GLP-1 Receptor Agonist and SGLT2 Inhibitor Prescribing in People With Type 1 Diabetes.

This pooled cross-sectional study explores prescribing rates for glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors among US patients with type 1 diabetes.

The Role of Urban Residence, Race and Ethnicity, and Glycemic Control in Receiving Standards of Care and Progression to Vision-Threatening Diabetic Retinopathy.

OBJECTIVE: Among patients with diabetes living in the U.S. with newly detected mild or moderate nonproliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME), we aimed to characterize determinants for receiving standards of care and progression to vision-threatening diabetic retinopathy (VTDR) (severe NPDR, proliferative diabetic retinopathy, DME). RESEARCH DESIGN AND METHODS: Electronic health records of patients newly detected with NPDR without DME between 2015 and 2023 were analyzed with use of the Epic Cosmos research platform. We characterized the adjusted associations of urban versus rural residence, race and ethnicity (Hispanic, non-Hispanic [NH] White, NH Black, other), and glycemic control (HbA1c <7.0%, 7.0%-8.9%, ≥9%, unavailable) separately with guideline-recommended care (two of three: ophthalmology visit, primary care visit, and measurement of HbA1c, blood pressure, and LDL cholesterol) in the 2 years after diagnosis and with progression to VTDR. RESULTS: Average (SD) age for the analytic sample (n = 102,919) was 63 (13.5) years, and 51% were female, 59% NH White, and 7% rural residents. Only 40% received guideline-recommended care, and 14% progressed to VTDR (median follow-up 35 months [interquartile range 18-63]). Urban residence was associated with receiving standards of care in both years (risk ratio 1.08 [95% CI 1.05-1.12]) and progression to VTDR (hazard ratio 1.07 [95% CI 0.99-1.15]). Racial and ethnic minority individulas were more likely to progress to VTDR. Individuals with poor or unknown glycemic control were less likely to receive standards of care and more likely to progress to VTDR. CONCLUSIONS: Understanding the management and progression of newly detected NPDR will require disentangling the independent and interdependent contributions of geography, race and ethnicity, and glycemia.

Technology and Continuous Glucose Monitoring Access, Literacy, and Use Among Patients at the Diabetes Center of an Inner-City Safety-Net Hospital: Mixed Methods Study.

BACKGROUND: Despite the existence of an increasing array of digital technologies and tools for diabetes management, there are disparities in access to and uptake and use of continuous glucose monitoring (CGM) devices, particularly for those most at risk of poor diabetes outcomes. OBJECTIVE: This study aims to assess communication technology and CGM access, literacy, and use among patients receiving treatment for diabetes at an inner-city safety-net hospital. METHODS: A survey on digital technology ownership and use was self-administered by 75 adults with type 1 and type 2 diabetes at the diabetes clinic of Grady Memorial Hospital in Atlanta, Georgia. In-depth interviews were conducted with 16% (12/75) of these patient participants and 6 health care providers (HCPs) to obtain additional insights into the use of communication technology and CGM to support diabetes self-management. RESULTS: Most participants were African American (66/75, 88%), over half (39/75, 52%) were unemployed or working part time, and 29% (22/75) had no health insurance coverage, while 61% (46/75) had federal coverage. Smartphone ownership and use were near universal; texting and email use were common (63/75, 84% in both cases). Ownership and use of tablets and computers and use and daily use of various forms of media were more prevalent among younger participants and those with type 1 diabetes, who also rated them as easier to use. Technology use specifically for diabetes and health management was low. Participants were supportive of a potential smartphone app for diabetes management, with a high interest in such an app helping them track blood sugar levels and communicate with their care teams. Younger participants showed higher levels of interest, perceived value, and self-efficacy for using an app with these capabilities. History of CGM use was reported by 56% (42/75) of the participants, although half (20/42, 48%) had discontinued use, above all due to the cost of the device and issues with its adhesive. Nonuse was primarily due to not being offered CGM by their HCP. Reasons given for continued use included convenience, improved blood glucose control, and better tracking of blood glucose. The in-depth interviews (n=18) revealed high levels of satisfaction with CGM by users and supported the survey findings regarding reasons for continued use. They also highlighted the value of CGM data to enhance communication between patients and HCPs. CONCLUSIONS: Smartphone ownership was near universal among patients receiving care at an inner-city hospital. Alongside the need to address barriers to CGM access and continued use, there is an opportunity to leverage increased access to communication technology in combination with CGM to improve diabetes outcomes among underresourced populations.

Longitudinal Fatigue Symptoms and Inflammatory Markers in African American Adults With Hypertension and Obstructive Sleep Apnea.

BACKGROUND: There is a dearth of research inclusive of African Americans living with obstructive sleep apnea (OSA) despite differences in symptom presentations compared to non-Hispanic White patient populations. Less is known regarding the potential effect of comorbidities, such as hypertension, on commonly reported symptoms, such as fatigue, and their association with inflammatory biomarkers. OBJECTIVE: This longitudinal pilot study aimed to characterize fatigue symptom presentations among African Americans newly diagnosed with OSA and discern peripheral blood analytes linked to symptoms while accounting for co-occurring hypertension. METHODS: Adult African Americans newly diagnosed with OSA with and without co-occurring hypertension were approached by study staff and recruited following their diagnostic visit with sleep medicine clinicians at two health systems and followed over 6 months after commencing continuous positive airway pressure treatment. Patient-Reported Outcomes Measurement Information System Fatigue surveys and plasma were collected every 3 months from 29 participants. Mixed effects models examined changes in fatigue symptom presentations over time while accounting for plasma-based analytes and hypertension status. RESULTS: Despite higher fatigue symptom severity upon diagnosis, participants with co-occurring hypertension reported greater improvements in fatigue scores after commencing continuous positive airway pressure treatment for up to 6 months than those without hypertension. Inverse correlations were observed between fatigue scores, C-reactive protein, matrix-metalloproteinase-8, and osteoprotegerin analyte levels among participants with/without hypertension. Across all participants, changes in interleukin-6 were associated with changes in fatigue scores in the first three months after diagnosis. DISCUSSION: Findings indicate that hypertension is linked to increased fatigue upon diagnosis of OSA in this sample of African Americans. Fatigue in persons with hypertension improved after treatment. These hypothesis-generating findings can inform future interventional studies aimed at improving fatigue among persons with OSA while leveraging markers linked to fatigue symptom severity as potential objective markers of improvements. Further research on the role of inflammatory markers, such as IL-6, on fatigue symptom presentations is warranted in those with OSA regardless of hypertension status.

Trends and Inequalities in Diabetes-Related Complications Among U.S. Adults, 2000-2020.

OBJECTIVE: We examined national trends in diabetes-related complications (heart failure [HF], myocardial infarction [MI], stroke, end-stage renal disease [ESRD], nontraumatic lower-extremity amputation [NLEA], and hyperglycemic crisis) among U.S. adults with diagnosed diabetes during 2000-2020 by age-group, race and ethnicity, and sex. We also assessed trends in inequalities among those subgroups. RESEARCH DESIGN AND METHODS: Hospitalization rates for diabetes-related complications among adults (≥18 years) were estimated using the 2000-2020 National (Nationwide) Inpatient Sample. The incidence of diabetes-related ESRD was estimated using the United States Renal Data System. The number of U.S. adults with diagnosed diabetes was estimated from the National Health Interview Survey. Annual percent change (APC) was estimated for assessment of trends. RESULTS: After declines in the early 2000s, hospitalization rates increased for HF (2012-2020 APC 3.9%, P < 0.001), stroke (2009-2020 APC 2.8%, P < 0.001), and NLEA (2009-2020 APC 5.9%, P < 0.001), while ESRD incidence increased (2010-2020 APC 1.0%, P = 0.044). Hyperglycemic crisis increased from 2000 to 2020 (APC 2.2%, P < 0.001). MI hospitalizations declined during 2000-2008 (APC -6.0%, P < 0.001) and were flat thereafter. On average, age inequalities declined for hospitalizations for HF, MI, stroke, and ESRD incidence but increased for hyperglycemic crisis. Sex inequalities increased on average for hospitalizations for stroke and NLEA and for ESRD incidence. Racial and ethnic inequalities declined during 2012-2020 for ESRD incidence but increased for HF, stroke, and hyperglycemic crisis. CONCLUSIONS: There was a continued increase of several complications in the past decade. Age, sex, and racial and ethnic inequalities have worsened for some complications.

Association between low cognitive performance and diabetes-related health indicators across racial and ethnic groups in adults with diabetes.

AIM: To examine the associations between low cognitive performance (LCP) and diabetes-related health indicators (including body mass index [BMI], HbA1c, systolic blood pressure [SBP], low-density lipoprotein [LDL] and self-reported poor physical health) and whether these associations vary across racial/ethnic subgroups. METHODS: We identified adults aged 60 years or older with self-reported diabetes from the 2011-2014 National Health and Nutrition Examination Survey. Individuals with cognitive test scores in the lowest quartile were defined as having LCP. We used regression models to measure the associations of LCP with diabetes-related biometrics (BMI, HbA1c, SBP and LDL); and self-reported poor physical health. Moreover, we explored potential variations in these associations across racial/ethnic subgroups. RESULTS: Of 873 (261 with LCP) adults with diabetes, LCP was associated with higher HbA1c, SBP and LDL (adjusted difference: 0.41%, 5.01 mmHg and 5.08 mg/dL, respectively; P < .05), and greater odds of reporting poor physical health (adjusted odds ratio: 1.59, P < .05). The association between LCP and HbA1c was consistent across racial/ethnic groups, and notably pronounced in Hispanic and Other. BMI worsened with LCP, except for non-Hispanic Black. Excluding the Other group, elevated SBP was observed in people with LCP, with Hispanic showing the most significant association. LDL levels were elevated with LCP for Hispanic and Other. Physical health worsened with LCP for both non-Hispanic Black and Hispanic. CONCLUSIONS: We quantified the association between LCP and diabetes-related health indicators. These associations were more pronounced in Hispanic and Other racial/ethnic groups.

Should We Stop Glucagon-Like Peptide-1 Receptor Agonists Before Surgical or Endoscopic Procedures? Balancing Limited Evidence With Clinical Judgment.

The American Society of Anesthesiologists (ASA) Task Force recently recommended discontinuing glucagon-like peptide-1 receptor agonist (GLP-1 RA) agents before surgery because of the potential risk of pulmonary aspiration. However, there is limited scientific evidence to support this recommendation, and holding GLP-1 RA treatment may worsen glycemic control in patients with diabetes. As we await further safety data to manage GLP-1 RA in the perioperative period, we suggest an alternative multidisciplinary approach to manage patients undergoing elective surgery. Well-conducted observational and prospective studies are needed to determine the risk of pulmonary aspiration in persons receiving GLP-1 RA for the treatment of diabetes and obesity, as well as the short-term impact of discontinuing GLP-1 RA on glycemic control before elective procedures in persons with diabetes.

Compliance with eye and foot preventive care in people with self-reported diabetes in Latin America and the Caribbean: Pooled, cross-sectional analysis of nine national surveys.

AIMS: To estimate the proportion of people with self-reported diabetes receiving eye and foot examinations in Latin America and the Caribbean (LAC). METHODS: Cross-sectional analysis of national health surveys in nine countries. Adults aged 25-64 years with self-reported diabetes. We quantified the proportion who reported having an eye examination in the last two years or a foot examination in the last year. We fitted multilevel Poisson regressions to assess socio-demographic (age and sex) and clinical (oral hypoglycemic medication and insulin treatment) variables associated with having had examinations. RESULTS: There were 7435 people with self-reported diabetes included in the analysis. In three countries (Chile [64%; 95% CI: 56%-71%], British Virgin Islands [58%; 95% CI: 51%-65%], and Brazil [54%; 95% CI: 50%-58%]), >50% of people with diabetes reported having had an eye examination in the last two years. Fewer participants (<50% across all countries) reported having had a foot examination in the last year, with Ecuador having the lowest proportion (12%; 95% CI: 8%-17%). Older people, and those taking oral medication or insulin, were more likely to have eye/foot examinations. CONCLUSIONS: The proportion of eye and foot examinations in people with self-reported diabetes across nine countries in LAC is low.

Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility Trial.

Introduction: Multiple daily injection insulin therapy frequently fails to meet hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery (AID) with remote glucose monitoring offers a solution to these shortcomings. Research Design and Methods: In a single-arm multicenter pilot trial, we tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized patients with insulin-requiring diabetes on nonintensive care unit medical-surgical units. Primary endpoints included the proportion of time in automated mode and percent time-in-range (TIR 70-180 mg/dL) among participants with >48 h of CGM data. Safety endpoints included incidence of severe hypoglycemia and diabetes-related ketoacidosis (DKA). Additional glycemic endpoints, CGM accuracy, and patient satisfaction were also explored. Results: Twenty-two participants were enrolled; 18 used the system for a total of 96 days (mean 5.3 ± 3.1 days per patient), and 16 had sufficient CGM data required for analysis. Median percent time in automated mode was 95% (interquartile range 92%-98%) for the 18 system users, and the 16 participants with >48 h of CGM data achieved an overall TIR of 68% ± 16%, with 0.17% ± 0.3% time <70 mg/dL and 0.06% ± 0.2% time <54 mg/dL. Sensor mean glucose was 167 ± 21 mg/dL. There were no DKA or severe hypoglycemic events. All participants reported satisfaction with the system at study end. Conclusions: The use of AID with a disposable tubeless patch-pump along with remote real-time CGM is feasible in the hospital setting. These results warrant further investigation in randomized trials.

A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials.

Diabetes Technology Society organized an expert consensus panel to develop metrics for research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts met virtually in small groups both before and after an April 13, 2023 virtual meeting of the entire panel. The goal of the panel was to develop consensus definitions in anticipation of greater use of CGMs in hospital settings in the future. Establishment of consensus definitions of inpatient analytical metrics will be easier to compare outcomes between studies. Panelists defined terms related to 10 dimensions of measurements related to the use of CGMs including (1) hospital hypoglycemia, (2) hospital hyperglycemia, (3) hospital time in range, (4) hospital glycemic variability, (5) hospital glycemia risk index, (6) accuracy of CGM devices and reference methods for CGMs in the hospital, (7) meaningful time blocks for hospital glycemic goals, (8) hospital CGM data sufficiency, (9) using CGM data for insulin dosing, and (10) miscellaneous factors. The panelists voted on 51 proposed recommendations. Based on the panel vote, 51 recommendations were classified as either strong (43) or mild (8). Additional research is needed on CGM performance in the hospital. This consensus report is intended to support that type of research intended to improve outcomes for hospitalized people with diabetes.

Diabetes Research and Resource Sharing During the COVID-19 Pandemic: A Systematic Review and Experience from an Academic/Non-Profit Resource Website.

BACKGROUND: The magnitude of the response of the diabetes professional community to the COVID-19 pandemic is not known. We aimed to examine diabetes technology research trends and resources offered by professional organizations during this period. METHODS: We explored patterns of the response from the professional diabetes community to the pandemic by (1) systematically searching for articles related to diabetes, COVID-19, and diabetes technologies; (2) examining publication trends of research protocols (clinicaltrials.gov) and preprints (medRxiv); and (3) reviewing online resources from professional organizations including our website (COVIDinDiabetes.org; an Emory University-Diabetes Technology Society collaboration). RESULTS: We identified 492 articles published between December 2019 and December 2022 meeting our inclusion criteria. Telemedicine and continuous glucose monitoring were the most common reported technologies from most parts of the world. The largest number of preprint articles was published in 2020, with a decline in 2021 and 2022. The number of research protocols related to COVID-19 was the highest in 2020 and declined in 2021 and 2022. Resources from organizations included protocols adapted to treat patients with diabetes and COVID-19, training programs, emergency preparedness, and literature on diabetes and COVID-19. On our website (COVIDinDiabetes.org), there were 12 236 visits and 18 149 pageviews, with 1.6 actions per visits, with most visits coming from North America (N = 7233, 54.2%), South America (N = 2663, 21.8%), and Europe (N = 1219). CONCLUSIONS: We conclude that the COVID-19 pandemic promoted unprecedented global research productivity related to diabetes and COVID-19 and that the transition to the use of technology resources has been evident during this period.

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.

Performance of PROMIS Measures to Assess Fatigue and Sleep Symptom Severity Among African American Patients Newly Diagnosed With Obstructive Sleep Apnea.

This pilot study examined the concurrent validity of Patient-Reported Outcomes Measurement Information System (PROMIS), Short Form, measures with the longer Multidimensional Fatigue Inventory among patients living with obstructive sleep apnea (OSA). A total of 26 African American patients living with prediabetes and newly diagnosed with OSA completed the six-item short form versions of PROMIS Fatigue and PROMIS Sleep Disturbance, and the longer 20-item Multidimensional Fatigue Inventory. Both PROMIS Fatigue and Sleep Disturbance scales demonstrated high reliability with Cronbach's α of .91 and .92, respectively. PROMIS Fatigue scores were significantly correlated with Multidimensional Fatigue Inventory scores (rs = .53; p = .006) and demonstrated concurrent validity. However, PROMIS Sleep Disturbance scores and Multidimensional Fatigue Inventory scores were not associated with one another. The brief PROMIS Fatigue scale is a useful, succinct approach to assess fatigue severity among diverse patient populations living with OSA. This study is among the first to evaluate the performance of PROMIS Fatigue in a sample living with OSA.

Continuous Glucose Monitoring in the Intensive Care Unit.

Traditionally, the care of critically ill patients with diabetes or stress hyperglycemia in the intensive care unit (ICU) demands the use of continuous intravenous insulin (CII) therapy to achieve narrow glycemic targets. To reduce the risk of iatrogenic hypoglycemia and to achieve glycemic targets during CII, healthcare providers (HCP) rely on hourly point-of-care (POC) arterial or capillary glucose tests obtained with glucose monitors. The burden of this approach, however, was evident during the beginning of the pandemic when the immediate reduction in close contact interactions between HCP and patients with COVID-19 was necessary to avoid potentially life-threatening exposures. Taking advantage of the advancements in current diabetes technologies, including continuous glucose monitoring (CGM) devices integrated with digital health tools for remote monitoring, HCP implemented novel protocols in the ICU to care for patients with COVID-19 and hyperglycemia. We provide an overview of research conducted in the ICU setting with the use of initial CGM technology to current devices and summarize our recent experience in the ICU.

Nursing Perspectives on the Use of Continuous Glucose Monitoring in the Intensive Care Unit.

BACKGROUND: The COVID-19 pandemic necessitated rapid implementation of continuous glucose monitoring (CGM) in the intensive care unit (ICU). Although rarely reported, perceptions from nursing staff who used the systems are critical for successful implementation and future expanded use of CGM in the inpatient setting. METHODS: A 22-item survey focused on CGM use was distributed to ICU nurses at two large academic medical centers in the United States in 2022. Both institutions initiated inpatient CGM in the spring of 2020 using the same CGM+point of care (POC) hybrid protocol. The survey employed a 1- to 5-point Likert scale regarding CGM sensor insertion, accuracy, acceptability, usability, training, and perceptions on workload. RESULTS: Of the 71 surveys completed, 68 (96%) nurses reported they cared for an ICU patient on CGM and 53% reported they had independently performed CGM sensor insertion. The ICU nurses overwhelmingly reported that CGM was accurate, reduced their workload, provided safer patient care, and was preferred over POC glucose testing alone. Interestingly, nearly half of nurses (49%) reported that they considered trend arrows in dosing decisions although trends were not included in the CGM+POC hybrid protocol. Nurses received training through multiple modalities, with the majority (80%) of nurses reporting that CGM training was sufficient and prepared them for its use. CONCLUSION: These results confirm nursing acceptance and preference for CGM use within a hybrid glucose monitoring protocol in the ICU setting. These data lay a blueprint for successful implementation and training strategies for future widespread use.

Phase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine 6 months later, in at-risk adults 18-49 years of age (PNEU-DAY): A subgroup analysis by baseline risk factors.

Immunocompetent adults with certain medical and behavioral factors are at increased risk of pneumococcal disease. In some countries, sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults. This subgroup analysis from a phase 3 study evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults 18-49 years of age with pre-defined risk factors for pneumococcal disease. Safety and immunogenicity post-vaccination were analyzed by type and baseline number of risk factors for pneumococcal disease (1 and ≥2 risk factors). This analysis included 1,131 participants randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. The majority (73.1%) of participants had at least one risk factor. Safety and tolerability profiles of V114 and PCV13 were similar across risk factor groups. V114 administered either alone or sequentially with PPSV23 6 months later was immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of the number of baseline risk factors. V114 has the potential to broaden serotype coverage for at-risk adults.

Characteristics and Outcomes of Black and White Patients Hospitalized With Nonalcoholic Steatohepatitis: A Nationwide Analysis.

BACKGROUND: Nonalcoholic steatohepatitis (NASH) is an increasingly common etiology for liver-related hospitalizations in the United States. The aim of this study was to examine the differences of disease characteristics and outcomes between hospitalized Black and White patients with NASH. MATERIALS AND METHODS: We used the National Inpatient Sample (NIS) to identify all adult hospitalizations with NASH (ICD-10 code: K75.81) from 2016 to 2018. We compared demographic and clinical characteristics between Black and White patients. Multivariable models were computed to compare all-cause mortality, length of stay (LOS), and total hospital costs between the groups. RESULTS: There were 43,409 hospitalizations with NASH (41,143 White, 2266 Black). Black patients were less likely to have cirrhosis (33.6%) compared with Whites (56.4%), P <0.0001. Black patients were less likely to have esophageal variceal bleeding (1.2% vs. 3.5%), ascites (17.1% vs. 28.8%), and acute liver failure (16.2% vs. 28.9%) compared with Whites (all P <0.0001). These findings were consistent among patients with cirrhosis. Mortality was higher among Blacks compared with Whites (3.9% vs. 3.7%, adjusted odds ratio=1.34; 95% confidence interval: 1.05-1.71, P =0.018). Compared with Whites, Blacks had a longer LOS (6.3 vs. 5.6, P <0.001), and higher hospital costs ($18,602 vs. $17,467; P =0.03). CONCLUSION: In this large population of inpatients with NASH, Black patients were less likely to have cirrhosis and liver disease-related complications, but had overall worse hospital mortality, longer LOS, and higher hospital costs. Further research is warranted to elaborate on factors that generate the health inequities in NASH outcomes between Black and White patients.

Interventions associated with brown adipose tissue activation and the impact on energy expenditure and weight loss: A systematic review.

Background: Brown adipose tissue (BAT) plays a role in modulating energy expenditure. People with obesity have been shown to have reduced activation of BAT. Agents such as ß-agonists, capsinoids, thyroid hormone, sildenafil, caffeine, or cold exposure may lead to activation of BAT in humans, potentially modulating metabolism to promote weight loss. Methods: We systematically searched electronic databases for clinical trials testing the effect of these agents and cold exposure on energy expenditure/thermogenesis and the extent to which they may impact weight loss in adults. Results: A total of 695 studies from PubMed, Web of Science, and Medline electronic databases were identified. After the removal of duplicates and further evaluation, 47 clinical trials were analyzed. We observed significant heterogeneity in the duration of interventions and the metrics utilized to estimate thermogenesis/energy expenditure. Changes observed in energy expenditure do not correlate with major weight changes with different interventions commonly known to stimulate thermogenesis. Even though cold exposure appears to consistently activate BAT and induce thermogenesis, studies are small, and it appears to be an unlikely sustainable therapy to combat obesity. Most studies were small and potential risks associated with known side effects of some agents such as ß-agonists (tachycardia), sibutramine (hypertension, tachycardia), thyroid hormone (arrhythmias) cannot be fully evaluated from these small trials. Conclusion: Though the impact of BAT activation and associated increases in energy expenditure on clinically meaningful weight loss is a topic of great interest, further data is needed to determine long-term feasibility and efficacy.

Treatment persistence and adherence in people with type 2 diabetes switching to iGlarLixi vs free-dose combinations of basal insulin and glucagon-like peptide 1 receptor agonist.

BACKGROUND: Fixed-ratio combinations of basal insulin (BI) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have greater simplicity of administration with expected improved adherence/persistence with therapy, but real-world data are lacking. OBJECTIVE: To compare medication persistence, adherence, and health care resource utilization (HRU) and costs for insulin glargine 100 U/mL and the GLP-1 RA lixisenatide (iGlarLixi) with newly initiated free-dose combinations of BI and GLP-1 RAs initiated simultaneously or sequentially. METHODS: This analysis used the US Optum Clinformatics (January 2017 to November 2019) database and included data from adults (aged ≥ 18 years) with type 2 diabetes and a glycated hemoglobin A1c (A1c) of 8% or more. Participants received iGlarLixi or free-dose combinations of BI and GLP-1 RAs prescribed simultaneously or subsequently. Participants were followed for 12 months. Cohorts were propensity score matched on baseline characteristics. The primary outcome was persistence (days on treatment without discontinuation). Secondary outcomes were adherence (proportion of days covered), change in A1c, and all-cause and diabetes-related health care resource utilization and costs. Subgroup analyses were performed for individuals with A1c levels of 9% or more. RESULTS: After propensity score matching, there were 1,357 patients in each group; groups were well balanced. In the free-dose combination group, 65.6% started on BI, then added GLP-1 RAs; 28.5% started on GLP-1 RAs, then added BI; and 5.9% started on GLP-1 RAs and BI on the same day. In the subgroup with a baseline of A1c levels of 9% or more, 952 (iGlarLixi) and 932 (free-dose combination) participants were included. A significantly higher proportion of participants in the overall population who received iGlarLixi vs free-dose combinations were persistent (44.8% vs 36.3% [hazard ratio = 1.22, 95% CI = 1.11-1.35, P < 0.001]; the median [Q1, Q3] number of persistent days was 150 [63, 360] vs 120 [60, 310]) and adherent to therapy (41.3% vs 18.7%, [odds ratio = 3.06, 95% CI = 2.57-3.65; P < 0.001]). Results for persistence in the subpopulation of participants with HbA1c levels of 9% or more were similar. Reductions in A1c from baseline were similar between iGlarLixi and the free-dose combination group (overall population: -1.2% vs -1.3%; P = 0.1913), but the number of participants in the database with follow-up A1c data was low. All-cause and diabetes-related pharmacy visits and total medication and diabetes medication pharmacy claims costs were significantly lower (all P < 0.001) for those receiving iGlarLixi vs free-dose combinations in both populations. CONCLUSIONS: In adults with type 2 diabetes, iGlarLixi was associated with longer persistence by approximately 30 days, improved adherence, and reductions in outpatient and pharmacy visits and in pharmacy costs. DISCLOSURES: This study was funded by Sanofi US. Medical writing support was provided by Barrie Anthony, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Edelman has been on an advisory board and speakers' bureau for AstraZeneca, MannKind, and Xeris and on an advisory board for BrightSight and is a board member for Senseonics and Team-Type1. Mr Cassarino is on the speakers' bureau for Sanofi. Dr Kayne has been a consultant and speakers' bureau member for AstraZeneca, Bayer, Dexcom, Eli Lilly & Company, Janssen, MannKind, Novo Nordisk, and Sanofi. Dr Dex and Mr Li are employees of Sanofi. Dr Pasquel has received unrestricted research support from Dexcom, Insulet, and Merck and has been a consultant for Medscape, AI Health, Boehringer Ingelheim, and Dexcom.