SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

INTRODUCTION: Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. METHODS: SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6 weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. RESULTS: Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] - 1.6 to - 1.0; p < 0.0001) after 26 ± 6 weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1 kg (95% CI - 1.5 to - 0.5; p < 0.0001), from a mean of 76.1 kg at baseline to 75.1 kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. CONCLUSION: In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05324462.

Semaglutide Effects on Metabolic Outcomes in Diabetes Mellitus Patients - Real World Study.

Purpose: Diabetes is a public health problem that requires strategies to impact glycemic control and reduce the risk of long-term medical complications. Pharmacological management is a necessary treatment for this disease. Therefore, semaglutide is an essential tool to achieve the treatment targets. The present study aimed to evaluate the semaglutide effects on a cohort with type 2 diabetes mellitus (T2DM) in Colombia. Materials and Methods: The cohort included 49 patients with T2DM that have been treated in a specialized care center. Their glycemic outcomes, weight, renal function, and adverse events were evaluated through a 3-, 6- and 12-month follow-up. Results: Significant differences were observed in the outcome evaluation: reduction of glycated hemoglobin levels (MD -2.74 CI -1.95 to -3.52 in 6 months), fasting plasma glucose levels, body weight (MD -7.11 CI -5.97 to -8.24), and the albumin-to-creatinine ratio. The results were maintained throughout the treatment period. The adverse event rate was 16.3%, predominating gastrointestinal events. Conclusion: This real-world evidence shows the efficacy of semaglutide in achieving treatment goals in patients with T2DM.

Accuracy of an Off-Label Transmitter and Data Manager Paired With an Intermittent Scanned Continuous Glucose Monitor in Adults With Type 1 Diabetes.

BACKGROUND: This work evaluates the accuracy and agreement between the FreeStyle Libre sensor (FSL) and an off-label converted real-time continuous glucose monitor (c-rtCGM) device consisting of the MiaoMiao transmitter and the xDrip+ application which can be coupled to the FSL. METHODS: Four weeks of glucose data were collected from 21 participants with type 1 diabetes using the c-rtCGM and FSL: two weeks with a single initial calibration (uncalibrated) and two weeks with a daily calibration (calibrated). Accuracy and agreement evaluation included mean absolute relative difference (MARD), the %20/20 rule, Bland-Altman plots, and the Consensus Error Grid analysis. RESULTS: Values reported by the c-rtCGM system compared with the FSL resulted in an overall MARD of 12.06% and 84.71% of the results falling within Consensus Error Grid Zone A when the device is calibrated. For uncalibrated devices, an overall MARD of 17.49% was obtained. Decreased accuracy was shown in the hypoglycemic range and for rates of change greater than 2 mg/dL/min. The between-device bias also incremented with increasing glucose values. CONCLUSION: Measurements recorded by the c-rtCGM were found to be accurate when compared with FSL data only when performing daily c-rtCGM device calibrations. High drops in accuracy and agreement between devices occurred when the c-rtCGM was not calibrated.

Short-Term Effectiveness and Reduction in Insulin Requirements in Patients With Type 2 Diabetes Treated With IdegLira in a Real-World Setting.

Background: Type 2 diabetes mellitus (T2DM) is a chronic, highly prevalent disease with a significant impact on health. Appropriate treatment requires effective and timely escalation to achieve metabolic control. To evaluate the effectiveness and safety of IDegLira on adults with T2DM previously treated with oral antidiabetics and/or insulin in a real-life setting. Methods: An observational study in a real-world setting was conducted. Patients were selected from the outpatient clinic of two centers dedicated to specialized diabetes care. Main outcomes were HbA1c, body weight, insulin dose changes, hypoglycemia, and other adverse events. Results: 67 T2DM patients treated with IDegLira were monitored between 3 and 7 months. At the end of foll ow-up, the median change in HbA1c was -1.05% (CI95% -1.45, -0.65), and a decrease in insulin requirement was also observed (mean difference -10 TDD units (CI95% - 17 to -2.5). No treatment discontinuation was reported, hypoglycemia events were reported in 3 patients at the end of follow-up versus 8 patients at baseline. Conclusions: This real-life study shows the effectiveness in glycemic control of IDegLira use in T2DM patients who do not achieve goals with other therapies, with an adequate safety profile. The findings need to be confirmed with evaluation of therapeutic results in larger cohorts.

Tratamiento farmacológico del paciente que vive con diabetes mellitus tipo 2 / Pharmacological treatment of the patient living with type 2 diabetes mellitus

Resumen Introducción: el abordaje del paciente con diabetes mellitus tipo 2 ha cambiado a lo largo del tiempo. Años anteriores el enfoque terapéutico giraba en torno al nivel de hemoglobina glicada (HbA1c); ahora, con el advenimiento de nuevas moléculas, y luego de entender que la meta terapéutica no es sólo un punto de corte de HbA1c, se ha modificado el objetivo, para estar centrado en el paciente, en sus comorbilidades macro y microvasculares, riesgo cardiovascular y falla cardíaca. En esta revisión de la literatura se exponen las preguntas que se deben resolver al momento de definir una estrategia terapéutica en el paciente con diabetes mellitus tipo 2. Métodos: valoración de guías locales e internacionales de tratamiento de diabetes mellitus tipo 2. Resultados: se valoraron las guías del tratamiento de la diabetes mellitus tipo 2 realizadas por la Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular, American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology. Además, se revisaron los ensayos clínicos que respaldan el uso de los diferentes grupos farmacológicos disponibles para el tratamiento de los pacientes con diabetes mellitus tipo 2. Conclusión: es menester del clínico realizar el abordaje terapéutico de los pacientes con diabetes mellitus tipo 2 de forma individualizada, centrado en el riesgo cardiovascular, comorbilidades asociadas, riesgo de hipoglucemia y costos de la intervención brindada.

Abstract Introduction: the approach to the patient with diabetes has changed over the past decade. Some years ago, the primary goal of treatment was to achieve a certain level of A1c as a marker of glucose control. Now, with new molecules in the market that can modify the disease and its complications the treatment is focused on the individual patient, his micro and macrovascular complications and the risk of cardiovascular, heart failure and renal complications. In this review of the literature, we expose some questions that need to be solved when approaching the treatment of a patient with type 2 diabetes. Methods: we reviewed local and international guidelines on the treatment of type 2 diabetes. Results: we reviewed guidelines in the treatment of diabetes, local guidelines; Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. International guidelines; American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology Additionally, we revised clinical trial that support the use of the different drugs that are recommended by the guidelines as first, second- or third-line treatment. Conclusion: as clinicians we are expected to give the patient an individualized approach, based on their own comorbidities, risk of cardiovascular and renal disease and risk of hypoglycemia guided by national and international guidelines and latest clinical trial that support our approach.

Efficacy and safety of carbohydrate counting versus other forms of dietary advice in patients with type 1 diabetes mellitus: a systematic review and meta-analysis of randomised clinical trials.

BACKGROUND AND AIMS: Diabetes mellitus (DM) is one of the most prevalent chronic noncommunicable diseases globally, and the only way to reduce its complications is good glycaemic control. Insulin remains the only approved treatment for type 1 DM (T1DM) and is used by many with type 2 DM (T2DM). Carbohydrate counting is considered the ideal way to calculate meal-related insulin doses as it allows greater flexibility in diet and could, in some people, reduce the burden of the disease. The primary objective of this systematic review was to assess carbohydrate counting efficacy in reducing glycated haemoglobin (HbA1c ) levels and safety by not increasing hypoglycaemia risk, inducing an increase in body weight or blood lipids, or reducing the quality of life of people with T1DM. METHODS: We included randomised controlled clinical trials with a parallel-group design comparing any carbohydrate counting forms with standard care or other forms of dietary advice or insulin dose calculation in people with T1DM with a follow up period of at least 3 months and with no restrictions in language, age or settings. As a primary outcome, we consider the change of HbA1c levels within at least 3 months. Secondary outcomes were hypoglycaemia events, body weight changes, blood lipids levels, and the total daily insulin dose. We also evaluated health-related quality-of-life changes and questionnaires on satisfaction with treatment of diabetes. RESULTS: Data from 11 studies with 899 patients were retrieved with a mean follow-up of 52 ± 35.5 weeks. Carbohydrate counting is not better in reducing HbA1c levels (SMD-0.24%, 95% CI -0.68 to 0.21) than all dietary advice forms. However, this finding was highly heterogeneous. We identified three studies that account for most of the heterogeneity using clustering algorithms. A second analysis excluding these studies shows a meaningful reduction in HbA1c levels (SMD-0.52%, 95% CI -0.82 to -0.23) with low heterogeneity. In the subgroup analysis, carbohydrate counting significantly reduces HbA1c levels compared with usual diabetes education. Carbohydrate counting does not relate to any substantial change in blood lipids, body weight, hypoglycaemia risk or daily insulin dose. Finally, we analysed the effect of trial duration on reduction in HbA1c levels and found no significant change related to time. CONCLUSIONS: Carbohydrate counting is an efficacious technique to safely reduce the levels of HbA1c in adults and children compared with standard diabetes education, and its effect does not appear to change with prolonged time. Standardisation in reporting important outcomes such as hypoglycaemia and quality of life are vital to produce comparable evidence in carbohydrate counting clinical trials. This systematic review was registered in PROSPERO under code: CRD42020218499.

The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy.

OBJECTIVE: This study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). METHODS: We compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. RESULTS: The CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14-0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. CONCLUSIONS: CDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up.

OBJECTIVE: To evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. METHODS: This was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. RESULTS: 162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (-0.9%, 95% CI: 0.5-1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7-2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (-8.1%, 95% CI: -16.5 to 0.3; p=0.03). CONCLUSIONS: SAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy.

OBJECTIVE: This study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). METHODS: We compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. RESULTS: The CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14-0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. CONCLUSIONS: CDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up.

OBJECTIVE: To evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. METHODS: This was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. RESULTS: 162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (-0.9%, 95% CI: 0.5-1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7-2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (-8.1%, 95% CI: -16.5 to 0.3; p=0.03). CONCLUSIONS: SAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

Efecto de terapias farmacológicas para el control glicémico en pacientes con diabetes mellitus tipo 2 en los desenlaces vasculares / Effect of pharmacological therapies for glycemic control in patients with type 2 diabetes mellitus on vascular outcomes

Resumen Introducción: en los últimos 5 años la publicación de conocimiento relacionado con la enfermedad vascular y la diabetes mellitus tipo 2 (DT2) ha ido en aumento. Sin embargo, debido a la ausencia de una revisión que recopilara todos los desenlaces vasculares de la DT2, la presente revisión de literatura tiene como objetivo agrupar todos los desenlaces vasculares relacionados con la DT2 y describir cómo la terapia farmacológica hipoglicemiante puede ser eficaz para lograr el control de estos desenlaces. Los eventos cardiovasculares como desenlace principal demuestran que los medicamentos antidiabéticos innovadores como la empagliflozina y la liraglutida pueden agregar un beneficio significativo para pacientes con DT2. Materiales y métodos: búsqueda sistemática de la literatura, de la cual se obtuvieron 141 referencias, después de eliminar duplicados, para la tamización pareada. Posterior a esto, se identificaron 2l referencias que cumplían con los criterios de inclusión para ser considerados en el análisis. Resultados: el efecto de un buen control glucémico, sobre los resultados clínicos, específicamente en la progresión de la enfermedad renal diabética, ha sido objetivo de múltiples estudios a gran escala, tanto en pacientes diabéticos tipo 1 como en diabéticos tipo 2. Los desenlaces micro y macrovasculares son los principales desenlaces de la DMT2, que incrementan la incidencia de comorbilidades y representan, a su vez, una mayor morbilidad. Conclusiones: dentro de las principales causas de morbilidad y mortalidad de los pacientes con DT2, se encuentran las relacionadas con daño vascular, en especial enfermedad cardiovascular y compromiso renal. En este contexto, el tratamiento farmacológico de la diabetes mellitus se ha enfocado en encontrar medicamentos que reduzcan de manera significativa los eventos cardiovasculares y que al mismo tiempo retrasen la aparición de nefropatía o su progresión. Las tiazolidinedionas, los inhibidores de DPP4 (alogliptina, saxagliptina y sitagliptina), la insulina glargina y degludec han demostrado seguridad cardiovascular, pero no beneficio cardiovascular incremental en pacientes con DT2 que tienen alto riesgo de enfermedad cardiovascular aterosclerótica.

Abstract Introduction: In the last 5 years the publication of knowledge related to vascular disease and diabetes mellitus type 2 (DT2) has been increasing. However, due to the absence of a review that collects all the vascular outcomes of T2D, the current review of the literature aims to group all vascular outcomes related to T2D and describe how hypoglycemic drug therapy can be effective for the control of these outcomes. Cardiovascular events as the main outcome show that innovative antidiabetic drugs such as empagliflozin and liraglutide can add significant benefits for patients with T2D. Materials and methods: Systematic search of the literature, from which 141 references were obtained, after eliminating duplicates, for paired screening. Subsequently, 21 references were identified that met the inclusion criteria to be considered in the analysis. Results: The effect of good glycemic control on clinical outcomes, specifically in the progression of diabetic kidney disease, has been the objective of multiple large-scale studies, both in type 1 diabetic patients and type 2 diabetics and macrovascular outcome of the primary DMT2, increasing the incidence of comorbidities and in turn representing greater morbidity. Conclusions: Among the main causes of morbidity and mortality of patients with T2D, are those with vascular damage, especially cardiovascular disease and renal involvement. In this context, the pharmacological treatment of diabetes mellitus has focused on finding drugs that reduce the importance of cardiovascular events and that at the same time delay the onset of nephropathy or its progression. Thiazolidinediones, DPP4 inhibitors (alogliptin, saxagliptin and sitagliptin), insulin glargine and degludec have demonstrated cardiovascular safety, but not incremental cardiovascular benefits, in patients with T2D who are at high risk of atherosclerotic cardiovascular disease.

Agonistas de GLP-1 más inhibidores de SGLT2. ¿Efectos cardioprotectores aditivos? / GLP-1 agonists plus SGLT2 inhibitors. Additive cardioprotective effects?

Resumen En Latinoamérica, Colombia ocupa el segundo lugar en número de pacientes con diabetes mellitus y probablemente en número de pacientes no diagnosticados. En Colombia se calculan más de 2 millones de personas con diabetes mellitus, con prevalencia de 9.6%, es la quinta causa de muerte y está entre las 10 enfermedades que motivan la asistencia clínica. Nuevos tratamientos con agonistas de GLP1 (AGLP1) e inhibidores de SGLT2 (iSGLT2) han demostrado de manera individual y por mecanismos de acción diferentes un efecto significativo en el control metabólico, en otros factores, como presión arterial, perfil lipídico, peso, así como en potencial protección renal y cardiovascular. Las guías actuales de tratamiento de la diabetes mellitus tipo 2 sugieren que en caso de persistencia de concentraciones de hemoglobina glucosilada (HA1c) fuera de metas a pesar de tratamiento dual durante tres meses, tendría lugar progresar a terapia triple. Se hizo una revisión de la bibliografía que incluyó buscadores en Pubmed, Embase y Cochrane; se incluyeron 12 artículos. Con base en esta revisión de la bibliografía, concluimos que deberían hacerse más estudios clínicos con la combinación de AGLP1 más iSGLT2 en el contexto de pacientes con diabetes mellitus tipo 2 con mal control metabólico a pesar de tratamientos duales y triples.

Abstract In South America, Colombia is secondly with number of diagnosed patients with diabetes mellitus (DM) and probably non-diagnostic patients. It has been calculated in Colombia 2 million people with diabetes mellitus, with a prevalence of 9.6% and it is the fifth position of causes of death and within the 10 causes that motivate the search for help. The new therapies with glucagon-like-1 receptors agonists (GLP-1 RAs) and SGLT2 inhibitors (SGLT2i) have been shown individually and through different mechanisms of action impact on the metabolic control and other variables such as blood pressure, lipid profile, weight, renal and cardiovascular protection. Type 2 diabetes mellitus treatment guides recommend for patients with dual therapy who continue HA1c out of goals, consider triple therapy if the patient has not achieved the goals after three months. A systematic search was made that included search engines such as Pubmed, Embase and Cochrane, resulting in 12 articles. More clinical studies should be done with the combination of GLP-1 RAs and SGLT2i in the context of patients with type 2 diabetes mellitus with poor metabolic control despite dual and triple therapies.

Characteristics of hyperglycemic crises in an adult population in a teaching hospital in Colombia.

BACKGROUND: Hyperglycemic crisis are the most serious forms of acute decompensation of diabetes mellitus and require urgent medical attention. The epidemiological data of these conditions in Latin America are scarce and in Colombia unknown, that is why we decided to describe the clinical characteristics and factors associated with the mortality of adults who presented with hyperglycemic crises in a teaching hospital in Colombia. MATERIALS AND METHODS: Retrospective cohort study of all episodes of hyperglycemic crisis treated in Pablo Tobón Uribe Hospital in a three-year period. RESULTS: The records of 2233 hospitalization episodes related to diabetes mellitus were review, the prevalence of hyperglycemic crises was 2%, half of the events were diabetic ketoacidosis and 57% of the events occurred in people with type 2 diabetes mellitus, 32% of the events were precipitated by an infection and 27% by and inadequate therapy. The average hospital length of stay was 14 ± 3 days and the mortality rate 2.27%. CONCLUSIONS: In a teaching hospital in Latin America hyperglycemic crises are common, with diabetic ketoacidosis being the most frequent, and in a significant number of cases may be preventable. The hospital length of stay in our population is longer than reported in the literature.

Maternal and perinatal outcomes in pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion and real time continuous glucose monitoring in two specialized centers in Medellin, Colombia.

OBJECTIVE: We assessed maternal and perinatal outcomes in pregnant women with type 1 diabetes, treated with continuous subcutaneous insulin infusion and real time continuous glucose monitoring. METHODS: This is a retrospective study, analyzing the basal characteristics, glycemic control, maternal and perinatal outcomes of pregnant women with type 1 diabetes, who were on an insulin pump with continuous glucose monitoring between 2011 and 2015. RESULTS: Fourteen patients were included. The median age was 33 and disease duration 12 years. Indications for therapy were mainly poor glycemic control and severe hypoglycemia. The median A1c decrease was 1.02% between the first and third trimester. Pregnancies were associated with complications: 7.1% of the patients had diabetic ketoacidosis, 7.1% had an abortion, 28.5% gestational hypertension and 12.2% preeclampsia. The median gestational age at birth was 37 weeks and four days; the frequency of preterm birth was 7.1% and macrosomia 21.4%. There were no congenital malformations or perinatal death. CONCLUSIONS: Baseline characteristics and results of patients in this study were similar to those reported in the previous literature. Continuous subcutaneous insulin infusion with continuous glucose monitoring is an alternative treatment option for pregnant women with type 1 diabetes before or during pregnancy.

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

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

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

Clinical Outcomes After 1 Year of Augmented Insulin Pump Therapy in Patients with Diabetes in a Specialized Diabetes Center in Medellín, Colombia.

BACKGROUND: Type 1 diabetes can be difficult to control. Augmented pump therapy (CSII-rtCGM) has become an important tool for controlling blood glucose and decreasing hypoglycemia. METHODS: Describe the results 1 year after starting CSII-rtCGM in patients with diabetes in Medellín, Colombia. This is an observational, retrospective study. Patients with type 1 and type 2 diabetes started on CSII-rtCGM between January 2008 and June 2015 were included. Qualitative variables were analyzed as absolute or relative frequencies. Quantitative variables were obtained through central tendency and dispersion according to the normal distribution of the analyzed variable using Kolmogorov-Smirnov. SPSS 19 from IBM was used. RESULTS: Two hundred forty-seven patients were identified, of those 183 were included. The starting HbA1C was 8.7% ± 1.7% and 7.4% ± 0.8% (P < 0.05) 1 year later. 16.5% of patients had been admitted to the hospital before starting CSII-rtCGM, after 1 year the admission rate was 6.0% (P < 0.05). The incidence of severe hypoglycemia at the beginning was 32%, 1 year later it was 7.1%. CONCLUSION: CSII-rtCGM therapy improves glucose control and decreases severe hypoglycemic events and hospital admission rate.

Tuberculoma intramedular / Intramedullary tuberculoma

Resumen Se describe el caso de un paciente masculino de 35 años de edad, que se presenta con un tuberculoma intramedular torácico, con diagnóstico de VIH (Virus de la inmunodeficiencia humana) de seis años de evolución y dos meses antes TB (tuberculosis) pulmonar; su manejo médico y HAART (terapia antirretroviral altamente efectiva) sin adecuada adherencia. Se describe la contribución al diagnóstico de la RM (resonancia magnética), en la cual se visualiza área de mielitis focal en T10 que se marca intensamente con el medio de contraste, imagen que sugiere infección por TB. El tuberculoma intramedular es raro, pero debe ser considerado como diagnóstico diferencial de síntomas compresivos medulares en pacientes infectados por VIH, de evolución no clara y estudios del líquido cefalorraquídeo negativos. (Acta Med Colomb 2016; 41: 141-143).

Abstract The case of a 35 years old male patient with a thoracic intramedullary tuberculoma, with diagnosis of HIV (Human Immunodeficiency Virus) of six years of evolution and of pulmonary TB (tuberculosis) two months before, is presented; he had medical management and HAART (highly effective anti retroviral therapy) without proper adhesion. The contribution of MRI (magnetic resonance imaging) to the diagnosis, in which an image of focal area of myelitis in T10 intensely marked with contrast medium, suggests TB infection, is described. The intramedullary tuberculoma is rare, but should be considered as a differential diagnosis of symptoms of spinal cord compression in HIV-infected patients with no clear evolution and negative cerebrospinal fluid studies. (Acta Med Colomb 2016; 41: 141-143).

Sitagliptina versus insulina en pacientes hospitalizados con diabetes tipo 2. Estudio comparativo de costos / Sitagliptin vs insulin in hospitalized patients with type 2 diabetes: a comparative cost analysis

Introducción: tradicionalmente, el paciente hospitalizado con diabetes tipo 2 (DT2) se trata con insulina en un esquema basal/bolo, pero han surgido investigaciones en las que se muestra similar control metabólico con agentes orales, como sitagliptina. Basado en un ensayo clínico aleatorizado en el que se pudo comprobar esta hipótesis se plantea en este estudio las consecuencias en el costo para instituciones en Colombia de esta alternativa. Objetivo:determinar, a partir de un ensayo clínico aleatorizado publicado, los costos derivados de la utilización de sitagliptina o sitagliptina más insulina basal o insulina basal/bolo, en pacientes hospitalizados con diagnóstico de diabetes tipo 2. Métodos: partiendo de un ensayo clínico aleatorizado de referencia se evaluaron tres brazos: 1) sitagliptina + correcciones, 2) sitagliptina + basal + correcciones y, 3) insulina basal/bolo. Se diseñó una matriz de costos con casos tipo para cada brazo. Se tuvo en cuenta la posibilidad de fallo terapéutico y la necesidad de correcciones con insulina de acción rápida. Se realizó un análisis de sensibilidad de una vía, evaluando la influencia de los cambios en el costo de sitagliptina. Resultados: en el caso base, se observó una diferencia de COL $2 cuando se comparó sitagliptina + correcciones contra insulina basal/bolo. El modelo fue sensible al cambio de precio de la sitagliptina. La estrategia sitagliptina + basal siempre se comportó como la más costosa. Conclusión: en los escenarios evaluados no existen diferencias entre el uso de sitagliptina + correcciones o el esquema basal/bolo en pacientes con diabetes hospitalizados y que ingresan sin medicación, usando un agente oral o usando dosis de insulina inferiores a 0,4 UI/kg. El modelo es sensible al cambio en el costo de sitagliptina.

Patients with type 2 diabetes admitted to the hospital have traditionally been treated with basal/bolus insulin. A study published by Umpierrez et al., has shown that the same glucose control can be achieved with Sitagliptin (DPP IV inhibitor) compared to insulin glargine and glulisine. Based on this data a cost analysis was made to assess if this strategy would change inpatient diabetic care in Colombia. Objectives: To determine, from a published randomized clinical trial, the cost of utilizing Sitagliptin or Sitagliptin and basal insulin or basal / bolus insulin in patients hospitalized with a diagnosis of T2DM. Methods: The study evaluated three arms: 1) Sitagliptin + supplemental insulin, 2) Sitagliptin + basal insulin + supplemental insulin and 3) Insulin basal / bolus + supplemental insulin. A Cost matrix was designed with type cases for each arm. It took into account the possibility of therapeutic failure and the need for corrections with a fast-acting insulin. A sensitivity analysis was performed in a platform, evaluating the influence of changes in the cost of Sitagliptin. Results: In the base case, a difference of $2 COP (Colombian pesos) was observed between the use of Sitagliptin + supplemental insulin compared with the basal/bolus + supplemental insulin strategy. The model is sensitive to the change in price of Sitagliptin. The Sitagliptin + Basal insulin strategy was the most expensive. Conclusion: In the 3 scenarios analyzed there was no difference between using Sitagliptin + supplemental insulin or basal / bolus + supplemental insulin in diabetic patients admitted to the hospital who were being treated with diet and exercise, oral agents or insulin at doses less than 0.4 IU / kg. The model is sensitive to changes in the cost of Sitagliptin.

Diagnostic dilemma: Intracardiac mass in a woman with Behçet's syndrome / Dilema diagnóstico: masa intracardiaca en una paciente con síndrome de Behçet

Intracardiac thrombosis is a rare manifestation of cardiac involvement in Behçet's disease, and it may be mistaken for a heart tumor. In this letter we present the case of a patient diagnosed with Behçet's disease who was incidentally found to have a mass in the right atrium suspicious of a cardiac tumor. Nevertheless, cardiac magnetic resonance showed a cardiac thrombus. Immunosuppressive therapy and anticoagulation were effective for thrombus resolution.

La trombosis intracardiaca es una manifestación muy rara del compromiso cardiaco en la enfermedad de Behçet, la cual puede confundirse con una masa tumoral. Se presenta el caso de una paciente con esta enfermedad a quien de manera incidental se le detectó una masa intraauricular derecha sugestiva de tumor intracardiaco. Sin embargo los hallazgos de la resonancia magnética cardiaca fueron los de un trombo intracavitario que se resolvió con tratamiento inmunosupresor y terapia anticoagulante.

Diagnostic dilemma: Intracardiac mass in a woman with Behçet's syndrome.

Intracardiac thrombosis is a rare manifestation of cardiac involvement in Behçet's disease, and it may be mistaken for a heart tumor. In this letter we present the case of a patient diagnosed with Behçet's disease who was incidentally found to have a mass in the right atrium suspicious of a cardiac tumor. Nevertheless, cardiac magnetic resonance showed a cardiac thrombus. Immunosuppressive therapy and anticoagulation were effective for thrombus resolution.