Efficacy of continuous glucose monitoring on maternal and neonatal outcomes in gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials.

AIMS: This systematic review aims to evaluate the effect of continuous glucose monitoring (CGM) on maternal and neonatal outcomes in gestational diabetes mellitus (GDM). METHODS: Two authors conducted a systematic search using PubMed, Embase, CENTRAL, CINAHL, Scopus, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The inclusion criteria for the systematic review were randomized clinical trials that compared the effects of CGM and blood glucose monitoring (BGM) in women with GDM. A restricted maximum likelihood random-effects model was used for the meta-analysis. The measures of effect were risk ratios for categorical data and mean differences for continuous data. RESULTS: Of the 457 studies reviewed, six randomized clinical trials met the inclusion criteria. A total of 482 patients were included in the meta-analysis. The use of CGM was associated with lower HbA1c levels at the end of pregnancy (mean difference: -0.22; 95%CI -0.42 to -0.03) compared to BGM. Women using CGM also had less gestational weight gain (mean difference: -1.17, 95%CI -2.15 to -0.19), and their children had lower birth weight (mean difference: -116.26, 95%CI -224.70 to -7.81). No differences were observed in the other outcomes evaluated. CONCLUSION: Women with GDM using CGM may achieve lower average blood glucose levels, lower maternal weight gain and infant birth weight than women using BGM. Nevertheless, current evidence is limited by the low number of studies and the small sample sizes of these studies. Larger clinical trials are needed to better understand the effects of CGM in GDM. REGISTRATION: PROSPERO registration ID CRD42021225651.

Glycemic variability: prognostic impact on acute ischemic stroke and the impact of corrective treatment for hyperglycemia. The GLIAS-III translational study.

INTRODUCTION: Glycemic variability (GV) represents the amplitude of oscillations in glucose levels over time and is associated with higher mortality in critically ill patients. Our aim is to evaluate the impact of GV on acute ischemic stroke (IS) outcomes in humans and explore the impact of two different insulin administration routes on GV in an animal model. METHODS: This translational study consists of two studies conducted in parallel: The first study is an observational, multicenter, prospective clinical study in which 340 patients with acute IS will be subcutaneously implanted a sensor to continuously monitor blood glucose levels for 96 h. The second study is a basic experimental study using an animal model (rats) with permanent occlusion of the middle cerebral artery and induced hyperglycemia (through an intraperitoneal injection of nicotinamide and streptozotocin). The animal study will include the following 6 groups (10 animals per group): sham; hyperglycemia without IS; IS without hyperglycemia; IS and hyperglycemia without treatment; IS and hyperglycemia and intravenous insulin; and IS and hyperglycemia and subcutaneous insulin. The endpoint for the first study is mortality at 3 months, while the endpoints for the animal model study are GV, functional recovery and biomarkers. DISCUSSION: The GLIAS-III study will be the first translational approach analyzing the prognostic influence of GV, evaluated by the use of subcutaneous glucose monitors, in acute stroke. Trial registration https://www.clinicaltrials.gov (NCT04001049).

Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol.

INTRODUCTION: Poststroke hyperglycaemia is an independent risk factor for poorer outcomes in patients treated with mechanical thrombectomy (MT) and is associated with a lower probability of functional recovery and higher mortality at 3 months. This study aims to evaluate the association between glucose levels during cerebral reperfusion with MT and functional recovery at 3 months, measured by subcutaneous continuous glucose monitoring (CGM) devices. METHODS: This prospective observational study aims to recruit 100 patients with ischaemic stroke and large anterior circulation vessel occlusion, in whom MT is indicated. CGM will be performed using a Freestyle Libre ProIQ device (FSL-CGM, Abbott Diabetes Care, Alameda, California, USA), which will be implanted on admission to the emergency department, to monitor glucose levels before, during and after reperfusion. The study's primary endpoint will be the functional status at 3 months, as measured by the dichotomised modified Rankin Scale (0-2 indicating good recovery and 3-6 indicating dependency or death). We will analyse expression profiles of microRNA (miRNA) at the time of reperfusion and 24 hours later, as potential biomarkers of ischaemic-reperfusion injury. The most promising miRNAs include miR-100, miR-29b, miR-339, miR-15a and miR-424. All patients will undergo treatment according to current international recommendations and local protocols for the treatment of stroke, including intravenous thrombolysis if indicated. ETHICS AND DISSEMINATION: This study (protocol V.1.1, dated 29 October 2021, code 6017) has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and has been registered in ClinicalTrials.gov (NCT05871502). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations. TRIAL REGISTRATION NUMBER: NCT05871502.

Expert Recommendations for Using Time-in-Range and Other Continuous Glucose Monitoring Metrics to Achieve Patient-Centered Glycemic Control in People With Diabetes.

New metrics for assessing glycemic control beyond HbA1c have recently emerged due to the increasing use of continuous glucose monitoring (CGM) in diabetes clinical practice. Among them, time in range (TIR) has appeared as a simple and intuitive metric that correlates inversely with HbA1c and has also been newly linked to the risk of long-term diabetes complications. The International Consensus on Time in Range established a series of target glucose ranges (TIR, time below range and time above range) and recommendations for time spent within these ranges for different diabetes populations. These parameters should be evaluated together with the ambulatory glucose profile (AGP). Using standardized visual reporting may help people with diabetes and healthcare professionals in the evaluation of glucose control in frequent clinical situations. The objective of the present review is to provide practical insights to quick interpretation of patient-centered metrics based on flash glucose monitoring data, as well as showing some visual examples of common clinical situations and giving practical recommendations for their management.

The Benefit of Bariatric Surgery on Histological Features of Metabolic Associated Fatty Liver Disease Assessed Through Noninvasive Methods.

BACKGROUND: In patients with clinically severe obesity, metabolic associated fatty liver disease (MAFLD) and steatohepatitis are highly prevalent. There is a lack of prospective studies evaluating the impact of bariatric surgery (BS) on MAFLD using both noninvasive and histological criteria. The present study aims to assess the impact of BS on MAFLD using histological and biochemical criteria. METHODS: This is a prospective study of 52 patients subjected to BS. Noninvasive fibrosis risk scores (NIFRS) along with anthropometric, clinical, and biochemical parameters were recorded pre- and 12 months post-BS. Liver biopsy was obtained in all individuals at baseline (wedge biopsy) and was repeated at 12 months (percutaneous Tru-cut) in those diagnosed with steatohepatitis. The primary outcome was the change in the degree of steatohepatitis and fibrosis. The secondary outcome was the change in scores for hepatocellular ballooning, lobular inflammation, steatosis, and fibrosis. RESULTS: One year after BS, steatohepatitis resolved in core biopsies with no worsening of fibrosis in 95.7% of individuals (n = 21, 95% CI: 87.3-100), and 13 (56.5%) exhibited complete resolution. Of 15 patients with fibrosis at baseline, 13 (86.7%) showed improvement and 12 exhibited fibrosis resolution. The values of transaminases improved, but only gamma glutamyl transferase (GGT) showed statistical significance. Among the NIFRS, NAFLD fibrosis score (NFS) and Hepamet fibrosis score (HFS) showed significant improvement. CONCLUSIONS: In the setting it was studied, BS improved or resolved steatohepatitis and fibrosis in patients with obesity. NIFRS, especially NFS and HFS, and levels of GGT could be used as markers of recovery of liver function after BS.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. / Resumen ejecutivo: Documento de posicionamiento: evaluación y manejo de la hipoglucemia en el paciente con diabetes mellitus 2020. Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición.

OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 28 February 2020 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 30 November 2019 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation.

The flash glucose monitoring (FGM) system FreeStyle Libre® is a device that measures interstitial glucose in a very simple way and indicates direction and speed of glucose change. This allows persons with diabetes to prevent hypoglycemic and hyperglycemic events. Scientific evidence indicates that the system can improve glycemic control and quality of life. To obtain the maximum benefit, it is necessary to properly handle glucose values and trends. Due to the generalization of the system use, the purpose of the document is to provide recommendations for the optimal use of the device, not only in the management of glucose values and trends but also in the prevention of hypoglycemia, actuation in exercise, special situations, and retrospective analysis of the glucose data, among others.

[Managing the discharge of diabetic patients from the emergency department: a consensus paper]. / Documento de consenso sobre el manejo al alta desde urgencias del paciente diabético.

EN: Eighty to 90% of patients attended in emergency departments are discharged to home. Emergency department physicians are therefore responsible for specifying how these patients are treated afterwards. An estimated 30% to 40% of emergency patients have diabetes mellitus that was often decompensated or poorly controlled prior to the emergency. It is therefore necessary to establish antidiabetic treatment protocols that contribute to adequate metabolic control for these patients in the interest of improving the short-term prognosis after discharge. The protocols should also maintain continuity of outpatient care from other specialists and contribute to improving the long-term prognosis. This consensus paper presents the consensus of experts from 3 medical associations whose members are directly involved with treating patients with diabetes. The aim of the paper is to facilitate the assessment of antidiabetic treatment when the patient is discharged from the emergency department and referred to outpatient care teams.

ES: El 80-90% de los pacientes atendidos en los servicios de urgencias son dados de alta desde los mismos, y por tanto los facultativos de urgencias son los responsables del tratamiento al alta en dichos pacientes. Se estima que la frecuencia de diabetes mellitus en urgencias es de un 30-40% y en muchos casos dicha diabetes está descompensada o con un mal control metabólico previo, por lo que es necesario establecer pautas de tratamiento antidiabético adecuadas de cara al alta que contribuyan a un adecuado control metabólico de dichos pacientes y favorezca un mejor pronóstico a corto plazo tras el alta, así como mantener una continuidad con la atención ambulatoria por parte de otras especialidades y contribuir a una mejoría del pronóstico a largo plazo. El presente documento es por tanto un consenso de expertos de tres sociedades científicas implicadas directamente en la atención del paciente diabético, que pretende facilitar la valoración del tratamiento al alta desde urgencias en cuanto a la diabetes se refiere y su continuidad asistencial ambulatoria.

Respuesta de los autores: Empleo de diuréticos y empagliflozina: ¿contraindicados? / Diuretics and empagliflozin use: authors' reply

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Position statement: hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (PubMed). Papers in English and Spanish with publication date before 15 February 2013 were included. For recommendations about drugs only those approved by the European Medicines Agency were included. After formulation of recommendations, they were discussed by the Working Group. CONCLUSIONS: The document provides evidence-based practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus.

Documento de consenso sobre el manejo al alta desde urgencias del paciente diabético / Managing the discharge of diabetic patients from the emergency department: a consensus paper

El 80-90% de los pacientes atendidos en los servicios de urgencias son dados de alta desde los mismos, y por tanto los facultativos de urgencias son los responsables del tratamiento al alta en dichos pacientes. Se estima que la frecuencia de diabetes mellitus en urgencias es de un 30-40% y en muchos casos dicha diabetes está descompensada o con un mal control metabólico previo, por lo que es necesario establecer pautas de tratamiento antidiabético adecuadas de cara al alta que contribuyan a un adecuado control metabólico de dichos pacientes y favorezca un mejor pronóstico a corto plazo tras el alta, así como mantener una continuidad con la atención ambulatoria por parte de otras especialidades y contribuir a una mejoría del pronóstico a largo plazo. El presente documento es por tanto un consenso de expertos de tres sociedades científicas implicadas directamente en la atención del paciente diabético, que pretende facilitar la valoración del tratamiento al alta desde urgencias en cuanto a la diabetes se refiere y su continuidad asistencial ambulatoria (AU)

Eighty to 90% of patients attended in emergency departments are discharged to home. Emergency department physicians are therefore responsible for specifying how these patients are treated afterwards. An estimated 30% to 40% of emergency patients have diabetes mellitus that was often decompensated or poorly controlled prior to the emergency. It is therefore necessary to establish antidiabetic treatment protocols that contribute to adequate metabolic control for these patients in the interest of improving the short-term prognosis after discharge. The protocols should also maintain continuity of outpatient care from other specialists and contribute to improving the long-term prognosis. This consensus paper presents the consensus of experts from 3 medical associations whose members are directly involved with treating patients with diabetes. The aim of the paper is to facilitate the assessment of antidiabetic treatment when the patient is discharged from the emergency department and referred to outpatient care teams (AU)

Documento de posicionamiento: evaluación y manejo de la hipoglucemia en el paciente concon diabetes mellitus. Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición / Position statement: Hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition

Objetivo Proporcionar unas recomendaciones prácticas para la evaluación y el manejo de la hipoglucemia en pacientes con diabetes mellitus. Participantes Miembros del Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición (SEEN).Métodos Las recomendaciones se formularon de acuerdo al sistema Grading of Recommendations, Assessment, Development, and Evaluation para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en MEDLINE (PubMed) de la evidencia disponible para cada tema, y se revisaron artículos escritos en inglés y castellano con fecha de inclusión hasta el 15 de febrero de 2013. Para las recomendaciones acerca del uso de fármacos, se consideraron tratamientos aprobados por la Agencia Europea de Medicamentos con esa misma fecha. Tras la formulación de las recomendaciones estas se discutieron conjuntamente por el Grupo de trabajo. Conclusiones El documento establece unas recomendaciones prácticas basadas en la evidencia acerca de la evaluación y manejo de la hipoglucemia en pacientes con diabetes mellitus (AU)

Objective To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus. Participants Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. Methods Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (PubMed). Papers in English and Spanish with publication date before 15 February 2013 were included. For recommendations about drugs only those approved by the European Medicines Agency were included. After formulation of recommendations, they were discussed by the Working Group. Conclusions The document provides evidence-based practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus (AU)