HbA1c overestimates the glucose management indicator: a pilot study in patients with diabetes, chronic kidney disease not on dialysis, and anemia using isCGM.

Introduction: There are multiple mechanisms by which HbA1c values can be altered in chronic kidney disease (CKD), which limits its usefulness as a strategy to assess glycemic control in this population. Methods: Concordance and agreement study between two diagnostic tests: HbA1c and glucose management indicator (GMI) measured by intermittently scanned continuous glucose monitoring (isCGM), based in a prospective cohort of patients with diabetes, CKD (glomerular filtration rate between 15 and 60 ml/min/1.73 m²), and anemia. The isCGM was performed for 3 months, and the GMI was compared with the HbA1c levels taken at the end of isCGM. Agreement was evaluated using Bland-Altman graph analysis and Lin's concordance correlation coefficient (CCC). The concordance of the measures with good glycemic control (<7%) was also evaluated. Results: A total of 74 patients were enrolled (median age 68.5 years, 51.3% female, 64.9% with CKD stage 3, hemoglobin 11.1 ± 1.2 g/l). The Bland-Altman analysis shows a mean difference between GMI and HbA1c of 0.757 ± 0.687% (95% limits of agreement: -0.590 and 2.105). Difference was greater as the values of GMI and HbA1c increased. The agreement was poor [CCC 0.477; 95% confidence interval (CI): 0.360-0.594], as well as the concordance of values with good glycemic control according to GMI versus HbA1c (67.5% versus 29.7%, p < 0.001) (Kappa 0.2430; 95% CI: 0.16-0.32). Conclusion: The HbA1c overestimates the GMI values with highly variable ranges of difference, which prevents a precise correction factor. isCGM probably is a safer option for monitoring and decision-making in this population, especially in patients treated with insulin where the risk of hypoglycemia is greater.

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

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.

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.

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