Evaluation of a Clinical Pathway for Thyroid Nodular Disease: Timings and Delays in the Diagnosis and Treatment of Thyroid Cancer.

BACKGROUND: Due to the high prevalence of nodular thyroid disease in the general population and the need to rule out malignant tumours, a clinical pathway for nodular thyroid disease was created at our tertiary-level hospital. Our study aimed to quantify timings and delays in diagnosis and treatment in this clinical pathway, specifically for patients who were diagnosed with thyroid cancer. METHODS: A retrospective review was conducted of patients who were newly diagnosed with thyroid cancer and who had been previously evaluated in the clinical pathway for nodular thyroid disease at our institution during 2015-2017. Patient demographics, previous diagnostic studies, cytological results, tumour details and key dates were analysed to identify wait times in diagnosis and treatment. RESULTS: Forty patients with thyroid cancer were included. The diagnostic delay had a median time of 60 days, and the treatment delay was dependent on cytopathological results. The main cause for delay in the diagnostic phase was the timing of the thyroid ultrasound performed by the radiology department. In the treatment phase, patients with a cytological result of Bethesda III, V or VI underwent surgery at the suggested time, while those in the Bethesda II or IV category did not. CONCLUSIONS: The major delay found in the diagnostic phase was the timing of the thyroid ultrasound performed by the radiology department. We are not suggesting that this step must be eliminated, though the implementation of routine ultrasonography in a thyroid clinic can help identify patients who need more urgent evaluation for fine needle aspiration cytology. In our hospital, decision for surgery is based mainly on the cytopathological report. Imaging studies and/or molecular testing could be considered to reduce treatment delays.

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion / Utilidad clínica de la monitorización Flash de glucosa en pacientes con diabetes mellitus tipo 1 tratados con infusión subcutánea de insulina

Aim: To analyze the clinical impact of the Flash glucose monitoring system in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). Methods: A 24-week retrospective cohort study in CSII-treated T1DM patients exposed (1:1) to the Flash glucose monitoring system vs. self-monitoring of capillary blood glucose (SMBG). The primary outcome was the difference in hemoglobin A1c (HbA1c) levels between both groups at the end of the study. Results: Thirty-six patients with a mean age of 38.2 years (range 22-55) and a mean T1DM duration of 20.9±7.8 years, treated with CSII for 7.1±5.4 years, were enrolled into the study. At the end of the study, mean HbA1c levels improved in patients in the Flash group (7.1±0.7 vs. 7.8±1.0, p=0.04). Only the Flash group showed a significant decrease in HbA1c levels of −0.4% (95% CI, −0.6, −0.2; p=0.004) during follow-up. Flash patients captured 93.9% of data through 17.8±9.9 scans daily. In fact, the Flash cohort showed a three-fold increase in daily self-monitoring of glucose, while daily frequency of SMBG decreased during the study (−1.8 tests/24h (95% CI −3, −0.7; p=0.01). No safety issues related to Flash use were recorded. Conclusions: The Flash glucose monitoring system is a novel approach to improve blood glucose control in CSII-treated T1DM patients. Randomized controlled trials are needed to assess the effectiveness of this system in CSII-treated T1DM patients

Objetivo: Analizar el efecto clínico de la monitorización Flash de glucosa intersticial en pacientes con diabetes mellitus tipo 1 (DM1) tratados con infusión subcutánea continúa de insulina (ISCI). Método: Estudio de cohortes de 24 semanas de duración de sujetos con DM1 tratados con ISCI expuestos (1:1) a monitorización Flash de glucosa intersticial vs. autodeterminación de la glucemia capilar (AGC). El objetivo principal fueron las diferencias en los valores de hemoglobina glucosilada (HbA1c) entre ambos grupos. Resultados: Treinta y seis pacientes fueron incluidos con edad media de 38,2 años (rango: 22-55 años), duración media de la DM1 de 20,9±7,8 años y tratados con ISCI durante 7,1±5,4 años. Detectamos una mejora al final del estudio en las cifras de HbA1c entre los pacientes del grupo Flash (7,1±0,7 vs. 7,8±1,0; p=0,04). Solo los pacientes del grupo Flash mostraron durante el seguimiento un descenso significativo en los valores de HbA1c de −0,4% (IC 95%: −0,6, −0,2; p=0,004). Los pacientes que usaron Flash capturaron el 93,9% de los datos mediante 17,8±9,9 escaneos diarios. De hecho, los pacientes de la cohorte Flash triplicaron la frecuencia de comprobación de su glucosa aunque la frecuencia diaria de AGC descendió a lo largo del estudio (−1,8 test/24h; IC 95%: −3, −0,7; p=0,01). No se detectaron eventos de seguridad relacionados con el uso de Flash. Conclusiones: La monitorización Flash de glucosa supone un abordaje novedoso para mejorar el control glucémico en pacientes con DM1 tratados con ISCI. Resultan necesarios ensayos clínicos randomizados en el futuro para valorar con mayor consistencia la efectividad de esta terapia en este subgrupo de pacientes

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion.

AIM: To analyze the clinical impact of the Flash glucose monitoring system in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). METHODS: A 24-week retrospective cohort study in CSII-treated T1DM patients exposed (1:1) to the Flash glucose monitoring system vs. self-monitoring of capillary blood glucose (SMBG). The primary outcome was the difference in hemoglobin A1c (HbA1c) levels between both groups at the end of the study. RESULTS: Thirty-six patients with a mean age of 38.2 years (range 22-55) and a mean T1DM duration of 20.9±7.8 years, treated with CSII for 7.1±5.4 years, were enrolled into the study. At the end of the study, mean HbA1c levels improved in patients in the Flash group (7.1±0.7 vs. 7.8±1.0, p=0.04). Only the Flash group showed a significant decrease in HbA1c levels of -0.4% (95% CI, -0.6, -0.2; p=0.004) during follow-up. Flash patients captured 93.9% of data through 17.8±9.9 scans daily. In fact, the Flash cohort showed a three-fold increase in daily self-monitoring of glucose, while daily frequency of SMBG decreased during the study (-1.8 tests/24h (95% CI -3, -0.7; p=0.01). No safety issues related to Flash use were recorded. CONCLUSIONS: The Flash glucose monitoring system is a novel approach to improve blood glucose control in CSII-treated T1DM patients. Randomized controlled trials are needed to assess the effectiveness of this system in CSII-treated T1DM patients.

Glycemic Variability and Its Association With Demographics and Lifestyles in a General Adult Population.

OBJECTIVE: The objective was to investigate glycemic variability indices in relation to demographic factors and common environmental lifestyles in a general adult population. METHODS: The A Estrada Glycation and Inflammation Study is a cross-sectional study covering 1516 participants selected by sampling of the population aged 18 years and over. A subsample of 622 individuals participated in the Glycation project, which included continuous glucose monitoring procedures. Five glycemic variability indices were analyzed, that is, SD, MAGE, MAG, CONGA1, and MODD. RESULTS: Participants had a mean age of 48 years, 62% were females, and 12% had been previously diagnosed with diabetes. In the population without diabetes, index distributions were not normal but skewed to the right. Distributional regression models that adjusted for age, gender, BMI, alcohol intake, smoking status, and physical activity confirmed that all indices were positively and independently associated with fasting glucose levels and negatively with heavy drinking. SD, MAGE, and CONGA1 were positively associated with aging, and MAG was negatively associated with BMI. None of the GVI studied were influenced by physical activity. Age-group-specific reference values are given for the indices. CONCLUSIONS: This study yielded age-specific reference values for glucose variability indices in a general adult population. Significant increases were observed with aging. Heavy drinking of more than 140 g/week was associated with significant decreases in variability indices. No differences were found between males and females. These normative ranges provide a guide for clinical care, and may offer an alternative treatment target among persons with diabetes.

High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study.

OBJECTIVES: Hypoglycemia is a limiting factor in the achievement of strict glycemic control. The primary objective of this 9-week study was to determine the frequency of hypoglycemia in patients with stable insulin-treated type 2 diabetes mellitus by comparing self-monitored blood glucose (SMBG) measurement with continuous glucose monitoring (CGM). METHODS: This was an observational prospective study. Included in the study were 63 stable, insulin-treated patients with type 2 diabetes. They were instructed to record 2 daily capillary blood glucose readings, pre- and/or postprandial, in a sequential way during 8 consecutive weeks. A CGM system was worn during an additional week. We evaluated the frequency of hypoglycemia using the 8-week SMBG profile and the 1 CGM week. RESULTS: SMBG revealed that 50% of the patients had experienced hypoglycemia. CGM found hypoglycemia in 59% of patients. Significantly higher percentages of hyperglycemic and hypoglycemic episodes were detected by CGM than by capillary blood glucose measurements (61.1% vs. 50.8%; p=0.047) and (3.8% vs. 1.7%; p=0.016); 33% of patients experienced nocturnal hypoglycemia, and 19% of patients who had no data concerning hypoglycemia recorded in the capillary blood glucose diary had experienced hypoglycemia as measured by CGM, and the hypoglycemia occurred mainly during the nocturnal period. CONCLUSIONS: In stable well-controlled, insulin-treated patients with type 2 diabetes, CGM showed higher numbers of hypoglycemic events than did SMBG, especially at night. CGM is a useful tool that provides clinically valuable information about glucose control in these patients.

Position statement on efficiency of technologies for diabetes management.

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality are of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring nd self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the directones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease.

Documento de posicionamiento sobre la eficiencia de las tecnologías aplicadas al manejo de la diabetes / Position statement on efficiency of technologies for diabetes management

Las cifras del estudio Di@bet.es en España son contundentes: la diabetes afecta al 13,8% de la población española. Pero si los datos estadísticos son alarmantes, el mayor problema lo constituye el ritmo de crecimiento, y las previsiones calculan en poco tiempo proporciones pandémicas de diabetes tipo 2 que pondrán en riesgo el estado de bienestar. Por ello, la diabetes no solo representa un desafío importante para los servicios de salud, sino que pasa a ser un reto para los Ministerios de Sanidad y Economía. La tecnología se ha convertido en una herramienta imprescindible en la atención de calidad del paciente con diabetes, pues facilita los procesos de atención y cuidados para obtener un buen control metabólico y prevenir las complicaciones. Las bombas de insulina, los sensores de glucosa y la automonitorización de la glucemia capilar ya han probado su eficiencia, y la telemedicina está en vías de hacerlo. Los costes indirectos de la diabetes en España son mucho más elevados que los directos, lo cual no deja de ser una paradoja que debemos invertir. La optimización de los recursos dependerá de la habilidad que tengamos los profesionales y la administración para implantar y mantener la innovación tecnológica en todos sus niveles y hacerla eficaz en la ecuación que examina los datos económicos y los beneficios. Los análisis de coste-efectividad y coste-utilidad son necesarios para establecer prioridades y permitir tomar decisiones de gestión sanitaria, que en el caso de enfermedades tan prevalentes como la diabetes tienen repercusiones directas en el gasto sanitario

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality care of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring and self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the direct ones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease

Documento de posicionamiento sobre la eficiencia de las tecnologías aplicadas al manejo de la diabetes / Position statement on efficiency of technologies for diabetes management

Las cifras del estudio Di@bet.es en España son contundentes: la diabetes afecta al 13,8% de la población española. Pero si los datos estadísticos son alarmantes, el mayor problema lo constituye el ritmo de crecimiento, y las previsiones calculan en poco tiempo proporciones pandémicas de diabetes tipo 2 que pondrán en riesgo el estado de bienestar. Por ello, la diabetes no solo representa un desafío importante para los servicios de salud, sino que pasa a ser un reto para los Ministerios de Sanidad y Economía. La tecnología se ha convertido en una herramienta imprescindible en la atención de calidad del paciente con diabetes, pues facilita los procesos de atención y cuidados para obtener un buen control metabólico y prevenir las complicaciones. Las bombas de insulina, los sensores de glucosa y la automonitorización de la glucemia capilar ya han probado su eficiencia, y la telemedicina está en vías de hacerlo. Los costes indirectos de la diabetes en España son mucho más elevados que los directos, lo cual no deja de ser una paradoja que debemos invertir. La optimización de los recursos dependerá de la habilidad que tengamos los profesionales y la administración para implantar y mantener la innovación tecnológica en todos sus niveles y hacerla eficaz en la ecuación que examina los datos económicos y los beneficios. Los análisis de coste-efectividad y coste-utilidad son necesarios para establecer prioridades y permitir tomar decisiones de gestión sanitaria, que en el caso de enfermedades tan prevalentes como la diabetes tienen repercusiones directas en el gasto sanitario

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality care of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring and self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the direct ones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease

Should the amounts of fat and protein be taken into consideration to calculate the lunch prandial insulin bolus? Results from a randomized crossover trial.

BACKGROUND: Concerning continuous subcutaneous insulin infusion (CSII), there are controversial results related to changes in glycemic response according to the meal composition and bolus design. Our aim is to determine whether the presence of protein and fat in a meal could involve a different postprandial glycemic response than that obtained with only carbohydrates (CHs). SUBJECTS AND METHODS: This was a crossover, randomized clinical trial. Seventeen type 1 diabetes (T1D) patients on CSII wore a blinded continuous glucose monitoring system sensor for 3 days. They ingested two meals (meal 1 vs. meal 2) with the same CH content (50 g) but different fat (8.9 g vs. 37.4 g) and protein (3.3 g vs. 28.9 g) contents. A single-wave insulin bolus was used, and the interstitial glucose values were measured every 30 min for 3 h. We evaluated the different postprandial glycemic response between meal 1 and meal 2 by using mixed-effects models. RESULTS: The postmeal glucose increase was 22 mg/dL for meal 1 and 31 mg/dL for meal 2. In univariate analysis, at different times not statistically significant differences in glucose levels between meals occurred. In mixed-model analysis, a time×meal interaction was found, indicating a different response between treatments along the time. However, most of the patients remained in the normoglycemic range (70-180 mg/dL) during the 3-h postmeal period (84.4% for meal 1 and 93.1% for meal 2). CONCLUSIONS: The presence of balanced amounts of protein and fat determined a different glycemic response from that obtained with only CH up to 3 h after eating. The clinical relevance of this finding remains to be elucidated.

Beneficios de la terapia con infusión subcutánea continua de insulina en pacientes diabéticos tipo 1 que presentan gran variabilidad glucémica / Benefits of subcutaneous continuous insulin infusion in type 1 diabetic patients with high glycemic variability

Introducción La hipoglucemia limita la eficacia de la terapia insulínica intensiva, principalmente en pacientes con gran variabilidad glucémica. Nuestro objetivo fue determinar si la terapia con infusión subcutánea contínua de insulina (ISCI) es útil y si logra disminuir la variabilidad glucémica e hipoglucemias, principalmente en los pacientes con mayor variabilidad. Método Se realizó una monitorización continua de glucosa de 3 días de duración a 24 pacientes con diabetes mellitus tipo 1 (DM1) en 2 ocasiones diferentes: antes de iniciar la terapia con ISCI y 6 meses después de su implantación. Se comparó la variabilidad glucémica con distintas medidas de variabilidad (desviación estándar [SD], amplitud media de las excursiones glucémicas [MAGE], valor M) y el área bajo la curva (AUC) <70mg/dl de forma global en todos los pacientes y en aquellos con mayor variabilidad inicial (MAGE en mayor cuartil) Resultados A los 6 meses, se observó un descenso de la variabilidad glucémica medida como MAGE (mediana:-28mg/dl [rango interquartílico {RI}, -48 a 1], p=0,03); valor M (-22 [-40 a 0], p=0,04) y SD (-11[-23 a 0], p=0,009) en todos los pacientes. Los pacientes con mayor variabilidad glucémica inicial (MAGE cuartil 4) mostraron un mayor descenso de MAGE (-47mg/dl [-103 a -34] vs -20 [-36 a 17], p=0,01) y de AUC<70 (-10,7mg/dlxdía [-15 a 0] vs -1,1[-4,7 a 3,8], p=0,03), que el resto. Los pacientes con más tiempo en hipoglucemia inicial (AUC cuartil 4) lograron una mayor reducción del AUC<70 (-9,7mg/dlxdía [-15 a -6,5] vs -0,08 [-2,9 a 3,8], p=0,003]. Se halló una correlación entre ΔMAGE-ΔAUC [r 0,4, p=0,03].Conclusiones Durante el tratamiento con ISCI, la variabilidad glucémica descendió significativamente, principalmente en aquellos pacientes con mayor variabilidad inicial. El tiempo en hipoglucemia también fue menor en aquellos con una mayor variabilidad. Los pacientes con más hipoglucemias iniciales experimentaron un mayor descenso de estas con ISCI (AU)

Background Hypoglycemia limits the efficacy of intensive insulin therapy, especially in patients with great glucose variability. The extent to which continuous subcutaneous insulin infusion (CSII) overcomes this limitation is unclear. Our aim was to determine whether CSII is helpful for decreasing glucose variability and hypoglycemia, mainly in patients with the greatest variability .Method Twenty-four patients with type 1 diabetes wore a continuous glucose monitoring system sensor for 3 days before starting therapy with CSII and 6 months later. Glucose variability (SD, MAGE, M) and hypoglycemia duration (area under the curve (AUC) <70mg/dL) were compared in all patients and in those with the greatest MAGE (highest quartile).Results At 6 months, a decreased glucose variability was seen, as measured by MAGE, M, and SD (median: −28mg/dL (interquartile range, −48 to 1), p=0.03; −22 (−40 to 0), p=0.04; −11 (−23 to 0), p=0.009; respectively). Patients with the greatest initial glucose variability (MAGE quartile 4) showed a greater decrease in both MAGE (−47mg/dL (−103 to −34) vs −20 (−36 to 17), p=0.01) and AUC <70 (−10.7mg/dL×day (−15 to 0) vs −1.1 (−4.7 to 3.8), p=0.03) as compared to all others. Patients with longer initial hypoglycemia (AUC quartile 4) achieved a greater reduction in AUC <70 (−9.7mg/dL×day (−15 to −6.5) vs −0.08 (−2.9 to 3.8), p=0.003). A correlation was found between ΔMAGE-ΔAUC (r 0.4, p=0.03).Conclusions During CSII, glucose variability significantly decreased, especially in patients with the greatest initial variability. Hypoglycemia was also markedly less in patients with greater variability, with the greatest reduction occurring in those who experienced more marked hypoglycemia with CSII (AU)

[Benefits of subcutaneous continuous insulin infusion in type 1 diabetic patients with high glycemic variability]. / Beneficios de la terapia con infusión subcutánea continua de insulina en pacientes diabéticos tipo 1 que presentan gran variabilidad glucémica.

BACKGROUND: Hypoglycemia limits the efficacy of intensive insulin therapy, especially in patients with great glucose variability. The extent to which continuous subcutaneous insulin infusion (CSII) overcomes this limitation is unclear. Our aim was to determine whether CSII is helpful for decreasing glucose variability and hypoglycemia, mainly in patients with the greatest variability. METHOD: Twenty-four patients with type 1 diabetes wore a continuous glucose monitoring system sensor for three days before starting therapy with CSII and 6 months later. Glucose variability (SD, MAGE, M) and hypoglycemia duration (area under the curve (AUC) <70mg/dL) were compared in all patients and in those with the greatest MAGE (highest quartile). RESULTS: At 6 months, a decreased glucose variability was seen, as measured by MAGE, M, and SD (median: -28mg/dL (interquartile range, -48 to 1), p=0.03; -22(-40 to 0), p=0.04; -11(-23 to 0), p=0.009; respectively). Patients with the greatest initial glucose variability (MAGE quartile 4) showed a greater decrease in both MAGE (-47mg/dL (-103 to -34) vs -20 (-36 to 17), p=0.01) and AUC <70 (-10.7mg/dL x day (-15 to 0) vs -1.1 (-4.7 to 3.8), p=0.03) as compared to all others. Patients with longer initial hypoglycemia (AUC quartile 4) achieved a greater reduction in AUC <70 (-9.7mg/dL x day(-15 to -6.5) vs -0.08 (-2.9 to 3.8), p=0.003). A correlation was found between ΔMAGE-ΔAUC (r 0.4, p=0.03). CONCLUSIONS: During CSII, glucose variability significantly decreased, especially in patients with the greatest initial variability. Hypoglycemia was also markedly less in patients with greater variability, with the greatest reduction occurring in those who experienced more marked hypoglycemia with CSII.

Galectin-1 synthesis in type 1 diabetes by different immune cell types: reduced synthesis by monocytes and Th1 cells.

Galectins are a group of ß-galactoside-binding mammalian lectins that play important roles in the regulation of the immune response by promoting T cell tolerance, blunting Th1 and Th17 responses and suppressing autoimmune inflammation. However, the synthesis of these molecules by different T helper (Th) subsets and in the context of human type 1 diabetes (T1D) has not yet been studied. Our results show that Th17 polarising conditions induce the synthesis of higher levels of galectin-1 compared to Th1-polarised lymphocytes. In the context of human diabetes, peripheral blood mononuclear cells (PBMCs) from T1D patients, either unstimulated or after stimulation, secreted significantly lower amounts of galectin-1 in vitro compared to healthy donors. The reduced galectin-1 synthesis observed in this autoimmune disease occurs in a dominant pro-inflammatory cytokine milieu and it is mainly due to the lower synthesis by monocytes. Surprisingly, CD4(+) T helper cells from these patients secreted similar levels of galectin-1 compared to healthy donors, probably mediated by Th17 cytokines. In conclusion, CD4(+) T helper lymphocytes from T1D patients produce normal levels of the immunoregulator galectin-1 but its reduced synthesis by monocytes helps to maintain a skewed pro-inflammatory response.