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OBJECTIVE: Intensive therapy targeting normal blood glucose increased mortality compared with standard treatment in a randomized clinical trial of 10,251 participants with type 2 diabetes at high-risk for cardiovascular disease (CVD) events. We evaluated whether the presence of cardiac autonomic neuropathy (CAN) at baseline modified the effect of intensive compared with standard glycemia treatment on mortality outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial participants. RESEARCH DESIGN AND METHODS: CAN was assessed by measures of heart rate variability (HRV) and QT index (QTI) computed from 10-s resting electrocardiograms in 8,135 ACCORD trial participants with valid measurements (mean age 63.0 years, 40% women). Prespecified CAN definitions included a composite of the lowest quartile of HRV and highest QTI quartile in the presence or absence of peripheral neuropathy. Outcomes were all-cause and CVD mortality. Associations between CAN and mortality were evaluated by proportional hazards analysis, adjusting for treatment group allocation, CVD history, and multiple prespecified baseline covariates. RESULTS: During a mean 3.5 years follow-up, there were 329 deaths from all causes. In fully adjusted analyses, participants with baseline CAN were 1.55-2.14 times as likely to die as participants without CAN, depending on the CAN definition used (P < 0.02 for all). The effect of allocation to the intensive group on all-cause and CVD mortality was similar in participants with or without CAN at baseline (Pinteraction > 0.7). CONCLUSIONS: Whereas CAN was associated with increased mortality in this high-risk type 2 diabetes cohort, these analyses indicate that participants with CAN at baseline had similar mortality outcomes from intensive compared with standard glycemia treatment in the ACCORD cohort.

Randomized treatment comparing an intensive glycemic treatment strategy with a standard strategy in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was ended early because of an unexpected excess of mortality in the intensive arm. As part of ongoing post hoc analyses of potential mechanisms for this finding, we explored whether on-treatment A1C itself had an independent relationship with mortality. Participants with type 2 diabetes (n = 10,251 with mean age 62 years, median duration of diabetes 10 years, and median A1C 8.1%) were randomly assigned to treatment strategies targeting either A1C <6.0% (intensive) or A1C 7.0-7.9% (standard). Data obtained during 3.4 (median) years of follow-up before cessation of intensive treatment were analyzed using several multivariable models. Various characteristics of the participants and the study sites at baseline had significant associations with the risk of mortality. Before and after adjustment for these covariates, a higher average on-treatment A1C was a stronger predictor of mortality than the A1C for the last interval of follow-up or the decrease of A1C in the first year. Higher average A1C was associated with greater risk of death. The risk of death with the intensive strategy increased approximately linearly from 6-9% A1C and appeared to be greater with the intensive than with the standard strategy only when average A1C was >7%. These analyses implicate factors associated with persisting higher A1C levels, rather than low A1C per se, as likely contributors to the increased mortality risk associated with the intensive glycemic treatment strategy in ACCORD.

This study evaluated the clinical utility of continuous glucose monitoring system (CGMS) in critically ill patients. In this randomized controlled trial, we randomly assigned critically ill participants with diabetes or stress-induced hyperglycemia to the CGMS group (n = 48) or to the conventional point-of-care monitoring (POCM) group (n = 48). The glucose values and clinical outcome were compared between the two group. The primary endpoint was 28-day mortality after intensive care unit admission. The 28-day mortality was not significantly different between the CGMS and POCM group (20.8% vs 31.3%, P = 0.25). The mean glucose, time-weighted average glucose, glucose standard deviation and time in range (3.9–10.0) were significantly improved in the CGMS group (all P < 0.05). Compared with conventional POCM, CGMS did not decrease the 28-day mortality in critically ill participants with diabetes or stress-induced hyperglycemia. But CGMS may improve the glycemic control and may be increasingly used in critically ill patients. •Continuous glucose monitoring did not reduce the mortality.•Continuous glucose monitoring may improve glycemic control in critically ill patients.•Continuous glucose monitoring increased glycemic time in range.

Background There is some evidence that hyperglycemia increases the rate of poor outcomes in patients with intracerebral hemorrhage (ICH). We explored the relationship between various parameters of serum glucose concentrations measured during acute hospitalization and hematoma expansion, perihematomal edema, and three month outcome among subjects with ICH. Methods A post-hoc analysis of a multicenter prospective study recruiting subjects with ICH and elevated systolic blood pressure (SBP) ≥170 mmHg who presented within 6 h of symptom onset was performed. The serum glucose concentration was measured repeatedly up to 5 times over 3 days after admission and change over time was characterized using a summary statistic by fitting the linear regression model for each subject. The admission glucose, glucose change between admission and 24 hour glucose concentration, and estimated parameters (slope and intercept) were entered in the logistic regression model separately to predict the functional outcome as measured by modified Rankin scale (mRS) at 90 days (0–3 vs. 4–6); hematoma expansion at 24 h (≤33 vs. >33%); and relative perihematomal edema expansion at 24 h (≤40 vs. >40%). Results A total of 60 subjects were recruited (aged 62.0 ±15.1 years; 56.7% men). The mean of initial glucose concentration (±standard deviation) was 136.7 mg/dl (±58.1). Thirty-five out of 60 (58%) subjects had a declining glucose over time (negative slope). The risk of poor outcome (mRS 4–6) in those with increasing serum glucose levels was over two-fold relative to those who had declining serum glucose levels (RR = 2.64, 95% confidence interval [CI]: 1.03, 6.75). The RRs were 2.59 (95% CI: 1.27, 5.30) for hematoma expansion >33%; and 1.25 (95% CI: 0.73, 2.13) for relative edema expansion >40%. Conclusions Decline in serum glucose concentration correlated with reduction in proportion of subjects with hematoma expansion and poor clinical outcome. These results provide a justification for a randomized controlled clinical trial to evaluate the efficacy of aggressive serum glucose reduction in reducing death and disability among patients with ICH.

Background Previous studies of glycemic control in non-neurologic ICU patients have shown conflicting results. The purpose was to investigate whether intensive insulin therapy (IIT) to keep blood glucose levels from 80 to 110 mg/dl or conventional treatment to keep levels less than 151 mg/dl was associated with a reduction of mortality and improved functional outcome in critically ill neurologic patients. Methods Within 24 h of ICU admission, mechanically ventilated adult neurologic patients were enrolled after written informed consent and randomized to intensive or conventional control of blood glucose levels with insulin. Primary outcome measure was death within 3 months. Secondary outcome measures included 90-day modified Rankin scale (mRS) score, ICU, and hospital LOS. Results 81 patients were enrolled. The proportion of deaths was higher among IIT patients but this was not statistically significant (36 vs. 25%, P  = 0.34). When good versus poor outcome at 3 months was dichotomized to mRS score 0–2 versus 3–6, respectively, there was no difference in outcome between the two groups (76.2 vs. 75% had a poor 3-month outcome, P  = 1.0). There was also no difference in ICU or hospital LOS. Hypoglycemia (<60 mg/dl) and severe hypoglycemia (<40 mg/dl) were more common in the intensive arm (48 vs. 11%, P  = 0.0006; and 4 vs. 0%, P  = 0.5, respectively). Conclusion There was no benefit to IIT in this small critically ill neurologic population. This is the first glycemic control study to specifically examine both critically ill stroke and traumatic brain injury (TBI) patients and functional outcome. Given these results, IIT cannot be recommended over conventional control.

Background Sepsis is a severe form of systemic inflammatory response syndrome that is caused by infection. Sepsis is characterized by a marked state of stress, which manifests as nonspecific physiological and metabolic changes in response to the disease. Previous studies have indicated that the stress hyperglycemia ratio (SHR) can serve as a reliable predictor of adverse outcomes in various cardiovascular and cerebrovascular diseases. However, there is limited research on the relationship between the SHR and adverse outcomes in patients with infectious diseases, particularly in critically ill patients with sepsis. Therefore, this study aimed to explore the association between the SHR and adverse outcomes in critically ill patients with sepsis. Methods Clinical data from 2312 critically ill patients with sepsis were extracted from the MIMIC-IV (2.2) database. Based on the quartiles of the SHR, the study population was divided into four groups. The primary outcome was 28-day all-cause mortality, and the secondary outcome was in-hospital mortality. The relationship between the SHR and adverse outcomes was explored using restricted cubic splines, Cox proportional hazard regression, and Kaplan‒Meier curves. The predictive ability of the SHR was assessed using the Boruta algorithm, and a prediction model was established using machine learning algorithms. Results Data from 2312 patients who were diagnosed with sepsis were analyzed. Restricted cubic splines demonstrated a \"U-shaped\" association between the SHR and survival rate, indicating that an increase in the SHR is related to an increased risk of adverse events. A higher SHR was significantly associated with an increased risk of 28-day mortality and in-hospital mortality in patients with sepsis (HR > 1, P < 0.05) compared to a lower SHR. Boruta feature selection showed that SHR had a higher Z score, and the model built using the rsf algorithm showed the best performance (AUC = 0.8322). Conclusion The SHR exhibited a U-shaped relationship with 28-day all-cause mortality and in-hospital mortality in critically ill patients with sepsis. A high SHR is significantly correlated with an increased risk of adverse events, thus indicating that is a potential predictor of adverse outcomes in patients with sepsis.

Background The prognostic role of hyperglycemia in patients with myocardial infarction and obstructive coronary arteries (MIOCA) is acknowledged, while data on non-obstructive coronary arteries (MINOCA) are still lacking. Recently, we demonstrated that admission stress-hyperglycemia (aHGL) was associated with a larger infarct size and inflammatory response in MIOCA, while no differences were observed in MINOCA. We aim to investigate the impact of aHGL on short and long-term outcomes in MIOCA and MINOCA patients. Methods Multicenter, population-based, cohort study of the prospective registry, designed to evaluate the prognostic information of patients admitted with acute myocardial infarction to S. Orsola-Malpighi and Maggiore Hospitals of Bologna metropolitan area. Among 2704 patients enrolled from 2016 to 2020, 2431 patients were classified according to the presence of aHGL (defined as admission glucose level ≥ 140 mg/dL) and AMI phenotype (MIOCA/MINOCA): no-aHGL (n = 1321), aHGL (n = 877) in MIOCA and no-aHGL (n = 195), aHGL (n = 38) in MINOCA. Short-term outcomes included in-hospital death and arrhythmias. Long-term outcomes were all-cause and cardiovascular mortality. Results aHGL was associated with a higher in-hospital arrhythmic burden in MINOCA and MIOCA, with increased in-hospital mortality only in MIOCA. After adjusting for age, gender, hypertension, Killip class and AMI phenotypes, aHGL predicted higher in-hospital mortality in non-diabetic (HR = 4.2; 95% CI 1.9–9.5, p = 0.001) and diabetic patients (HR = 3.5, 95% CI 1.5–8.2, p = 0.003). During long-term follow-up, aHGL was associated with 2-fold increased mortality in MIOCA and a 4-fold increase in MINOCA (p = 0.032 and p = 0.016). Kaplan Meier 3-year survival of non-hyperglycemic patients was greater than in aHGL patients for both groups. No differences in survival were found between hyperglycemic MIOCA and MINOCA patients. After adjusting for age, gender, hypertension, smoking, LVEF, STEMI/NSTEMI and AMI phenotypes (MIOCA/MINOCA), aHGL predicted higher long-term mortality. Conclusions aHGL was identified as a strong predictor of adverse short- and long-term outcomes in both MIOCA and MINOCA, regardless of diabetes. aHGL should be considered a high-risk prognostic marker in all AMI patients, independently of the underlying coronary anatomy. Trial registration data were part of the ongoing observational study AMIPE: Acute Myocardial Infarction, Prognostic and Therapeutic Evaluation. ClinicalTrials.gov Identifier: NCT03883711.

The stress hyperglycemia ratio (SHR) is established as a reliable marker for assessing the severity of stress-induced hyperglycemia. While its effectiveness in managing patients with Acute Ischemic Stroke (AIS) remains to be fully understood. We aim to explore the relationship between SHR and clinical prognosis in AIS patients and to assess how diabetes status influences this relationship. In this study, we analyzed data from the Medical Information Mart for Intensive Care (MIMIC-IV) database, selecting patients with AIS who required ICU admission. These patients were categorized into tertiles based on their SHR levels. We applied Cox hazard regression models and used restricted cubic spline (RCS) curves to investigate relationships between outcomes and SHR. The study enrolled a total of 2029 patients. Cox regression demonstrated that a strong correlation was found between increasing SHR levels and higher all-cause mortality. Patients in the higher two tertiles of SHR experienced significantly elevated 30-day and 90-day mortality rates compared to those in the lowest tertile. This pattern remained consistent regardless of diabetes status. Further, RCS analysis confirmed a progressively increasing risk of all-cause mortality with higher SHR levels. The findings indicate that SHR is association with increased 30-day and 90-day mortality among AIS patients, underscoring its potential value in risk stratification. Although the presence of diabetes may weaken this association, significant correlations persist in diabetic patients.

Background The stress hyperglycemia ratio (SHR) was developed to mitigate the influence of long-term chronic glycemic factors on stress hyperglycemia levels, which are associated with adverse clinical events, particularly cardiovascular events. However, studies examining the SHR index and its prognostic significance in patients with atrial fibrillation (AF) are lacking. This study aims to evaluate the relationship between the SHR index and all-cause mortality in critically ill patients with AF upon Intensive Care Unit admission. Methods The patients’ data were extracted from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. All patients were categorized into four groups based on the SHR index. The outcomes include both primary and secondary endpoints, with the primary endpoints being 30-day and 365-day all-cause mortality, and the secondary endpoints being 90-day and 180-day all-cause mortality. The SHR index was analyzed using quartiles, and the Kaplan-Meier curve was employed to compare the outcomes across groups. Cox proportional-hazards regression and restricted cubic splines (RCS) were used to assess the relationship between the SHR index and the outcomes. Results Out of a total of 1,685 participants, the average age was 63.12 years (range: 40.17 to 101.49), with 1,004 (59.58%) being male. Higher levels of the SHR index were associated with an increased risk of all-cause mortality at 30 days, 90 days, 180 days, and 365 days, as indicated by the Kaplan-Meier curves (log-rank P  < 0.01). Additionally, Cox proportional-hazards regression analysis revealed that the risk of mortality at these time points was significantly higher in the highest quartile of the SHR index. Restricted cubic splines (RCS) analysis demonstrated U-shaped relationships between the SHR index and all-cause mortality, with inflection points at 0.73 for 30-day mortality and 0.76 for 365-day mortality. Compared to patients with SHR levels below these inflection points, those with higher levels had a 69.9% increased risk for 30-day all-cause mortality (hazard ratio [HR] 1.699; 95% confidence interval [CI] 1.336 to 2.159) and a 61.6% increased risk for 365-day all-cause mortality (HR 1.616; 95% CI 1.345 to 1.942). Conclusion In critically ill patients with AF, higher levels of the SHR index are significantly associated with an increased risk of all-cause mortality at 30 days, 90 days, 180 days, and 365 days. The SHR index may serve as a valid indicator for assessing the severity and guiding the treatment of AF patients in the ICU.

Hyperglycemia may increase mortality in patients who receive total parenteral nutrition (TPN). However, this has not been well studied in noncritically ill patients (i.e., patients in the nonintensive care unit setting). The aim of this study was to determine whether mean blood glucose level during TPN infusion is associated with increased mortality in noncritically ill hospitalized patients. This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included prospectively, and data were collected on demographic, clinical, and laboratory variables as well as on in-hospital mortality. The study included 605 patients (mean age 63.2 ± 15.7 years). The daily mean TPN values were 1.630 ± 323 kcal, 3.2 ± 0.7 g carbohydrates/kg, 1.26 ± 0.3 g amino acids/kg, and 0.9 ± 0.2 g lipids/kg. Multiple logistic regression analysis showed that the patients who had mean blood glucose levels >180 mg/dL during the TPN infusion had a risk of mortality that was 5.6 times greater than those with mean blood glucose levels <140 mg/dL (95% CI 1.47-21.4 mg/dL) after adjusting for age, sex, nutritional state, presence of diabetes or hyperglycemia before starting TPN, diagnosis, prior comorbidity, carbohydrates infused, use of steroid therapy, SD of blood glucose level, insulin units supplied, infectious complications, albumin, C-reactive protein, and HbA1c levels. Hyperglycemia (mean blood glucose level >180 mg/dL) in noncritically ill patients who receive TPN is associated with a higher risk of in-hospital mortality.