Bolus versus continuous insulin infusion in immediate postoperative blood glucose control in liver transplantation: pragmatic clinical trial

ABSTRACT Objective: To analyze the effectiveness and safety of two insulin therapy techniques (continuous and intermittent infusion) in the blood glucose control of people who have undergone liver transplantation, in the immediate postoperative period. Methods: The study was a prospective, open, pragmatic clinical trial with 42 participants, divided into two groups of 21 patients each, in the immediate postoperative period following liver transplantation. Participants in the Experimental Group and Control Group received continuous infusion and bolus insulin, respectively, starting at capillary blood glucose ≥150mg/dL. Results: There were no statistically significant differences in the blood glucose reduction time to reach the target range between the Experimental Group and Control Group in the transplanted patients (p=0.919). No statistically significant differences regarding the presence of low blood glucose (p=0.500) and in the initial blood glucose value (p=0.345) were found. The study identified the final blood glucose value in postoperative intensive care unit lower and statistically significant in the continuous infusion pump group in relation to the Bolus Group (p<0.001). Additionally, the variation of blood glucose reduction was higher and statistically significant in the continuous method group (p<0.05). Conclusion: The continuous infusion method was more effective in the blood glucose control of patients in the postoperative period following liver transplantation. Brazilian Registry of Clinical Trials: RBR-9Y5tbp

Serial album on Continuous Insulin Infusion System as an innovative educational technology in diabetes / Álbum en serie sobre el Sistema de Infusión Continua de Insulina como tecnología educativa innovadora en diabetes / Álbum seriado sobre Sistema de Infusão Contínua de Insulina como tecnologia educativa inovadora no diabetes

ABSTRACT Objective: to build and validate a serial album content and appearance on insulin therapy using a Continuous Infusion System. Method: a methodological study, carried out in three stages in Fortaleza, Ceará, Brazil, from August to November 2018. The serial album construction and content and appearance validity were carried out by experts, and assessment, by the target audience. Content Validity Index and Concordance Index were calculated. Results: the judges considered the serial album content and appearance to be valid, which means that the material is suitable as an educational technology. Experts suggested adjustments, incorporated into the material for print production of the final version. The target audience also assessed the serial album positively. Conclusion: we realized that the serial album was considered an innovative educational technology in diabetes, valuable for promoting knowledge about Continuous Insulin Infusion System, with rich, updated content, combined with clarity, suitable format and explanatory illustrations.

RESUMEN Objetivo: construir y validar el contenido y la apariencia de un álbum en serie sobre terapia con insulina utilizando un Sistema de Infusión Continua. Método: estudio metodológico, realizado en tres etapas en Fortaleza, Ceará, Brasil, de agosto a noviembre de 2018. La construcción del álbum en serie y la validación de contenido y apariencia fueron realizadas por los especialistas, y evaluación del público objetivo. Se calcularon el Índice de Validez de Contenido y el Índice de Concordancia. Resultados: los jueces consideraron válido el contenido y la apariencia del álbum, lo que significa que el material es apto como tecnología educativa. Los expertos sugirieron ajustes, incorporados al material para la producción impresa de la versión final. El público objetivo también evaluó positivamente el álbum en serie. Conclusión: percibimos que el álbum en serie fue considerado una tecnología educativa innovadora en diabetes, valiosa para la promoción del conocimiento sobre el Sistema de Infusión Continua de Insulina, con contenido rico y actualizado, combinado con claridad, formato adecuado e ilustraciones explicativas.

RESUMO Objetivo: construir e validar conteúdo e aparência de álbum seriado sobre insulinoterapia por Sistema de Infusão Contínua. Método: estudo metodológico, realizado em três etapas em Fortaleza, Ceará, Brasil, nos meses de agosto a novembro de 2018. Realizou-se a construção do álbum seriado e a validação de conteúdo e aparência pelos especialistas, e avaliação do público-alvo. Calcularam-se Índice de Validade de Conteúdo e Índice de Concordância. Resultados: os juízes consideraram válidos o conteúdo e a aparência do álbum, o que representa que o material é adequado como tecnologia educativa. Os especialistas sugeriram ajustes, incorporados ao material para produção impressa da versão final. O público-alvo também avaliou de forma positiva o álbum seriado. Conclusão: percebemos que o álbum seriado foi considerado uma tecnologia educacional inovadora em diabetes, valiosa para a promoção do conhecimento sobre Sistema de Infusão Contínua de Insulina, com conteúdo rico, atualizado, aliado à clareza, formato adequado e ilustrações explicativas.

Uso do sistema de infusão contínua de insulina em crianças e adolescentes com diabetes mellitus tipo 1: revisão de mapeamento sistemático / Use of continuous insulin infusion systems in children and adolescents with type 1 diabetes mellitus

Um dos avanços tecnológicos no tratamento do diabetes mellitus tipo 1 (DM1) é o uso do sistema de Infusão Contínua de Insulina (SICI). Essa revisão sistemática de mapeamento teve como objetivo agrupar e descrever as evidências dos estudos relacionados ao uso do SICI em crianças e adolescentes com DM1. A estratégia de busca foi estruturada a partir da ferramenta PCO, utilizando-se uma combinação de descritores e palavras-chaves. Buscas bibliográficas foram conduzidas nas seguintes bases de dados: PubMed, Embase, CINAHL, Lilacs e PsycINFO, aplicando-se um único filtro, que foi o temporal, delimitando-se a publicação dos estudos até dezembro de 2020. Os critérios de inclusão foram: estudos primários e secundários, quantitativos e qualitativos, que tivessem como objetivo abordar o uso do SICI em crianças e adolescentes (0-18 anos) com DM1; e estudos que abordassem as perspectivas das próprias crianças e adolescentes, dos profissionais de saúde e dos familiares. Constituíram critérios de exclusão: estudos que comparassem a terapia de múltiplas injeções de insulina com a terapia por meio do SICI ou que incluíssem adultos jovens e adultos conjuntamente às crianças e adolescentes, participantes com diabetes mellitus tipo 2 (DM2) ou usuários do SICI com foco no sistema de monitorização contínua de glicose (CGM) ou pâncreas artificial. Utilizou-se o software Rayyan para exclusão das referências duplicadas e para a triagem dos títulos e resumos das referências capturadas, a qual foi conduzida por dois revisores independentes. Os dados dos estudos incluídos foram analisados com auxílio de uma ferramenta de extração adaptada e validada por pesquisadores especialistas em diabetes e com experiência no desenvolvimento de métodos de síntese de conhecimento. Os resultados foram analisados segundo a técnica de análise de conteúdo. Incluiu-se um total de 113 estudos na revisão, dentre eles, estudos originais, revisões de literatura e publicações de literatura cinzenta. Mapas de geocodificação dos estudos foram produzidos com auxílio do software ArcGis 10.5 para ilustrar o local de desenvolvimento dos estudos. A análise geográfica dos estudos possibilitou identificar maior concentração de publicações conduzidas em países desenvolvidos. Esta revisão reuniu as evidências para o uso do SICI em crianças e adolescentes com DM1, as quais foram apresentadas por meio das seguintes categorias: indicações e contraindicações para o uso do SICI; controle metabólico; redes de apoio; e benefícios e desafios do uso do SICI. As indicações para o uso do SICI superam as contraindicações. Apesar de grande parte dos estudos evidenciar melhora do controle metabólico de crianças e adolescentes em uso do SICI, a piora desse controle foi descrita em algumas pesquisas, o que sugere que esse parâmetro não deve ser analisado de forma isolada. As redes de apoio foram citadas como um dos fatores que influenciam os parâmetros de controle metabólico, conformando as subcategorias: apoio familiar e apoio da equipe de saúde e escola. Foram elencados desafios para o uso do SICI na população pediátrica, porém, vale ressaltar que parte destes desafios tem sido superada com o avanço da ciência e da tecnologia moderna. Múltiplos benefícios também foram descritos na literatura, os quais podem auxiliar profissionais de saúde na tomada de decisão para a melhor escolha e acompanhamento do tratamento do DM1 em crianças e adolescentes. Esta revisão reúne evidências sobre o uso do SICI em crianças e adolescentes com DM1 e contribui com o corpo de conhecimento relacionado à temática

One of the technological advances in type 1 diabetes mellitus (T1DM) treatment is the use of Continuous Subcutaneous Insulin Infusion (CSII). The aim of this systematic mapping review was to group and describe the evidence from research on the use of CSII in children and adolescents with T1DM. The search strategy was structured based on the PCO tool, using a combination of descriptors and keywords. Bibliographic searches were undertaken in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, applying a single time-based filter to delimit the publication of studies until December 2020. The inclusion criteria were: primary and secondary studies, quantitative and qualitative, aimed at discussing the use of CSII in children and adolescents (0-18 years) with T1DM; and studies addressing the perspectives of the actual children and adolescents, the health professionals and Family members. Exclusion criteria were: studies that compared multiple insulin injection therapy with therapy using CSII or that included young adults and adults together with the children and adolescents, participants with type 2 diabetes mellitus (T2DM), or with CSII users focusing on the continuous glucose monitoring (CGM) system or artificial pancreas. The software Rayyan was used to exclude duplicated references and to screen the titles and abstracts of the collected references, which was conducted by two independent reviewers. The data from the included studies were analyzed with the help of an extraction tool, adapted and validated by researchers with diabetes expertise and knowledgeable on the development of knowledge synthesis methods. The content analysis technique was used to analyze the results. In total, 113 studies were included in the review, covering original studies, literature reviews and grey literature publications. Geocoding maps of the studies were produced in ArcGis 10.5 to illustrate where the studies had been developed. Through the geographic analysis of the studies a greater concentration of publications in developed countries was identified. This review gathered evidence on the use of CSII in children and adolescents with T1DM, presented in the following categories: indications and contraindications for the use of CSII; metabolic control; support networks; and benefits and challenges of CSII use. The indications in favor of using CSII outweigh the contraindications. Although most of the studies evidence improved metabolic control in children and adolescents who use CSII, some studies described worse control, suggesting that this parameter should not be analyzed in isolation. The support networks were mentioned as one of the factors that influence the metabolic control parameters. This category includes the following subcategories: family support and support from the health team and school. Challenges were listed for the use of CSII in the pediatric population, although it should be highlighted that advanced science and modern technology have overcome some of these. Multiple benefits have also been described in the literature, which can help health professionals to make decisions in order to better choose and monitor T1DM treatment in children and adolescents. This review gathers evidence on the use of CSII in children and adolescents with T1DM and contributes to the body of knowledge on the theme

Uso do sistema de infusão contínua de insulina em crianças e adolescentes com diabetes mellitus tipo 1: revisão de mapeamento sistemático / Use of continuous insulin infusion systems in children and adolescents with type 1 diabetes mellitus

Um dos avanços tecnológicos no tratamento do diabetes mellitus tipo 1 (DM1) é o uso do sistema de Infusão Contínua de Insulina (SICI). Essa revisão sistemática de mapeamento teve como objetivo agrupar e descrever as evidências dos estudos relacionados ao uso do SICI em crianças e adolescentes com DM1. A estratégia de busca foi estruturada a partir da ferramenta PCO, utilizando-se uma combinação de descritores e palavras-chaves. Buscas bibliográficas foram conduzidas nas seguintes bases de dados: PubMed, Embase, CINAHL, Lilacs e PsycINFO, aplicando-se um único filtro, que foi o temporal, delimitando-se a publicação dos estudos até dezembro de 2020. Os critérios de inclusão foram: estudos primários e secundários, quantitativos e qualitativos, que tivessem como objetivo abordar o uso do SICI em crianças e adolescentes (0-18 anos) com DM1; e estudos que abordassem as perspectivas das próprias crianças e adolescentes, dos profissionais de saúde e dos familiares. Constituíram critérios de exclusão: estudos que comparassem a terapia de múltiplas injeções de insulina com a terapia por meio do SICI ou que incluíssem adultos jovens e adultos conjuntamente às crianças e adolescentes, participantes com diabetes mellitus tipo 2 (DM2) ou usuários do SICI com foco no sistema de monitorização contínua de glicose (CGM) ou pâncreas artificial. Utilizou-se o software Rayyan para exclusão das referências duplicadas e para a triagem dos títulos e resumos das referências capturadas, a qual foi conduzida por dois revisores independentes. Os dados dos estudos incluídos foram analisados com auxílio de uma ferramenta de extração adaptada e validada por pesquisadores especialistas em diabetes e com experiência no desenvolvimento de métodos de síntese de conhecimento. Os resultados foram analisados segundo a técnica de análise de conteúdo. Incluiu-se um total de 113 estudos na revisão, dentre eles, estudos originais, revisões de literatura e publicações de literatura cinzenta. Mapas de geocodificação dos estudos foram produzidos com auxílio do software ArcGis 10.5 para ilustrar o local de desenvolvimento dos estudos. A análise geográfica dos estudos possibilitou identificar maior concentração de publicações conduzidas em países desenvolvidos. Esta revisão reuniu as evidências para o uso do SICI em crianças e adolescentes com DM1, as quais foram apresentadas por meio das seguintes categorias: indicações e contraindicações para o uso do SICI; controle metabólico; redes de apoio; e benefícios e desafios do uso do SICI. As indicações para o uso do SICI superam as contraindicações. Apesar de grande parte dos estudos evidenciar melhora do controle metabólico de crianças e adolescentes em uso do SICI, a piora desse controle foi descrita em algumas pesquisas, o que sugere que esse parâmetro não deve ser analisado de forma isolada. As redes de apoio foram citadas como um dos fatores que influenciam os parâmetros de controle metabólico, conformando as subcategorias: apoio familiar e apoio da equipe de saúde e escola. Foram elencados desafios para o uso do SICI na população pediátrica, porém, vale ressaltar que parte destes desafios tem sido superada com o avanço da ciência e da tecnologia moderna. Múltiplos benefícios também foram descritos na literatura, os quais podem auxiliar profissionais de saúde na tomada de decisão para a melhor escolha e acompanhamento do tratamento do DM1 em crianças e adolescentes. Esta revisão reúne evidências sobre o uso do SICI em crianças e adolescentes com DM1 e contribui com o corpo de conhecimento relacionado à temática

One of the technological advances in type 1 diabetes mellitus (T1DM) treatment is the use of Continuous Subcutaneous Insulin Infusion (CSII). The aim of this systematic mapping review was to group and describe the evidence from research on the use of CSII in children and adolescents with T1DM. The search strategy was structured based on the PCO tool, using a combination of descriptors and keywords. Bibliographic searches were undertaken in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, applying a single time-based filter to delimit the publication of studies until December 2020. The inclusion criteria were: primary and secondary studies, quantitative and qualitative, aimed at discussing the use of CSII in children and adolescents (0-18 years) with T1DM; and studies addressing the perspectives of the actual children and adolescents, the health professionals and Family members. Exclusion criteria were: studies that compared multiple insulin injection therapy with therapy using CSII or that included young adults and adults together with the children and adolescents, participants with type 2 diabetes mellitus (T2DM), or with CSII users focusing on the continuous glucose monitoring (CGM) system or artificial pancreas. The software Rayyan was used to exclude duplicated references and to screen the titles and abstracts of the collected references, which was conducted by two independent reviewers. The data from the included studies were analyzed with the help of an extraction tool, adapted and validated by researchers with diabetes expertise and knowledgeable on the development of knowledge synthesis methods. The content analysis technique was used to analyze the results. In total, 113 studies were included in the review, covering original studies, literature reviews and grey literature publications. Geocoding maps of the studies were produced in ArcGis 10.5 to illustrate where the studies had been developed. Through the geographic analysis of the studies a greater concentration of publications in developed countries was identified. This review gathered evidence on the use of CSII in children and adolescents with T1DM, presented in the following categories: indications and contraindications for the use of CSII; metabolic control; support networks; and benefits and challenges of CSII use. The indications in favor of using CSII outweigh the contraindications. Although most of the studies evidence improved metabolic control in children and adolescents who use CSII, some studies described worse control, suggesting that this parameter should not be analyzed in isolation. The support networks were mentioned as one of the factors that influence the metabolic control parameters. This category includes the following subcategories: family support and support from the health team and school. Challenges were listed for the use of CSII in the pediatric population, although it should be highlighted that advanced science and modern technology have overcome some of these. Multiple benefits have also been described in the literature, which can help health professionals to make decisions in order to better choose and monitor T1DM treatment in children and adolescents. This review gathers evidence on the use of CSII in children and adolescents with T1DM and contributes to the body of knowledge on the theme

Custo direto da judicialização dos sistemas de infusão contínua de insulina (Sici) no município do Rio de Janeiro / Direct cost of the judicialization of continuous insulin infusion systems (Sici) in the city of Rio de Janeiro

Objetivo: Estimar o custo direto anual da judicialização dos sistemas de infusão contínua de insulina (Sici), no município do Rio de Janeiro, entre 2015 e 2017, e analisar as características dos processos relacionados à referida tecnologia. Métodos: Estudo transversal descritivo que analisou os pareceres técnicos emitidos pelo Núcleo de Assessoria Técnica em Ações de Saúde e os respectivos processos judiciais. As informações relacionadas aos custos foram provenientes do relatório de solicitação de empenho da Central de Atendimento às Demandas Judiciais do Estado do Rio de Janeiro e de orçamentos fornecidos pelos fabricantes/distribuidores. Resultados: Foram avaliados 189 processos emitidos. A média de idade dos autores dos processos foi de 25,1 anos e 57,1% eram do sexo feminino. Em 98 casos (51,9%), o documento utilizado no processo foi proveniente de médicos da rede pública de saúde. O juiz deferiu o pleito em 153 processos (80,9%). De um total de 75 médicos prescritores, nove foram responsáveis por 43,9% das prescrições, demonstrando uma concentração das prescrições em determinados profissionais. O valor estimado de custo direto acumulado (2015- 2017) decorrente da judicialização dos Sici, no município do Rio de Janeiro, corresponde a R$ 6,9 milhões, o que representa 6,7% dos gastos de judicialização da saúde no mesmo período. Conclusão: Considerando que a tecnologia analisada é recorrentemente judicializada, os dados coletados podem gerar informações úteis para os gestores governamentais da área da saúde, na avaliação da eficiência na alocação dos recursos públicos, para os profissionais que trabalham na assistência judiciária e para os juízes.

Objective: To estimate the annual direct cost of the Judicialization of Continuous Insulin Infusion Systems (Sici), in the city of Rio de Janeiro, between 2015 and 2017. Methods: It is a cross sectional study that analyzed the technical opinions on the Sici issued by the Core of Technical Advice on Health Actions and the respective judicial processes. The information related to the costs was obtained from the Report of Request for Compromise provided by the Center of Attendance to the Lawsuits of the state of Rio de Janeiro and budgets of the manufacturer /distributors. Results: There were 189 processes and the average age of the authors was 25.1 years and that the majority was female (57.1%). In 98 cases (51.9%) the document used in the process came from doctors of the public health network. The judge granted the suit in 153 cases (80.9%). Nine physicians were responsible for 43.9% of the prescriptions, out of a total of 75 prescribing physicians, demonstrating a concentration of prescribing physicians. The estimated value of accumulated direct cost (2015-2017), due to the Sici's judicialization in the city of Rio de Janeiro, corresponds to R$ 6.9 million, which represents 6.7% of health care expenditures in the same period. Conclusion: Considering that the technology under review is repeatedly judicialized, the data collected can generate useful information to public healthcare decision makers, the evaluation of efficiency in the allocation of public resources, and professionals working in legal aid or for the judges themselves.

Survey on hypoglycemia among insulin-treated patients with diabetes: The Colombian International Operations Hypoglycemia Assessment Tool population / Encuesta sobre hipoglucemia en pacientes con diabetes tratados con insulina: la población colombiana del International Operations Hypoglycemia Assessment Tool

Abstract Introduction: The non-interventional International Operations Hypoglycemia Assessment Tool (IO-HAT) study assessed the incidence of hypoglycemia in patients with insulin-treated diabetes across nine countries, including a cohort of patients in Colombia. Materials and methods: Hypoglycemia incidence among patients with insulin-treated diabetes was assessed across 26 sites in Colombia. Hypoglycaemic events (any, nocturnal or severe) were reported in self-assessment questionnaires (SAQ) and patient diaries based on capillary blood glucose measurement or symptoms. Retrospective events (severe events 6 months before baseline and any event 4 weeks before baseline) were recorded in SAQ, Part 1, and prospective events (4 weeks from baseline) were recorded in SAQ, Part 2, and patient diaries. Differences in hypoglycemia incidence reported in the retrospective and prospective periods were assessed using two-sided tests. Results: Of the 664 patients assessed, 213 had type 1 diabetes (T1D) and 451 had type 2 diabetes (T2D). Nearly all patients experienced at least one hypoglycaemic event in the prospective period (97.1% T1D; 93.3% T2D). Rates of hypoglycemia (events per person- year, PPY) were higher prospectively than retrospectively for any hypoglycemia (T1 D: 121.6 vs. 83.2, p<0.001; T2D: 28.1 vs. 24.6, p=0.127) and severe hypoglycemia (T 1D: 15.3 vs. 9.2, p=0.605; T 2 D: 9.5 vs. 3.5 p=0.040). Conclusion: These results, the first from a patient-reported dataset on hypoglycemia in insulin-treated patients with diabetes in Colombia, show that patients reported higher rates of any hypoglycemia during the prospective period.

Resumen Introducción. En el estudio no intervencionista International Operations Hypoglycemia Assessment Tool (IO-HAT), se evalúo la incidencia de hipoglucemia en pacientes diabéticos tratados con insulina en nueve países, incluido Colombia. Materiales y métodos. La incidencia de hipoglucemia entre pacientes diabéticos tratados con insulina se evaluó en 26 centros médicos en Colombia. Los episodios de hipoglucemia determinados con base en la medición de la glucemia capilar o en los síntomas se reportaron en el cuestionario de autoevaluación (Self-Assessment Questionnaire, SAQ) y en el diario del paciente. Los episodios retrospectivos (episodios graves y cualquiera ocurrido 6 meses y 4 semanas antes del inicio del estudio, respectivamente) se registraron en el SAQ, parte 1, y los eventos prospectivos (4 semanas desde el inicio), en el SAQ, parte 2, y en el diario del paciente. Las diferencias en la incidencia de la hipoglucemia entre los períodos retrospectivo y prospectivo se evaluaron mediante una prueba de dos colas. Resultados. De los 664 pacientes evaluados, 213 tenían diabetes de tipo 1 y 451 tenían diabetes de tipo 2. Casi todos los pacientes experimentaron al menos un episodio de hipoglucemia en el período prospectivo (97,1 %, diabetes de tipo 1, y 93,3 %, diabetes de tipo 2). Los índices de hipoglucemia (episodios año-persona) fueron mayores prospectivamente que retrospectivamente para cualquier tipo de hipoglucemia (diabetes de tipo 1: 121,6 Vs. 83,2; p<0,001; la diabetes de tipo 2: 28,1 Vs. 24,6; p=0,127) y para la hipoglucemia grave (diabetes de tipo 1: 15,3 Vs. 9,2; p=0,605; diabetes de tipo 2: 9,5 Vs. 3,5; p=0,040). Conclusión. Estos resultados, que constituyen el primer conjunto de datos sobre hipoglucemia informados por pacientes diabéticos colombianos tratados con insulina, evidenciaron tasas más altas para ambos tipos de hipoglucemia durante el período prospectivo.

Características clínicas, esquemas de tratamiento, grado de control y variables asociadas a este en una cohorte de adultos con diabetes mellitus tipo 1 en un centro terciario / Clinical features and management of 205 adults with type 1 diabetes mellitus

Background: Few studies have evaluated the details of insulin therapy for type 1 diabetes mellitus (T1D) in Chile. Aim: To describe clinical features and treatment details of adults with T1D and its association with metabolic control. Material and Methods: Review of medical records of patients with T1D treated in a clinical network. Demographic and clinical features, types and doses of insulin and glycated hemoglobin levels were registered. The use flash glucose monitors (FGM) and insulin pumps (CSII) were also recorded. Results: 205 records were reviewed, with T1d lasting 12 ± 10 years. Twenty six percent had hypothyroidism, 1% had celiac disease, 12% had hypertension, 20% had dyslipidemia; 13% had diabetic retinopathy, 2% had diabetic nephropathy, 8% had neuropathy and 2% cardiovascular diseases. Mean body mass index was 25 kg/ m2 and mean glycated hemoglobin was 8%. Eighty-two percent used multiple daily injections, 18% used CSII and 24% used FGM. As basal insulin, 35% used slow acting analogs and 65% used ultra-slow analogs. As rapid acting insulin, 69 patients used Lispro, 79 Aspart and 50 Glulisin. Bolus doses were calculated using only capillary glucose in 22%, while 78% also considered carbohydrate consumption. Variables significantly associated to better control were the use of carbohydrates for dosing rapid insulin (A1c 7,85% vs 8,59%, p = 0,008), use of CSII (A1c 7,36% vs 8,16%, p = 0,008), and basal dose < 0,4 U/kg (A1c 7,81% vs 8,58%, p = 0,003). There were no differences regarding insulin type or use of FGM. Conclusions: The use of formulas considering carbohydrates for dosing rapid insulin, use of infusion pumps and physiological doses of basal insulin are significantly associated with a better metabolic control in adults with T1d.

Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

By providing blood glucose (BG) concentration measurements in an almost continuous-time fashion for several consecutive days, wearable minimally-invasive continuous glucose monitoring (CGM) sensors are revolutionizing diabetes management, and are becoming an increasingly adopted technology especially for diabetic individuals requiring insulin administrations. Indeed, by providing glucose real-time insights of BG dynamics and trend, and being equipped with visual and acoustic alarms for hypo- and hyperglycemia, CGM devices have been proved to improve safety and effectiveness of diabetes therapy, reduce hypoglycemia incidence and duration, and decrease glycemic variability. Furthermore, the real-time availability of BG values has been stimulating the realization of new tools to provide patients with decision support to improve insulin dosage tuning and infusion. The aim of this paper is to offer an overview of current literature and future possible developments regarding CGM technologies and applications. In particular, first, we outline the technological evolution of CGM devices through the last 20 years. Then, we discuss about the current use of CGM sensors from patients affected by diabetes, and, we report some works proving the beneficial impact provided by the adoption of CGM. Finally, we review some recent advanced applications for diabetes treatment based on CGM sensors.

Therapeutic effect of insulin pump combined alprostadil on diabetic peripheral neuropathy in aged pa-tients / 心血管康复医学杂志

Objective :To explore therapeutic effect of insulin pump combined alprostadil on diabetic peripheral neu-ropathy (DPN) in aged patients .Methods : A total of 134 aged DPN patients treated in our hospital were selected and randomly , equally divided into routine treatment group and combined treatment group (received insulin pump combined alprostadil based on routine treatment ) ,both groups were treated for two weeks .Therapeutic effect ,lev-els of blood lipids ,serum superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) before and after treat-ment were compared between two groups .Results : After treatment , total effective rate of combined treatment group was significantly higher than that of routine treatment group (92-5% 比74-6%, P＝0-005).Compared with routine treatment group after treatment ,there were significant rise in serum levels of SOD [ (78-54 ± 9-48) nU／ml vs.(88-29 ± 9-08) nU／ml] ,GSH-Px [(486-53 ± 32-84) U／L vs.(552-31 ± 89-86) U／L] and high density lipopro-tein cholesterol [HDL-C ,(5-88 ± 1-48) mmol／L vs.(6-59 ± 1-63) mmol／L] ,and significant reductions in serum levels of triglyceride [TG ,(2-05 ± 0-34) mmol／L vs.(1-35 ± 0-26) mmol／L] and low density lipoprotein choles-terol [LDL-C ,(3-48 ± 0-48 ) mmol／L vs.(2-48 ± 0-88 ) mmol／L ] in combined treatment group , P＝ 0-001 all. Conclusion : Insulin pump combined alprostadil possess significant therapeutic effect on aged DPN patients .It can significantly improve blood lipid levels ,and relieve oxidative stress state ,which is worth extending .

Indicators for best practices in glycemic control in the intensive care unit / Indicativos para mejores prácticas en el control glicémico en una unidad de terapia intensiva / Indicativos para melhores práticas no controle glicêmico em unidade de terapia intensiva

Abstract Objective: To understand the perception of the nursing team' regarding the management of the intensive glycemic control protocol in order to obtain better practices in glycemic control in the Intensive Care Unit of a University Hospital. Method: A qualitative, convergent care study carried out in an Intensive Care Unit of a university hospital. The data were collected through interviews and workshops and analyzed through thematic analysis. Thirty nursing professionals participated in the study. Results: The importance of the glycemic control protocol which standardizes and guides care was reported by the participants, however they indicated that the used protocol is confusing, difficult to understand and does not include some important guidelines. Restructuring was recommended by adding aspects such as: the desired glycemic value, spaces between glycaemia recording, diet and others; as well as training for its application. Conclusion: The participants recognized the weaknesses of the protocol, and reaffirmed the potentialities of this instrument and defended permanent education as a fundamental factor for the best practices in intensive care.

Resumen Objetivo: Conocer la percepción del equipo de enfermería sobre el manejo del protocolo de control glicémico intensivo, con el objetivo de obtener mejores prácticas en el control glicémico en la Unidad de Terapia Intensiva de un Hospital Universitario. Método: Estudio cualitativo y convergente asistencial realizado en una Unidad de Terapia Intensiva de un hospital universitario. Los datos fueron obtenidos através de entrevistas y talleres y analizados através del análisis temático. Participaron del estudio 30 profesionales de enfermería. Resultados: Relatan la importancia del protocolo de control glicémico que estandariza y guía la asistencia. Sin embargo, refieren que el protocolo utilizado es confuso, difícil de entender y no contempla algunas orientaciones importantes. Recomiendan su reestructuración agregando aspectos como: valor de glicemía pretendido, espaciamiento entre glicemías, dieta y otros, y la capacitación para su ejecución. Conclusión: Reconocen las fragilidades del protocolo utilizado, reafirman las potencialidades de este instrumento y defienden la educación permanente como factor fundamental para mejores prácticas en terapia intensiva.

Resumo Objetivo: Conhecer a percepção da equipe de enfermagem quanto ao manejo do protocolo de controle glicêmico intensivo, com vistas a obter melhores práticas no controle glicêmico na Unidade de Terapia Intensiva de um Hospital Universitário. Método: Estudo qualitativo, convergente assistencial, realizado em Unidade de Terapia Intensiva de um hospital universitário. Os dados foram coletados através de entrevistas e oficinas e analisados por meio da análise temática. Participaram do estudo 30 profissionais de enfermagem. Resultados: Relatam a importância do protocolo de controle glicêmico, que padroniza e guia a assistência, entretanto referem que o protocolo utilizado é confuso, difícil de entender não contemplando algumas orientações importantes. Recomendam sua reestruturação acrescentando aspectos como: valor de glicemia pretendido, espaçamento entre glicemias, dieta e outros; bem como capacitação para sua execução. Conclusão: Reconhecem as fragilidades do protocolo utilizado, reafirmam as potencialidades desse instrumento e defendem a educação permanente como fator fundamental para as melhores práticas em terapia intensiva.

Bombas de insulina en diabetes tipo 2, del fundamento a la práctica / Pumps in Type 2 diabetes, from basics to practice

Resumen Las bombas de insulina han sido usadas por más de 35 años, principalmente en pacientes con diabetes tipo 1 y en menor medida en diabetes tipo 2. En esta última población hay una liberación más funcional de insulina, se puede prevenir el fenómeno de alba y mantener por más tiempo los niveles adecuados de glucemia. Las indicaciones de bomba en diabetes tipo 2 son poco claras, pero los que tal vez más se benefician son aquellos con historia de mal control metabólico, hipoglucemias severas o asintomáticas. El uso de esta tecnología durante la hospitalización ha sido difícil, principalmente por el desconocimiento del personal de salud en su uso; no obstante, se ha demostrado que es factible mantener a los pacientes en esta terapia mientras están hospitalizados, siempre y cuando se tenga un adecuado protocolo, disposición del personal y educación del paciente. El costo ha sido una de las cuestiones más controversiales con el uso de estos sistemas. Los análisis de costo-efectividad han encontrado una disminución del número de hipoglucemiantes orales, las visitas a urgencias y las dosis de insulina, llegando algunos a aseverar que en tres años podrían compensarse los costos.

Abstract Insulin pumps have been used for over 35 years, mostly in patients with type 1 diabetes and to a lesser extent in type 2 diabetes. The use of pumps in this population is supported by a more physiological release of insulin, prevention of the dawn phenomenon and enabling patients to achieve better glucose targets. Pump indications in type 2 diabetes are less clear than in patients with type 1, but perhaps those who benefit most, are patients with a history of significant glycemic excursions, severe or asymptomatic hypoglycemia. Pump management as inpatient has been limited by lack of personal knowledge, however it has been reported that it is feasible to keep patients who are using this technology to continue it while they are in the hospital provided that a suitable protocol has been standardized and the patient has enough knowledge. Costs have been one of the most controversial issues with the use of these technology, cost-effectiveness analysis have found that there is a decrease in the number of oral agents, emergency room visits and insulin doses, reaching some studies to conclude that three years could offset the pump cost.

De la bomba de insulina y el monitoreo continuo de glucosa al páncreas artificial / From insulin pump and continuous glucose monitoring to the artificial pancreas

Technology for diabetes care has undergone major development during recent decades. These technological advances include continuous subcutaneous insulin infusion (CSII), also known as insulin pumps, and real-time continuous glucose monitoring system (RT-CGMS). The integration of CSII and RT-CGMS into a single device has led to sensor-augmented pump therapy and more recently, a technology that has automated delivery of basal insulin therapy, known as hybrid system. These new technologies have led to benefits in attaining better metabolic control and decreasing the incidence of severe hypoglycemia, especially in patients with type 1 diabetes. This review describes the types of technologies currently available or under investigation for these purposes, their benefits and disadvantages, recommendations and the appropriate patient selection for their use. The clinical use of the hybrid system and artificial pancreas seem to be possible in the near future.

Impact of targeted education on managing warning and error signals by children and adolescents with type 1 diabetes using the Accu-Chek Combo Insulin Pump System

PURPOSE: Insulin pumps are widely used in diabetes. They are equipped with safety alarms to alert users. Pump manuals contain alarm codes and how to troubleshoot them. However, these manuals are lengthy and difficult to use, particularly in emergencies. We aim to assess the impact of targeted education on warnings and errors in improving competency to troubleshoot the alarms. METHODS: Twenty-one patients, with a median age of 13, were recruited over a 5-month period. Each patient had 2 study visits. The frequencies and types of alarms were recorded, and patients were given a summary sheet that outlined common alarms encountered and troubleshooting tips. In visit 2, the frequencies and types of alarms were compared to those of visit 1. The patients were asked to fill a questionnaire and to rate the education session given in visit 1, their level of competency in decrypting alarm codes, and their promptness in responding to alarms. RESULTS: Low cartridge (W1), low battery (W2), and bolus cancelled (W8) were the commonest warnings. The most noted errors were occlusion (E4), power interruption (E8), empty battery (E2), set not primed (E11), and cartridge empty (E1). The numbers of warning and error signals markedly decreased after targeted education (P < 0.05). The ability in decrypting warning signals significantly improved (P=0.02), and the frequency of response to pump alarms significantly increased (P=0.001). CONCLUSION: Certain warnings and errors are more common than others in insulin pumps. Targeted education is useful in improving competency and response of patients in managing pump alarms.

Infusão subcutânea contínua de insulina: cenário nacional e internacional / Continuous subcutaneous insulin infusion: national and international scenario

Resumo Introdução O sistema de bomba de infusão contínua de insulina (SIC) é uma alternativa à aplicação múltipla diária de insulina por pacientes diabéticos. Embora apresente inúmeras vantagens, a sua disponibilidade no sistema público de saúde ainda é muito baixa. Esse trabalho objetivou identificar práticas e experiências de secretarias e organizações de saúde quanto à utilização do SIC. Método Foram aplicados questionários às secretarias de saúde dos Estados brasileiros (SES) e às organizações internacionais de avaliação de tecnologias em saúde (ATS). Resultados A maioria das SES (83%) tem recebido demandas judiciais, com um aumento de uso do SIC nos últimos cinco anos. As organizações internacionais informaram que, em 47% dos países pesquisados, o SIC é disponibilizado à população pelo governo por meio do sistema de saúde público. Conclusão O uso do SIC resulta em vários benefícios, contudo está atrelado a um custo adicional anual de cerca de R$9.500,00 por paciente. Portanto é evidente a necessidade de se realizar estudos para avaliar a incorporação do SIC e seu impacto orçamentário no sistema de saúde brasileiro, além de definir em quais circunstâncias ele será disponibilizado à população.

Abstract Introduction The Continuous Subcutaneous Insulin Infusion pump system (CSII) is an alternative to multiple daily administration of insulin in diabetic patients. Although it has many advantages, its availability in the public health system is still very low. This study aimed to identify practices and experiences of health departments and organizations on the use of CSII. Method Questionnaires were applied to Brazilian Health Departments of the States (SES) and international organizations for health technologies evaluation. Results Most of the SES (83%) have received lawsuits and the use of CSII has increased in the last 5 years. International organizations reported that in 47% of countries, the CSII is available to patients through the public health system. Conclusion The use of CSII brings several benefits, but also a high annual additional cost of approximately R$ 9,500 per patient. Therefore, there is an evident need to conduct studies assessing the incorporation of CSII, its budgetary impact in the Brazilian health system, and the definition of which circumstances this will be made available to the population.

Continuous insulin therapy versus multiple insulin injections in the management of type 1 diabetes: a longitutinal study / Insulinoterapia contínua versus múltiplas injeções de insulina no tratamento da diabetes tipo 1: um estudo longitudinal

To compare multiple doses of insulin and continuous insulin infusion therapy as treatment for type 1 diabetes mellitus. Methods: 40 patients with type 1 diabetes mellitus (21 female) with ages between 10 and 20 years (mean=14.2) and mean duration of diabetes of 7 years used multiple doses of insulin for at least 6 months and after that, continuous insulin infusion therapy for at least 6 months. Each one of the patients has used multiple doses of insulin and continuous insulin infusion therapy. For analysis of HbA1c, mean glycated hemoglobin levels (mHbA1c) were obtained during each treatment period (multiple doses of insulin and continuous insulin infusion therapy period). Results: Although mHbA1c levels were lower during continuous insulin infusion therapy the difference was not statistically significant. During multiple doses of insulin, 14.2% had mHbA1c values below 7.5% vs. 35.71% while on continuous insulin infusion therapy; demonstrating better glycemic control with the use of continuous insulin infusion therapy. During multiple doses of insulin, 15–40 patients have severe hypoglycemic events versus 5–40 continuous insulin infusion therapy. No episodes of ketoacidosis events were recorded. Conclusions: This is the first study with this design comparing multiple doses of insulin and continuous insulin infusion therapy in Brazil showing no significant difference in HbA1c; hypoglycemic events were less frequent during continuous insulin infusion therapy than during multiple doses of insulin and the percentage of patients who achieved a HbA1c less than 7.5% was greater during continuous insulin infusion therapy than multiple doses of insulin therapy.

Comparar terapia com múltiplas doses de insulina e o sistema de infusão continua de insulina no tratamento da diabetes melito tipo 1. Métodos: 40 pacientes com diabetes melito tipo 1 (21 mulheres) com idades entre 10 e 20 anos (média=14,2) e duração média do diabetes de sete anos utilizaram múltiplas doses de insulina durante pelo menos seis meses e, depois disso, sistema de infusão continua de insulina por pelo menos seis meses. Todos os pacientes usaram múltiplas doses de insulina e sistema de infusão continua de insulina. Para a análise de HbA1c, níveis médios de hemoglobina glicada (mHbA1c) foram obtidos em cada período de tratamento (múltiplas doses de insulina e sistema de infusão continua de insulina). Resultados: Embora os níveis de mHbA1c tenham sido menores com o uso de sistema de infusão continua de insulina a diferença não foi estatisticamente significante. Durante o uso de múltiplas doses de insulina, 14,2% tiveram valores de mHbA1c <7,5% vs. 35,71% quando usando sistema de infusão continua de insulina; demonstrando melhor controle glicêmico com o uso de sistema de infusão continua de insulina. Durante o uso de múltiplas doses de insulina, 15-40 pacientes tiveram eventos hipoglicêmicos graves contra 5–40 com sistema de infusão continua de insulina. Não foram registrados episódios de cetoacidose. Conclusões: Esse é o primeiro estudo cujo desenho comparou o uso de múltiplas doses de insulina e sistema de infusão continua de insulina no Brasil, não demonstrando nenhuma diferença significativa nos níveis de HbA1c. Eventos hipoglicêmicos foram menos frequentes com o uso de sistema de infusão continua de insulina do que com múltiplas doses de insulina e a porcentagem de pacientes que obteve um HbA1c <7,5% foi maior com sistema de infusão continua de insulina do que com múltiplas doses de insulina.

Progress of management and standardization strategy research in diabetics with insulin pump therapy outside hospital / 中国实用护理杂志

The role of insulin pump in the treatment of diabetes is becoming more and more significant. Based on the systematic literature review, collation and analysis, this article introduces the management of insulin pump outside the hospital from the development trend of insulin pump, application and common problems. In order to enhance the therapeutic satisfaction of patients and improve their quality of life, our aims are to put forward the strategy of standardized management and provide a reference for establishing and improving the standardized management system of insulin pump therapy outside hospital.

Efficacy and safety of short-term sensor-augmented insulin-pump therapy for poorly controlled patients with type 1 diabetes mellitus / 中华全科医师杂志

Objective To evaluate the efficacy and safety of short-term sensor-augmented insulin-pump (SAP) therapy for poorly controlled patients with type 1 diabetes mellitus (T1DM).Methods Sixty T1DM patients with glycosylated hemoglobin (HbA1c)>9.0% were randomly assigned to 2 groups treated with SAP or multiple daily insulin injection ( MDI) for 6 days, then all patients converted to MDI therapy. Results Compared with MDI group and before therapy, the mean blood glucose concentration ( MBG) , SD of blood glucose, mean amplitude of glycemic excursion ( MAGE) and 24-h area under curve at 10.0 ( AUC10.0 ) levels in SAP group significantly decreased after 6-day therapy ( compared with MDI group:t=1.761,P=0.028, t=2.569,P=0.037, t=2.712,P=0.020, t=2.985,P=0.014, compared with before therapy:t=3.128,P=0.006, t=2.689,P=0.024, t=2.966,P=0.013, t=3.076,P=0.009);while there was no difference in 24-h area under curve at 3.9 (AUC3.9) between groups (P>0.05).After 1 month follow-up HbA1c levels decreased in SAP group (t=2.344,P=0.023) and were significantly lower than those in MDI group (t=1.844, P=0.035).There was no difference in daily insulin dosage, fasting C peptide (FCP) and postprandial 2h C peptide (2hCP) between two groups (P>0.05).Age (t=2.125, P=0.012) and SAP therapy (t=3.376, P=0.009) were independently correlated with the HbA1c after 1 month.Conclusion Short-term SAP therapy is effective and safe for poorly controlled T1DM patients with rapid glucose lowering and glycemic excursions reduction.

Comparison of therapeutic effect of different insulin administration route in treatment of juvenile type 1 diabetes mellitus / 天津医药

Objective To compare the therapeutic efficacy of two different administration routes of insulin administra?tion on juvenile type 1 diabetes mellitus (T1DM) complicated with diabetic ketoacidosis(DKA). Methods A total of 223 cases of juvenile T1DM was included in this study, among which 98 were complicated with DKA. Insulin was delivered through either continuous subcutaneous insulin infusion(CSII) by insulin pump or via multiple subcutaneous insulin injec?tion (MSII). Recovery period of blood glucose, insulin doses that were adminstrated, the urinary ketone bodies clearance time, the recovering time from DKA and the frequency of hypoglycemia incidence were all compared between these two routes. Results Both CSII and MSII routes reversed blood glucose and DKA effectively. However the recovering time of blood glucose and DKA, insulin dosage,the urinary ketone bodies clearance time and the frequency of hypoglycemia inci?dence all improved better or quicker in CSII than in MSII. Conclusion CSII by insulin pump is safer and more effective than MSII in the treatment of junvenile T1DM with metabolic disturbance and diabetic ketoacidosis.

The efficacy of insulin pump therapy for type 2 diabetes and its impact on quality of life / 中国基层医药

Objective To study the efficacy of insulin pump therapy for type 2 diabetes and its impact on quality of life.Methods 60 patients with type 2 diabetes were selected and divided into A group and B group according to a random number table,30 cases in each group.The patients of B group were given conventional therapy,and which of A group was treated with insulin pump.The fasting plasma glucose,0.5h fasting blood glucose and 2h postprandial blood glucose were measured and compared before and after treatment,the quality of life was evaluated by quality of life scale(QOL),the QOL score before and after treatment between two groups was compared.Results The fasting plasma glucose,0.5h fasting blood glucose and 2h postprandial blood glucose of A group after treatment were (5.69 ±0.19)mmol/L,(5.28 ± 1.03) mmol/L and (7.31 ±2.14) mmol/L,respectively,which were significantly lower than (6.72 ± 2.04) mmol/L,(6.39 ± 1.69) mmol/L and (9.72 ± 1.57) mmol/L of B group (t =9.798,10.023,9.971,P =0.035,0.027,0.032) ; The QOL score of the group A was (78.4 ± 0.8) points,which was significantly better than that before treatment (t =9.064,P =0.023),and better than that of group B (t =10.853,P =0.019).Conclusion Insulin pump has better clinical efficacy in the treatment of type 2 diabetes compared with conventional therapy,it can effectively control blood sugar and improve the quality of life of patients.

Clinical observation of dynamic blood sugar monitoring combined with insulin pump in the treatment of newly diagnosed type 2 diabetes mellitus in the elderly / 中华老年医学杂志

Objective To evaluate islet cells functional recovery and clinical effects of dynamic blood sugar monitoring combined with insulin pump in newly diagnosed type 2 diabetes mellitus in the elderly.Methods 300 cases with newly diagnosed type 2 diabetes mellitus were randomly divided into treatment group (n=150) and control group (n=150) accompanying with three months follow-up.Body mass indexes (BMI),levels of hemoglobin A1c (HbA1c),fasting plasma glucose (FPG),2-h postprandial blood glucose,fasting insulin,2-h postprandial insulin,fasting C-peptide,2-h postprandial C peptide,and the percentage of patients who took oral hypoglycemic drugs alone without insulin could well control the blood glucose were compared between the two groups before versus after treatment.Results The levels of BMI,HbA1c,FPG,2-h postprandial blood glucose,fasting insulin,2-h postprandial insulin,fasting C peptide,2-h postprandial C peptide in the two groups were significantly decreased after treatment as compared with the pretreatment (P ＜ 0.05).The improvement of blood sugar spectrum was better in treatment group than in control group(P＜0.05) and the percentage of patients who took oral hypoglycemic drugs alone without insulin could well control the blood glucose was significantly higher in treatment group than in control group(21％ vs.3％,x2 =22.475,P＜0.05).Conclusions The clinical effects of dynamic blood sugar monitoring combined with insulin pump on newly diagnosed type 2 diabetes mellitus in the elderly is definite and can improve the recovery of islet cells function.It is worthy of clinical promotion.