Recommendations on the use of the flash continuous glucose monitoring system in hospitalized patients with diabetes in Latin America.

BACKGROUND: Continuous glucose monitoring can improve glycemic control for hospitalized patients with diabetes, according to current evidence. However, there is a lack of consensus-established recommendations for the management of hospitalized patients with diabetes using flash continuous glucose monitoring system (fCGM) in Latin America. Therefore, this expert consensus exercise aimed to establish guidelines on the implementation of fCGM in the management of hospitalized patients with diabetes in Latin America. METHODS: The modified Delphi method was applied on a panel of nine specialists, establishing consensus at 80%. A twenty-two-question instrument was developed to establish recommendations on the use of fCGM in hospitalized patients living with diabetes. RESULTS: Based on consensus, experts recommend the use of fCGM in hospitalized patients with diabetes starting at admission or whenever hyperglycemia (> 180 mg/dl) is confirmed and continue monitoring throughout the entire hospital stay. The recommended frequency of fCGM scans varies depending on the patient's age and diabetes type: ten scans per day for pediatric patients with type 1 and 2 diabetes, adult patients with type 1 diabetes and pregnant patients, and seven scans for adult patients with type 2 diabetes. Different hospital services can benefit from fCGM, including the emergency room, internal medicine departments, intensive care units, surgery rooms, and surgery wards. CONCLUSIONS: The use of fCGM is recommended for patients with diabetes starting at the time of admission in hospitals in Latin America, whenever the necessary resources (devices, education, personnel) are available.

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.

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.

Determination of time in range associated with HbA1c ≤ 6.5% in Latin American pregnant women diagnosed with type 1 diabetes mellitus using an automated insulin delivery system.

AIMS: To determine the correlation between %TIR and HbA1c in pregnant women with type 1 diabetes mellitus (DM1). METHODS: Diagnostic test study in a prospective cohort of pregnant patients with DM1 using automated insulin delivery system (AID)in Colombia and Chile. RESULTS: Fifty-two patients were included [mean age 31.8 ± 6.2 years, pregestational HbA1c 7.2% [interquartile range (IQR), 6.5-8.2]. During follow-up, we found a better metabolic control during the second (HbA1c 6.40%, IQR 5.9,7.1) and third trimesters (HbA1c 6.25%;IQR 5.9,6.8). A weak and negative correlation between %TIR and HbA1c was found for all the gestation (Spearman's rank correlation coefficient:-0.22, p:0.0329), and in the second (r:-0.13, p: 0.38) and third trimesters (r:-0.26, p = 0.08). %TIR had poor discriminating capacity for predicting HbA1c < 6% (area under the curve [AUC], 0.59; 95% confidence interval [CI],0.46-0.72) and for predicting HbA1c < 6.5% (AUC, 0.57;95% CI,0.44-0.70). The optimal cutoff points for %TIR were > 66.1% for predicting HbA1c < 6% (65% sensitivity, 62% specificity) and %TIR > 61.1% for HbA1c < 6.5% (59% sensitivity, 54% specificity). CONCLUSION: The correlation between HbA1c and %TIR during pregnancy was weak. The optimal cutoff points for identifying patients with HbA1c < 6.0% and < 6.5% were %TIR > 66.1% and > 61.1%, respectively, with moderate sensitivity and specificity.

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.

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.

Consensus for the use of flash glucose monitoring in the Colombian adult population with type 1 and 2 diabetes mellitus / Consenso para el uso de monitoreo de glucosa flash en la población adulta colombiana con diabetes mellitus tipo 1 y 2

Abstract Introduction: in Colombia, the Clinical Practice Guidelines for the treatment of patients with type 1 (DM1) and type 2 (DM2) diabetes do not mention the use of flash glucose monitoring, as this system was not available. The objective of this study was to establish a set of recommendations for the use of intermittent flash monitoring in Colombia. Methods: the group of experts consisted of eight Colombian physicians from different cities within Colombia, with expertise in the management of patients with DM1 and DM2; a certified diabetes nurse educator; a patient with DM1; and a methodological expert. Using the Zoom Enterprise video conferencing application (Zoom Video Communications, San Jose, California), the group generated questions through the Metaplan method, then carried out a systematic literature search and evidence review. The recommendations were made according to the degree of evidence and strength of the recommendation, following the GRADE method. Results: clinical recommendations were made for: a) patients with DM1 and hypoglycemia; b) patients with DM1 and poor metabolic control; c) patients with insulin-treated DM2; d) pregestational diabetes; e) quality of life; and f) inpatient use. Conclusions: this consensus's clinical recommendations guide clinical decision making with regard to the use of intermittent flash monitoring in patients with diabetes in various clinical settings. (Acta Med Colomb 2022; 47. DOI:https://doi.org/10.36104/amc.2022.2239).

Resumen Introducción: en Colombia las Guías de Práctica Clínica para el manejo del paciente con diabetes tipo 1 (DM1) y tipo 2 (DM2) no mencionan el uso del monitoreo de glucosa flash dado que dicho sistema no estaba disponible. El objetivo del presente trabajo fue establecer un grupo de recomendaciones sobre el uso del monitoreo intermitente flash en Colombia. Métodos: el grupo de expertos estuvo conformado por ocho médicos colombianos expertos en el manejo de pacientes con DM1 y DM2 de diversas ciudades de Colombia, una enfermera licenciada educadora en diabetes, una paciente con diagnóstico de DM1 y un experto metodológico. A través de Zoom Enterprise versión de la aplicación de videoconferencia Zoom (Zoom Video Communications, San Jose, California) el grupo generó las preguntas con metodología Metaplan. Posteriormente, se realizó una búsqueda sistemática de la literatura y análisis de la evidencia. Las recomendaciones se generaron mediante grupo nominal según el grado de evidencia y la formaleza de la recomendación siguiendo la metodología GRADE. Resultados: se generaron recomendaciones clínicas enfocadas a: a) paciente con diagnóstico de DM1 e hipoglucemia; b) paciente con diagnóstico de DM1 y mal control metabólico, c) paciente con diagnóstico de DM tipo 2 tratado con insulina, d) diabetes pregestacional, e) calidad de vida y f) uso intrahospitalario. Conclusiones: las recomendaciones clínicas del presente consenso orientan la toma de decisiones clínicas con respecto al uso de monitoreo intermitente flash en el paciente con diagnóstico de diabetes en diferentes escenarios clínicos. (Acta Med Colomb 2022; 47. DOI:https://doi.org/10.36104/amc.2022.2239).

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.

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.