research Medical University. The publisher apologizes to readers and authors for the errors and is confident that the correction of errors will ensure the correct perception and interpretation of the results of the study described in the text.
Assuntos
Glicemia , Humanos , Glicemia/análise , Sistemas Automatizados de Assistência Junto ao Leito , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Testes Imediatos , Vigilância de Produtos Comercializados/métodos , Federação RussaRESUMO
BACKGROUND: A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second - they can't be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children's Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model. AIM: To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD). MATERIALS AND METHODS: Performance of the Accu-Chek Inform II was tested by comparing the results of parallel CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria. RESULTS: The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r=1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%). CONCLUSION: The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics.
Assuntos
Automonitorização da Glicemia , Glicemia , Sistemas Automatizados de Assistência Junto ao Leito , Humanos , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Automonitorização da Glicemia/normas , Federação Russa , Sistemas Automatizados de Assistência Junto ao Leito/normas , Testes Imediatos/normas , Reprodutibilidade dos Testes , Diabetes Mellitus/sangue , Diabetes Mellitus/diagnósticoRESUMO
BACKGROUND: Self-monitoring of blood glucose (SMBG) with glucometers provides only a snapshot of the glycemic profile and is accompanied by significant psychological discomfort and pain, especially in children. Flash Glucose Monitoring System - FreeStyle Libre (FSL) overcomes many of the barriers associated with glucose measurement and improves metabolic control. AIM: To evaluate the efficacy of FSL in children with type 1 diabetes mellitus (T1DM) in terms of glycemic control, episodes of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA). MATERIALS AND METHODS: A multicenter, prospective, observational study in real clinical practice was carried out. A total of 469 subjects (258 boys and 211 girls) aged 4-18 were included in the study. The median age was 11.3 (8.4-14.6) years, duration of T1DM - 4.2 (2.1-7.1) years. After FSL start, patient was followed up for 6 months. RESULTS: After 3 and 6 months of FSL use, HbA1c significantly decreased from 7.4% to 7.1% and 7.2%, respectively (p<0.001). The number of children with HbA1c ><7.5% increased from 51% to 60% and 58% at 3 and 6 months, respectively (p><0.001). The incidence of DKA and SH, as well as the proportion of patients experiencing at least one episode of DKA and SH, were significantly reduced after 6 months of FSL use compared with baseline (p><0.001). CONCLUSION: The Study demonstrated a significant improvement in metabolic control in children with T1DM 6 months after FSL start: decrease in HbA1c, accompanied by reduction in incidence of DKA and SH.