Correlación entre tiempo en rango y hemoglobina glicosilada en personas con diabetes mellitus: revisión sistemática / Correlation between time on target and glycated hemoglobin in people with diabetes mellitus: systematic review / Correlação entre tempo no alvo e hemoglobina glicada de pessoas com diabetes mellitus: revisão sistemática

Objetivo: analizar la correlación entre el tiempo en rango y la hemoglobina glicosilada de personas que viven con diabetes mellitus y realizan la monitorización continua de la glucemia o el automonitoreo de la glucemia capilar Método: revisión sistemática de etiología y riesgo basada en las directrices del JBI e informada según los Preferred Reporting Items for Systematic Reviews and Meta-Analyses, abarcando seis bases de datos y la literatura gris. La muestra incluyó 16 estudios y la calidad metodológica fue evaluada utilizando las herramientas del JBI. Protocolo registrado en Open Science Framework, disponible en https://doi.org/10.17605/OSF.IO/NKMZB. Resultados: tiempo en rango (70-180 mg/dl) mostró una correlación negativa con la hemoglobina glicosilada, mientras que el tiempo por encima del rango (>180 mg/dl) mostró una correlación positiva. Los coeficientes de correlación variaron entre -0,310 y -0,869 para el tiempo en rango, y entre 0,66 y 0,934 para el tiempo por encima del rango. Un estudio se realizó en una población que hacía el automonitoreo. Conclusión: hay una correlación estadísticamente significativa entre el tiempo en rango y el tiempo por encima del rango con la hemoglobina glicosilada. Cuanto mayor sea la proporción en el rango glucémico adecuado, más cerca o por debajo del 7% estará la hemoglobina glicosilada. Se necesitan más estudios que evalúen esta métrica con datos del automonitoreo de la glucemia.

Objective: to analyze the correlation between time on target and glycated hemoglobin in people living with diabetes mellitus and carrying out continuous blood glucose monitoring or self-monitoring of capillary blood glucose. Method: systematic review of etiology and risk based on JBI guidelines and reported according to Preferred Reporting Items for Systematic Reviews and Meta- Analyses, covering six databases and grey literature. The sample included 16 studies and methodological quality was assessed using JBI tools. Protocol registered in the Open Science Framework, available at https://doi.org/10.17605/OSF.IO/NKMZB. Results: time on target (70-180 mg/dl) showed a negative correlation with glycated hemoglobin, while time above target (>180 mg/dl) showed a positive correlation. Correlation coefficients ranged between -0.310 and -0.869 for time on target, and between 0.66 and 0.934 for time above target. A study was carried out on a population that performed self-monitoring. Conclusion: there is a statistically significant correlation between time on target and time above target with glycated hemoglobin. The higher the proportion in the adequate glycemic range, the closer to or less than 7% the glycated hemoglobin will be. More studies are needed to evaluate this metric with data from self-monitoring of blood glucose.

Objetivo: analisar a correlação entre o tempo no alvo e a hemoglobina glicada de pessoas que vivem com diabetes mellitus e realizam a monitorização contínua da glicemia ou a automonitorização da glicemia capilar. Método: revisão sistemática de etiologia e de risco pautada nas diretrizes do JBI e reportada conforme Preferred Reporting Items for Systematic Reviews and Meta-Analyses, abrangendo seis bases de dados e a literatura cinzenta. A amostra incluiu 16 estudos e a qualidade metodológica foi avaliada utilizando as ferramentas do JBI. Registrado protocolo no Open Science Framework, disponível em https://doi.org/10.17605/OSF.IO/NKMZB. Resultados: tempo no alvo (70-180 mg/dl) apresentou correlação negativa com a hemoglobina glicada, enquanto o tempo acima do alvo (>180 mg/dl) mostrou correlação positiva. Os coeficientes de correlação variaram entre -0,310 e -0,869 para o tempo no alvo, e entre 0,66 e 0,934 para o tempo acima do alvo. Um estudo foi efetuado com população que realizava a automonitorização. Conclusão: há correlação estatisticamente significativa entre o tempo no alvo e o tempo acima do alvo com a hemoglobina glicada. Quanto maior a proporção na faixa glicêmica adequada, mais próxima ou inferior a 7% estará a hemoglobina glicada. São necessários mais estudos que avaliem essa métrica com dados da automonitorização da glicemia.

Tradução, adaptação cultural e validação do Instrumento de Autoavaliação em Diabetes / Translation, cultural adaptation and validation of the diabetes self-report tool / Traducción, adaptación cultural y validación de la herramienta de autoevaluación de la diabetes

Objetivo: realizar tradução, adaptação cultural e validação do Instrumento de Autoavaliação em Diabetes para aplicação no contexto brasileiro. Métodos: estudo metodológico realizado com 132 profissionais, entre os anos de 2016 e 2018, em seis etapas: 1 - Tradução inicial; 2 - Síntese da tradução; 3 - Retrotradução (back translation); 4 - Avaliação pelo comitê de juízes; 5 - Adequação cultural (pré teste); e 6 - Reprodutibilidade. Houve participação de profissionais de equipes multiprofissionais envolvidas no tratamento do diabetes por meio da plataforma e-surv. Resultados: entre os participantes, predominaram o sexo feminino (73,5%), profissionais com especialização (pós-graduação Lato Sensu) (51,5%) e com experiência na assistência a pessoas com diabetes (84,4%). O Índice de Validade de Conteúdo (IVC) foi satisfatório (0,850). O instrumento apresentou boa consistência interna (Alfa de Cronbach = 0,878). A análise de confiabilidade do instrumento, realizada pelo cálculo do coeficiente de correlação intraclasse (CCI), indicou concordância adequada em todas as medidas, 0,878 (IC 95%: 0,864 - 0,891), com Kappa Ponderado médio de 0,714 e índices acima de 0,60 em 85% os itens, mostrando boa concordância teste e reteste. Conclusão: a versão traduzida e culturalmente adaptada do Instrumento d e Autoavaliação em Diabetes apresentou boa confiabilidade, aceitabilidade e estabilidade temporal satisfatórias conforme os parâmetros internacionais, podendo ser utilizada, pelos profissionais da saúde, para autoavaliação em diabetes.(AU)

Objective: to carry out translation, cultural adaptation, and validation of the Diabetes Self-Report Instrument for application in the Brazilian context. Methods: methodological study carried out with 132 professionals, between 2016 and 2018, in six steps: 1 - Initial translation; 2 - Synthesis of the translation; 3 - Back translation; 4 - Evaluation by the judging committee; 5 - Cultural adequacy (pre-test); and 6 - Reability. There was participation of professionals from multidisciplinary teams involved in the treatment of diabetes through the e-surv platform. Results: among the participants, there was a predominance of females (73.5%), professionals with specialization (Lato sensu postgraduate degree) (51.5%) and with experience in caring for people with diabetes (84.4%). The Content Validity Index (CVI) was satisfactory (0.850). The instrument showed good internal consistency (Cronbach's alpha=0.878). The instrument's reliability analysis, carried out by calculating the intraclass correlation coefficient (ICC), indicated adequate agreement in all measurements, 0.878 (95% CI: 0.864 - 0.891), with mean weighted Kappa of 0.714 and indices above 0. 60 out of 85% of the items, showing good test-retest agreement. Conclusion: the translated and culturally adapted version of the Diabetes Self-report Instrument showed good reliability, acceptability, and satisfactory temporal stability according to international parameters, and can be used by healthcare professionals for self-report of diabetes.(AU)

Objetivo: realizar la traducción, adaptación cultural y validación de la Herramienta de Autoevaluación de Diabetes para aplicación en el contexto brasileño. Métodos: estudio metodológico realizado con 132 profesionales, entre 2016 y 2018, en seis etapas: 1 ­ Traducción inicial; 2 ­ Síntesis de la traducción; 3 ­ Traducción inversa; 4 ­ Evaluación por el comité de jueces; 5 ­ Adecuación cultural (pre-test); y 6 ­ Reproducibilidad. Se contó con la participación de profesionales de equipos multidisciplinarios...(AU)

Mediating effect of self-efficacy on self-management ability and self-management behavior in patients with type 2 diabetes mellitus / 北京大学学报(医学版)

OBJECTIVE@#To investigate the mechanism of self-efficacy between self-management ability and self-management behavior and its differences among patients with different disease courses through mediation tests.@*METHODS@#In the study, 489 patients with type 2 diabetes who attended the endocrinology departments of four hospitals in Shanxi Province and Inner Mongolia Autonomous Region from July to September 2022 were enrolled as the study population. They were investigated by General Information Questionnaire, Diabetes Self-Management Scale, Chinese version of Diabetes Empowerment Simplified Scale, and Diabetes Self-Efficacy Scale. Mediation analyses were performed using the linear regression model, Sobel test, and Bootstrap test in the software Stata version 15.0 and divided the patients into different disease course groups for subgroup analysis according to whether the disease course was > 5 years.@*RESULTS@#In this study, the score of self-management behavior in the patients with type 2 diabetes was 6.16±1.41, the score of self-management ability was 3.99±0.74, and the score of self-efficacy was 7.05±1.90. The results of the study showed that self-efficacy was positively correlated with self-management ability (r=0.33) as well as self-management behavior (r=0.47) in the patients with type 2 diabetes (P < 0.01). The mediating effect of self-efficacy accounted for 38.28% of the total effect of self-management ability on self-management behaviors and was higher in the behaviors of blood glucose monitoring (43.45%) and diet control (52.63%). The mediating effect of self-efficacy accounted for approximately 40.99% of the total effect for the patients with disease course ≤ 5 years, while for the patients with disease course > 5 years, the mediating effect accounted for 39.20% of the total effect.@*CONCLUSION@#Self-efficacy enhanced the effect of self-management ability on the behavior of the patients with type 2 diabetes, and this positive effect was more significant for the patients with shorter disease course. Targeted health education should be carried out to enhance patients' self-efficacy and self-management ability according to their disease characteristics, to stimulate their inner action, to promote the development of their self-management behaviors, and to form a more stable and long-term mechanism for disease management.

Continuous Blood Glucose Monitoring:Technological Progress and Application Extension / 中国医疗器械杂志

Continuous glucose monitoring (CGM) technology developed rapidly in recent years, and new products came out all the time. Nowadays, CGM plays an important role in diabetes management and has been recommended by various guideline all over the world. CGM equipment classification, progress on glucose sensor technology, and the new application and expansion of CGM technology in the field of diabetes and non-diabetes were briefly introduced in the study.

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.

Relationships of habitual daily alcohol consumption with all-day and time-specific average glucose levels among non-diabetic population samples

BACKGROUND@#Alcohol consumption is a prevalent behavior that is bi-directionally related to the risk of type 2 diabetes. However, the effect of daily alcohol consumption on glucose levels in real-world situations in the general population has not been well elucidated. This study aimed to clarify the relationship between alcohol consumption and all-day and time-specific glucose levels among non-diabetic individuals.@*METHODS@#We investigated 913 non-diabetic males and females, aged 40-69 years, during 2018-2020 from four communities across Japan. The daily alcohol consumption was assessed using a self-report questionnaire. All-day and time-specific average glucose levels were estimated from the interstitial glucose concentrations measured using the Flash glucose monitoring system for a median duration of 13 days. Furthermore, we investigated the association between all-day and time-specific average glucose levels and habitual daily alcohol consumption levels, using never drinkers as the reference, and performed multiple linear regression analyses after adjusting for age, community, and other diabetes risk factors for males and females separately.@*RESULTS@#All-day average glucose levels did not vary according to alcohol consumption categories in both males and females. However, for males, the average glucose levels between 5:00 and 11:00 h and between 11:00 and 17:00 h were higher in moderate and heavy drinkers than in never drinkers, with the difference values of 4.6 and 4.7 mg/dL for moderate drinkers, and 5.7 and 6.8 mg/dL for heavy drinkers. Conversely, the average glucose levels between 17:00 and 24:00 h were lower in male moderate and heavy drinkers and female current drinkers than in never drinkers; the difference values of mean glucose levels were -5.8 for moderate drinkers, and -6.1 mg/dL for heavy drinkers in males and -2.7 mg/dL for female current drinkers.@*CONCLUSIONS@#Alcohol consumption was associated with glucose levels in a time-dependent biphasic pattern.

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.

Decreasing complexity of glucose time series derived from continuous glucose monitoring is correlated with deteriorating glucose regulation / 医学前沿

Most information used to evaluate diabetic statuses is collected at a special time-point, such as taking fasting plasma glucose test and providing a limited view of individual's health and disease risk. As a new parameter for continuously evaluating personal clinical statuses, the newly developed technique "continuous glucose monitoring" (CGM) can characterize glucose dynamics. By calculating the complexity of glucose time series index (CGI) with refined composite multi-scale entropy analysis of the CGM data, the study showed for the first time that the complexity of glucose time series in subjects decreased gradually from normal glucose tolerance to impaired glucose regulation and then to type 2 diabetes (P for trend < 0.01). Furthermore, CGI was significantly associated with various parameters such as insulin sensitivity/secretion (all P < 0.01), and multiple linear stepwise regression showed that the disposition index, which reflects β-cell function after adjusting for insulin sensitivity, was the only independent factor correlated with CGI (P < 0.01). Our findings indicate that the CGI derived from the CGM data may serve as a novel marker to evaluate glucose homeostasis.

Comparación de los valores de glucosa en caninos obtenidos con glucómetros portátiles y la prueba estándar de laboratorio / Comparação dos valores de glicose em caninos obtidos com glicômetros portáteis e o teste laboratorial padrão / Comparison of glucose values in dogs obtained with portable glucometers and the standard laboratory test

La medición de glucosa en caninos es un procedimiento habitual en la clínica diaria, actualmente este valor se puede obtener mediante dispositivos portátiles y pruebas laboratoriales. Se realizó esta investigación con el fin de aportar mayor conocimiento sobre la importancia de la medición de glucosa, ya que en los últimos años ha perdido valor entre las pruebas hematológicas a considerar debido a que solo se relaciona con determinadas patologías como la diabetes u otras enfermedades metabólicas. El presente trabajo tiene como objetivo comparar los valores de glucosa en caninos obtenidos mediante un glucómetro portátil de uso humano (Accu-chek® Active, Roche Diagnostic, Mannheim, Alemania); veterinario (aLcose® Vet Glu, jjPlus Corporation, New Taipei, Taiwán) y la prueba estándar de laboratorio, esto nos indicará la fiabilidad de los resultados obtenidos mediante estos métodos. Se realizó la toma de muestras de sangre de 50 caninos clínicamente sanos, de los cuales se obtuvo el resultado de glucemia mediante estos tres métodos. Los resultados de nuestra investigación evidenciaron que las tres formas de evaluación de la glucosa sanguínea en perros brindaban resultados estadísticamente diferentes (p < 0.05). Se obtuvo valores de glucosa diferentes entre los tres métodos de medición, teniendo como promedios finales 84.14 mg/dL, 101.12 mg/dL y 91.12 mg/dL correspondientes al glucómetro portátil de uso humano, veterinario y a la prueba estándar de laboratorio respectivamente. En conclusión, los glucómetros portátiles de uso humano subestiman los valores reales de glucosa, mientras que los de uso veterinario lo sobreestiman, comparados con la prueba estándar de laboratorio.

A medição de glicose nos cães é um procedimento habitual realizado no atendimento clínico. Atualmente este valor pode ser obtido por meio de dispositivos portáteis e testes laboratoriais. Esta pesquisa foi realizada com a finalidade de destacar a importância da medição de glicose, visto que nos últimos anos esta avaliação não tem sido muito valorada entre os testes hematológicos, sendo considerada relevante apenas em relação a patologias como a diabetes e outras doenças metabólicas. O presente estudo teve como objetivo comparar os valores de glicose em cães obtidos com glicômetro portátil de uso humano; veterinário e o teste padrão de laboratório. Esta comparação poderá indicar a confiabilidade dos resultados obtidos mediante os métodos avaliados. Foi realizada a amostragem do sangue de 50 caninos clinicamente sadios os quais foram submetidos a avaliação de glicose mediante os três métodos. Os resultados de nossa investigação evidenciaram que as três formas de avaliação da glicose sanguínea têm resultados estatisticamente diferentes (p < 0,05). Os valores de glicose tiveram medias finais de 84,14 mg/dL, 101,12 mg/dL e 91,12 mg/dL para o glicômetro portátil de uso humano (Accu-chek® Active, Roche Diagnostic, Mannheim, Alemanha), veterinário (aLcose® Vet Glu, jjPlus Corporation, Nova Taipei, Taiwan) e o teste padrão de laboratório, respectivamente. Ao concluir, os glicômetros portáteis de uso humano subestimam os valores reais de glicose e os de uso veterinário os superestimam quando comparados com o teste padrão de laboratório.

The measurement of glucose in canines is a common procedure in daily clinical practice. Currently this value can be obtained by use of portable devices and laboratory tests. This research was carried out in order to provide more knowledge about the importance of glucose measurement, since in recent years it has lost value among the hematological tests to be considered because it is only related to certain pathologies such as diabetes or other metabolic diseases. The present study aimed to compare the glucose values in dogs obtained with a portable glucometer for human use, veterinarian use, and the standard laboratory test. This comparison may indicate the reliability of the results obtained through the evaluated methods. A blood sampling of 50 clinically healthy canines was taken and submitted to glucose evaluation using the three methods. Our investigation showed that the three ways of assessing blood glucose have statistically different results (p < 0.05). Glucose values had final averages of 84.14 mg/dL, 101.12 mg/dL, and 91.12 mg/dL for the portable glucometer for human use (Accu-chek® Active, Roche Diagnostic, Mannheim, Germany), veterinary (aLcose® Vet Glu, jjPlus Corporation, New Taipei, Taiwan) and the standard laboratory test, respectively. In conclusion, portable glucometers for human use underestimate the glucose values, and those for veterinary use overestimate them compared to the standard laboratory test.

Lesiones cutáneas asociadas al uso de bombas de insulina y sistemas de monitoreo: un problema desafiante / Insulin pumps and glucose monitors related cutaneous lesions: a challenging problem

Los cuidados actuales de la diabetes incluyen altos niveles de tecnología y los pacientes utilizan diferentes dispositivos que pueden ayudar en su control metabólico, pero pueden impactar negativamente en su piel. Sensores de glucosa como el Freestyle, Dexcom, el Enlite de Medtronic y los sistemas de infusión continua de insulina contienen diferentes productos químicos que están en contacto directo con la piel del paciente y pueden causar una dermatitis irritativa o de contacto alérgica. Las lesiones incluyen eczema, prurito, heridas, cicatrices y cambios en la pigmentación de la piel. Los productos químicos involucrados que pueden ocasionarlas son el isobornil acrilato, N, N- dimetilacrilamida, etil cianoacrilato y colophonium, forzando a los pacientes a cambiar los sitios de infusión, el set de infusión o el sensor mismo más pronto de lo esperado, para reducir el nivel de daño en la piel. Existe gran número de productos que permiten proteger la piel y reducir el contacto de la piel con la cánula de la bomba o el sensor. Para reducir o prevenir el daño existen productos como cremas o spray y parches de hidrocoloide que actúan como barrera y existen técnicas para aplicar y retirar cuidadosamente los parches y adhesivos de los dispositivos. Una vez que las lesiones se han producido, el tratamiento incluye pomadas y a veces corticoides tópicos y/o antibióticos. Para prevenir o reducir el daño de la piel asociado al sensor y uso de la bomba de insulina, la industria que los produce debería incluir la información en relación a los productos químicos incluidos en cada dispositivo.

Diabetes care nowadays includes a high level of technology and patients use different devices which can help them in their glycemic control, but can have a negative impact on their skin. Glucose sensors such as Freestyle, Dexcom, Medtronic Enlite and also continuous subcutaneous insulin infusion systems contain different chemical products which are in direct contact with the patient's skin and can cause irritative or allergic contact dermatitis. Lesions include eczema, pruritus, wounds, scars and changes in skin pigmentation. The chemical products which can induce them are isobornyl acrylate, N, N- dimethylacrylamide, ethyl cyanoacrylate and colophonium, forcing patients to change the infusion site, set or the sensor itself, earlier than expected, in order to reduce the level of skin damage. There are a number of products which can protect the skin and reduce it's contact with the pump cannula or the sensor. To reduce or prevent damage, we have products such as barrier cream or spray films and hydrocolloid blister plasters and actions such as careful application and removal of device's patches and adhesives. Once lesions are established, treatment includes ointments and sometimes topical steroids and/ or antibiotics. In order to prevent or reduce skin damage related to sensor and insulin pump use, the manufacturers should include the information related to the chemicals included in each device.

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.

Factors associated with glycemic variability in children with type 1 diabetes mellitus based on flash glucose monitoring system / 中南大学学报(医学版)

OBJECTIVES@#Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability.@*METHODS@#A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema.@*RESULTS@#HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group.@*CONCLUSIONS@#The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.

Research Progress on Enzyme-free Blood Glucose Sensor / 中国医疗器械杂志

Blood glucose monitoring is of great significance to diabetic patients, and the development of rapid, accurate and real-time glucose detection technology has become a research hotspot nowadays. This study introduces the concept and classification of the enzyme-free glucose sensor, expounds enzymefree glucose sensor electrode characterization methods and the application progress of different materials in enzyme-free blood glucose sensors. Meanwhile, some problems of enzyme-free glucose sensor existing in the current research and its future application prospects also will be discussed.

Type 1 diabetes care in mexico: an analysis of the renaced-dt1 national registry

Background: Information regarding diagnosis, treatment, and follow-up of patients with type 1 diabetes (PWT1D) in Mexico is limited. We developed an on-line platform Registro Nacional de Pacientes con Diabetes Tipo 1 (RENACED-DT1). Objective: The objective of the study was to describe the characteristics and healthcare of PWT1D registered in RENACED-DT1. Methods: Analyses of 965 PWT1D from July 2014 to January 2018 in different endocrinology clinics around Mexico. Results: Sixty-one percent were female with median age of 21 years, age at diagnosis 11 years, and disease duration at inclusion 8.2 years. Treatment regimen was basal-bolus in 61% and insulin-pumps in 21% (mainly in the private sector); 33.3% with self-monitoring of blood-glucose (SMBG) ≥4 times/day. Mean HbA1c at last follow-up was 8.7 ± 2.1% (72±23 mmol/mol), 18% had HbA1c < 7% (53 mmol/mol), and 35% > 9% (75 mmol/mol). SMBG ≥ 4 times/day was associated with HbA1c < 7%. Time since diagnosis > 10 years, female sex, BMI ≥ 30 kg/m2, SMBG < 4 times/day, and any hypoglycemia were associated with microvascular complications (p < 0.05). Conclusions: Percentage of patients achieving HbA1c < 7% is low; increased blood glucose monitoring is associated with better glycemic control. The achievement of optimal glycemic control must be increased to reduce the incidence of chronic complications and improve quality of life in PWT1D.

Flash glucose monitoring system: impact on glycemic control and body mass index in type 1 diabetes mellitus

ABSTRACT Objective: Flash glucose monitoring (FGM) is increasingly used in type 1 diabetes mellitus (T1D) management. This study aimed to assess glycated hemoglobin (HbA1c) and body mass index (BMI) in the first year of FGM use in patients with T1D and to identify predictive factors of benefit associated with its use. Subjects and methods: Retrospective study of T1D patients, using FGM for ≥ 6 months and under intensive insulin therapy with multiple daily injections. Results: In 179 patients with a median (Md) age of 43.0 years (P25 31.0; P75 52.0) and disease duration of 18.0 years (P25 10.0; P75 28.0), initial HbA1c was 7.9% (P25 7.2; P75 8.8) and initial BMI was 24.0 kg/m2 (P25 21.9; P75 26.2). With FGM, HbA1c improved significantly to 7.6% (P25 7.0; P75 8.3) at 6 months and 7.7% (P25 6.95; P75 8.5) at 12 months (p < 0.05), with more patients with HbA1c < 7% (16.1% vs 22.5%) and fewer patients with HbA1c ≥ 8% (49.1% vs 35.8%) (p < 0.05). Initial HbA1c 8.0-8.9% (HR 1.886; 95% CI 1.321-2.450) and ≥ 9.0% (HR 3.108, 95% CI 2.454-3.761) predicted greater HbA1c reduction. BMI increased significantly, especially between 6 and 12 months (BMI Md 23.8 [P25 21.9; P75 26.2] kg/m2 and 24.0 [P25 22.0; P75 26.2] kg/m2, respectively) (p < 0.05). Overweight (HR 4.319, 95% CI 3.185-5.453) and obesity (HR 8.112, 95% CI 3.919-12.306) predicted greater weight gain. Conclusions: FGM use was associated with significant improvement in HbA1c, mainly in patients with worse previous glycemic control. It was also associated with increased BMI, especially if baseline BMI ≥ 25 kg/m2, so weight control strategies should be emphasized.

Autocuidado de usuários com diabetes mellitus inseridos em um programa de automonitorização da glicemia capilar / Self-care of users with diabetes mellitus entered into a program of capillary blood glucose self-monitoring / Autocuidado de los usuarios con diabetes mellitus entrado en un programa de la sangre capilar automonitorización de la glucosa

Objetivo: Avaliar o desempenho das atividades de autocuidado de usuários com diabetes mellitus inseridos em um programa de automonitorização da glicemia capilar no domicílio. Método: estudo transversal, descritivo, com abordagem quantitativa, realizado no domicílio de usuários com diabetes mellitus que realizam a automonitorização da glicemia capilar, totalizando uma amostra de 279 usuários. Na avaliação das atividades de autocuidado utilizou-se o Questionário de Atividades de Autocuidado com o Diabetes, e para coleta dos dados sociodemográficos e clínico foi aplicado um roteiro sistematizado. Resultados: os dados revelaram que as dimensões alimentação específica, atividade física e monitorização glicêmica demostra comportamento de autocuidado não desejável, enquanto adesão medicamentosa apresentou o melhor comportamento de autocuidado desejável. Conclusão: os usuários com diabetes mellitus que realizam a automonitorização da glicemia capilar no domicílio necessitam de um acompanhamento específico, acrescido de práticas educativas contínuas que estimulem a participação efetiva nas atividades de autocuidado

Objective:To evaluate the performance of self-care activities of users with diabetes mellitus entered into a program of capillary blood glucose self-monitoring at home. Method: cross-sectional study, descriptive, with a quantitative approach, held at the domicile of users with diabetes mellitus that perform capillary blood glucose self-monitoring, totaling a sample of 279 users. In the evaluation of the activities of self-care Questionnaire was used of Self-care activities with Diabetes, and to collect demographic and clinical data was applied a systematic roadmap. Results: the data revealed that the specific power supply dimensions, physical activity and monitoring Glycemic demonstrates behavior of self-care is not desirable, while drug membership presented the best self-care behavior desirable. Conclusión: users with diabetes mellitus that perform capillary blood glucose self-monitoring at home require a specific accompaniment, plus continuous educational practices that foster the effective participation in the activities of self-care

Objetivo: Evaluar el desempeño de las actividades de autocuidado de los usuarios con diabetes mellitus entró en un programa de sangre capilar glucosa autocontrol en casa. Método: estudio transversal descriptivo con enfoque cuantitativo, celebrada en el domicilio de los usuarios con diabetes mellitus que realizan sangre capilar Self-monitoring de la glucosa, por un total de una muestra de 279 usuarios. En la evaluación de las actividades de autocuidado se utilizó cuestionario de actividades de autocuidado con Diabetes, y recopilar datos demográficos y clínicos se aplicó un plan sistemático. Resultados:Los datos revelaron que la alimentación específicos dimensiones, actividad física y control glicémico demuestra comportamiento de autocuidado no es deseable, mientras que miembros de drogas presentaron el mejor comportamiento de autocuidado deseable. Conclusión: los usuarios con diabetes mellitus que realizan sangre capilar glucosa autocontrol en casa requieren de un acompañamiento específico, además de continuas prácticas educativas que fomentan la participación efectiva en las actividades de cuidados personales

Relationship of abnormal mid-term oral glucose tolerance test and maternal weight gain with adverse pregnancy outcomes in women with gestational diabetes mellitus / 浙江大学学报·医学版

To explore the correlation of mid-term oral glucose tolerance test (OGTT) and maternal weight gain with adverse pregnancy outcomes in women with gestational diabetes mellitus (GDM). A total of 2611 pregnant women with GDM who were examined and delivered in Women's Hospital, Zhejiang University School of Medicine from July 1st 2017 to 30th June 2018 were enrolled in this study. According to the number of abnormal items of mid-term OGTT results or maternal gestational weight gain (GWG), patients were classified. The incidence of adverse perinatal outcomes in each group and its relation with OGTT results and GWG were analyzed. The incidence of gestational hypertension, premature delivery, macrosomia and large for gestational age infant (LGA) in three abnormal items GDM patients were significantly higher than those in one or two abnormal items GDM patients (all <0.017). The incidence of gestational hypertension and premature delivery in two abnormal items GDM patients were higher than those in one abnormal item GDM patients (all <0.017). The incidence of gestational hypertension and macrosomia in excessive GWG patients were significantly higher than those in inadequate and appropriate GWG patients (all <0.017), and the incidence of LGA were higher than that in inadequate GWG patients (all <0.017). The incidence of premature delivery and low birth weight infants in appropriate GWG patients were significantly lower than those in inadequate and excessive GWG patients, and the incidence of small for gestational age infant (SGA) were significantly lower than that in inadequate GWG patients (all <0.017). In one abnormal item GDM patients, inadequate GWG was a risk factor for premature delivery and SGA (=1.66, 95%: 1.10-2.52; =2.20, 95%: 1.07-4.53), and protective factor for LGA (=0.40, 95%: 0.27-0.59). And excessive GWG was a risk factor for gestational hypertension, premature delivery and low birth weight infants (=2.15, 95%: 1.35-3.41; =1.80, 95%: 1.20-2.72; =2.18, 95%: 1.10-4.30).In two abnormal items GDM patients, inadequate GWG was a protective factor for macrosomia and LGA (=0.24, 95%: 0.09-0.67; =0.54, 95%: 0.34-0.86), while excessive GWG was risk factor for premature delivery (=1.98, 95%: 1.23-3.18).In three abnormal items GDM patients, there was no significant relationship between GWG and adverse pregnancy outcomes. For GDM women with one or two items of elevated blood glucose in OGTT, reasonable weight management during pregnancy can reduce the occurrence of adverse pregnancy outcomes. For those with three items of elevated blood glucose in OGTT, more strict blood glucose monitoring and active intervention measures should be taken in addition to weight management during pregnancy.

Association between time in range and cancer mortality among patients with type 2 diabetes: a prospective cohort study / 中华医学杂志(英文版)

BACKGROUND@#Little was known about the association among time in range (TIR), time above range (TAR), time below range (TBR), and cancer mortality among patients with type 2 diabetes. We aimed to investigate the association among TIR, TAR, TBR, and the risk of cancer mortality among patients with type 2 diabetes.@*METHODS@#A total of 6225 patients with type 2 diabetes were prospectively recruited in Shanghai, China. TIR was measured with continuous glucose monitoring at baseline and was defined as the average percentage of time in the target glucose range during a 24 h period. Cox proportion hazard regression analysis was used to determine the association between TIR and the risk of cancer mortality.@*RESULTS@#During a mean follow-up of 7.10 years, we confirmed 237 death events related to cancer. The multivariable-adjusted hazard ratio (HR) for cancer mortality was 1.32 (95% confidence interval [CI]: 1.01-1.75) in patients with TIR ≤70% compared with those with TIR >70%. When TIR was considered as a continuous variable, the multivariable-adjusted HR for cancer mortality associated with each 10% decrease in TIR was 1.07 (95% CI: 1.02-1.14). In the site-specific analysis, a significant association between TIR as a continuous variable and the risk of hepatocellular cancer was found (HR: 1.24; 95% CI: 1.09-1.41). However, no relationship between hemoglobin A1c and cancer mortality was observed (HR: 1.04; 95% CI: 0.97-1.10).@*CONCLUSIONS@#The present study found an inverse association of TIR with the risk of cancer mortality among patients with type 2 diabetes. New evidence of TIR was added into the clinical practice that TIR may be an optimal target of glycemic control among patients with type 2 diabetes.

Is biochemical hypoglycemia necessary during an insulin tolerance test?

ABSTRACT Objective The insulin tolerance test (ITT) has been accepted as the gold standard test for assessing the integrity of the growth hormone (GH) - insulin-like growth factor (IGF-1) axis and the hypothalamic-pituitary-adrenal (HPA) axis. The goal of the test is to achieve clinical and biochemical hypoglycemia at a blood glucose level ≤ 40 mg/dL to effectively and correctly assess the HPA and GH-IGF-1 axes. In this study, the GH and cortisol responses of patients who achieved and failed to achieve biochemical hypoglycemia during an ITT were compared. Subjects and methods One hundred thirty-five patients with pituitary disorders were included in the study. Samples for blood glucose levels were obtained after clear symptoms of clinical hypoglycemia developed. The patients were enrolled in the hypoglycemic and nonhypoglycemic groups according to whether their plasma glucose level ≤ 40 mg/dL or > 40 mg/dL during an ITT, and the groups were compared in terms of their GH and cortisol responses. Results The mean age, body mass index and waist circumference of the two patient groups were found to be similar. The mean blood glucose level was significantly lower in the hypoglycemic group than in the nonhypoglycemic group (19.3 and 52.0 mg/dL, respectively). When the two groups were compared in terms of peak cortisol and GH responses, no statistically significant differences were found. Conclusion The data presented suggest that clinically symptomatic hypoglycemia is as effective as biochemically confirmed hypoglycemia during an ITT. Arch Endocrinol Metab. 2020;64(1):82-8

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.