Continuous Glucose Monitoring Metrics and Hemoglobin A1c Relationship in Patients with Type 2 Diabetes Treated by Hemodialysis.

Background:There is a need for accurate glycemic control metrics in patients with diabetes and end-stage kidney disease (ESKD). Hence, we assessed the relationship of continuous glucose monitoring (CGM) metrics and laboratory-measured hemoglobin A1c (HbA1c) in patients with type 2 diabetes (T2D) treated by hemodialysis. Methods: This prospective observational study included adults (age 18-80 years) with T2D (HbA1c 5%-12%), treated by hemodialysis (for at least 90 days). Participants used a Dexcom G6 Pro CGM for 10 days. Correlation analyses between CGM metrics [mean glucose, glucose management indicator (GMI), and time-in-range (TIR 70-180 mg/dL)] and HbA1c were performed. Results: Among 59 participants (mean age was 57.7 ± 9.3 years, 58% were female, 86% were non-Hispanic blacks), the CGM mean glucose level was 188.9 ± 45 mg/dL (95% CI: 177.2, 200.7), the mean HbA1c and GMI were 7.1% ± 1.3% and 7.8% ± 1.1%, respectively (difference 0.74% ± 0.95). GMI had a strong negative correlation with TIR 70-180 mg/dL (r = -0.96). The correlation between GMI and HbA1c (r = 0.68) was moderate. Up to 29% of participants had a discordance between HbA1c and GMI of <0.5%, with 22% having a discordance between 0.5% and 1%, and 49% having a discordance of >1%. Conclusions: In patients with diabetes and ESKD treated by hemodialysis, the GMI has a strong correlation with TIR, while HbA1c underestimated the average glucose and GMI. Given the limitations of HbA1c in this population, GMI or mean glucose and TIR may be considered as more appropriate glucose control markers.

Continuous Glucose Monitoring-Guided Insulin Administration in Long-Term Care Facilities: A Randomized Clinical Trial.

OBJECTIVES: To evaluate the efficacy of real-time continuous glucose monitoring (rt-CGM) in adjusting insulin therapy in long-term care facilities (LTCF). DESIGN: Prospective randomized clinical trial. SETTINGS AND PARTICIPANTS: Insulin-treated patients with type 2 diabetes (T2D) admitted to LTCF. METHODS: Participants in the standard of care wore a blinded CGM with treatment adjusted based on point-of-care capillary glucose results before meals and bedtime (POC group). Participants in the intervention (CGM group) wore a Dexcom G6 CGM with treatment adjusted based on daily CGM profile. Treatment adjustment was performed by the LTCF medical team, with a duration of intervention up to 60 days. The primary endpoint was difference in time in range (TIR 70-180 mg/dL) between treatment groups. RESULTS: Among 100 participants (age 74.73 ± 11 years, 80% admitted for subacute rehabilitation and 20% for nursing home care), there were no significant differences in baseline clinical characteristics between groups, and CGM data were compared for a median of 17 days. There were no differences in TIR (53.38% ± 30.16% vs 48.81% ± 28.03%, P = .40), mean daily mean CGM glucose (184.10 ± 43.4 mg/dL vs 190.0 ± 45.82 mg/dL, P = .71), or the percentage of time below range (TBR) <70 mg/dL (0.83% ± 2.59% vs 1.18% ± 3.54%, P = .51), or TBR <54 mg/dL (0.23% ± 0.85% vs 0.56% ± 2.24%, P = .88) between rt-CGM and POC groups. CONCLUSIONS AND IMPLICATIONS: The use of rtCGM is safe and effective in guiding insulin therapy in patients with T2D in LTCF resulting in a similar improvement in glycemic control compared to POC-guided insulin adjustment.

Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes.

OBJECTIVE: Patients with diabetes and end-stage kidney disease (ESKD) may experience "burnt-out diabetes," defined as having an HbA1c value <6.5% without antidiabetic therapy for >6 months. We aim to assess glycemic control by continuous glucose monitoring (Dexcom G6 CGM) metrics and glycemic markers in ESKD patients on hemodialysis with burnt-out diabetes. RESEARCH DESIGN AND METHODS: In this pilot prospective study, glycemic control was assessed by continuous glucose monitoring (CGM), HbA1c measures, and glycated albumin and fructosamine measurements in patients with burnt-out diabetes (n = 20) and without a history of diabetes (n = 20). RESULTS: Patients with burnt-out diabetes had higher CGM-measured daily glucose levels, lower percent time in the range 70-180 mg/dL, higher percent time above range (>250 mg/dL), and longer duration of hyperglycemia >180 mg/dL (hours/day) compared with patients without diabetes (all P < 0.01). HbA1c and fructosamine levels were similar; however, patients with burnt-out diabetes had higher levels of glycated albumin than did patients without diabetes. CONCLUSIONS: The use of CGM demonstrated that patients with burnt-out diabetes have significant undiagnosed hyperglycemia. CGM and glycated albumin provide better assessment of glycemic control than do values of HbA1c and fructosamine in patients with ESKD.

A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9-15%: DUAL HIGH Trial.

OBJECTIVE: In participants with type 2 diabetes (T2D) and HbA1c >9.0-10.0%, guidelines recommend treatment with basal-bolus insulin. RESEARCH DESIGN AND METHODS: This randomized trial compared the efficacy and safety of insulin degludec and liraglutide (IDegLira) and basal-bolus among participants with high HbA1c ≥9.0-15.0%, previously treated with 2 or 3 oral agents and/or basal insulin, allocated (1:1) to basal-bolus (n = 73) or IDegLira (n = 72). The primary end point was noninferiority (0.4%) in HbA1c reduction between groups. RESULTS: Among 145 participants (HbA1c 10.8% ± 1.3), there was no statistically significant difference in HbA1c reduction (3.18% ± 2.29 vs. 3.00% ± 1.79, P = 0.65; estimated treatment difference (ETD) 0.18%, 95% CI -0.59, 0.94) between the IDegLira and basal-bolus groups. IDegLira resulted in significantly lower rates of hypoglycemia <70 mg/dL (26% vs. 48%, P = 0.008; odds ratio 0.39, 95% CI 0.19, 0.78), and less weight gain (1.24 ± 8.33 vs. 5.84 ± 6.18 kg, P = 0.001; ETD -4.60, 95% CI -7.33, -1.87). CONCLUSIONS: In participants with T2D and HbA1c ≥9.0-15.0%, IDegLira resulted in similar HbA1c reduction, less hypoglycemia, and less weight gain compared with the basal-bolus regimen.

Diabetic retinopathy in African-Americans with end-stage kidney disease: a cross-sectional study on prevalence and impact on quality of life.

INTRODUCTION: The prevalence, severity, and quality of life (QoL) impact of diabetic retinopathy (DR) among African-Americans (AAs) with end-stage kidney disease (ESKD) undergoing dialysis are unknown. RESEARCH DESIGN AND METHODS: A cross-sectional study was conducted on 93 AA adults with diabetes and ESKD. The diagnosis of DR was based on a review of medical records and/or a positive photograph with a portable hand-held device reviewed by both artificial intelligence software and a retinal specialist. QoL, physical disability social determinants of health (SDoHs) were assessed by standardized questionnaires. RESULTS: The prevalence of DR was 75%, with 33% of participants having mild, 9.6% moderate and 57.4% severe DR. A total of 43% had normal visual acuity; 45% had moderate visual impairment; and 12% had severe visual impairment. We found a high burden of disease, multiple SDoH challenges, and low QoL and general health among patients with ESKD. The presence of DR had no significant impact on physical health and QoL compared with participants without DR. CONCLUSIONS: DR is present in 75% of AA patients with diabetes and ESKD on haemodialysis. ESKD has a significant burden on general health and QoL; however, DR has a minor additional impact on the overall physical health and QoL in people with ESKD.

Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia.

BACKGROUND: Peripheral arterial disease is a major health problem, and in about 1% to 2% of patients, the disease progresses to critical limb ischaemia (CLI), also known as critical limb-threatening ischaemia. In a substantial number of individuals with CLI, no effective treatment options other than amputation are available, with around a quarter of these patients requiring a major amputation during the following year. This is the second update of a review first published in 2011. OBJECTIVES: To evaluate the benefits and harms of local intramuscular transplantation of autologous adult bone marrow mononuclear cells (BMMNCs) as a treatment for CLI. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 8 November 2021. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) of CLI in which participants were randomly allocated to intramuscular administration of autologous adult BMMNCs or control (either no intervention, conventional conservative therapy, or placebo). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes of interest were all-cause mortality, pain, and amputation. Our secondary outcomes were angiographic analysis, ankle-brachial index (ABI), pain-free walking distance, side effects and complications. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included four RCTs involving a total of 176 participants with a clinical diagnosis of CLI. Participants were randomised to receive either intramuscular cell implantation of BMMNCs or control. The control arms varied between studies, and included conventional therapy, diluted autologous peripheral blood, and saline. There was no clear evidence of an effect on mortality related to the administration of BMMNCs compared to control (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.15 to 6.63; 3 studies, 123 participants; very low-certainty evidence). All trials assessed changes in pain severity, but the trials used different forms of pain assessment tools, so we were unable to pool data. Three studies individually reported that no differences in pain reduction were observed between the BMMNC and control groups. One study reported that reduction in rest pain was greater in the BMMNC group compared to the control group (very low-certainty evidence). All four trials reported the rate of amputation at the end of the study period. We are uncertain if amputations were reduced in the BMMNC group compared to the control group, as a possible small effect (RR 0.52, 95% CI 0.27 to 0.99; 4 studies, 176 participants; very low-certainty evidence) was lost after undertaking sensitivity analysis (RR 0.52, 95% CI 0.19 to 1.39; 2 studies, 89 participants). None of the included studies reported any angiographic analysis. Ankle-brachial index was reported differently by each study, so we were not able to pool the data. Three studies reported no changes between groups, and one study reported greater improvement in ABI (as haemodynamic improvement) in the BMMNC group compared to the control group (very low-certainty evidence). One study reported pain-free walking distance, finding no clear difference between BMMNC and control groups (low-certainty evidence). We pooled the data for side effects reported during the follow-up, and this did not show any clear difference between BMMNC and control groups (RR 2.13, 95% CI 0.50 to 8.97; 4 studies, 176 participants; very low-certainty evidence). We downgraded the certainty of the evidence due to the concerns about risk of bias, imprecision, and inconsistency. AUTHORS' CONCLUSIONS: We identified a small number of studies that met our inclusion criteria, and these differed in the controls they used and how they measured important outcomes. Limited data from these trials provide very low- to low-certainty evidence, and we are unable to draw conclusions to support the use of local intramuscular transplantation of BMMNC for improving clinical outcomes in people with CLI. Evidence from larger RCTs is needed in order to provide adequate statistical power to assess the role of this procedure.

Anastomotic biliary stricture following liver transplantation and management analysis: 15 years of experience at a high-volume transplant center.

INTRODUCTION: The occurrence of anastomotic biliary stricture (BS) remains an essential issue following liver transplantation (LT). The present study aimed to compare our findings regarding the incidence of anastomotic BS to what is known. METHODS: The present study is a single-center, retrospective cohort study of a total number of 717 consecutive patients (426 men and 291 women) who had undergone LT from January 2001 to March 2016. Multivariable Cox regression analysis was conducted to evaluate the risk factors associated with anastomotic BS development. RESULTS: Post-transplant anastomotic BS developed in 70 patients (9.8%). In the Cox multivariate analysis (a stepwise forward conditional method), factors including biliary leak (hazard ratio [HR]: 6.61, 95% confidence interval [CI]: 3.08-17.58, p < 0.001), hepatic artery thrombosis (HR: 2.29, 95% CI: 1.03-5.88; p = 0.003), and acute rejection (HR: 2.18, 95% CI: 1.16-3.37; p = 0.006) were identified as independent risk factors for the development of anastomotic BS. Surgery in 6 cases (66.7%), followed by endoscopic retrograde cholangiopancreatography (ECRP) with a metal stent in 18 cases (62.1%), percutaneous transhepatic biliary drainage in 9 (20.9%), and ERCP with a single plastic stent in 8 (18.2%), had the highest effectiveness rates in the management of BS, respectively. CONCLUSIONS: Risk factors including biliary leak, hepatic artery thrombosis, and acute rejection were independently associated with an anastomotic BS. ERCP with a metal stent may be considered as an effective treatment procedure with a relatively low complication rate in the management of benign post-LT anastomotic BS.

A Pilot Randomized, Clinical Trial of the Anti-pruritus Effect of Melatonin in Patients with Chronic Liver Disease.

Pruritus is one of the disturbing complications induced by chronic liver disease (CLD), bearing a negative impact on patient quality of life and potentially resulting in early liver transplants. Given the main role of the autotaxin enzyme in pruritus induced by CLD and the suppressive effects of melatonin on the expression of the autotaxin gene, this study was designed to evaluate the antipruritic effect of melatonin in patients with CLD. A double-blind, cross-over, randomized, placebo-controlled pilot trial was conducted on patients with CLD -induced pruritis. Patients were randomly assigned to two groups where they received melatonin 10-mg at night or placebo for 2 weeks. After a 2-week washout period, patients were then crossed over to the other group. The Visual Analog Scale (VAS) and the 12-Item Pruritus Severity Score (12-PSS) were used to assess patient response to therapy as the co-primary outcomes, while liver function tests were assayed too. Forty patients completed the study. The VAS score showed alleviation of 3.21 ± 2.24 (in pruritus) with melatonin (p-value <0.05). The study goal (a reduction of at least 20% in VAS) was achieved in 33 (82%) of study participants. In patients who received melatonin, the 12-PSS and Body Surface Area (BSA) affected by pruritus decreased on average 46.57% and 51.71%, respectively, with mood, sleep pattern and daily activity levels also demonstrating significant improvement (p-value < 0.05). Melatonin was found to be effective for managing pruritus in patients with CLD.

Prognostic Factors Associated with Survival in Patients Infected with COVID-19: A Retrospective Study on 214 Patients from Iran.

BACKGROUND: Decision-making on allocating scarce medical resources is crucial in the context of a strong health system reaction to the coronavirus disease 2019 (COVID-19) pandemic. Therefore, understanding the risk factors related to a high mortality rate can enable the physicians for a better decision-making process. METHODS: Information was collected regarding clinical, demographic, and epidemiological features of the definite COVID-19 cases. Through Cox regression and statistical analysis, the risk factors related to mortality were determined. The Kaplan-Meier curve was used to estimate survival function and measure the mean length of living time in the patients. RESULTS: Among about 3000 patients admitted in the Taleghani hospital as outpatients with suspicious signs and symptoms of COVID-19 in 2 months, 214 people were confirmed positive for this virus using the polymerase chain reaction (PCR) technique. Median time to death was 30 days. In this population, 24.29% of the patients died and 24.76% of them were admitted to the ICU (intensive care unit) during hospitalization. The results of Multivariate Cox regression Analysis showed that factors including age (HR, 1.031; 95% CI, 1.001-1.062; P value=0.04), and C-reactive protein (CRP) (HR, 1.007; 95% CI, 1.000-1.015; P value=0.04) could independently predict mortality. Furthermore, the results showed that age above 59 years directly increased mortality rate and decreased survival among our study population. CONCLUSION: Predictor factors play an important role in decisions on public health policy-making. Our findings suggested that advanced age and CRP were independent mortality rate predictors in the admitted patients.

Effectiveness of dietary interventions on cardio-metabolic risk factors in patients with nonalcoholic fatty liver disease: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Dietary modification is considered as one of the main strategies in the management of nonalcoholic fatty liver disease (NAFLD). The objective of this study was to systematically investigate the effect of dietary interventions on the cardio-metabolic risk factors, including lipid profile and insulin resistance in this population. METHODS: We searched electronic databases of PubMed and Scopus until January 2020 and included randomized controlled trials that compared the effect of dietary modifications vs. control on lipid profile and insulin resistance in patients with NAFLD. The random-effect analysis was performed to calculate pooled weighted mean differences (WMD). RESULTS: Our finding showed that serum triglycerides (TG) (n=5, WMD -38.50 mg/dL, 95% confidence interval [CI] -61.68 to -15.31; P=0.001) and total cholesterol (TC) (n=4, WMD -18.70 mg/dL, 95%CI -34.85 to -2.53; P=0.023) decrease following diet intervention along with marginally significant weight reduction (n=5, WMD -3.61 mg/dL, 95%CI -7.25 to 0.04; P=0.053). There was no change in the homeostatic model assessment for insulin resistance, high- and low-density lipoprotein (LDL) levels (P>0.05). Subgroup analysis revealed that Mediterranean diet reduced TG (n=2, WMD -57.52 mg/dL, 95%CI -75.73 to -39.31; P<0.001) and weight (n=2, WMD -7.59 Kg, 95%CI -13.53 to -1.66; P=0.012), and also increased LDL level (n=2, WMD 29.73 mg/dL, 95%CI 13.82-45.65; P<0.001). However, standard hypocaloric diet improved TC (n=2, WMD -23.20 mg/dL, 95%CI -36.96 to -9.44; P=0.001) and LDL (n=2, WMD -16.82 mg/dL, 95%CI -29.44 to -4.19; P=0.009). CONCLUSION: Dietary modifications may improve serum TG, TC, and obesity in NAFLD.

Comparison of Platelet Count Reduction in Patients awaiting Liver Transplantation with and without Primary Sclerosing Cholangitis: A Cohort Study.

BACKGROUND: Thrombocytopenia is the most well-known hematological abnormality occurring in patients with liver cirrhosis. However, the rate of platelet count reduction is not the same across different chronic liver disease etiologies. Therefore, the aim of the present study was to compare the differences in the platelet count levels between primary sclerosing cholangitis-related cirrhosis (PSC-C) and other causes of liver disease. METHODS: In this cohort study, the association between PSC-C and risk of platelet count reduction was investigated. The platelet counts were repeatedly measured among 242 consecutive cirrhotic patients (144 males and 98 females) including 67 patients with PSC-C and 175 patients with non-PSC-C who were on the waiting list for liver transplantation. The Poisson regression analysis was used to assess the relationship between platelet count reduction and PSC-C, after adjusting for potential confounding factors. RESULTS: During the five years of follow-up, comparison between the two groups revealed that significantly higher levels of platelet were found in PSC-C patients when compared to the non-PSC-C group [148 (106-280) (×103 /µL) vs. 79 (50-110) (×103 /µL), respectively, P < 0.001]. After adjusting for confounding factors, a significant association was observed between non-PSC-C and the risk of platelet count reduction (relative risk, RR: 14.81, 95% CI: 1.21-160.42; P = 0.03). CONCLUSION: The findings indicate that PSC-C patients present with mild degrees of thrombocytopenia compared to other causes of chronic liver disease.

Pulmonary Complications in Candidates for Liver Transplantation.

The liver plays a pivotal role in maintaining the homeostasis of various organ systems. Also, end-stage liver disease and its complications are major causes of morbidity and mortality among adults. Individuals who develop a chronic liver disease are at increased risk of progression to multi-organ dysfunction, including the pulmonary system. The clinical complications of pulmonary problems related to the presence of liver disease range from mild (such as hypoxemia) to life-threatening diseases (such as portopulmonary hypertension and hepatopulmonary syndrome). Herein, the major pulmonary complications related to liver cirrhosis and considerations for performing liver transplantation are reviewed.

Efficacy of Plasmapheresis and Immunoglobulin Replacement Therapy (IVIG) on Patients with COVID-19.

Since the rapidly evolving outbreak of COVID-19, several empirical therapeutic options have been recommended including the use of antivirals, steroids, and vaccines. According to recent observations about different modalities in treatment of patients infected with COVID-19, plasmapheresis and intravenous immunoglobulin (IVIg) have been reported to be an effective empirical therapeutic option to control the infection. In this review, we aimed to provide an overview on the possible application of plasmapheresis and intravenous immunoglobulin in patients with COVID-19.

COVID-19 and telemedicine: Immediate action required for maintaining healthcare providers well-being.

The well-being of the health care workforce is the cornerstone of every well-functioning health system. As a result of the pandemic, medical healthcare providers are under an enormous amount of workload pressure along with increased total health expenditures. The overwhelming burden of COVID-19 illness could lead to caregiver burnout. Direct-to-consumer telemedicine can enable patients to connect with their healthcare provider at a distance. This virtual platform could be used by smartphones or webcam-enabled computers and allows physicians to effectively screen patients with early signs of COVID-19 before they reach to hospital.

An update on treatment options for primary sclerosing cholangitis.

Primary sclerosing cholangitis is a chronic cholestatic liver disease defined by strictures of the biliary tree which could ultimately lead to liver cirrhosis and cholangiocarcinoma. Although the exact underlying etiology of this disorder is not fully understood, the pathology is believed to be caused by immune mediated mechanisms. Growing body of evidence suggests several treatment modalities mainly focusing on the inflammation aspect of this disorder. However, there is still no consensus regarding the best treatment option for these patients. Thus, the present study aimed to review the current treatment options for patients with primary sclerosing cholangitis.

Factors Associated With Length of Hospital Stay Following Liver Transplant Surgery.

OBJECTIVES: Length of stay is considered an important surrogate for transplant survival rate and resource utilization. Therefore, in the present study, our aim was to determine factors affecting length of hospital stay. MATERIALS AND METHODS: We retrospectively analyzed records of patients who underwent liver transplant at the Tehran University of Medical Sciences Liver Transplantation Center from March 2014 to March 2016. RESULTS: For our final analyses, there were 161 adult recipients, including 106 males (65.8%) and 55 females (34.1%). Univariate analyses showed that body mass index, Modelfor End-Stage Liver Disease score, duration of surgery, number of administered packed red blood cells and fibrinogen during surgery, reoperation, retransplant, bacterial infection, pleural effusion, ascites, renal failure that required dialysis, and wound infection were risk factors for length of hospital stay. After multivariate linear regression analysis, only body mass index (ß = 0.016; P = .028), Model for End-Stage Liver Disease score (ß = 0.017; P = .002), surgical duration (ß = 0.002; P = .001), reoperation (ß = 0.016; P < .001), presence of pleural effusion (ß = 0.212; P = .042), and management of bacterial infection (ß = 0.21; P = .03) and psychiatric problems after liver transplant (ß = 0.213; P = .025) were independent risk factors for length of hospital stay. CONCLUSIONS: The present study showed that multiple preoperative, intraoperative, and postoperative variables could have an impact on length of hospitalization. Therefore, methods for assessing these factors could improve patient outcomes and resource savings in liver transplant centers.