Observaciones en el mundo real sobre la efectividad del sistema flash de monitorización de glucosa en la práctica clínica en Chile / Real-world observations of the effectiveness of the flash glucose monitoring in clinical practice in Chile

OBJETIVO: Evaluar el tiempo en rango de glucosa y su asociación con otras medidas del control glicémico establecidas por el consenso internacional del tiempo en rango en usuarios de vida real del sistema flash de monitorización de glucosa FreeStyle LibreTM en Chile. MÉTODOS: Se analizaron los datos provenientes de la base de datos Freestyle Libre™ entre diciembre de 2014 y enero de 2022. Las lecturas se dividieron en 10 grupos (deciles) del mismo tamaño (cada decil contenía aproximadamente 498 usuarios) en función del tiempo en rango. Para cada decil se calculó la media de determinaciones diarias, el promedio de glucosa, la HbA1c, la desviación estándar de glucosa, el coeficiente de variación de la glucosa, el tiempo en rango, el tiempo de glucosa (porcentaje) por encima de 250 mg/dL (TA250), el tiempo de glucosa (porcentaje) por encima de 180 mg/dL (TA180), el tiempo por debajo (porcentaje) de 70 mg/dL (TB70) y el tiempo por debajo (porcentaje) de 54 mg/dL (TB54). RESULTADOS: Desde diciembre de 2014 hasta enero de 2022 hubo 4984 lectores. El grupo con el mayor tiempo en rango mostró significativamente una menor glucosa promedio que el grupo con el tiempo en rango más bajo (decil 1: media 248,3 mg/dL, decil 10: media 113,2 mg/L, diferencia ­135,1 mg/dL, p<0.05). Asimismo, el mayor tiempo en rango se asoció con una menor desviación estándar (decil 1: media 93,7mg/dL, decil 10: media 26,7mg/L, diferencia: -67,0 mg/ dL, p<0,05), menor coeficiente de variación (decil 1: media 37,8%, decil 10: media 23,3%, diferencia: -14,5%, p<0,05), menor TA250 (decil 1: media 46,5%, decil 10: media 0,2%, diferencia: -46,3%, p<0.05), menor TA180 (decil 1: media 73,9%, decil 10: media 3,8%, diferencia: -70,1%, p<0.05), menor TB70 (decil 5: mediana 6,13%, decil 10: mediana 1,70%, diferencia: -4,43%, p<0.05) y menor TB54 (decil 5: mediana 1,79%, decil 10: mediana 0,12%, diferencia: -1,67%, p<0.05). El mayor tiempo en rango se asoció también significativamente con más determinaciones diarias (decil 1: media 11,4, decil 10: media 16,6, diferencia: 5,2, p<0,05). La frecuencia media de las determinaciones entre todos los lectores fue de 14,7 determinaciones diarias. CONCLUSIONES: En los pacientes con diabetes en Chile, el empleo del sistema flash de monitorización demuestra la asociación entre el mayor tiempo en rango, la reducción de la variabilidad de la glucosa y un menor riesgo de hiperglucemias e hipoglicemias y también con un mayor compromiso.

OBJECTIVE: To evaluate glucose time in range and its association with other metrics of glucose control established by the International Consensus on TIR amongst real-life patients using the Flash Glucose Monitoring system FreeStyle LibreTM in Chile. METHODS: Data from the Freestyle Libre™ database between December 2014 and January 2022 were analyzed. Readers were divided into 10 groups (deciles) of the same size (each decile had approximately 498 users) according to time in range. For each decile of time in range, the mean of daily scans, average glucose, estimated HbA1c, glucose standard deviation, glucose coefficient of variation, time in range, glucose time (percentage) above 250 mg/dL (TA250), and glucose time (percentage) above 180 mg/dL (TA180), and the median of glucose time (percentage) below 70 mg/dL (TB70) and glucose time (percentage) below 54 mg/dL (TB54), were calculated. RESULTS: From December 2014 to January 2022, there were 4984 readers. The group with the highest TIR showed significantly lower average glucose than the group with the lowest TIR (decile 1: mean 248.3 mg/dL, decile 10: mean 113.2 mg/L, difference: ­135.1 mg/dL, p<0.05). In addition, more time in range was associated with a lower glucose standard deviation (decile 1: mean 93.7 mg/dL, decile 10: mean 26.7 mg/L, difference: -67.0 mg/dL, p<0.05), lower glucose coefficient of variation (decile 1: mean 37.8%, decile 10: mean 23.3%, difference: -14.5%, p<0.05), lower TA250 (decile 1: mean 46.5%, decile 10: mean 0.2%, difference: -46.3%, p<0.05),lower TA180 (decile 1: mean 73.9%, decile 10: mean 3.8%, difference: -70.1%, p<0.05), lower TB70 (decile 5: median 6.13%, decile 10: median 1.70%, difference: -4.43%, p<0.05) and lower TB54 (decile 5: median 1.79%, decile 10: median 0.12%, difference: -1.67%, p<0.05). Greater TIR was also associated with significantly more daily scans (decile 1: mean 11.4, decile 10: mean 16.6, difference: 5.2, p<0.05). Mean scan frequency amongst all readers was 14.7 daily scans. CONCLUSIONS: In patients with diabetes from Chile, the use of the flash glucose monitoring system demonstrates the association between greater TIR, reduced glucose variability, and reduced risk of hyperglycemia and hypoglycemia, and also its association with greater engagement.

Research progress on minimally invasive and non-invasive blood glucose detection methods / 生物医学工程学杂志

Blood glucose monitoring has become the weakest point in the overall management of diabetes in China. Long-term monitoring of blood glucose levels in diabetic patients has become an important means of controlling the development of diabetes and its complications, so that technological innovations in blood glucose testing methods have far-reaching implications for accurate blood glucose testing. This article discusses the basic principles of minimally invasive and non-invasive blood glucose testing assays, including urine glucose assays, tear assays, methods of extravasation of tissue fluid, and optical detection methods, etc., focuses on the advantages of minimally invasive and non-invasive blood glucose testing methods and the latest relevant results, and summarizes the current problems of various testing methods and prospects for future development trends.

Technical Difficulties in the Implementation of the Continuous Glucose Monitoring System / 中国医疗器械杂志

The continuous glucose monitoring system (CGMS) has been clinically applied to monitor the dynamic change of the subcutaneous interstitial glucose concentration which is a function of the blood glucose level by glucose sensors. It can track blood glucose levels all day along, and thus provide comprehensive and reliable information about blood glucose dynamics. The clinical application of CGMS enables monitoring of blood glucose fluctuations and the discovery of hidden hyperglycemia and hypoglycemia that are difficult to be detected by traditional methods. As a CGMS needs to work subcutaneously for a long time, a series of factors such as biocompatibility, enzyme inactivation, oxygen deficiency, foreign body reaction, implant size, electrode flexibility, error correction, comfort, device toxicity, electrical safety, et al. should be considered beforehand. The study focused on the difficulties in the technology, and compared the products of Abbott, Medtronic and DexCom, then summarized their cutting-edge. Finally, this study expounded some key technologies in dynamic blood glucose monitoring and therefore can be utilized as a reference for the development of CGMS.

Use of flash glucose-sensing technology in patients with type 2 diabetes treated with liraglutide combined with CSII: a pilot study

Glycemic variability (GV) may be linked to the development of diabetic complications by inducing inflammation, oxidative stress, and endothelial dysfunction. Flash glucose monitoring (FGM) provides a novel method of continuously monitoring interstitial glucose levels for up to 14 days. This study randomly assigned poorly controlled type 2 diabetes mellitus patients treated with metformin and multiple daily injections of insulin (n=60) to either continuous subcutaneous insulin infusion (CSII) treatment or CSII in combination with liraglutide (CSII+Lira) treatment for 14 days during hospitalization. GV was assessed using a FGM system; weight and cardiometabolic biomarkers were also evaluated. The coefficient of variation was significantly reduced in the CSII+Lira group (P<0.001), while no significant change was observed in the CSII group. The changes differed significantly between the two groups in mean amplitude of glycemic excursions (P=0.004), standard deviation (P=0.006), and the percentage of time in the target range (4-10 mmol/L, P=0.005 and >10 mmol/L, P=0.028). The changes in mean of daily differences, interquartile range, and percentage of time in hypoglycemia (<3.3 mmol/L) and hyperglycemia (>13.9 mmol/L) identified by FGM showed no difference. Treatment with liraglutide increased serum adiponectin [33.5 (3.5, 47.7) pg/mL, P=0.003] and heme oxygenase-1 levels [0.4 (-0.0, 1.8) ng/mL, P=0.001] and reduced serum leptin levels [-2.8 (3.9) pg/mL, P<0.001]. Adding the glucagon-like peptide-1 analog liraglutide improved GV, weight, and some cardiometabolic risk markers. The FGM system is, therefore, shown to be a novel and useful method for glucose monitoring.

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.

The characteristics of blood glucose fluctuations in patients with fulminant type 1 diabetes mellitus in the stable stage

ABSTRACT Objective: The aim was to characterize blood glucose fluctuations in patients with fulminant type 1 diabetes (FT1DM) at the stable stage using continuous blood glucose monitoring systems (CGMSs). Subjects and methods: Ten patients with FT1DM and 20 patients with classic type 1 diabetes mellitus (T1DM) (the control group) were monitored using CGMSs for 72 hours. Results: The CGMS data showed that the mean blood glucose (MBG), the standard deviation of the blood glucose (SDBG), the mean amplitude glycemic excursions (MAGE), the blood glucose areas and the percentages of blood glucose levels below 13.9 mmol/L were similar between the two groups. However, the percentage of blood glucose levels below 3.9 mmol/L was significantly higher in the FT1DM group compared to the T1DM group (p < 0.05). The minimum (Min) blood glucose level in the FT1DM group was significantly lower than that of the T1DM group (p < 0.05). Patients with FT1DM had severe dysfunction of the islet beta cells and alpha cells compared to patients with T1DM, as indicated by lower C-peptide values and higher glucagon/C-peptide values. Conclusion: In conclusion, patients with FT1DM at the stable stage were more prone to hypoglycemic episodes as recorded by CGMSs, and they had a greater association with severe dysfunction of both the beta and alpha islet cells compared to patients with T1DM.

Selfmonitoring of blood glucose practices by people living with diabetes who use their personal glucometers in Port Harcourt, Niger Delta Region, Nigeria

Self-monitoring of blood glucose (SMBG) assists persons living with diabetes with the day-to-day behavioral and therapeutic adjustments to their diabetes care. It is a cheaper and more available alternative to glycated haemoglobin (HbA1c) in Nigeria for monitoring glycaemic control. Information on SMBG practices of Nigerians living with diabetes using their personal glucometers is scanty. The aim of the study is to assess the intensity and frequency of SMBG by glucometer owners, and the extent the patients and/or the health care providers (HCP) utilize SMBG to achieve personalized treatment goals via behavioral/treatment adjustments. This was a cross sectional study carried out among persons living with diabetes that accessed diabetes care at the diabetes clinic of the University of Port Harcourt Teaching Hospital (UPTH) and using their personal glucometers. They were consecutively recruited. Data obtained by using interviewer-administered questionnaires were analyzed using SPSS version 20.0, and pvalue <0.05 was considered significant. A total of 128 persons living with diabetes participated in the study of which 40 (31%) were males and 88 (69%) were females; the mean age of the subjects was 52.05 ± 11.24 years with a range of 26­70 years. The majority of the study subjects (72%) were in the active working age group (25­60years). The highest frequency of glucometer use was in the 26 subjects (20%) who checked their blood glucose every morning while 62 (48%) of the subjects checked their blood glucose any morning they felt like. Most of the subjects (60%) did not have any recording device. Glucometer owners were not just the insulin-requiring people living with diabetes as more than half of the subjects, 66 (52%) were on oral anti diabetic drugs (OAD) only. Glucometer ownership was mainly by those that were in the working age group. SMBG protocol (frequency) was variable and SMBG data were not maximally utilized

Avaliação da frutosamina como parâmetro de controle glicêmico na gestante diabética / Evaluation of fructosamine as a parameter of blood glucose control in diabetic pregnant women

Objetivo Avaliar parâmetros alternativos para monitorar a glicemia em portadoras de diabetes na gestação estudando a relação entre a frutosamina e a automonitoração em gestantes portadoras de diabetes. Materiais e métodos: A frutosamina sérica e os parâmetros da automonitoração nos 14 dias que antecederam a coleta da frutosamina foram avaliados em 47 gestantes portadoras de diabetes. Resultados Setenta e uma determinações de frutosamina e 2.238 glicemias capilares (GCs) foram analisadas. A frutosamina correlacionou-se com o índice de excursões hiperglicêmicas (HBGI) e o desvio-padrão das glicemias (r = 0,28; p = 0,021 e r = 0,26; p = 0,03, respectivamente). A comparação entre as mães dos neonatos com peso adequado ou grandes ao nascer com as genitoras que tiveram neonatos pequenos para a idade gestacional (PIG) revelou que estas tiveram menor média glicêmica (105 vs. 114 e 119 mg/dL), maior índice de excursões hipoglicêmicas (5,8 vs. 1,3 e 0,7) e maior percentual de hipoglicemias (11 vs. 0 e 0%) mesmo com frutosamina dentro dos valores de referência (242 vs. 218 e 213 μmol/l). Conclusão A frutosamina pode ser utilizada como parâmetro auxiliar à automonitoração para avaliação de hiperglicemias e variabilidade glicêmica, entretanto pode subestimar hipoglicemias em gestantes com fetos PIG. .

Objective To evaluate the alternative parameters to monitor glycemia in pregnant women with diabetes studying the relationship between fructosamine testing and self monitoring of blood glucose in pregnant women with diabetes. Materials and methods Serum fructosamine levels and the self monitoring of blood glucose over 14 days before the collection of fructosamine were evaluated in 47 diabetic pregnant women. Results Seventy-one fructosamine levels and 2,238 glucose measurements (CGs) were analysed. Levels of fructosamine correlated with high blood glucose index (HBGI) and the standard deviation of glycemias (r = 0.28; p = 0.021 and r = 0.26; p = 0.03, respectively). The comparison between the mothers of the newborns with appropriated or large birthweight and those who gave birth to small newborns for their gestational age (SGA) showed that the latter had a lower glycemic mean (105 vs. 114 and 119 mg/dL), a higher low blood glucose index (5.8 vs. 1.3 and 0.7) and a higher percentage of hyperglycemias (11 vs. 0 and 0%) even when the fructosamine falls within the reference values (242 vs. 218 and 213 μmol/l). Conclusion The levels of fructosamine can be used as further parameter to aid self monitoring of blood glucose to evaluate hyperglycemias and glycemic variability, however, this can underestimate hypoglycemias in pregnant women carrying small-for-gestational age fetuses. .

Efeito de diferentes modalidades de educação para o autocuidado a pacientes com diabetes / Effect of different types of self-management education in patients with diabetes

A educação é parte importante do tratamento do diabetes melito (DM), e é por meio dela que os pacientes são capacitados para realizar o gerenciamento da sua doença. Existe uma gama variada de intervenções educativas já testadas nos pacientes com DM, não havendo, até o momento, um modelo universal definido que possa ser padronizado e reconhecido como eficaz para todos os indivíduos com a doença. Este artigo tem por objetivo revisar o efeito das diferentes modalidades de intervenções educativas para o autocuidado no controle glicêmico de pacientes com DM tipo 2, além de definir recomendações gerais para a utilização desta estratégia de tratamento.

Education plays an important role in diabetes mellitus (DM) treatment, as it enables patients to manage their disease. There is a wide range of tested educational interventions, and, to date, no universal model that can be standardized and recognized as effective for all individuals with the disease has been defined. This article aims to review the effect of different types of educational interventions for self-management of glycemic control in patients with DM type 2, in addition to define general recommendations for this treatment strategy.

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.

Continuous glucose monitoring system: dawn period calibration does not change accuracy of the method / Sistema de monitorização contínua de glicose: calibração da madrugada não interfere na acurácia do método

INTRODUCTION: Continuous glucose monitoring system is a valuable instrument to measure glycemic control, which uses a retrospective calibration based upon 3 to 4 capillary glucose meter values inserted by the patient each day. OBJECTIVE: We evaluated the interference of calibration during the dawn period in the system accuracy. METHODS: The monitoring data were retrospectively divided into two groups: with (Group A) or without (Group B) the dawn period calibration (between 1:00 and 5:00 AM). Accuracy of the method was expressed by relative absolute difference. RESULTS: Thirty-four continuous glucose monitoring data were evaluated comprising a total of 112 nights. A total of 289 paired readings were analyzed - 195 in Group A and 94 in Group B. We did not find a difference in relative absolute difference (RAD%) in any analyzed period of day by adding dawn calibration. CONCLUSIONS: These data suggest that dawn calibration does not alter accuracy of method.

INTRODUÇÃO: O CGMS (sigla do inglês continuous glucose monitoring system) é um instrumento valioso no controle glicêmico e utiliza uma calibração por meio de 3 ou 4 medidas de glicemia capilar inseridas pelo paciente em cada dia do exame. OBJETIVO: Avaliar a interferência da calibração durante a madrugada na acurácia do sistema. MÉTODOS: Os dados das monitorizações foram divididos retrospectivamente em dois grupos: com (Grupo A) ou sem (Grupo B) a calibração da madrugada (entre 1:00 e 5:00 AM). A acurácia do método foi mostrada pela diferença relativa absoluta (DRA por cento). RESULTADOS: Trinta e quarto dados de monitorização foram avaliados em um total de 112 noites. Um total de 289 leituras pareadas foi analisado - 195 no Grupo A e 94 no Grupo B. Não foi encontrada diferença em DRA% em nenhum período do dia quando adicionada a calibração durante a madrugada. CONCLUSÕES: Esses dados sugerem que a calibração da madrugada não altera a acurácia do método.

Home blood glucose monitoring in type 1 diabetes mellitus / Monitorización, en el domicilio, de la glucemia en pacientes con diabetes mellitus tipo 1 / Monitorização domiciliar da glicemia em pacientes com diabetes mellitus do tipo 1

OBJECTIVE: To determine which of two simplified blood glucose monitoring schemes promotes better metabolic control in type1 diabetic patients during 12 months of participation in educational groups. METHODS: A crossover clinical trial involving 21 patients divided into two groups was conducted. They were submitted to a two monitoring schemes:2 alternate daily preprandial measurements and 2 alternate daily pre-and postprandial measurements. The effectiveness of the schemes was evaluated based on HbA1c. Variations in mean HbA1c were analyzed by Friedman test. RESULTS: The groups were homogenous in terms of sociodemographic and clinical variables (p>0.05). Mean HbA1c levels ranged from 8.48 (±1.00) to 7.37 (±0.99) over time in Group A and from 9.89 (±0.86) to 8.34 (±1.06) in Group B. The analysis of the HbA1c showed a significant reduction in the first and last 6 months and over the 12 months of the study in two groups (p<0.05). The preprandial scheme demonstrated the largest number and highest percentage of significant drops in HbA1c. CONCLUSIONS: The two monitoring improved the metabolic control and the preprandial scheme was more effective.

OBJETIVO: Identificar cual de los dos esquemas de monitorización propuestos posibilita realizar un mejor control metabólico, en diabéticos del tipo1, durante los 12 meses de participación en grupos educativos. MÉTODO: Ensayo clínico cruzado con 21 pacientes divididos en dos grupos y sometidos a dos diferentes esquemas de monitorización. La efectividad de los esquemas fue evaluada por medio de la HbA1c. La variación de los promedios de HbA1c fue analizada con la prueba de Friedman. RESULTADOS: Durante todo el estudio la variación de los promedios de HbA1c, para el grupo A, fue de 8,48(±1,00) la 7,37(±0,99) y de 9,89(±0,86) la 8,34(±1,06) para el grupo B. Los análisis de la variación de la HbA1c colocaron en evidencia una reducción significativa (p<0,05) en los dos grupos, en los 3 periodos evaluados: primeros y últimos 6 meses y durante los 12 meses de estudio. CONCLUSIONES: Los dos esquemas mejoraron el control metabólico y el esquema antes de las comidas fue más efectivo.

OBJETIVO: Identificar qual de dois esquemas simplificados de monitorização da glicemia viabiliza melhor controle metabólico, em pacientes com diabetes mellitus tipo 1, ao longo de 12 meses de participação em grupos educativos. MÉTODO: Ensaio clínico cruzado, com 21 pacientes divididos em dois grupos. Eles foram submetidos a dois esquemas de monitorização: duas medidas diárias pré-prandiais alternadas e duas medidas diárias pré e pós-prandiais alternadas. A efetividade dos esquemas foi avaliada pelos níveis de HbA1c. Para estudar a variação das médias das HbA1c aplicou-se o teste não paramétrico de Friedman. RESULTADOS: Os grupos eram homogêneos ao início do estudo com relação às variáveis sócio-demográficas e clinicas(p>0,05). A variação das médias de HbA1c, ao longo do tempo para o grupo A foi de 8,48(±1,00) a 7,37(±0,99) e para o grupo B de 9,89(±0,86) a 8,34(±1,06). O resultado da análise da variação da HbA1c mostrou redução significativa nos dois grupos, nos primeiros e últimos 6 meses e ao longo dos 12 meses nos dois grupos (p<0,05). O Esquema de monitorizações pré-prandiais possibilitou o maior número e os maiores percentuais de quedas estatisticamente significativas nos níveis de hemoglobina glicada. CONCLUSÕES: Os dois esquemas melhoraram o controle metabólico e esquema pré-prandial foi mais efetivo.

Avaliação da glicemia capilar na ponta de dedo versus locais alternativos: valores resultantes e preferência dos pacientes / Analysis of fingerstick capillary glycemia versus alternative site: results and patients preferences

O trabalho visa avaliar eficácia e a preferência dos pacientes na monitorização da glicemia capilar em locais alternativos: lóbulo de orelha, antebraço e panturrilha em relação à ponta de dedo. Foram avaliados 89 pacientes (39 M/50 F) com diabetes melito tipo 2 (DM2). A monitorização foi feita com glicosímetro digital (ACCU - CHEK Performa, Roche), lancetador ACCU-CHEK Multiclix, em grau 5 na face palmar da falange distal do 3º dedo da mão direita, porção inferior do lóbulo da orelha direita, antebraço direito e região superior da panturrilha direita. Não houve diferença da glicemia capilar na ponta de dedo em relação aos locais alternativos. A ponta de dedo foi o local mais doloroso. Quanto ao local de preferência, a orelha e a ponta de dedo foram os preferidos. A monitorização glicêmica em locais alternativos é simples, segura e eficaz, como a glicemia de ponta de dedo.

This paper evaluate the efficacy and patients preferences of glucose monitoring in alternatives sites: ear lobe, forearm and calf against conventional fingerstick. We studied 89 patients (39 M/ 50 F) with type 2 diabetes mellitus (DM2). Glucose monitoring was measured using a digital glucosimeter (ACCU - CHEK Performa, Roche), and ACCU-CHEK Multiclix lancetador, with grade 5 on the distal phalange on the right hand's third finger, inferior part of right ear lobe, right forearm and right calf. There was not statistical significance on the comparative analyzes of fingerstick and alternatives sites. There was more pain in fingerstick. The patients preferred the fingerstick and the ear lobe. Glucose monitoring in alternative sites is as simple, safe and efficient as fingerstick.

A hipoglicemia silenciosa é parte do controle glicêmico ideal em pacientes com DM1?: tempo de hipoglicemia pelo CGMS versus média glicêmica / Is silent hypoglycemia part of ideal glycemic control in DM1 patients?: hypoglycemic state by CGMS vs. glycemic average

OBJETIVO: Avaliar o impacto do tempo de hipoglicemia silenciosa no controle glicêmico de pacientes diabéticos tipo 1 (DM1) sob monitorização contínua de glicose (CGMS). MÉTODOS: Oitenta e sete pacientes DM1 (45 por centoM/55 por centoF), divididos em quatro grupos, submetidos à CGMS 72 horas. Foram analisados: hipoglicemia silenciosa (HS) (< 70 mg/dL); tempo de hipoglicemia pelo CGMS, sendo os pacientes classificados em G1 (< 5 por cento), G2 (5-10 por cento), G3 (10 por cento a 20 por cento) e G4 (> 20 por cento); níveis de A1c e médias glicêmicas. RESULTADOS: A HS foi detectada em 64,5 por cento dos casos, sendo mais duradoura (mín.) durante a noite versus o dia (p < 0,001). Quanto ao tempo de HS, 41,4 por cento dos pacientes ficaram < 5 por cento, 21,8 por cento entre 5 por cento a 10 por cento, 23 por cento entre 10 por cento a 20 por cento e 13,8 por cento com > 20 por cento do CGMS 72 horas. Verificou-se menor média glicêmica quanto maior o tempo de hipoglicemia (p = 0,006). CONCLUSÃO: A hipoglicemia silenciosa é freqüente em pacientes com DM1, no período noturno. Observou-se tempo de 10 por cento a 20 por cento de hipoglicemia silenciosa para a média glicêmica entre 120 a 160 mg/dL.

BACKGROUND: To evaluate the impact of silent hypoglycemic state in glycemic control in type 1 diabetic patients (DM1) by CGMS. METHODS: 87 DM1 patients (45 percentM/55 percentF) submitted to a 72h CGMS profile were classified in 4 groups. It was analyzed: unrecognized hypoglycemia (<70mg/dL); duration time of silent hypoglycemia in which patients were classified into G1 (<5 percent), G2 (5-10 percent), G3 (10-20 percent) and G4 (>20 percent) of hypoglycemic state by CGMS; A1c and mean capillary glucose (MCG) in each group. RESULTS: The silent hypoglycemia was detected in 64.5 percent of patients and nighttime episodes of hypoglycemia lasted longer (min) than daytime episodes in all groups (p<0.001). It was verified 41.4 percent of patients under than 5 percent of time in hypoglycemic state, 21.8 percent between 5-10 percent, 23 percent between 10-20 percent and 13.8 percent with more than 20 percent of CGMS in silent hypoglycemia. This data showed significant decreased in MCG when the duration time of silent hypoglycemia was longer (p=0.006). CONCLUSION: The silent hypoglycemia is common in DM1 patients and most frequently in night time period. To take an average glycemia of 120-160mg/dL in these patients, it was necessary a 10-20 percent of CGMS period in silent hypoglycemia in these patients.

Hiperglicemia pós-prandial em pacientes com diabetes melito tipo 2 / Post-prandial hyperglycemia in type 2 diabetes patients

OBJETIVOS: Por meio da análise de um grupo de pacientes com DM2, temos por objetivos: avaliar por monitoração da glicose subcutânea (MGSG) as excursões pós-prandiais da glicose subcutânea; analisar as correlações da glicose subcutânea e glicemias capilares com a HbA1c e avaliar a eficácia, a segurança e a tolerabilidade da MGSC. MÉTODOS: Foram analisados 40 pacientes com DM2, com HbA1c até 7,3 por cento, em uso de agentes orais e com menos de 10 anos de diagnóstico. Foram submetidos à MGSC por 72 horas, cujos dados foram confrontados com a HbA1c e as glicemias capilares. RESULTADOS: A excursão média da glicose subcutânea do desjejum foi estatisticamente maior que a do jantar (95 por centoIC -24,96 a -1,66). A razão excursão da glicose subcutânea/conteúdo de carboidrato da refeição foi estatisticamente maior no desjejum que nas demais refeições (p = 0,001). Não houve correlação entre as taxas de glicose subcutânea e as glicemias capilares com HbA1c. Não houve complicações com o uso da MGSC. CONCLUSÕES: As excursões de glicose subcutânea predominaram no desjejum. Não se encontrou correlação entre HbA1c e parâmetros de controle glicêmico. A MGSC mostrou-se eficaz, segura e bem tolerada nesse grupo de pacientes.

OBJECTIVES: Through the analysis of a group of type 2 diabetes patients, the aims of this study are: to evaluate through CGMS (continuous glucose monitoring system) the post-prandial subcutaneous glucose excursions; to analyze the correlations between subcutaneous glucose and capillary glycemia with HbA1c and to evaluate the effectiveness, safety and broadmindedness of the CGMS. METHODS: Forty type 2 diabetes patients were analyzed, with HbA1c until 7.3 percent, in use of oral agents and within less than a ten-year diagnosis. They were submitted to CGMS for 72h, whose data were compared with HbA1c and capillary glycemia. RESULTS: The average subcutaneous glucose excursion at breakfast was statistically bigger than at dinner (95 percentCI -24,96 a -1,66). The subcutaneous glucose excursion/meal carbohydrates content ratio was statistically bigger at breakfast than at other meals (p 0,001). There was no correlation between the levels of subcutaneous glucose and capillary glycemia with HbA1c. There weren’t complications using CGMS. CONCLUSIONS: The subcutaneous glucose excursions were predominant at breakfast. There were no correlations between HbA1c and glycemic control parameters. CGMS showed itself efficient, secure and well tolerated in this group of patients.

Uso da monitorização contínua de glicose (CGMS) por quatro (96 horas) ou cinco (120 horas) dias em pacientes com DM1: existe vantagem? / Continuous glucose monitoring system (CGMS) in type 1 diabetic patients during 4 (96h) or 5 (120h) days: there is advantage?

OBJETIVO: Avaliar a acurácia, as complicações e o impacto no controle glicêmico de pacientes com diabetes melito tipo 1 (DM1) submetidos ao uso da monitorização contínua de glicose (CGMS) por quatro e cinco dias. MÉTODOS: Estudamos 36 pacientes DM1 (44,5 por centoM/55,5 por centoF), divididos em três grupos, com idade, tempo de DM e A1c semelhantes (p < 0,05), submetidos ao CGMS por 72 h (G1), 96 h (G2) e 120 h (G3). Foram analisados: GC média e pelo sensor, número de leituras, coeficiente de correlação, mediana da diferença absoluta (MAD por cento); complicações (trauma, infecção, desconexão, abandono); hiperglicemia pós-prandial (HPP) e hipoglicemia assintomática (< 70 mg/dl). Os níveis de A1c após três meses e um ano foram determinados nos três grupos. RESULTADOS: Não houve diferença técnica entre os grupos: coeficiente de correlação > 0,79 e MAD por cento < 28 por cento (p < 0,01) em 95 por cento. O uso do sensor por > 72 h não se associou com erro de sinal, desconexão, trauma, alarmes ou infecção local (p < 0,01). Verificou-se alta correlação entre GC média e pelo sensor, nos três grupos (p = 0,01). A hipoglicemia silenciosa foi mais duradoura (min.) à noite versus dia (p = 0,05), em todos os grupos. A HPP foi estatisticamente mais detectada nos grupos 1 e 3. Observou-se redução significante da A1c três meses após a CGMS no G1 (72 h) e G3 (120 h) (p < 0,001 e p = 0,002, respectivamente), que se manteve após um ano (p < 0,001 e p = 0,047, respectivamente). CONCLUSÃO: Evidenciamos alta acurácia/eficácia técnica com baixo índice de complicações em pacientes submetidos ao CGMS por 96 h ou 120 h. Não verificamos benefícios em relação à CGMS por 72 h quanto à redução da A1c em curto (três meses) e médio (um ano) prazo. O sensor CGMS pode ser utilizado por > 72 h, sem prejuízo técnico, mas sem grandes benefícios do ponto de vista clínico, para pacientes com DM1.

BACKGROUND: To evaluate the accuracy, complications and impact in glycemic control in type 1 diabetic patients (DM1) submitted to 4 or 5 days of CGMS. METHODS: We studied 36 DM1 patients (44.5 percentM/55.5 percentF), in three groups without no difference about age, DM duration and A1c levels (p < 0.05), submitted to 72h (G1), 96h (G2) and 120h (G3) CGMS profile. It were analyzed: capillary glycemia (CG) and mean CGMS sensor’s glycemic value; correlation coefficient, median absolute percent difference (MAD percent), number of sensor reading, complications (trauma, local infection, disconnection, dropped), postprandial hyperglycemia, unrecognized hypoglycemia (< 70 mg/dl). A1c levels were measured at the start (1 month before) and after 3 and 12 months in each group. RESULTS: No technical difference were observed into 3 groups: correlation coefficient > 0.79 and MAD < 28 percent in 95 percent (p < 0.01). The use of CGMS sensor more than 72h was not related to signal error, trauma, local infection or disconnection. The mean capillary glucose values showed no difference by glucose CGMS sensor (p = 0.01) in all groups. The nighttime episodes of hypoglycemia lasted longer (min) than daytime episodes in all groups (p = 0.05). The postprandial hyperglycemia was statistically identified in groups 1 and 3. This data showed significant decreased A1c level three months after the CGMS in G1 (72h) and G3 (120h) (p < 0.001 and p = 0.002, respectively), which sustained after 1 year (p < 0.001 e p = 0.047, respectively). CONCLUSIONS: The CGMS showed to be a very safety method, with high accuracy/technical efficacy in patients undergoing 96 h and 120 h of CGMS. We do not observed advantages in the use of CGMS during 96 h or 120 h against 72 h in decrease A1c levels after 3 and 12 months. It is possible the use of CGMS > 72h, with no technical damage. However, we do not observed significant clinical benefits of this conduct in DM1 patients.

Como a monitorização contínua de glicose subcutânea pode colaborar na interpretação dos valores da HbA1c no diabetes melito tipo 1?: [revisão] / How the continuous glucose monitoring system can contribute to HbA1c interpretation in type 1 diabetes mellitus?: [review]

O objetivo desta revisão é avaliar como o sistema de monitorização contínua de glicose subcutânea (CGMS®) pode colaborar na interpretação dos valores da hemoglobina glicada (A1c) no diabetes melito tipo 1. Foi realizada uma revisão bibliográfica dos benefícios, dos métodos, da interpretação e da experiência com CGMS®. A utilização de sensores contínuos pode ser útil na avaliação de pacientes com diabetes melito com oscilações glicêmicas, hipoglicemias graves, especialmente as noturnas, e hiperglicemias pós-prandiais. A identificação de padrões glicêmicos alterados permite ajustes terapêuticos e melhora do controle metabólico. O CGMS® é um procedimento de fácil utilização, com efeitos adversos de pequena intensidade e boa tolerância pelos pacientes. Embora o fabricante preconize um período de utilização de até três dias, observa-se que o prolongamento do teste por mais dias permite a obtenção de dados que auxiliam em mudanças terapêuticas superiores às realizadas com os registros do tempo convencional.

The aim of the present study is a literature revision of the contribution of continuous glucose monitoring system (CGMS®) in the interpretation of HbA1c levels in type 1 diabetes (T1DM). We performed a revision of the efficacy, benefits, interpretation of methods and experience with this system. The CGMS® could be useful in T1DM patients that present great glycemic variability or severe hypoglycemia (mainly nocturnal) and postprandial hyperglycemia. The identification of altered patterns or the glycemic variability allows therapeutic adjustment and improvement of the metabolic control. CGMS® is a safe method with a rare occurrence of side effects and it is well-tolerated by patients. The extension of the procedure for more days, over the 72h period recommended by the standard test, allows us to get important data to changes and adjustments on the insulin management of the type 1 diabetes mellitus patients.