Education in Diabetes Mellitus for blood glucose self-monitoring: a quasi-experimental study / Educación en Diabetes Mellitus para automonitorización de la glucemia: estudio cuasi-experimental / Educação em Diabetes Mellitus para automonitorização da glicemia: estudo quase-experimental

ABSTRACT Objective: to evaluate the contributions of an educational program for capillary blood glucose self-monitoring. Method: a quasi-experimental study performed in an outpatient unit of a tertiary health care service in a sample of 25 people with Type 2 Diabetes Mellitus, from July 2016 to December 2017, developed through interactive tools for care with capillary blood glucose self-monitoring. Results: among the items of capillary blood glucose self-monitoring that showed improvement after participation in the educational program, the most noteworthy are the "postprandial blood glucose values" (p=0.0039), "Interpretation of capillary blood glucose results with meals and medications" (p=0.0156), "recognition of the 'weakness' symptom for hyperglycemia" (p=0.0386) and "administration of medications correctly" for hyperglycemia prevention (p=0.0063). Conclusion: the study made it possible to recognize the main characteristics of blood glucose self-monitoring that may contribute to the care for the person with diabetes.

RESUMEN Objetivo: evaluar las contribuciones de un programa educativo para la automonitorización de la glucemia capilar. Método: el estudio cuasi-experimental, realizado en unidad ambulatoria de un servicio de atención terciaria a la salud, en muestra de 25 personas con Diabetes Mellitus tipo 2, en el período de julio de 2016 a diciembre de 2017, desarrollado por medio de herramientas interactivas para el cuidado con la automonitorización de la glucemia capilar. Resultados: entre los ítems de la automonitorización de la glucemia capilar que presentaron mejoría después de la participación en el programa educativo, se destacan los "valores de la glucemia postprandial" (p=0,0039), "Interpretación de los resultados de glucemia capilar con las comidas y medicamentos" (p=0,0156), "reconocimiento del síntoma" debilidad "para la hiperglicemia" (p=0,0386) y "administración de medicamentos correctamente" para prevenir la hiperglucemia (p=0,0063). Conclusión: el estudio posibilitó reconocer las principales características de la automonitorización de la glucemia que pueden contribuir para el cuidado a la persona portadora de la enfermedad.

RESUMO Objetivo: avaliar as contribuições de um programa educativo para a automonitorização da glicemia capilar. Método: estudo quase-experimental, realizado em unidade ambulatorial de um serviço de atenção terciária à saúde, em amostra de 25 pessoas com Diabetes Mellitus tipo 2, no período de julho de 2016 a dezembro de 2017, desenvolvido por meio de ferramentas interativas para o cuidado com a automonitorização da glicemia capilar. Resultados: entre os itens da automonitorização da glicemia capilar que apresentaram melhora após a participação no programa educativo, destacam-se os "valores da glicemia pós-prandial" (p=0,0039), "interpretação dos resultados de glicemia capilar com as refeições e medicamentos" (p=0,0156), "reconhecimento do sintoma 'fraqueza' para a hiperglicemia" (p=0,0386) e "administração de medicamentos corretamente" para prevenção da hiperglicemia (p=0,0063). Conclusão: o estudo possibilitou reconhecer as principais características da automonitorização da glicemia que poderão contribuir para o cuidado à pessoa portadora da doença.

Monitoreo continuo de glucosa: Utilidad e indicaciones / Continuous glucose monitoring. Utility and indications

Un adecuado control glucémico evita o retarda la aparición y/o evolución de las complicaciones crónicas en pacientes con diabetes mellitus (DM). Para lograrlo es necesario adecuar las dosis de insulina en personas con DM tipo 1 o tipo 2 en insulinoterapia, por el tradicional automonitoreo de glucosa capilar (AGC) que presenta aún limitaciones para generar un registro adecuado de datos, es invasivo y tiene baja adherencia. En contraposición, los nuevos sistemas de monitoreo continuo de glucosa (MCG) brindan una información más completa, más dinámica y con mejor tolerancia. Están constituidos por un sensor subcutáneo que informa ininterrumpidamente los niveles de glucosa del tejido celular subcutáneo y un módulo receptor que permite su lectura y almacenamiento. Los modelos de tiempo real (MCG-RT) permiten observar continuamente los datos, mientras que los sistemas intermitentes (MCG-Flash/EI) los muestran siempre y cuando se acerque el receptor al módulo sensor, generando una lectura voluntaria e intermitente, aunque almacenan todo en la memoria. El MCG informa además las tendencias glucémicas, indicando si están en ascenso o descenso y a qué velocidad cambian. El uso del MCG vs. AGC reduce la hemoglobina glicosilada (A1c) entre 0.53 y 1.0% con disminución significativa (38%) del tiempo de exposición a hipoglucemias. Presenta además, mayor adherencia. Los objetivos de esta revisión son: describir la homeostasis glucémica, evaluar la precisión del MCG, interpretar los datos adecuadamente y finalmente, sugerir en forma práctica los cambios para incorporar a la insulinoterapia tradicional, basados en la información que aportan estos novedosos sistemas de monitoreo.

An adequate glycemic control prevents and/or delays the development and/or progression of chronic complications in patients with diabetes mellitus (DM). To achieve this control, it is necessary to adjust insulin doses, in type 1 or insulinized type 2 DM persons, based on traditional capillary glucose self-monitoring, which has limitations to generate an adequate data record, is invasive and has low adherence. In contrast, new continuous glucose monitoring (CGM) systems provide more complete and dynamic information, and better compliance. In these systems, a subcutaneous sensor continuously sends glucose values which are captured and stocked by a receptor module. Real-time models (CGM-RT) allow continuous and real-time readings of interstitial glucose, whereas CGM-Flash/EI systems require lector approach to sensor module performing intermittent scanning. CGM shows if glycemic levels are increasing or decreasing and how fast it is happening (tendency). CGM decreases glycosylated hemoglobin between 0.53% and 1.0%, as well as time in hypoglycemia by 38%, increasing the time in range of glucose levels, in patients with high adherence. The objectives of this review are to describe the glycemic homeostasis, to evaluate the accuracy of the CGM to interpret the data adequately and finally, based on the information provided by these novel monitoring systems, to suggest a practical way to be added to the traditional intensive insulin therapy.

Conhecimento e práticas de usuários com diabetes mellitus sobre a automonitorização da glicemia capilar no domicilio / Knowledge and practices of users with diabetes mellitus on capillary blood glucose self-monitoring at home / Conocimientos y prácticas de los usuarios con diabetes mellitus en sangre capilar glucosa autocontrol en casa

Objective:To analyze the knowledge and practices of users with Diabetes Mellitus (DM) on the capillary blood glucose self-monitoring (AMGC) held at home. Methods: descriptive-exploratory study with qualitative methodology, developed in April and May 2013, with users with DM in the public health system of an interior. The data were collected through interviews and categorial analysis verified the sample. The theme was selected by saturation of the speech totaling 12 DM users that perform AMGC at home. Results: the content analysis of data made it possible to identify three categories: realization of non-rational AMGC; The absence of educational programmes to steer on the realization of AMGC; Insufficient availability of inputs to users who perform AMGC. Conclusion: Despite advances legally reached by public policies, users with DM are unaware of the legislation and how it directly interferes in the conduct of AMGC's

Objetivo: Analisar o conhecimento e as práticas de usuários com Diabetes Mellitus (DM) acerca da Automonitorização da Glicemia Capilar (AMGC) realizada no domicílio. Métodos: Estudo descritivo-exploratório, com metodologia qualitativa, desenvolvido em abril e maio 2013, com usuários com DM atendidos pelo sistema público de saúde de um interior pernambucano. Os dados foram coletados por meio de entrevistas e verificados por análise categorial temática, a amostra foi selecionada por meio da saturação do discurso totalizando 12 usuários com DM que realizam a AMGC no domicílio. Resultados: A análise de conteúdo dos dados possibilitou identificar três categorias: Realização da AMGC de forma não racional; Ausência de programas educativos para orientar sobre a realização da AMGC; Disponibilização insuficiente de insumos aos usuários que realizam a AMGC. Conclusão: Apesar dos avanços legalmente alcançados pelas políticas públicas, os usuários com DM desconhecem a legislação e como está interfere diretamente na realização da AMGC

Objetivo: Analizar los conocimientos y prácticas de los usuarios con Diabetes Mellitus (DM) de la glucosa en sangre capilar Self-monitoring (AMGC) llevó a cabo en casa. Métodos: estudio descriptivo exploratorio con metodología cualitativa, desarrollado en abril y mayo de 2013, con usuarios con DM en el sistema de salud pública de un interior. Los datos fueron recogidos a través de entrevistas y análisis categorial verificado que el tema de la muestra fue seleccionado por la saturación del discurso por un total de 12 DM usuarios que realizan la AMGC en casa. Resultados: el análisis del contenido de los datos permitió identificar tres categorías: realización de AMGC no racional; La ausencia de programas educativos para orientar en la realización de AMGC; Disponibilidad insuficiente de insumos a los usuarios que realizan AMGC. Conclusión: A pesar de los avances alcanzados legalmente por las políticas públicas, usuarios con DM desconocen la legislación y cómo está directamente interfiere en la AMGC de conducta

Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study / Avaliação de um aparelho de diagnóstico local para hemoglobina glicada (A1CNow+) comparado com um método imunoturbidimétrico: estudo de acurácia de teste diagnóstico

CONTEXT AND OBJECTIVE: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. DESIGN AND SETTING: Cross-sectional accuracy study conducted at a university hospital in Brazil. METHODS: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. RESULTS: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. CONCLUSIONS: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients.

CONTEXTO E OBJETIVO: Para monitorar o controle glicêmico dos diabéticos, é recomendado medir regularmente a hemoglobina glicada (HbA1c). Isso pode ser difícil em locais distantes sem acesso a laboratórios. Uma alternativa é usar aparelhos portáteis à beira do leito do paciente. Nosso estudo visou avaliar o desempenho de um deles: A1CNow+, da Bayer. TIPO DE ESTUDO E LOCAL: Estudo transversal de acurácia realizado em hospital universitário no Brasil. MÉTODOS: Medimos, com o A1CNow+, três vezes seguidas, a HbA1c capilar de 55 diabéticos voluntários, enquanto a mesma medida era feita em sangue venoso pelo método de referência do hospital (Vitros 5,1 FS). Usamos a análise gráfica de Bland-Altman para avaliar o A1CNow+ em relação ao Vitros 5,1 FS. Verificamos a utilidade clínica através do cálculo da sensibilidade e da especificidade do A1CNow+ para detectar pacientes com HbA1c abaixo de 7%, limite usual indicando glicemia controlada. RESULTADOS: O coeficiente de variação entre testes repetidos do A1CNow+ foi de 3,6%. A diferença média entre o A1CNow+ e o Vitros 5,1 FS foi de +0,67% (95% intervalo de confiança, IC: +0,52 para +0,81). Os limites de concordância do gráfico de Bland-Altman foram -0,45 (95% IC: -0,71 para -0,19) and +1,82 (95% IC: +1,52 para +2,05). A sensibilidade e a especificidade em relação ao limite de 7% foram 100% e 67,7%, respectivamente. CONCLUSÃO: Apesar da boa sensibilidade, o A1CNow+ não tem acurácia suficiente para ser utilizado no monitoramento do controle glicêmico de pacientes diabéticos em substituição das medidas da HbA1c em laboratório.

Continuous glucose monitoring in acute coronary syndrome / Monitoreo continuo de glucosa en pacientes con síndrome coronario agudo

Background: Diabetes mellitus is an independent risk factor for cardiovascular disease. Objective: To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters: time to achieve normoglycemia, period of time in normoglycemia, and episodes of hypoglycemia. Methods: We performed a pilot, non-randomized, unblinded clinical trial that included 16 patients with acute coronary artery syndrome, a capillary or venous blood glucose ≥ 140 mg/dl, and treatment with a continuous infusion of fast acting human insulin. These patients were randomized into 2 groups: a conventional group, in which capillary measurement and recording as well as insulin adjustment were made every 4h, and an intervention group, in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system. Student's t-test was applied for mean differences and the X² test for qualitative variables. Results: We observed a statistically significant difference in the mean time for achieving normoglycemia, favoring the conventional group with a P = 0.02. Conclusion: Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia.

Antecedentes: La diabetes mellitus es un factor de riesgo independiente de enfermedad cardiovascular. Objetivo: Comparar la eficacia de los dispositivos de monitorización continua de glucosa y monitorización de glucosa capilar en pacientes hospitalizados con síndrome coronario agudo, mediante los siguientes parámetros: tiempo en lograr normoglucemia, periodo en normoglucemia y número de hipoglucemias. Métodos: Ensayo clínico no aleatorizado, no ciego, que incluyó a 16 pacientes con síndrome coronario agudo, glucosa capilar o venosa ≥ 140mg/dl, en tratamiento con infusión de insulina humana de acción rápida durante 48 h. Se distribuyeron en 2 grupos: convencional, con medición y registro de glucosa capilar, y ajuste de insulina cada 4h, y de intervención, con medición y registro de glucosa intersticial y ajuste de insulina cada hora a través de un dispositivo de monitorización continua colocado vía subcutánea. Se aplicaron pruebas t para diferencia de medias y prueba de X² para las variables cualitativas. Resultados: Se observó diferencia significativa en la media del tiempo para lograr normoglucemia a favor del grupo convencional, con un valor de p = 0.02. Conclusión: Los dispositivos de monitorización continua de glucosa son tan útiles como la monitorización de glucosa capilar para lograr normoglucemia.

Spurious Elevation of Glucose Concentration during Administration of High Dose of Ascorbic Acid in a Patient with Type 2 Diabetes on Hemodialysis

We describe herein a case of life-threatening hypoglycemia due to spurious elevation of glucose concentration during the administration of ascorbic acid in a type 2 diabetic patient. A 31-year-old female was admitted for proliferative diabetic retinopathy treatment and prescribed high dose ascorbic acid. During hospitalization, she suddenly lost her consciousness and her glucose concentration was 291 mg/dL, measured using self-monitoring blood glucose (SMBG) device, while venous blood glucose concentration was 12 mg/dL. After intravenous injection of 50% glucose solution, the patient became alert. We reasoned that glucose measurement by SMBG device was interfered by ascorbic acid. Physicians should be aware of this interference; high dose ascorbic acid may cause spurious elevation of glucose concentration when measuring with SMBG devices.

Prática da utilização de lancetas ou agulhas na automonitorização da glicemia capilar no domicílio / Use of lancets or needles in the blood glucose self-monitoring at home / Práctica de uso de lancetas o agujas en la automonitorización de la glucosa sanguínea en domicilio

Estudo descritivo transversal que teve como objetivo conhecer o comportamento de pessoas com diabetes mellitus em relação à prática de utilização das lancetas e/ou agulhas na automonitorização da glicemia capilar no domicílio. O estudo foi realizado em uma Unidade Básica de Saúde no município de Ribeirão Preto-SP, de agosto de 2008 até julho de 2009. Os dados foram obtidos através de entrevista dirigida, com 57 sujeitos. Os resultados mostraram que 41 (71,9%) pessoas reutilizavam as lancetas e/ou agulhas, na frequência de 1 a 5 vezes (52,6%). Todos os sujeitos referiram que não compartilham a mesma lanceta e/ou agulha com outras pessoas. Torna-se necessário incrementar estudos futuros para investigar os riscos e benefícios dessa prática, como também cursos de capacitação em educação em diabetes para os profissionais de saúde, visando atender à complexidade do cuidado dos usuários.

Sectional descriptive study that aimed to understand the behavior of people with diabetes mellitus in relation to the practice of use of lancets and / or needles in self-monitoring of blood glucose at home The study was conducted at the Centro de Saúde Escola Joel Domingos Machado, da Faculdade de Medicina de Ribeirão Preto-SP, from August 2008 to July 2009. Data were collected through direct interviews, involving 57 subjects. The results showed that 41 (71.9%) people reuse lancets and / or needles, in a frequency of 1-5 times (52.6%). All subjects reported they did not share the same lancet and / or needles with others. It is necessary to enhance future studies to investigate the risks and benefits of this practice, as well as training courses on diabetes education for healthcare professionals, aiming to meet the complexity of care for users.

Estudio descriptivo transversal. Dirigido a entender el comportamiento de las personas con diabetes mellitus en relación con la práctica de uso de lancetas y / o agujas en la automonitorización de la glucosa en la sangre en el país El estudio se realizó en la Centro de Saúde Escola Joel Domingos Machado, da Faculdade de Medicina de Ribeirão Preto en agosto de 2008 a julio 2009. Los datos fueron recolectados a través de entrevistas directas. 57 sujetos participaron. Los resultados mostraron que 41 (71,9%) personas lancetas reutilización y / o agujas, la frecuencia de 5.1 veces (52,6%). Todos los sujetos informaron que no compartían la misma lanceta y / o agujas con otros. Es necesario aumentar los estudios futuros para investigar los riesgos y beneficios de esta práctica, así como cursos de capacitación sobre educación en diabetes para los profesionales de la salud, con el objetivo de atender a la complejidad de la atención para los usuarios.

Determinação das glicemias capilar e venosa com glicosímetro versus dosagem laboratorial da glicose plasmática / Determination of capillary blood glucose and venous blood glucose with a glucometer versus laboratory determination of venous plasma glucose

INTRODUÇÃO E OBJETIVOS: Diabetes mellitus (DM) é a mais importante patologia que envolve o pâncreas endócrino, sendo uma das principais causas de morbidade e mortalidade na população geral. O objetivo deste trabalho foi avaliar a determinação da glicemia em diferentes tipos de amostras e metodologias. MÉTODOS: Utilizando um equipamento Accu-Check Advantage (Roche), foi avaliada a glicemia em amostras de sangue capilar (GCG) e de sangue venoso (GVG), e a dosagem da glicemia venosa em plasma (GVE) foi realizada por método enzimático de rotina. RESULTADOS E CONCLUSÃO: Foi observada boa correlação entre a GCG e a GVG (r = 0,8742). Entretanto, houve diferença significativa entre a GCG e a GVE (r = 0,6543) e entre a GVG e a GVE (r = 0,5038) (p < 0,001). Essa diferença é maior considerando-se apenas os pacientes normoglicêmicos. O fato de haver diferentes estudos com resultados conflitantes entre si não depende somente da marca ou série específica do glicosímetro, já que uma mesma marca pode apresentar resultados inconsistentes em diferentes estudos.

INTRODUCTION AND OBJECTIVES: Diabetes mellitus is the most important pathology that affects the endocrine pancreas and one of the main causes of morbidity and mortality among the general population. The aim of this work was to evaluate the correlation of blood glucose determination in different types of samples and methodologies. METHODS: Using an Accu-Check Advantage glucometer (Roche), it was determined the blood glucose levels in capillary (CBG) and venous (VBG) samples, and plasma venous glucose was determined by routine enzymatic methodology (EVG). RESULTS AND CONCLUSION: It was observed a good correlation between CBG and VBG (r = 0.8742). However, there was a significant difference between CBG and EVG (r = 0.6543) and between VBG and EVG (r = 0.5038) (p < 0.001). These differences are even more substantial considering only normoglycemic patients. The existence of different studies with inconsistent results does not depend only on the glucometer brand or its specific series, as the same device may present inconsistent results in different studies.

¿Podemos confiar en una glicemia realizada en un glucómetro al lado de la cama del enfermo? / Are blood glucose measurements made with portable glucometers reliable?

Examinations performed beside the bed of patients ("Point-ofcare testing, POCT") provide immediate results and are simple to perform. The most common of these tests is the self control of blood glucose levels in diabetic patients. The use of these devices at the hospital level, introduces a new set of requirements to health institutions, which should monitor all aspects of the process, including training of final users, proper quality control, development of written procedures for use and even participation in surveys of external quality control, avoiding the generation of errors and guaranting patient safety (Rev Méd Chile 2009; 137:1261-4).

Los exámenes realizados al lado de la cama del enfermo ("Point of care testing, POCT") tienen como mayor ventaja la rapidez en la entrega de resultados y la simplicidad de uso, siendo su principal aplicación el autocontrol de la glicemia en pacientes diabéticos. El uso de estos equipos a nivel hospitalario introduce exigencias a las instituciones de salud, las cuales deben monitorizar todos ¡os aspectos del proceso, incluyendo la capacitación de los usuarios, el adecuado control de calidad, el desarrollo de procedimientos escritos para su uso e inclusive la participación en encuestas de control de calidad externo, evitando la generación de errores y colaborando así con la seguridad del paciente.

Prevalence and extent of glycemic excursions in well-controlled patients with type 2 diabetes mellitus using continuous glucose-monitoring system.

BACKGROUND : Continuous glucose-monitoring system (CGMS) is a tool for assessment of glycemic excursions. Glucose variability is a risk factor independent of glycosylated hemoglobin (HbA1c) for diabetic complications; hence CGMS may be a better method for management of diabetes. AIM: To evaluate the extent of glycemic excursions in well-controlled type 2 diabetic patients. SETTING AND DESIGN :The study was carried out in 21 diabetic patients on oral agents. MATERIALS AND METHODS: Patients underwent continuous glucose-monitoring by CGMS for 3 days. Number and duration of glycemic excursions, correlation coefficient (%) between CGMS and self-monitoring blood glucose (SMBG), mean absolute difference (%MAD) and complications of CGMS were analyzed. STATISTICAL ANALYSES : The statistical analyses were performed with the use of mean +/- SD, t-test and Mann-Whitney test. RESULTS :The mean age of patients was 51.9 +/- 9.7 years. The mean HbA1c was 6.7 +/- 0.38%. The mean number of glycemic readings was 753.6 +/- 203.5 times. The correlation coefficient was 0.83 and the MAD was 11.7 +/- 8.0%, which were considerable. Three (14.2%) patients experienced, altogether, 9 hypoglycemic events with an average duration of 162 minutes. Twenty (94.7%) patients had hyperglycemic events. The mean duration of hyperglycemia was 19.4 +/- 12.8 hours. All events were asymptomatic. Disconnection of device was the most common complication (3 patients). CONCLUSION : This study demonstrated that well-controlled type 2 diabetic patients have a considerable number of hypoglycemia and hyperglycemia events that may be missed by SMBG.

Analytical Performance Evaluation of Glucose Monitoring System Following ISO15197 / 대한진단검사의학회지

BACKGROUND: We have evaluated the analytical performance of SureStep Flexx (Johnson and Johnson, USA) which can report the plasma equivalent glucose test results and be connected to the hospital information networks, following ISO15197 analytic procedure for glucometer for the first time. METHODS: Adopting the guidelines of ISO15197, we measured the precision of ten glucometers from their repeatability and intermediate precision, and determined the accuracies of the glucometer, comparing to those of GEM Premier 4000 (Instrumentation Laboratory, USA). In addition, the guidelines of CLSI EP9-A2 and EP6-A were applied to correlate between data of glucometer and those of laboratory reference method by TBA-200FR (Toshiba Medical Systems, Japan) and to examine its linearity of glucose concentrations measured by SureStep Flexx. We used the clinical specimens and commercial control materials. RESULTS: Repeatabilities and intermediate precisions of those glucometers were 4.0-7.3%, and 4.3-6.2%, respectively. When glucose levels are under 75 mg/dL, the difference between results of those meters and the reference values were within +/-6 mg/dL. However when glucose levels are over 75 mg/dL, those differences were within +/-12.7%. These results were acceptable for the ISO15197 criteria in all glucose concentrations. The glucose concentrations showed the clinically relevant linearity in the range from 36 mg/dL to 491 mg/dL. Moreover, Error Grid Analysis showed that all glucose results were in "zone A", which means that these values were clinically accurate. CONCLUSIONS: This study showed that SureStep Flexx can provide reliable results for patients and clinicians to manage the diabetes mellitus, satisfying the ISO15197 criteria.

Evaluation of GLUCOCARD X-METER Glucose Monitoring System / 대한진단검사의학회지

BACKGROUND: Point-of-care testing (POCT) glucometers are increasingly being used for making important therapeutic decisions and managing diabetes. We examined the analytical performance of GLUCOCARD X-METER (ARKRAY Global Business Inc., Japan) against three other glucometers and a reference laboratory method. METHODS: We evaluated the analytical performance of GLUCOCARD X-METER in comparison with three other glucometers. Studies on precision, linearity, the analysis time, and effects of hematocrit and temperature were carried out and the results were compared with those of the laboratory reference method (hexokinase method by Hitachi 760, Hitachi Co., Japan). RESULTS: GLUCOCARD X-METER showed a good linearity and within-run and total-run precision. Comparison between each glucometer and the Hitachi 7600 showed a good correlation. Although differences with the reference method were within an allowable range, all glucometers showed variable bias. Application of an insufficient amount of blood could produce some changes in test results. Changes in hematocrit were found to cause overestimation or underestimation of glucose values. For some test strips, the results were affected by prolonged exposure to room temperature or 4degrees C refrigerator. CONCLUSIONS: GLUCOCARD X-METER showed a good analytical performance in linearity, precision, and comparison. The effect of hematocrit, sample volume, and storage condition for test strips were noted and glucometers had variable deviations to both directions from laboratory reference values (<20%). The GLUCOCARD X-METER provided rapid and reliable measurements of blood glucose. It could be appropriate for monitoring blood glucose values in diabetic patients.

Comparação entre a bomba de infusão de insulina subcutânea e o esquema de múltiplas doses de insulina em adolescentes com diabetes melito do tipo 1 da rede pública de saúde na abordagem da hipoglicemia grave / Comparison between continuous subcutaneous insulin infusion and multiple daily injection regimens in adolescent with type 1 diabetes from a public health care system approach to severe hypoglycemia

OBJETIVO: Avaliação comparativa da freqüência de hipoglicemia severa após mudança da terapia com múltiplas doses de insulina (MDI) para bomba de insulina subcutânea (BIISC). PACIENTES E MÉTODOS: Sete pacientes DM1, idade Mi = 14 anos e tempo médio de diabetes de 8 anos, comparados de acordo com a incidência de hipoglicemia, a dose total de insulina (U/Kg/d), IMC (Kg/m²) e HbA1c (vn: 3,5-6,7 por cento) 1 ano antes e 1 ano após a transferência de terapêutica. Houve redução significativa dos episódios de hipoglicemia severa (1,3 episódio/paciente/ano para zero episódio/paciente/ano; p = 0,04), na dose total diária de insulina (1,33 ± 0,26 U/Kg/dia para 0,87 ± 0,17 U/kg/dia; p = 0,04) e na HbA1c (8,7 ± 0,7 por cento para 7,8 ± 0,9 por cento; p = 0,05 com BIISC). Concluímos que a BIISC é eficaz e segura na redução de hipoglicemia severa em um subgrupo de pacientes DM1 com MDI. Entretanto, os resultados obtidos precisam ser reproduzidos em centros semelhantes e estudos de custo são necessários para que a sua viabilidade seja confirmada e aplicada nos sistemas públicos de saúde, que correspondem à maioria no nosso país.

OBJECTIVE: We compared the incidence of severe hypoglycemia episodes with therapy with multiple doses of insulin (MDI) and after changing to pump (CSII). PATIENTS AND METHODS: 7 T1DM patients with 14 years median and median duration of diabetes of 8 years. We analyzed insulin requirement (U/kg/day), BMI (Kg/m²), HbA1c (normal range: 3.5-6.7 percent) one year before and one year after changing therapy. The severe hypoglycemia episodes decreased from 1.3 to 0 episodes/patient/year; p = 0.00). The insulin requirement decreased from 1.33 ± 0.26 U/Kg/day to 0.87 ± 0.17 U/kg/day; p = 0.04 and HbA1c decreased from 8.7 ± 0.7 percent to 7.8 ± 0.9 percent; p = 0.05. CONCLUSION: CSII is efficient in decreasing severe hypoglycemia in a subgroup of T1DM using MDI also in Public Health Care System (PHCS) conditions. However, these finding should be reproduced by other Diabetes Care centers and cost studies are necessary to confirm the viability and possibility of this therapy, when necessary, to T1DM patients, which correspond to the majority of these individuals in our country, seeing in the PHCS.

Acurácia, efeitos na terapia insulínica e controle glicêmico e complicações do sistema de monitorização contínua da glicose em pacientes com diabetes mellitus tipo 1 / Accuracy, effect on insulin therapy and glycemic control and complications of the continuous glucose monitoring system in type 1 diabetic patients

Para avaliar a acurácia, segurança e complicações do sistema de monitorização contínua da glicose (CGMS) em pacientes com diabetes mellitus tipo 1 (DM1), estudamos retrospectivamente 30 pacientes (25,8 ± 12,2 anos) sob monitorização contínua da glicose (CGM) (Medtronic; Northridge, CA) por 72hs. Foram analisados: glicemia capilar (GC) média e pelo sensor durante a CGM, coeficiente de correlação ( por cento), mediana da diferença percentual absoluta (MAD por cento), número de leituras, excursões glicêmicas (sensor CGMS vs. GC), presença de complicações (trauma, infecção, desconexão), abandono e conduta após CGMS. Os níveis de A1c foram determinados 1 mês antes e 3 meses após o CGMS. A GC média durante a utilização do CGMS foi de 186,5 ± 43,3mg/dl vs. 179,7 ± 48,1mg/dl detectada pelo sensor, com correlação significativa (p= 0,001). O número de leituras pelo sensor CGMS foi de 772,4 ± 254,1 (VR > 680), com duração média de 68,7 ± 19,8hs de exame. O coeficiente de correlação foi de 0,86 ± 0,21 (VR > 0,79). Quanto à MAD por cento, observou-se valor de 13,9 ± 4,7 por cento (VR < 28 por cento). O CGMS mostrou-se estatisticamente mais eficaz na detecção de excursões glicêmicas em relação à GC (p= 0,009). Observou-se redução significante da A1c três meses após o CGMS nesse grupo de pacientes (p= 0,018). Não houve complicações durante a CGM em 96,7 por cento dos exames. Não houve registro de trauma, infecção local ou sangramento em nenhum caso. A CGM promoveu mudança de conduta terapêutica em 100 por cento dos pacientes. A CGM mostrou-se método seguro, bem tolerado, com alta acurácia nos valores glicêmicos detectados, sendo método de alta eficácia, com baixo índice de complicações e abandono, devendo sua prática ser cada vez mais estimulada em nosso meio.

Efficacy of continuous glucose monitoring system to detect unrecognized hypoglycemia in children and adolescents with type 1 diabetes

Foram estudados retrospectivamente 17 pacientes (15,76 ± 4,5 anos) submetidos a monitorização subcutânea contínua da glicemia (CGMS) (Medtronic; CA) por 72 horas. Buscou-se avaliar a acurácia da CGMS em crianças e adolescentes com diabetes mellitus tipo 1 (DM1) e sua eficácia na detecção de hipoglicemia assintomática nesse grupo de pacientes. Foram analisados os valores de glicemia capilar (GC) e pelo sensor CGMS; excursões glicêmicas; hiperglicemia pós-prandial; hipoglicemia assintomática; complicações e conduta após a CGMS. Os níveis de A1c foram determinados antes e 3 meses após a CGMS. A correlação sensor/glicemia capilar foi avaliada durante normo, hipo e hiperglicemia, bem como a sensibilidade e especificidade. A GC média durante a CGMS foi de 213,8 ± 63,4mg/dl vs. 209,7 ± 52,5mg/dl detectada pelo sensor, com correlação de Pearson significante (p< 0,001). Não houve diferença significante entre a CGMS e GC na detecção de excursões glicêmicas (p= 0,32). A hiperglicemia pós-prandial e hipoglicemia assintomática foram identificadas em 66,7% e 56,2% dos pacientes durante a CGMS, respectivamente. A correlação entre sensor CGMS e GC durante hipoglicemia assintomática mostrou-se não significante (p= 0,32) vs. durante hiperglicemia (p= 0,001). O sensor CGMS apresentou baixa sensibilidade (63,3%) para detecção de hipoglicemia assintomática. Observou-se redução significante da A1c três meses após a CGMS em crianças e adolescentes com DM1 (p= 0,03). A CGMS mostrou-se método seguro, bem tolerado, com alta acurácia nos valores glicêmicos detectados, com baixo índice de complicações. Esses dados comprovam a alta eficácia da CGMS na detecção de hiperglicemia pós-prandial, na redução da A1c e melhora do controle metabólico, com baixas sensibilidade para na identificação de hipoglicemia assintomática em crianças e adolescentes com DM1.

Assessment of glycemia in diabetes mellitus--self-monitoring of blood glucose.

Self-monitoring of blood glucose (SMBG) is an integral component of diabetes self-care and, if use optimally, essential to obtaining glycemic control. There are many methods currently available and the use of glucometers can provide readily available information on blood glucose patterns over time. However, some barriers to the use of SMBG, such as its cost, are significant. Other barriers, such as pain, patient denial or insufficient encouragement from the health care professional, should be overcome. While we find pre-prandial testing to be more informative, there are instances where post-prandial testing may be useful such as in pregnancy or in patients with early stages of glucose intolerance. In the future, continuous glucose monitoring will become available, and ultimately an insulin delivery device will be linked to continuous monitoring making the "closed loop" artificial pancreas a reality. At present, SMBG is an under-utilized but important part of modern diabetes care and should be recommended for all people with diabetes.

Evaluation of One Touch HORIZON--a highly affordable glucose monitor.

BACKGROUND AND OBJECTIVE: Despite the growing evidence on the benefits of self-monitoring in diabetes, the use of these meters has been low in developing countries, particularly India. Cost seems to be the major constraint. The aim of the present study is to evaluate the accuracy of One Touch HORIZON an affordable glucose meter with laboratory assessment of blood glucose. METHODS: 100 subjects with diabetes over the age of 18 years were recruited from the MV Diabetes Specialities Centre, Chennai. All the study subjects had their fasting blood tested for glucose in One Touch HORIZON by finger prick. Fasting blood glucose was also assessed in YSI 2300 STATPLUS (Yellow Springs Instruments, Ohio, USA) glucose analyzer. The Parke's Error Grid model was used to assess the accuracy of the meter against YSI plasma glucose values. RESULTS: Of the total 100 study subjects, 97 were Type 2 diabetic subjects and three were Type 1 diabetic subjects. 62% of the study subjects were males. 89% did not perform SMBG and only 2% of the diabetic subjects performed SMBG daily. The Parke's Error Grid analysis revealed 97% of results to be in Zone A when patient performed the test, 99 - 100% in Zone A when clinical staff performed the test indicating excellent accuracy and precision. CONCLUSION: One Touch HORIZON meter is an affordable meter with good accuracy and precision, specifically designed to cater to the needs of diabetic patients in developing countries.

Glicemia capilar medida por dois aparelhos de automonitorizaçäo: quanto eles podem estimar a glicemia plasmática na rotina médica? / Capillary blood glucose measurement by tho self-monitoring equipment: how can they to estimate a plasma blood grucose in medical routine?

O desenvolvimento de monitores portáteis para automonitorização da glicose sangüínea tem fácil aceitação pelos pacientes e médicos, sendo amplamente utilizado atualmente, o que torna essencial avaliar o quanto esses resultados correspondem à glicemia plasmática. Assim, avaliamos a acurácia e precisão de dois monitores digitais à disposição no mercado: um utiliza a glicose desidrogenase (Ap1) e o outro a glicose oxigenase (Ap2) na mensuração da glicemia capilar

Comparative accuracy of glucose monitors

Background. Self-monitoring of blood glucose levels has become an important instrument for the management of patients with diabetes mellitus. Both patients and physicians expect that monitors will provide reliable results. Numerous environmental, physiologic, and operational factors can affects system performance, yielding results that are inaccurate or unpredictable. Methods. This study examined the effect of one factor -high altitude- on the performance of seven blood glucose monitoring systems. The following monitors were compared. two One Touch II; two One Touch Basic; two Reflolux II (Accu-Chec in the USA); two Glucometer 3; one Glucometer 2, and one Accutrend Alpha. Double blood glucose level values were compared with a cotrolled reference laboratory test values, which was unknown to the investigator until the end of the study because the study was double blind. Blood glucose values were obtained using each of the monitors in 200 patients; 150 with diabetes mellitus, and 50 healthy subjects. Results. The One Touch monitors were the only monitors that reported adjusted straight lines (Y0a+bX) that were very similar for all three techniques. In addition, these adjusted straight lines are those closest to the ideal line, Y=X. These same monitors were the only ones that did not reject the null hypothesis Ho: a=0. The relative deviation index at the 20 percent level was less than 3.5 percent for the One Touch II and One Touch Basic monitors; for the rest of the monitors the index was over 14 percent. The clinically accepted EGA region was similar for all study monitors. Conclusions. In conclusion, the One Touch II and One touch Basic Monitors showed greater accuracy in comparison to the other devices. The evaluation of the clinically acceptable region shows practical reliability for all of the monitor used