Characteristics Associated With Elevated Time Below Range in Elderly Patients With Type 1 Diabetes Using an Automated Insulin Delivery System.

BACKGROUND: This study investigated the characteristics associated with an increased risk of hypoglycemia, in elderly patients with type 1 diabetes mellitus (T1D) using automated insulin delivery (AID) systems. METHODS: Cross-sectional observational study including patients >60 years, using sensor-augmented insulin pump therapy with predictive low-glucose management (SAPT-PLGM), hybrid closed-loop (HCL), and advanced hybrid closed-loop (AHCL), for more than three months. A geriatric assessment was performed, and body composition was determined to investigate its association with achieving time below range (TBR) <70 mg/dL goals. RESULTS: The study included 59 patients (47.5% of men, mean age of 67.6 years, glycated hemoglobin [HbA1c] of 7.5 ± 0.6%, time in range (TIR) 77.8 ± 9.9%). Time below range <70 and <54 mg/dL were 2.2 ± 2.3% and 0.4 ± 0.81%, respectively. Patients with elevated TBR <70 mg/dL (>1%) had higher HbA1c levels, lower TIR, elevated time above range (TAR), and high glycemic variability. Regarding body composition, greater muscle mass, grip strength, and visceral fat were associated with a lower TBR <70 mg/dL. These factors were independent of the type of technology used, but TIR was higher when using AHCL systems compared with SAPT-PLGM and HCL systems. CONCLUSIONS: In elderly patients treated with AID systems with good functional status, lower lean mass, lower grip strength, and lower visceral fat percentage were associated with TBR greater than 1%, regardless of the device used. A similar finding along was found with CGM indicators such as higher HbA1c levels, lower TIR, higher TAR, and higher CV. Geriatric assessment is crucial for personalizing patient management.

Adherencia al automonitoreo en diabetes tipo 2: plataforma "ClouDi" vs. Educación presencial. / Adherence to self-monitoring in type 2 diabetes: "ClouDi" platform vs. Face-to-face follow-up / Adesão à automonitorização na diabetes tipo 2: plataforma "ClouDi" vs. acompanha-mento presencial

Introducción: El uso de mHealth puede mejorar la adherencia a el automonitoreo con glucometría capilar (GC) en la transición del ámbito hospitalario al ambulatorio. Objetivo: evaluar la adherencia al automonitoreo con GC de los pacientes con Diabetes Tipo 2 (DM2) vinculados a un programa de educación usuarios de mHealth (ClouDi) comparado con el programa de educación y seguimiento presencial usual. Materiales y métodos: Estudio longitudinal prospectivo. Se analizaron pacientes con DM2 valorados por consulta de educación de diabetes con indicación de tratamiento con insulina al egreso hospitalario. Se analizaron dos grupos: uno con seguimiento presencial y otro vinculado a un programa educativo y uso de ClouDi. Resultados: De los 86 pacientes (44% de sexo femenino, 41 usuarios ClouDi, edad promedio 58.8 ± 11.2 años, con una media de duración de la diabetes de 7.8 ± 7.4 años), 53.6% se encontraban en estrato 2, el 92.9% pertenecían al régimen contributivo, el 42.9% con educación básica primaria y 51.2% empleados. Fue considerada la adherencia a la GC al realizar y registrar 3 o más mediciones por día en los pacientes de ClouDi fue mayor comparado con los pacientes en cuidado usual (64.4% vs 28.2%, p <0.001), independiente de las variables sociodemográficas. Conclusión: El uso de ClouDi se asoció a mayor adherencia a automonitoreo con GC comparado con seguimiento presencial independiente de variables sociodemográficas. El uso de esta tecnología podría ser útil en el seguimiento de pacientes usuarios de insulina al egreso hospitalario

Introduction: The use of mHealth can improve adherence to self-monitoring blood Glucose (SMBG) in the transition from hospital to outpatient setting. Objective: To evaluate adherence to self-monitoring with GC in patients with type 2 diabetes (T2DM) linked to an mHealth user education program (ClouDi) compared with the usual face-to-face education and follow-up program. Materials and Methods: Prospective longitudinal study. Patients with T2D assessed by diabetes education counseling with an indication for insulin treatment at hospital discharge were analyzed. Two groups were analyzed: one with face-to-face follow-up and another linked to an educational program and use of ClouDi. Results: Of the 86 patients (44% female, 41 ClouDi users, mean age 58.8 ± 11.2 years, with a mean duration of diabetes of 7.8 ± 7.4 years), 53.6% were in stratum 2, 92.9% belonged to the contributory system, 42.9% with basic pri-mary education and 51.2% were employed. Compliance with the SMBG was considered if 3 or more measurements per day were taken and recorded, was higher in ClouDi patients com-pared to usual care patients (64.4% vs. 28.2%, p <0.001), independent of sociodemographic variables.Conclusions: The use of ClouDi was associated with greater adherence to SMBG compared to in-person follow-up, independent of sociodemographic variables. The use of this technology may be useful in monitoring insulin-using patients after hospital discharge

Introdução: A utilização do mHealth pode melhorar a adesão à automonitorização com glico-metria capilar (GC) na transição do hospital para o ambulatório. Objetivo: avaliar a adesão ao automonitoramento com GC de pacientes com Diabetes Tipo 2 (DM2) vinculados a um progra-ma de educação de usuários de mHealth (ClouDi) em comparação com o programa habitual de educação e acompanhamento presencial. Materiais e métodos: Estudo prospectivo longitudi-nal. Foram analisados pacientes com DM2 avaliados por consulta de educação em diabetes com indicação de tratamento insulínico na alta hospitalar. Foram analisados dois grupos: um com acompanhamento presencial e outro vinculado a um programa educativo e uso do ClouDi. Re-sultados: Dos 86 doentes (44% do sexo feminino, 41 utilizadores do ClouDi, idade média 58,8 ± 11,2 anos, com duração média da diabetes de 7,8 ± 7,4 anos), 53,6% encontravam-se no estra-to 2, 92,9% pertenciam ao regime contributivo, 42,9% com ensino fundamental básico e 51,2% empregados. A adesão ao GC foi considerada quando realizada e registrada 3 ou mais medidas por dia em pacientes ClouDi foi maior em comparação aos pacientes em cuidados habituais (64,4% vs 28,2%, p <0,001), independente das variáveis sociodemográficas. Conclusão: O uso do ClouDi esteve associado à maior adesão ao automonitoramento com GC em comparação ao acompanhamento presencial independente das variáveis sociodemográficas. O uso dessa tecnologia pode ser útil no monitoramento de pacientes usuários de insulina na alta hospitalar

Validation of the hypoglycemia awareness questionnaire to assess hypoglycemia awareness in patients with type 2 diabetes treated with insulin.

AIMS: Given the implications of impaired hypoglycemia awareness in patients with type 2 diabetes (T2D), it is necessary to identify reliable and valid instruments for its measurement. The Hypoglycemia Awareness Questionnaire (HypoA-Q) measures impaired awareness, symptom severity, and symptom frequency. The present study evaluated the HypoA-Q validity for assessing awareness of hypoglycemia in patients with T2D treated with insulin. METHODS: The questionnaire was administered to 406 patients diagnosed with T2D on insulin treatment at four centers in Bogotá, Colombia. The internal structure of the questionnaire was analyzed using exploratory and confirmatory factor analyses, internal consistency and test-retest reliability were evaluated, and criterion validity was rated by assessing its correlation with the Clarke scale. RESULTS: Factor analysis identified an empirical structure of four domains that adequately represented the construct. Cronbach's alpha and McDonald's Omega coefficients yielded values between 0.75 and 0.79 for the impaired awareness scale. Lin and intraclass correlation coefficients were 0.86 and 0.85, respectively. The correlation between the impaired awareness subscale and Clarke scale was 0.654, and differences were found between patients with good and poor awareness of hypoglycemia. CONCLUSIONS: The HypoA-Q is a valid and reliable tool for measuring the awareness of hypoglycemia in patients with T2D who are treated with insulin.

Results From a Virtual Clinic for the Follow-up of Patients Using the Advanced Hybrid Closed-Loop System.

BACKGROUND: Evidence regarding the implementation of medium-term strategies in advanced hybrid closed-loop (AHCL) system users is limited. Therefore, this study aimed to describe the efficacy and safety of the AHCL system in patients with type 1 diabetes (T1D) on a six-month follow-up in a virtual diabetes clinic (VDC). METHOD: A prospective cohort of adult patients with T1D treated using the AHCL system (Mini Med 780G; Medtronic, Northridge, California) in a VDC follow-up. Standardized training and follow-up were conducted virtually. Clinical data and metabolic control outcomes were reported at baseline, and at three and six months. RESULTS: Sixty-four patients (mean age = 42 ± 14.6 years, 65% men, 54% with graduate education) were included. Percentage time in range (%TIR) increased significantly regardless of prior therapy with intermittently scanned continuous glucose monitoring + multiple daily injections and sensor-augmented pump therapy with predictive low-glucose management after starting AHCL and persisted during the follow-up period with no hypoglycemic events. The %TIR 70 to 180 mg/dL according to socioeconomic strata was 73.4% ± 5.3%, 78.1% ± 8.1%, and 84.2% ± 7.5% for the lower, middle, and upper strata, respectively. The sensor was used more frequently in the population with a higher education level. Adherence to sensor use and SmartGuard retention were higher in patients who underwent the VDC follow-up. CONCLUSIONS: Medium-term follow-up of users of AHCL systems in a VDC contributes to safely achieving %TIR goals. Virtual diabetes clinic follow-up favored adherence to sensor use and continuous SmartGuard use. Socioeconomic strata were associated with a better glycemic profile and education level was associated with better adherence to sensor use.

Factors associated with different patterns of weight change after bariatric surgery: A longitudinal study.

Background: The mean weight loss (WL) after successful bariatric surgery is approximately one third of the initial body weight, which is mainly achieved between the first 2 years of follow-up. However, 15%-35% of patients do not achieve a significant percentage of total WL (%TWL). Information on factors associated with a higher or lower WL after bariatric surgery is limited. This study aimed to assess the change in %TWL and describe the factors associated with greater or lesser WL over time. Methods: This prospective longitudinal study included patients treated with laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. Baseline data were recorded before surgery. Follow-up was performed at 3 (n = 141), 6 (n = 208), 9 (n = 115), 12 (n = 216), 24 (n = 166), and 36 months (n = 99). Generalized estimating equation analysis was performed to assess the changes in %TWL over time and factors associated with different patterns of WL. Results: In total, 231 patients were included (women, 82.2%; basal body mass index (BMI) 41.4 ± 5.1 kg/m2). The tendencies to increase %TWL (32 ± 6.5) were evident in the first year and stabilized thereafter. Sustained nutritionist follow-up (2.3%, p = 0.004), baseline BMI >40 kg/m2 (0.4%, p < 0.001), and WL ≥ 10 kg before surgery (0.3%, p = 0.001) were associated with a higher %TWL. Patients who performed physical activity >30 min/day after surgery reduced their %TWL by 0.6% (p = 0.002). Conclusions: Modifiable factors such as nutritional monitoring and WL before surgery are associated with a significant increase in %TWL over time. Basal BMI was associated with a significant decrease in %TWL.

Glycemic control metrics in a cohort of hospitalized patients with type 1 diabetes using hybrid closed-loop and advanced hybrid closed-loop systems.

AIMS: To describe Hybrid closed-loop (HCL) and advanced hybrid closed-loop (AHCL) performance in the hospital setting based on the continuous glucose monitoring (CGM) metrics description. METHODS: This was an observational study from a cohort of patients with T1D using HCL/AHCL with history of hospitalization. CGM metrics were analyzed during the hospital stay. CGM metrics sub-analysis of the population with active Automated Mode (AM) and SmartGuard (SG) during hospitalization and/or surgical procedure was performed. RESULTS: Twenty-four patients were included (50 % women; mean age, 49 years [inter-quartile range (IQR), 39-62 years]). During hospitalization 70.8 % patients achieved %Time in Range (TIR) between 70 and 180 mg/dL ≥ 70 %. The overall %TIR was 75.5 % (IQR, 67.3-81.5 %), % time below range (TBR) < 70 mg/dL was 2.1 % (IQR, 0.7-5.4 %) and %TBR < 54 mg/dL was 0 % (IQR, 0-5.4 %). Users of the AHCL with active SG achieved a non-significant higher %TIR during hospitalization (79 % [73.8.88 %] vs. 76 % [72.81 %], p = 0.312) and had a shorter stay (3[IQR, 2.4] vs. 6 days[IQR, 5.7], p = 0.045) compared to the users of the HCL with AM active. No device-related serious adverse events occurred for users of either system. CONCLUSIONS: HCL/AHCL systems with active AM/SG in patients with T1D in the hospital environment leads to %TIR > 70 % in ranges of 70-180 mg/dL in patients without increasing hypoglycemia.

Numerical and clinical precision in hypoglycemia of the intermittent FreeStyle Libre glucose monitoring through an NFC-Bluetooth transmitter associated with the xDrip+ algorithm in diabetic patients under insulin therapy.

INTRODUCTION: There are data capture devices that attach to the FreeStyle Libre sensor and convert its communication from NFC (Near-field communication) to Bluetooth technology, generating real-time continuous glucose monitoring. The accuracy of hypoglycemia measurements displayed by smartphone apps using this device has not been established. METHODS: Study of diagnostic tests. Numerical accuracy was evaluated, utilizing the absolute difference with respect to capillary glucometry (ISO 15197:2015 standard) and clinical accuracy, using the Clarke and Parkes (Consensus) error grids, for glucose measurements less than 70mg/dL performed with the FreeStyle Libre system and with the digital estimation xDrip+ app, in diabetic patients managed with insulin therapy. RESULTS: Twenty-seven patients were included (TIR 73.4%, TBR70 5.6%), who contributed 83 hypoglycemic events. Numerical accuracy was adequate in similar proportions with the FreeStyle Libre system compared to the xDrip+ app (81.92% vs. 68.67%, p=0.0630). The clinical accuracy evaluation showed that 92.8% of the measurements for xDrip+ and 98.8% for FreeStyle libre met the criteria according to the Parkes (Consensus) grid (p=0.0535); and 79.5% and 91.6% of the measurements met the criteria according to the Clarke grid (p=0.0273), being higher with FreeStyle libre. CONCLUSIONS: The use of the NFC-Bluetooth transmitter (Miao-Miao) associated with the xDrip+ app does not improve numerical or clinical accuracy for detecting hypoglycemic events in diabetic patients managed with insulin therapy, compared to the FreeStyle Libre device.

Hypertonic saline infusion does not improve the chance of primary fascial closure after damage control laparotomy: a randomized controlled trial.

BACKGROUND: Previous observational studies showed higher rates of abdominal wall closure with the use of hypertonic saline in trauma patients with abdominal injuries. However, no randomized controlled trials have been performed on this matter. This double-blind randomized clinical trial assessed the effect of 3% hypertonic saline (HS) solution on primary fascial closure and the timing of abdominal wall closure among patients who underwent damage control laparotomy for bleeding control. METHODS: Double-blind randomized clinical trial. Patients with abdominal injuries requiring damage control laparotomy (DCL) were randomly allocated to receive a 72-h infusion (rate: 50 mL/h) of 3% HS or 0.9 N isotonic saline (NS) after the index DCL. The primary endpoint was the proportion of patients with abdominal wall closure in the first seven days after the index DCL. RESULTS: The study was suspended in the first interim analysis because of futility. A total of 52 patients were included. Of these, 27 and 25 were randomly allocated to NS and HS, respectively. There were no significant differences in the rates of abdominal wall closure between groups (HS: 19 [79.2%] vs. NS: 17 [70.8%]; p = 0.71). In contrast, significantly higher hypernatremia rates were observed in the HS group (HS: 11 [44%] vs. NS: 1 [3.7%]; p < 0.001). CONCLUSION: This double-blind randomized clinical trial showed no benefit of HS solution in primary fascial closure rates. Patients randomized to HS had higher sodium concentrations after the first day and were more likely to present hypernatremia. We do not recommend using HS in patients undergoing damage control laparotomy. Trial registration The trial protocol was registered in clinicaltrials.gov (identifier: NCT02542241).

Effectiveness and safety of new oral and injectable agents for in-hospital management of type 2 diabetes in general wards: Systematic review and meta-analysis.

BACKGROUND: Current guidelines recommend insulin alone for in-hospital management of diabetes, but growing information suggests that new oral or injectable agents may be as effective and safe. METHODS: Systematic review and meta-analysis with evidence from randomized (RCT) and non-randomized (NRS) studies in PubMed, EMBASE and LILACS databases up to February 10, 2022, for studies including hospitalized type 2 diabetes patients, comparing dipeptidyl peptidase 4 inhibitors (DPP4i), sodium glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP1Ra) with insulin alone for glycemic control and safety outcomes. FINDINGS: 7 RCT and 3 NRTs were included. There were no differences in mean blood glucose, measurements within range or rate of hypoglycemia between DPP4i and insulin. We found a lower mean glucose for GLP1Ra plus insulin subgroup (-16.36 mg/dL, 95 % CI -27.31, -5.41; I2 = 0 %) with lower incidence of hypoglycemia < 70 mg/dL with GLP1Ra (RR 0.31, CI 95 % 0.14-0.70, I2 = 0 %). SGLT2i data was limited. Adverse events rates were similar between treatments. CONCLUSION: Our review suggests that inpatient management in the general ward with DPP4i and GLP1Ra is as effective and safe as management with insulin. More randomized studies are required to support these findings before they could be recommended as usual practice.

Validación transcultural del HypoA-Q para medir conciencia de hipoglucemia en pacientes diabéticos / Cross-cultural validation of the HypoA-Q to measure hypoglycemic awareness in diabetic patients / Validação transcultural do HypoA-Q para mensurar consciência de hipoglicemia em pacientes diabéticos

Introducción: La hipoglucemia inadvertida incrementa el riesgo de la hipoglucemia severa en pacientes con diabetes. Una medición objetiva de la misma requiere instrumentos como el HypoA-Q, que, a diferencia de otros, mide conciencia de episodios nocturnos; sin embargo, no se dispone de una versión en español. Objetivo: Traducir y adaptar culturalmente la escala HypoA-Q para la medición de conciencia de la hipoglucemia en pacientes colombianos con Diabetes Mellitus. Metodología: Estudio de Adaptación transcultural del instrumento Hy-poA-Q. Se obtuvo la autorización de la autora para su traducción y adaptación a la población colombiana. Se siguió la metodología de la European Organisation for Research and Treat-ment for Cancer (EORTC). Al respecto, se realizaron dos traducciones directas por hablantes nativos del español, una versión reconciliada, dos traducciones inversas por dos hablantes nativos del inglés y una prueba piloto en 15 pacientes con diagnóstico de diabetes. Resulta-dos: Aunque las traducciones directas al español fueron similares, se hicieron ajustes para obtener una versión reconciliada con palabras más fáciles de comprender cambiando las uni-dades de mmol/L a mg/dl. Las traducciones inversas fueron similares al original en inglés. La prueba piloto, realizada en 15 pacientes, no requirió ajustar ningún ítem, pues la frecuencia de ítems con dificultades de comprensión, confusión o palabras ofensivas fue menor al 15%. Conclusiones: Se dispone de la versión en español para Colombia de la escala HypoA-Q. Se aconseja realizar un estudio de evaluación de sus propiedades psicométricas antes de ser usada en investigaciones o en la práctica clínica

Introdução: a hipoglicemia inadvertida incrementa o risco de hipoglicemia severa em pacientes com diabetes. Uma medição da mesma requer instrumentos como o HypoA-Q, que a diferença de outros, mede consciência de episódios noturnos; entretanto, não se dispõe de uma versão em espanhol. Objetivo: traduzir e adaptar culturalmente a escala HypoA-Q para mensurar a consciência de hipoglicemia em pacientes colombianos com Diabetes Mellitus. Materiais e métodos: estudo de adaptação transcultural do instrumento HypoA-Q. Obteve-se a autorização da autora para a sua tradução e adaptação à população colombiana. Seguiu-se a metodologia da European Organization for Research Treatment for Cancer (EORTC). Realizaram-se duas traduções diretas por falantes nativos de língua espanhola e uma versão conciliada, duas traduções inversas por falantes nativos da língua inglesa e uma prova piloto em 15 pacientes com diagnostico de diabetes. Resultados: Embora as traduções diretas ao espanhol foram semelhantes, foram feitos ajustes para obter uma versão conciliada com palavras mais simples de compreender substituindo as unidades de mmol/L para mg/dl. As traduções inversas foram semelhantes ao instrumento original em inglês. A prova piloto realizada não precisou ajustar nenhum item, devido a que os itens com dificuldade de compreensão, confusão ou palavras ofensivas foi inferior ao 15%. Conclusão: Dispõe-se da versão em espanhol para Colômbia da escala HypoA-Q. Aconselha-se realizar um estudo de avaliação das propriedades psicométricas antes de ser usada em pesquisa ou na prática clinica

Efficacy and safety of sensor augmented insulin pump therapy with low-glucose suspend feature in older adults: A retrospective study in Bogota, Colombia.

BACKGROUND AND AIMS: The literature has supported the efficacy and safety of insulin pump therapy in young adults diagnosed with type 1 diabetes (DM1). However, there is limited evidence in older adults with DM1 and DM2. METHODS: A retrospective cohort study was conducted in patients ≥60 years-old with DM1 and DM2, who started Sensor Augmented Insulin Pump therapy with low-glucose suspend feature (SAP + LGS) at Hospital Universitario San Ignacio diabetes center in Bogotá, Colombia. Patients were evaluated between 2009 and 2019 and were treated with Paradigm VEO or Medtronic MiniMed 640 insulin pumps and continuous glucose monitoring system. Glycated hemoglobin (A1c), severe hypoglycemia and hypoglycemia unawareness were assessed at least every 3 months, and hospitalizations and ketoacidosis episodes incidence were assessed yearly. RESULTS: 36 patients were analyzed, (67.36 ± 4.88 years-old) (body mass index 25.48 ± 4.61 kg/m2). The most common indications for starting SAP + LGS were hypoglycemia (58.3%), high glycemic variability (25.0%) and poor metabolic control (16.7%). 26 patients used VEO (72.2%) whereas 27.8% started 640 insulin pump. Data from 32 participants showed A1c decreased from 8.57 ± 1.73% to 7.42 ± 0.96 after a year of therapy (Mean difference -1.15%, p < 0.05); 28.12% reached A1c levels <7% and 42.85% < 7.5%. There was a significant decrease in the proportion of patients with at least one severe hypoglycemia (56.7 vs 3.3%), one or more hospitalizations (20 vs 3.3%), and hypoglycemia unawareness after the first year of follow-up (p < 0.05). CONCLUSIONS: These results suggest that SAP + LGS is safe and effective in people 60 years or older after one year of therapy. Future randomized clinical trials are needed in the elderly.

Hypoglycemia Incidence and Factors Associated in a Cohort of Patients With Type 2 Diabetes Hospitalized in General Ward Treated With Basal Bolus Insulin Regimen Assessed by Continuous Glucose Monitoring.

INTRODUCTION: Continuous glucose monitoring (CGM) is a better tool to detect hyper and hypoglycemia than capillary point of care in insulin-treated patients during hospitalization. We evaluated the incidence of hypoglycemia in patients with type 2 diabetes (T2D) treated with basal bolus insulin regimen using CGM and factors associated with hypoglycemia. METHODS: Post hoc analysis of a prospective cohort study. Hypoglycemia was documented in terms of incidence rate and percentage of time <54 mg/dL (3.0 mmol/L) and <70 mg/dL (3.9 mmol/L). Factors evaluated included glycemic variability analyzed during the first 6 days of basal bolus therapy. RESULTS: A total of 34 hospitalized patients with T2D in general ward were included, with admission A1c of 9.26 ± 2.62% (76.8 ± 13 mmol/mol) and mean blood glucose of 254 ± 153 mg/dL. There were two events of hypoglycemia below 54 mg/dL (3.0 mmol/L) and 11 events below 70 mg/dL (3.9 mmol/L) with an incidence of hypoglycemic events of 0.059 and 0.323 per patient, respectively. From second to fifth day of treatment the percentage of time in range (140-180 mg/dL, 7.8-10.0 mmol/L) increased from 72.1% to 89.4%. Factors related to hypoglycemic events <70 mg/dL (3.9 mmol/L) were admission mean glucose (IRR 0.86, 95% CI 0.79, 0.95, P < .01), glycemic variability measured as CV (IRR 3.12, 95% CI 1.33, 7.61, P < .01) and SD, and duration of stay. CONCLUSIONS: Basal bolus insulin regimen is effective and the overall incidence of hypoglycemia detected by CGM is low in hospitalized patients with T2D. Increased glycemic variability as well as the decrease in mean glucose were associated with events <70 mg/dL (3.9 mmol/L).

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes.

INTRODUCTION: Degludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV). METHODS: A prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis. RESULTS: 60 patients with basal bolus therapy and history of hypoglycemia were included. 18 patients had High GV (HGV). In this group a significant reduction of 11.1% of CV (95% CI: 6.3, 15.9, p = 0.01) was found. GEE analysis confirmed a higher impact over time on patients with HGV (p < 0.001). The percentage of patients with at least 1 episode of hypoglycemia decreased from 66.6% to 22.2% (p = 0.02) and from 37.14% to 5.71% (p < 0.01) for global and nocturnal hypoglycemia, respectively. Changes were not significant in patients with low GV. A reduction of A1c was observed in both groups (p < 0.001). CONCLUSIONS: The results suggest that treatment with IDeg reduces GV, A1c levels and the incidence of global and nocturnal hypoglycemia events in patients with HGV, but not in patients with low GV.

Devices for continuous monitoring of glucose: update in technology.

Continuous glucose monitoring (CGM) is a tool that allows constant evaluation of glycemic control, providing data such as the trend and fluctuation of interstitial glucose levels over time. In clinical practice, there are two modalities: the professional or retrospective and the personal or real-time CGM (RT-CGM). The latest-generation sensors are more accurate and sensitive for hypoglycemia, improving adherence to self-monitoring, which has allowed optimizing glycemic control. The development of algorithms that allow the suspension of the infusion of insulin during hypoglycemia gave rise to the integrated therapy or sensor-augmented insulin pump therapy with low glucose suspend, which has proven to be an effective and safe alternative in the treatment of diabetic patients with high risk of hypoglycemia. The objective of this review is to present the evidence of the advantages of RT-CGM, the clinical impact of integrated therapy, and cost-effectiveness of its implementation in the treatment of patients with diabetes mellitus.

Mortalidad precoz en trasplante cardíaco / Early mortality in heart transplant

Resumen Objetivo: describir las principales causas de mortalidad en los 30 primeros días postrasplante cardíaco. Métodos: cohorte retrospectiva de pacientes con trasplante cardiaco realizado de 2008 a 2015, que murieron en los primeros 30 días luego del procedimiento. La información se recolectó del registro institucional de trasplante cardíaco. Se describieron variables sociodemográficas, clínicas, características del receptor, causas de muerte, complicaciones y características del pre- intra- y postoperatorio. Resultados: desde enero de 2008 hasta agosto de 2015 se realizaron 74 trasplantes cardíacos. De estos, 10 pacientes murieron en los primeros 30 días postrasplante (mortalidad de 13,51%).La mediana de edad fue 55 años (rango intercuartil [RIQ] 26-62 años) y 50% de ellos fueron de sexo masculino. La mediana de fracción de eyección pretrasplante fue 24% (RIQ 18-47) y el tiempo en lista de espera 81 días (RIQ 12-157 días). Cuatro pacientes se encontraban en estadio 0 A y los seis restantes en estadio 1. La mediana de tiempo entre el trasplante y la muerte fue un día (RIQ 0-3 día) y la mortalidad más tardía se presentó a los 18 días. Las principales causas de muerte fueron: falla multiorgánica (5 casos), falla aguda del injerto (3 casos) y coagulopatía perioperatoria (2 casos). Conclusiones: en una institución de referencia para trasplante cardíaco del suroccidente colombiano, la mortalidad precoz postrasplante cardíaco fue del 13,51%, similar a la reportada por registros internacionales. La principal causa de muerte fue la falla multiorgánica, que ocurrió principalmente en las primeras 24 horas después del trasplante cardíaco.

Abstract Objective: To describe the main causes of mortality in the first 30 days post-heart transplant. Methods: A study was conducted on a representative patient cohort with a heart transplant performed between 2008 and 2015, and who died in the first 30 days after the procedure. The information was collected from an institutional heart transplant register. A description is presented of the sociodemographic and clinical variables, the receiver characteristics, causes of death, as well as pre-, intra-, and post-operative characteristics and complications. Results: A total of 74 heart transplants were performed between January 2008 and August 2015. Of these, 10 patients died in the first 30 days post-transplant (a mortality rate of 13.51%). The median age was 55 years (Inter-quartile range (IQR) 26-62 years) and 50% of them were male. The median ejection fraction pre-transplant was 24% (IQR 18-47) and time on the waiting list of 81 days (IQR 12-157 days). Four of the patients were in Stage 0 A, and the remaining 6 were in Stage 1. The median time between the transplant and death was 1 day (IQR 0-3 days, and the later mortality rate was at 18 days. The main causes of death were: multi-organ failure (5 cases), acute graft failure (3 cases), and peri-operative coagulopathy (2 cases). Conclusions: In an institution of reference for heart transplantation in South-West Colombia, the early post-transplant mortality rate was 13.51%, similar to that reported in international registers. The main cause of death was multi-organ failure, which occurred mainly in the first 24 hours after the heart transplant.

Perfiles clínicos y hemodinámicos en pacientes con falla cardiaca aguda / Clinical and haemodynamic profiles of patients with acute heart failure

Resumen Objetivo: describir los perfiles clínicos y hemodinámicos de pacientes hospitalizados por falla cardíaca aguda. Métodos: estudio transversal de pacientes de 18 años o más, con diagnóstico de falla cardíaca aguda admitidos a un centro hospitalario de alta complejidad en Cali, Colombia, en un período de 7 meses. Se recolectó información sociodemográfica, clínica, perfiles clínicos y hemodinámicos de la falla cardiaca al ingreso, estancia hospitalaria y mortalidad. Se describieron las variables cuantitativas como promedios o medianas, y las categóricas como valor absoluto y porcentajes. Se realizaron tablas de frecuencia, y se graficaron los porcentajes de pacientes que ingresaron según el perfil clínico y hemodinámico de falla cardiaca aguda. Resultados: se incluyeron 99 pacientes con 143 episodios de falla cardíaca aguda. La mitad eran hombres y la mediana de edad 66 años (rango 21 a 97 años). 60% fueron afrodescendientes y 14,14% mestizos. Los perfiles clínicos más frecuentes fueron falla cardíaca aguda descompensada (72,46%), edema pulmonar agudo (10,14%) y falla cardiaca asociada a síndrome coronario agudo en 6,52%. Los perfiles hemodinámicos fueron ''caliente y seco'' 10,87%, ''caliente y húmedo'' 55,07%, ''frío y húmedo'' 28,26% y ''frío y seco'' en 5,8%. Conclusiones: la falla cardíaca aguda descompensada es el perfil de presentación clínica más común en nuestra población con dos tercios del total de casos. El perfil hemodinámico más frecuente fue el ''caliente y húmedo'' (Stevenson B), resultados que concuerdan con lo observado en estudios locales y registros internacionales.

Abstract Objective: To describe the clinical and haemodynamic profiles of patients admitted to hospital due to acute heart failure. Methods: A cross-sectional study was conducted on patients aged 18 years or older with a diagnosis of acute heart failure admitted to a high complexity hospital in Cali, Colombia, during a 7-month period. Sociodemographic, clinical and haemodynamic information of the cardiac failure was recorded on admission, as well as hospital stay and mortality. The quantitative variables are described as means or medians, and the categorical variables as absolute value and percentages. Frequency tables were made, and a graph made of the percentages of patients admitted, according to the clinical and haemodynamic profile of the acute heart failure. Results: The study included as total of 99 patients with 143 episodes of acute heart failure. Half of the patients were male, and the median age was 66 years (range 21 to 97 years). The majority (60%) were of African descent and 14.14% were Mestizos. The most common clinical profiles were decompensated heart failure (72.46%), acute pulmonary edema (10.14%), and heart failure associated with acute coronary syndrome in 6.52%. The haemodynamic profiles were ''warm and dry'' in 10.87%, ''warm and wet'' in 55.07%, ''cold and wet'' in 28.26%, and ''cold and dry'' in 5.8%. Conclusions: Decompensated acute heart failure is the most common clinical presentation profile in the population studied, with two-thirds of all cases. The most frequent haemodynamic profile was ''warm and wet'', results that agree with those observed in local studies and in international registers.

Incidencia de eventos cardiovasculares mayores asociada a la suspensión de doble terapia antiagregante en pacientes con enfermedad coronaria e implante de stent / Incidence of major adverse cardiovascular events associated to suspension of dual antiplatelet therapy in patients with coronary disease and stent implants

Resumen Objetivo: Determinar el riesgo de presentar eventos cardiovasculares mayores en pacientes con síndrome coronario agudo e implante de stent, que suspendieron la doble terapia antiagregante antes de un año de tratamiento. Métodos: Estudio analítico de pacientes con síndrome coronario agudo e implante de stent que recibieron doble terapia antiagregante al egreso hospitalario. Se describieron las características sociodemográficas, clínicas y paraclínicas. Se determinó la prevalencia de suspensión de doble terapia antiagregante antes de un año de tratamiento y el riesgo de eventos cardiovasculares mayores mediante un modelo de riesgos proporcionales Cox. Resultados: Se incluyeron 873 pacientes. La prevalencia de suspensión de doble terapia antiagregante fue 39,18%. El grupo que continuó la terapia por un año tuvo mayor frecuencia de enfermedad coronaria previa (19,13% p = 0,03). La principal indicación del procedimiento en los pacientes que suspendieron la terapia fue infarto sin ST elevado (36,8%). La suspensión de la doble terapia antiagregante antes del año estuvo asociada con mayor incidencia de MACE a un año (HR 1,31 95% IC 0,65-2,62 p = 0,45). La presencia de enfermedad arterial periférica, diabetes mellitus y más de un vaso enfermo se relacionó con eventos adversos cardiovasculares a un año. Conclusiones: La suspensión antes de los doce meses de la doble terapia antiagregante en pacientes con implante de stent posterior a un síndrome coronario agudo, es frecuente y parece no estar asociada con mayor incidencia de desenlaces cardiovasculares mayores; sin embargo, la causa de la interrupción puede influir en los desenlaces clínicos y debe tenerse en cuenta en la práctica clínica.

Abstract Objective: To determine the risk of developing major adverse cardiovascular events (MACEs) in patients with acute coronary syndrome and stent implant who suspended dual antiplatelet therapy before one year of treatment. Methods: Analytical study of patients with acute coronary syndrome and stent implant who received dual antiplatelet therapy upon hospital admission. Sociodemographic, clinical and paraclinical features were described. The prevalence of dual antiplatelet therapy suspensión before one year of treatment was determined, and for assessing the risk of major adverse cardiovascular events a Cox proportional hazard regression model was used. Results: 873 patients were included. Prevalence of dual antiplatelet therapy suspension was 39.18%. The group who continued the therapy during a year had a higher frequency of previous coronary disease (19.13%, p = 0.03). The main indication for the procedure in patients who interrupted their treatment was infarction without ST elevation (36.8%). Dual therapy suspensión before one year was not related to a higher incidence of MACEs after one year (HR1.31, CI 95% 0.65-2.62 p = 0.45). The presence of peripheral arterial disease, diabetes mellitus and more than one abnormal vessel was related to adverse cardiovascular effects within one year. Conclusions: The suspension of dual antiplatelet therapy before twelve months in patients with a stent implant posterior to an acute coronary syndrome is frequent and does not seem to be associated to a higher incidence of major adverse cardiovascular events; nevertheless, the reason for the interruption could influence the clinical outcome and must be taken into account for clinical practice.

Maternal-Fetal Outcomes in 34 Pregnant Women with Type 1 Diabetes in Sensor-Augmented Insulin Pump Therapy.

BACKGROUND: Pregnancy in women with type 1 diabetes (T1D) is associated with increased risk of maternal complications and neonatal morbidity and mortality. Optimizing glycemic control improves these outcomes. OBJECTIVE: To describe the experience of using sensor-augmented insulin pump therapy (SAPT) and SAPT + low-glucose suspension (LGS) on pregnant women with T1D, including neonatal and maternal outcomes. METHODS: A prospective observational study was conducted in women with T1D who started SAPT and SAPT + LGS before or during pregnancy at the San Ignacio University Hospital Diabetes Center in Bogotá, Colombia. The main indication was severe hypoglycemia (SH) and poor glycemic control. Glycated hemoglobin (A1c), hypoglycemia, and maternal and fetal outcomes were assessed. RESULTS: Thirty-four pregnant women with T1D on SAPT and SAPT + LGS were included. Sixteen patients started therapy during pregnancy at a mean gestational age of 17.6 ± 8.3 weeks. Mean preconceptional A1c was 8.24% ± 2.02%. Absolute reduction of A1c level from prepregnancy to third trimester was -1.63% (P < 0.0001), with a significant clinical and statistical reduction in both groups, women who initiated SAPT before or during pregnancy. 52.9% of patients in second trimester and 66.6% in third trimester achieved A1c <6.5%, respectively. 91.1% underwent cesarean section. The main reasons were iterative cesarean (30%), fetal distress (20%), and preeclampsia (16%). The median gestational age at delivery was 37 weeks and 15 pregnancies resulted in preterm delivery. There was neither maternal-fetal mortality nor severe hypoglycemic episodes. Two patients had diabetic ketoacidosis. CONCLUSIONS: In pregnant patients with T1D and high risk of hypoglycemia, SAPT and SAPT + LGS should be considered as a therapeutic alternative for A1c reduction with a low risk of SH. However, additional studies are required to evaluate the efficacy and safety of this therapy during pregnancy.

Long-Term Efficacy and Safety of Sensor Augmented Insulin Pump Therapy with Low-Glucose Suspend Feature in Patients with Type 1 Diabetes.

BACKGROUND: Literature supports short-term efficacy and safety of Sensor Augmented Insulin Pump (SAP) therapy in patients with type 1 diabetes (T1D). However, no data are available showing long-term outcomes. Our study describes the long-term outcomes of SAP therapy with low-glucose suspend feature (SAP+LGS) in hypoglycemia in a Colombian population with T1D and hypoglycemia. METHODS: A cohort study was conducted with T1D patients receiving SAP+LGS therapy who initiated this therapy because of hypoglycemia at San Ignacio University Hospital diabetes center in Bogotá, Colombia. Glycated hemoglobin (A1c) was assessed at least every 6 months, severe hypoglycemia (SH) and hypoglycemia unawareness (HU) incidence yearly. Adherence to therapy was also evaluated. RESULTS: One hundred eleven patients were included in the analysis. Total daily insulin dose was reduced during follow-up (mean difference -0.22 U/kg; 95% confidence interval [CI] -0.18 to -0.26; P < 0.001). A1c levels were reduced from a baseline value of 8.8% ± 1.9% to 7.5% ± 1.0% at 5 months (mean difference -1.3%; 95% CI -1.09 to -1.50; P < 0.001) and 7.1% ± 0.8% (mean difference -1.7%; 95% CI -1.59 to -1.90; P < 0.001) at the end of follow-up (47 months on average). The incidence of SH and HU episodes decreased significantly since the first year, and this effect was maintained over time (P < 0.001). CONCLUSIONS: SAP+LGS therapy in T1D patients with hypoglycemia led to a significant and sustained decrease in A1c during long periods of follow-up, as well as a significant reduction in SH and HU. Future randomized clinical trials are desired.

Prevalencia de la insuficiencia de vitamina D en pacientes con osteoporosis / Prevalence of vitamin D deficiency in patients with osteoporosis

(AU) Introducción. La insuficiencia de vitamina D se considera una epidemia mundial. Se estima que un billón de personas a escala mundial padecen de insuficiencia de vitamina D. Según diferentes estudios el 100% de la población adulta mayor de Estados Unidos y Europa presentan esta condición, la cual se ha tratado de atribuir a la hipovitaminosis D, como factor causal de muchas patologías, entre ellas a la osteoporosis, por su rol esencial en el metabolismo del calcio y en la prevención de fracturas. Objetivo. Determinar la prevalencia de la insuficiencia de vitamina D en una población de pacientes con osteoporosis, atendidos en una clínica de alta complejidad en Colombia.Materiales y métodosEstudio retrospectivo y descriptivo que incluía pacientes atendidos en la consulta externa, en las diferentes especialidades de medicina interna, en un hospital de alta complejidad en Cali, Colombia, entre los años 2013 a 2014, con diagnóstico de osteoporosis e insuficiencia de vitamina D. Se describieron las características sociodemográficas, antecedentes médicos y resultado de niveles de vitamina D, parathormona, densitometría ósea. Se determinó la prevalencia de déficit de vitamina D en pacientes con osteoporosis.ResultadosSe incluyeron 206 pacientes con diagnóstico de osteoporosis, de los cuales 114 presentaron insuficiencia de 25-hidroxicolecalciferol, para una prevalencia de 55,3%. El promedio de niveles de vitamina D fue 22ng/ml (p=0,00), con reportes de densitometría ósea que para el momento del estudio presentaban un promedio de T score de –2,1 en columna vertebral (p=0,55) y T score de –1,7 en cuello femoral (p=0,00).ConclusionesLa insuficiencia de vitamina D se ha determinado como uno de los factores asociados con osteoporosis. En una población con osteoporosis del suroccidente colombiano, la prevalencia de la insuficiencia de vitamina D fue de 53%, más baja que la reportada en otras ciudades de Colombia