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Objective-To determine which measuresdimpaired fasting glucose (IFG), elevated HbA1c, or bothdbest predict incident diabetes in older adults. RESEARCH DESIGN ANDMETHODSdFrom the Health, Aging, and Body Composition study, we selected individuals without dia

Objective: To compare the risk of hospitalization for infection among patients who achieve intensive versus relaxed glycemic control., Research Design and Methods: This retrospective cohort study included adults age ≥65 years with type 2 diabetes from an integrated health care delivery system. Negative binomial models were used to estimate incidence rates and relative risk (RR) of hospitalization for infections (respiratory; genitourinary; skin, soft tissue, and bone; and sepsis), comparing two levels of relaxed (hemoglobin A1c [HbA1c] 7% to <8% and 8% to <9%) with intensive (HbA1c 6% to <7%) glycemic control from 1 January 2019 to 1 March 2020., Results: Among 103,242 older patients (48.5% with HbA1c 6% to <7%, 35.3% with HbA1c 7% to <8%, and 16.1% with HbA1c 8% to <9%), the rate of hospitalization for infections was 51.3 per 1,000 person-years. Compared with HbA1c 6% to <7%, unadjusted risk of hospitalization for infections was significantly elevated among patients with HbA1c 8% to <9% (RR 1.25; 95% CI 1.13, 1.39) but not among patients with HbA1c 7% to <8% (RR 0.99; 95% CI 0.91, 1.08), and the difference became nonsignificant after adjustment. Across categories of infections, the adjusted RR of hospitalization was significantly higher among patients with HbA1c 8% to <9% only for skin, soft tissue, and bone infection (RR 1.33; 95% CI 1.05, 1.69)., Conclusions: Older patients with type 2 diabetes who achieve relaxed glycemic control levels endorsed by clinical guidelines are not at significantly increased risk of hospitalization for most infections, but HbA1c 8% to <9% is associated with an increased risk of hospitalization for skin, soft tissue, and bone infections., (© 2024 by the American Diabetes Association.)

Background: Severe hypoglycemia is a serious adverse drug event associated with hypoglycemia-prone medications; older patients with diabetes are particularly at high risk. Economic food insecurity (food insecurity due to financial limitations) is a known risk factor for hypoglycemia; however, less is known about physical food insecurity (due to difficulty cooking or shopping for food), which may increase with age, and its association with hypoglycemia., Objective: Study associations between food insecurity and severe hypoglycemia., Design: Survey based cross-sectional study., Participants: Survey responses were collected in 2019 from 1,164 older (≥ 65 years) patients with type 2 diabetes treated with insulin or sulfonylureas., Main Measures: Risk ratios (RR) for economic and physical food insecurity associated with self-reported severe hypoglycemia (low blood glucose requiring assistance) adjusted for age, financial strain, HbA1c, Charlson comorbidity score and frailty. Self-reported reasons for hypoglycemia endorsed by respondents., Key Results: Food insecurity was reported by 12.3% of the respondents; of whom 38.4% reported economic food insecurity only, 21.1% physical food insecurity only and 40.5% both. Economic food insecurity and physical food insecurity were strongly associated with severe hypoglycemia (RR = 4.3; p = 0.02 and RR = 4.4; p = 0.002, respectively). Missed meals ("skipped meals, not eating enough or waiting too long to eat") was the dominant reason (77.5%) given for hypoglycemia., Conclusions: Hypoglycemia prevention efforts among older patients with diabetes using hypoglycemia-prone medications should address food insecurity. Standard food insecurity questions, which are used to identify economic food insecurity, will fail to identify patients who have physical food insecurity only., (© 2024. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Introduction and Objective: Continuous glucose monitoring (CGM) can improve glycemic control in people with diabetes on insulin therapy. We assessed rates of prescriptions for CGM in a national sample of Veterans across subgroups defined by race and ethnicity. Methods: This cross-sectional analysis of data from the U.S. Veterans Health Administration included adults with type 1 or type 2 diabetes on insulin therapy. Main exposures included self-reported race and ethnicity, and primary outcome was the percentage of patients with at least one CGM prescription between January 1, 2020, and December 31, 2021. Association of race and ethnicity categories with CGM prescription was examined using multilevel, multivariable mixed-effects models. Results: Among 368,794 patients on insulin (mean age, 68.5 years; 96% male; 96.8% type 2 diabetes; 0.8% American Indian or Alaska Native, 0.7% Asian, 18.9% Black or African American, 0.9% Native Hawaiian or other Pacific Islander, 70.2% White, 2.8% multiracial, 5.7% with unknown race, and 7.0% Hispanic or Latino ethnicity), 11.2% were prescribed CGM. CGM was prescribed for 10.4% American Indian or Alaska Native, 9.7% Asian, 9.2% Black or African American, 9.3% Native Hawaiian or other Pacific Islander, 11.8% White, 11.8% multiracial, and 10.1% patients with unknown race. CGM was prescribed for 8.3% Hispanic or Latino, 11.4% non-Hispanic, and 11.5% of patients with unknown ethnicity. After accounting for patient-, clinical-, and system-level factors, Black or African American patients had significantly lower odds of CGM prescription compared with White patients (adjusted odds ratio [aOR] 0.62, 95% confidence interval [CI] 0.59-0.64), whereas Hispanic or Latino patients had significantly lower odds compared with non-Hispanic patients (aOR 0.79, 95% CI 0.74-0.84). Findings were consistent across subgroups with clinical indications for CGM use. Conclusions: Among Veterans with diabetes on insulin therapy, there were significant disparities in prescribing of CGM technology by race and ethnicity, which require further study and intervention.

Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., "product hopping") and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California's CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care., (© 2024 by the American Diabetes Association.)

Background: Rental assistance programs have been linked to better housing quality, stability, healthcare access, and reduced likelihood of uncontrolled diabetes. However, its direct association with diabetes screening is uncertain., Objective: To determine whether federal rental assistance programs are associated with lower odds of undiagnosed diabetes., Design: We used a quasi-experimental approach, comparing outcomes among adults receiving rental assistance to those who entered assisted housing within 2 years after their health data were collected. We test the a priori hypothesis that rental assistance will be associated with decreased odds of undiagnosed diabetes., Participants: Participants in the National Health and Nutrition Examination Survey 1999-2018 who received rental assistance and who had diabetes., Intervention: Current rental assistance participation, including specific housing programs., Main Measures: Undiagnosed diabetes based on having hemoglobin A1c ≥ 6.5% but answering no to the survey question of being diagnosed with diabetes., Key Results: Among 435 eligible adults (median age 54.5 years, female 68.5%, non-Hispanic white 32.5%), 80.7% were receiving rental assistance programs at the time of the interview, and 19.3% went on to receive rental assistance within 2 years. The rates of undiagnosed diabetes were 15.0% and 25.3% among those receiving rental assistance programs vs. those in the future assistance group (p-value = 0.07). In an adjusted logistic regression model, adults receiving rental assistance had lower odds of undiagnosed diabetes (OR 0.52, 95% CI 0.28-0.94) than those in future assistance groups. Sex, race and ethnic group, educational level, and poverty ratio were not significantly associated with having undiagnosed diabetes, but individuals aged 45-64 years had significantly lower odds of undiagnosed diabetes (OR 0.21, 95% CI 0.08-0.53) compared with those aged 18-44., Conclusions: Rental assistance was linked to lower odds of undiagnosed diabetes, suggesting that affordable housing programs can aid in early recognition and diagnosis, which may improve long-term outcomes., (© 2024. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: To examine the willingness of older patients to take less diabetes medication (de-intensify) and to identify characteristics associated with willingness to de-intensify treatment., Methods: Survey conducted in 2019 in an age-stratified, random sample of older (65-100 years) adults with diabetes on glucose-lowering medications in the Kaiser Permanente Northern California Diabetes Registry. We classified survey responses to the question: "I would be willing to take less medication for my diabetes" as willing, neutral, or unwilling to de-intensify. Willingness to de-intensify treatment was examined by several clinical characteristics, including American Diabetes Association (ADA) health status categories used for individualizing glycemic targets. Analyses were weighted to account for over-sampling of older individuals., Results: A total of 1337 older adults on glucose-lowering medication(s) were included (age 74.2 ± 6.0 years, 44% female, 54.4% non-Hispanic white). The proportions of participants willing, neutral, or unwilling to take less medication were 51.2%, 27.3%, and 21.5%, respectively. Proportions of willing to take less medication varied by age (65-74 years: 54.2% vs. 85+ years: 38.5%) and duration of diabetes (0-4 years: 61.0% vs. 15+ years: 44.2%), both p < 0.001. Patients on 1-2 medications were more willing to take less medication(s) compared with patients on 10+ medications (62.1% vs. 46.6%, p = 0.03). Similar proportions of willingness to take less medications were seen across ADA health status, and HbA1c. Willingness to take less medication(s) was similar across survey responses to questions about patient-clinician relationships., Conclusions: Clinical guidelines suggest considering treatment de-intensification in older patients with longer duration of diabetes, yet patients with these characteristics are less likely to be willing to take less medication(s)., (© 2024 The American Geriatrics Society.)

This article reports on a study to assess the feasibility of research procedures and acceptability of QBSAFE, a set of conversation cards focused on quality of life, treatment burden, safety, and avoidance of future events in people with type 2 diabetes. The study enrolled 84 patients and 7 clinicians. Of the 58 patients who completed questionnaires, 64% agreed that the QBSAFE agenda-setting kit (ASK) helped them discuss their situation, 78% agreed that others could benefit from it, and 38% said they would use it again. Most clinicians felt confident responding to issues (in 89% of encounters) and said they would use the kit again (78%) and recommend it to colleagues (82%). The QBSAFE ASK can be feasibly implemented and holds promise in facilitating discussion and collaborative problem-solving., Competing Interests: No potential conflicts of interest relevant to this article were reported., (©2024 by the American Diabetes Association.)

Background: For older adults with type 2 diabetes (T2D) treated with insulin or sulfonylureas, Endocrine Society guideline recommends HbA1c between 7% to <7.5% for those in good health, 7.5% to <8% for those in intermediate health, and 8% to <8.5% for those in poor health. Our aim was to examine associations between attained HbA1c below, within (reference), or above recommended target range and risk of complication or mortality., Methods: Retrospective cohort study of adults ≥65 years old with T2D treated with insulin or sulfonylureas from an integrated healthcare delivery system. Cox proportional hazards models of complications during 2019 were adjusted for sociodemographic and clinical variables. Primary outcome was a combined outcome of any microvascular or macrovascular event, severe hypoglycemia, or mortality during 12-month follow-up., Results: Among 63,429 patients (mean age: 74.2 years, 46.8% women), 8773 (13.8%) experienced a complication. Complication risk was significantly elevated for patients in good health (n = 16,895) whose HbA1c was above (HR 1.97, 95% CI 1.62-2.41) or below (HR 1.29, 95% CI 1.02-1.63) compared to within recommended range. Among those in intermediate health (n = 30,129), complication risk was increased for those whose HbA1c was above (HR 1.45, 95% CI 1.30-1.60) but not those below the recommended range (HR 0.99, 95% CI 0.89-1.09). Among those in poor health (n = 16,405), complication risk was not significantly different for those whose HbA1c was below (HR 0.98, 95% CI 0.89-1.09) or above (HR 0.96, 95% CI 0.88-1.06) recommended range., Conclusions: For older adults with T2D in good health, HbA1c below or above the recommended range was associated with significantly elevated complication risk. However, for those in poor health, achieving specific HbA1c levels may not be helpful in reducing the risk of complications., (© 2023 The American Geriatrics Society.)

Objective: To estimate rates of severe hypoglycemia and falls among older adults with diabetes and evaluate their association., Research Design and Methods: Survey in an age-stratified, random sample adults with diabetes age 65-100 years; respondents were asked about severe hypoglycemia (requiring assistance) and falls in the past 12 months. Prevalence ratios (adjusted for age, sex, race/ethnicity) estimated the increased risk of falls associated with severe hypoglycemia., Results: Among 2,158 survey respondents, 79 (3.7%) reported severe hypoglycemia, of whom 68 (86.1%) had no ED visit or hospitalization for hypoglycemia. Falls were reported by 847 (39.2%), of whom 745 (88.0%) had no fall documented in outpatient or inpatient records. Severe hypoglycemia was associated with a 70% greater prevalence of falls (adjusted prevalence ratio = 1.7 (95% CI, 1.3-2.2))., Conclusion: While clinical documentation of events likely reflects severity or care-seeking behavior, severe hypoglycemia and falls are common, under-reported life-threatening events., Competing Interests: Conflicts of interest The authors have no conflicts of interest.

Background: Estimated life expectancy for older patients with diabetes informs decisions about treatment goals, cancer screening, long-term and advanced care, and inclusion in clinical trials. Easily implementable, evidence-based, diabetes-specific approaches for identifying patients with limited life expectancy are needed., Objective: Develop and validate an electronic health record (EHR)-based tool to identify older adults with diabetes who have limited life expectancy., Design: Predictive modeling based on survival analysis using Cox-Gompertz models in a retrospective cohort., Participants: Adults with diabetes aged ≥ 65 years from Kaiser Permanente Northern California: a 2015 cohort (N = 121,396) with follow-up through 12/31/2019, randomly split into training (N = 97,085) and test (N = 24,311) sets. Validation was conducted in the test set and two temporally distinct cohorts: a 2010 cohort (n = 89,563; 10-year follow-up through 2019) and a 2019 cohort (n = 152,357; 2-year follow-up through 2020)., Main Measures: Demographics, diagnoses, utilization and procedures, medications, behaviors and vital signs; mortality., Key Results: In the training set (mean age 75 years; 49% women; 48% racial and ethnic minorities), 23% died during 5 years follow-up. A mortality prediction model was developed using 94 candidate variables, distilled into a life expectancy model with 11 input variables, and transformed into a risk-scoring tool, the Life Expectancy Estimator for Older Adults with Diabetes (LEAD). LEAD discriminated well in the test set (C-statistic = 0.78), 2010 cohort (C-statistic = 0.74), and 2019 cohort (C-statistic = 0.81); comparisons of observed and predicted survival curves indicated good calibration., Conclusions: LEAD estimates life expectancy in older adults with diabetes based on only 11 patient characteristics widely available in most EHRs and claims data. LEAD is simple and has potential application for shared decision-making, clinical trial inclusion, and resource allocation., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: We set out to identify empirically-derived health status classes of older adults with diabetes based on clusters of comorbid conditions which are associated with future complications., Methods: We conducted a cohort study among 105,786 older (≥65 years of age) adults with type 2 diabetes enrolled in an integrated healthcare delivery system. We used latent class analysis of 19 baseline comorbidities to derive health status classes and then compared incident complication rates (events per 100 person-years) by health status class during 5 years of follow-up. Complications included infections, hyperglycemic events, hypoglycemic events, microvascular events, cardiovascular events, and all-cause mortality., Results: Three health status classes were identified: Class 1 (58% of the cohort) had the lowest prevalence of most baseline comorbidities, Class 2 (22%) had the highest prevalence of obesity, arthritis, and depression, and Class 3 (20%) had the highest prevalence of cardiovascular conditions. The risk for incident complications was highest for Class 3, intermediate for Class 2 and lowest for Class 1. For example, the age, sex and race-adjusted rates for cardiovascular events (per 100 person-years) for Class 3, Class 2 and Class 1 were 6.5, 2.3, and 1.6, respectively; 2.1, 1.2, 0.7 for hypoglycemia; and 8.0, 3.8, and 2.3 for mortality., Conclusions: Three health status classes of older adults with diabetes were identified based on prevalent comorbidities and were associated with marked differences in risk of complications. These health status classes can inform population health management and guide the individualization of diabetes care., (© 2023 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society.)

The U.S. is experiencing a severe housing affordability crisis, resulting in households having to make difficult trade-offs between paying for a place to live and basic health necessities such as food. Rental assistance may mitigate these strains, improving food security and nutrition. However, only one in five eligible individuals receive assistance, with an average wait time of two years. Existing waitlists create a comparable control group, allowing us to examine the causal impact of improved housing access on health and well-being. This national quasi-experimental study utilizes linked NHANES-HUD data (1999-2016) to investigate the impacts of rental assistance on food security and nutrition using cross-sectional regression. Tenants with project-based assistance were less likely to experience food insecurity (B = -0.18, p = 0.02) and rent-assisted individuals consumed 0.23 more cups of daily fruits and vegetables compared the pseudo-waitlist group. These findings suggest that the current unmet need for rental assistance and resulting long waitlists have adverse health implications, including decreased food security and fruit and vegetable consumption., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: W. Denary reported receiving grants from the NIDDK, NIH during the conduct of the study. A. Fenelon reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) during the conduct of the study. S. Whittaker reported receiving grants from the NIMHD and Robert Wood Johnson Foundation Health Policy Research Fellowship during the conduct of the study. D. Esserman reported receiving grants from the NIH during the conduct of the study. K. Lipska reported receiving grants from the NIDDK, NIH during the conduct of the study and receiving grants from the NIH, the Patient-Centered Outcomes Research Institute, and the centers for Medicare & Medicaid Services and personal fees from UpToDate outside the submitted work. D. Keene reported receiving grants from the NIDDK, NIH during the conduct of the study and outside the submitted work. No other disclosures were reported., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Importance: Adjusting quality measures used in pay-for-performance programs for social risk factors remains controversial., Objective: To illustrate a structured, transparent approach to decision-making about adjustment for social risk factors for a measure of clinician quality that assesses acute admissions for patients with multiple chronic conditions (MCCs)., Design, Setting, and Participants: This retrospective cohort study used 2017 and 2018 Medicare administrative claims and enrollment data, 2013 to 2017 American Community Survey data, and 2018 and 2019 Area Health Resource Files. Patients were Medicare fee-for-service beneficiaries 65 years or older with at least 2 of 9 chronic conditions (acute myocardial infarction, Alzheimer disease/dementia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease or asthma, depression, diabetes, heart failure, and stroke/transient ischemic attack). Patients were attributed to clinicians in the Merit-Based Incentive Payment System (MIPS; primary health care professionals or specialists) using a visit-based attribution algorithm. Analyses were conducted between September 30, 2017, and August 30, 2020., Exposures: Social risk factors included low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility., Main Outcomes and Measures: Number of acute unplanned hospital admissions per 100 person-years at risk for admission. Measure scores were calculated for MIPS clinicians with at least 18 patients with MCCs assigned to them., Results: There were 4 659 922 patients with MCCs (mean [SD] age, 79.0 [8.0] years; 42.5% male) assigned to 58 435 MIPS clinicians. The median (IQR) risk-standardized measure score was 38.9 (34.9-43.6) per 100 person-years. Social risk factors of low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility were significantly associated with the risk of hospitalization in the univariate models (relative risk [RR], 1.14 [95% CI, 1.13-1.14], RR, 1.05 [95% CI, 1.04-1.06], and RR, 1.44 [95% CI, 1.43-1.45], respectively), but the association was attenuated in adjusted models (RR, 1.11 [95% CI 1.11-1.12] for dual eligibility). Across MIPS clinicians caring for variable proportions of dual-eligible patients with MCCs (quartile 1, 0%-3.1%; quartile 2, >3.1%-9.5%; quartile 3, >9.5%-24.5%, and quartile 4, >24.5%-100%), median measure scores per quartile were 37.4, 38.6, 40.0, and 39.8 per 100 person-years, respectively. Balancing conceptual considerations, empirical findings, programmatic structure, and stakeholder input, the Centers for Medicare & Medicaid Services decided to adjust the final model for the 2 area-level social risk factors but not dual Medicare-Medicaid eligibility., Conclusions and Relevance: This cohort study demonstrated that adjustment for social risk factors in outcome measures requires weighing high-stake, competing concerns. A structured approach that includes evaluation of conceptual and contextual factors, as well as empirical findings, with active engagement of stakeholders can be used to make decisions about social risk factor adjustment.

Insulin is considered an essential medicine for people with diabetes, but its price has doubled during the past decade, posing substantial financial barriers to patients in the US. In this article we describe out-of-pocket spending on insulin and consider risk factors that could contribute to the likelihood of a person experiencing catastrophic spending, defined as spending more than 40 percent of their postsubsistence family income on insulin alone. Using nationally representative data from the 2017 and 2018 Medical Expenditure Panel Surveys, we examined out-of-pocket spending on insulin among people who filled at least one insulin prescription. Among Americans who use insulin, 14.1 percent reached catastrophic spending over the course of one year, representing almost 1.2 million people. Nearly two-thirds of patients who experienced catastrophic spending on insulin were Medicare beneficiaries. Catastrophic spending was 61 percent less likely among Medicaid beneficiaries than among Medicare beneficiaries, suggesting that factors other than income, such as different types of insurance coverage, may influence catastrophic insulin spending. Policy reform is needed to curb out-of-pocket spending, especially for Medicare beneficiaries and people with low incomes, who appear to be particularly vulnerable to catastrophic spending.

Importance: Programs that provide affordable and stable housing, such as federal rental assistance, may be associated with improved mean blood glucose levels and related diabetes outcomes., Objective: To assess whether 2 different types of federal rental assistance programs are associated with glycated hemoglobin A1c (HbA1c) levels among middle-aged and older US adults., Design, Setting, and Participants: This cohort study used data from the National Health and Nutrition Examination Survey (NHANES) linked with US Department of Housing and Urban Development records of rental assistance participation. Adults aged 45 years or older who were receiving 2 types of rental assistance (project-based housing or housing vouchers) at the time of the NHANES interview and those who would receive rental assistance within the subsequent 2 years (waitlist group) were included. Data were collected from January 1999 to December 2016 and analyzed in October 2021., Exposures: Rental assistance participation, including project-based housing (subsidized housing developments including public housing) and housing vouchers (tenant-based subsidies for private market housing)., Main Outcomes and Measures: The primary outcome was continuous HbA1c level, a common measure of blood glucose reflecting diabetes control. Linear regression was used to estimate the association between the 2 rental assistance programs and HbA1c level. Logistic regression was used to assess the association between rental assistance programs and HbA1c cut points (prediabetes: 5.7% to ≤6.5%; diabetes: >6.5%; uncontrolled diabetes: ≥9% [to convert to proportion of total Hb, multiply by 0.01]). Analyses used weights created by the National Center for Health Statistics that adjust for linkage eligibility., Results: Among 1050 adults in the study (41.6% aged ≥65 years; 70.1% female), 795 were receiving rental assistance at time of the NHANES interview (450 lived in project-based housing, and 345 had housing vouchers), and 255 received rental assistance within 2 years after the interview. Participants in project-based housing had lower HbA1c levels compared with individuals in the waitlist group (β, -0.290; 95% CI, -0.599 to 0.020), but the difference was not significant. No significant differences in HbA1c levels were found between those receiving housing vouchers and those in the waitlist group (β, 0.051; 95% CI, -0.182 to 0.284). Receiving project-based housing was associated with a reduced likelihood of uncontrolled diabetes (-3.7 percentage points; 95% CI, -7.0 to -0.0 percentage points) compared with being in the waitlist group., Conclusions and Relevance: In this cohort study of a nationally representative sample of US adults, living in project-based, federally subsidized housing was associated with a reduced likelihood of uncontrolled diabetes. The findings suggest that affordable housing programs may be associated with improved diabetes outcomes.

Importance: Some practice guidelines warn against generic L-thyroxine preparation switching., Objective: To examine the rates of generic L-thyroxine preparation switching within one year of initiating L-thyroxine, and to examine factors associated with switching., Design and Setting: Retrospective study using national data from a large administrative claims database from January 2008 through November 2018., Patients: Medicare or commercially insured adults (≥18 years) who filled a generic L-thyroxine preparation., Main Outcome Measures: At least one switch from one generic L-thyroxine preparation to another within 1 year of L-thyroxine initiation defined by prescription fills., Results: From January 2008 to November 2018, we included 483,390 patients who initiated generic L-thyroxine: mean (SD) age was 61.4 years (15.2), 75.2% were female, 72.6% were white. Within 1 year of initiating therapy, 98,013 (20%) switched to another L-thyroxine generic preparation at least once. In a multivariate logistic regression analysis, factors associated with switching included the number of pharmacies visited to fill L-thyroxine (>2 vs 1 adjusted OR [aOR] 7.15, 95% confidence interval [CI] 6.97-7.34), age ≥75 vs. <45 years (aOR 1.29, 95% CI 1.26-1.33), history of thyroid surgery (aOR 1.22, 95% CI 1.13-1.31), and first L-thyroxine fill date in 2018 vs. 2008 (aOR 3.32, 95% CI 3.14-3.51)., Conclusions and Relevance: One in five patients switched among generic L-thyroxine manufacturers within one year of treatment initiation. Generic L-thyroxine switching occurred more often when more pharmacies were used to fill L-thyroxine. Given existing guideline recommendations, additional studies should clarify the impact of generic L-thyroxine switching on thyroid hormone values., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Importance: Switching among generic levothyroxine sodium products made by different manufacturers typically occurs at the pharmacy and may affect serum thyrotropin (TSH) levels., Objective: To compare TSH levels between patients who continued taking the same sourced generic levothyroxine product and those who switched., Design, Setting, and Participants: This comparative effectiveness research study with 1:1 propensity matching used data from OptumLabs Data Warehouse, a national administrative claims database linked to laboratory test results. Adults aged 18 years or older were included if they filled a generic levothyroxine prescription between January 1, 2008, and June 30, 2019, and had a stable drug dose, the same drug manufacturer, and a normal TSH level (0.3-4.4 mIU/L) for at least 3 months before either continuing to take the same product or switching among generic levothyroxine products (index date). Patients were excluded if they were pregnant, had diagnosed hypopituitarism or hyperthyroidism, or had a medical condition or used medications that could affect thyrotropin levels. They were also excluded if they filled a prescription for other forms of thyroid replacement therapy between 6 months before the index date and when the first TSH level was obtained 6 weeks to 12 months after the index date. Data were analyzed from December 1, 2019, to November 24, 2021., Main Outcomes and Measures: Proportion of individuals with a normal (0.3-4.4 mIU/L) or markedly abnormal (<0.1 or >10.0 mIU/L) TSH level using the first available laboratory result 6 weeks to 12 months after the index date. A propensity score model was developed to minimize confounding using logistic regression with the binary outcome of continuing the same sourced levothyroxine product vs switching generic levothyroxine. Covariates were demographics, comorbidities, and baseline TSH level. The balance among the treatment groups was evaluated by comparing standardized mean differences of baseline covariates between the groups., Results: A total of 15 829 patients filled generic levothyroxine (mean [SD] age, 58.9 [14.6] years; 73.4% [11 624] were women; 4.5% [705] were Asian, 10.2% [1617] were Black, 11.4% [1801] were Hispanic, and 71.4% [11 295] were White individuals); of these patients, 56.3% [8905] received a daily levothyroxine dose of 50 μg or less. A total of 13 049 patients (82.4%) continued taking the same sourced preparation, and 2780 (17.6%) switched among generic levothyroxine preparations. Among 2780 propensity-matched patient pairs, the proportion of patients with a normal TSH level after the index date was 82.7% (2298) among nonswitchers and 84.5% (2348) among switchers (risk difference, -0.018; 95% CI, -0.038 to 0.002; P = .07). The proportion of patients with a markedly abnormal TSH level after the index date was 3.1% (87) among nonswitchers and 2.5% (69) among switchers (risk difference, 0.007; 95% CI, -0.002 to 0.015; P = .14). The mean (SD) TSH levels after the index date were 2.7 (2.3) mIU/L among nonswitchers and 2.7 (3.3) mIU/L among switchers (P = .94)., Conclusions and Relevance: Results of this comparative effectiveness research study suggest that switching among different generic levothyroxine products was not associated with clinically significant changes in TSH level. These findings conflict with the current guideline recommendation that warns clinicians about potential changes in TSH level associated with switching among levothyroxine products sourced from different manufacturers.

Introduction: Antihyperglycemic agents are significant contributors to adverse drug events, responsible for emergency department visits, hospitalizations, and death. Nationally, the rate of serious hypoglycemic events associated with these agents remains high despite widespread efforts to improve drug safety. Transitions of care between healthcare settings can lead to communication challenges between care professionals and increase the risk of adverse drug events. System-based improvements are needed to assure the safe transitions for patients with diabetes who are on antihyperglycemic agents. The objective of this study was to develop a consensus list of requisite elements that should be communicated between care settings during transitions of patients who are prescribed antihyperglycemic agents., Methods: The Island Peer Review Organization (IPRO) Hypoglycemia Coalition identified suboptimal transitions of care as a barrier to improving patient safety and quality of diabetes care. The Coalition formed a multidisciplinary Task Force with experts in the field of diabetes care. The Task Force created a draft list of requisite communication elements through literature review and deliberation on monthly conference calls. A blinded iterative Delphi process was subsequently performed to generate a consensus list of requisite communication elements that participating experts agreed were necessary to safely and effectively assume the management of patients with diabetes upon care transitions., Results: The Task Force completed a series of four iterative polls from September 2015 to August 2016, resulting in a final list of 22 requisite communication elements (the Diabetes Management Discharge Communication List), with the elements conceptually categorized into three domains: diagnosis and treatment, factors affecting glycemic control or patient risk, and patient self-management., Conclusions: The Diabetes Management Discharge Communication List provides an initial framework for the development of diabetes-specific resources to improve clinical communication between care settings., (© 2022. The Author(s).)

Purpose: To compare cardiovascular outcomes and rates of fractures and falls among patients with persistent brand-name versus generic L-thyroxine use., Methods: Retrospective, 1:1 propensity-matched longitudinal study using a national administrative claims database to examine adults (≥18 years) who initiated either brand or generic L-thyroxine between 2008 and 2018, censored at switch or discontinuation of L-thyroxine formulation or disenrollment from the health plan. Main outcome measures included rates of hospitalization for atrial fibrillation, myocardial infarction, congestive heart failure, stroke, spine and hip fractures, and rate of falls in the outpatient or inpatient setting. Hospitalizations for pneumonia were used as a negative control., Results: 195,046 adults initiated treatment with L-thyroxine between 2008 and 2017: 87% generic and 13% brand formulations. They were mostly women (76%), young (94.6% under age 65), white (66%), and 47% had baseline thyroid stimulating hormone levels between 4.5 and 9.9 mIU/L. Among 35,667 propensity-matched patients, there were no significant differences between patients treated with brand versus generic L-thyroxine in atrial fibrillation (HR 0.96, 0.58-1.60), myocardial infarction (HR 0.66, 0.39-1.14), congestive heart failure (HR 1.30, 0.78-2.16), stroke (0.72, 0.49-1.06), spine (HR 0.87, 0.38-1.99) and hip fractures (HR 0.86, 0.26-2.82), or fall outcomes (HR 1.02, 0.14-7.32). Hospitalization rates for pneumonia (used as negative control) did not differ between groups (HR 0.85, 0.61-1.19). There were no interactions between brand versus generic L-thyroxine, these outcomes, and thyroid cancer, age, or L-thyroxine dose subgroups., Conclusions: We found no significant differences in cardiovascular outcomes and rates of falls and fractures for patients who filled brand versus generic L-thyroxine., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Diabetes care has been traditionally focused on targeting certain levels of glycemic control. This narrow emphasis may impose burdens on patients, including high treatment costs, illness-related work, or side effects from medications, while leaving other patient needs and goals under-addressed. The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future events: the QBSAfe domains., Methods: We describe a single-arm pilot study to assess the feasibility and acceptability of using the QBSAfe agenda setting kit (ASK) during routine clinical visits. The set of 14 conversation aid cards was co-developed with patients, family caregivers, and clinicians. The ASK will be used in the context of a clinic visit, which will be recorded by members of the study team to identify patterns of clinician-patient conversations. Feasibility will be measured by the number of participants recruited, time to goal accrual, and completeness of data collection; acceptability will be assessed using post-visit surveys of patients and clinicians. A subgroup of patients will be invited to participate in post-visit qualitative semi-structured interviews for additional feedback. This study will be conducted across three medical centers in the Midwest and East Coast of the USA., Discussion: Current healthcare infrastructure and associated demands and pressures on clinicians make changes in care difficult. However, this intervention has the potential to shift conversations during clinical encounters so they can address and directly respond to patient needs, symptoms, and capacity. As part of the QBSAfe ASK, the authors are also actively collaborating with a variety of stakeholders to create tools to help clinicians respond more effectively to patient concerns as they are raised during the clinical encounters. Additional insights about the use of the QBSAfe approach in the virtual space will be gathered during the process of our study due to restrictions imposed upon face to face visit during the COVID-19 pandemic., Trial Registration: ClinicalTrials.gov , NCT04514523 . Registered 17 August 2020-retrospectively registered., (© 2021. The Author(s).)

Background: Hospital admissions for severe hypoglycemia are associated with significant healthcare costs, decreased quality of life, and increased morbidity and mortality, especially for older adults with diabetes. Understanding the reasons for hypoglycemia hospitalization is essential for the development of effective interventions; yet, the causes and precipitants of hypoglycemia are not well understood., Methods: We conducted a qualitative study of non-nursing home patients aged 65 years or older without cognitive dysfunction admitted to a single tertiary-referral hospital with diabetes-related hypoglycemia. During the hospitalization, we conducted one-on-one, in-depth, semi-structured interviews to explore: (1) experiences with diabetes management among patients hospitalized for severe hypoglycemia; and (2) factors contributing and leading to the hypoglycemic event. Major themes and sub-themes were extracted using the constant comparative method by 3 study authors., Results: Among the 17 participants interviewed, the mean age was 78.9 years of age, 76.5% were female, 64.7% African American, 64.7% on insulin, and patients had an average of 13 chronic conditions. Patients reported: (1) surprise at hypoglycemia despite living with diabetes for many years; (2) adequate support, knowledge, and preparedness for hypoglycemia; (3) challenges balancing a diet that minimizes hyperglycemia and prevents hypoglycemia; (4) the belief that hyperglycemia necessitates medical intervention, but hypoglycemia does not; and (5) tension between clinician-prescribed treatment plans and self-management based on patients' experience. Notably, participants did not report the previously cited reasons for hypoglycemia, such as food insecurity, lack of support or knowledge, or treatment errors., Conclusions: Our findings suggest that some hypoglycemic events may not be preventable, but in order to reduce the risk of hypoglycemia in older individuals at risk: (1) healthcare systems need to shift from their general emphasis on the avoidance of hyperglycemia towards the prevention of hypoglycemia; and (2) clinicians and patients need to work together to design treatment regimens that fit within patient capacity and are flexible enough to accommodate life's demands.

Objective: To examine prevalence and characteristics of newly diagnosed diabetes (NDD) in younger adults hospitalised with acute myocardial infarction (AMI) and investigate whether NDD is associated with health status and clinical outcomes over 12-month post-AMI., Methods: In individuals (18-55 years) admitted with AMI, without established diabetes, we defined NDD as (1) baseline or 1-month HbA1c≥6.5%; (2) discharge diabetes diagnosis or (3) diabetes medication initiation within 1 month. We compared baseline characteristics of NDD, established diabetes and no diabetes, and their associations with baseline, 1-month and 12-month health status (angina-specific and non-disease specific), mortality and in-hospital complications., Results: Among 3501 patients in Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study, 14.5% met NDD criteria. Among 508 patients with NDD, 35 (6.9%) received discharge diagnosis, 91 (17.9%) received discharge diabetes education and 14 (2.8%) initiated pharmacological treatment within 1 month. NDD was more common in non-White (OR 1.58, 95% CI 1.23 to 2.03), obese (OR 1.72, 95% CI 1.39 to 2.12), financially stressed patients (OR 1.27, 95% CI 1.02 to 1.58). Compared with established diabetes, NDD was independently associated with better disease-specific health status and quality of life (p≤0.04). No significant differences were found in unadjusted in-hospital mortality and complications between NDD and established or no diabetes., Conclusions: NDD was common among adults≤55 years admitted with AMI and was more frequent in non-White, obese, financially stressed individuals. Under 20% of patients with NDD received discharge diagnosis or initiated discharge diabetes education or pharmacological treatment within 1 month post-AMI. NDD was not associated with increased risk of worse short-term health status compared with risk noted for established diabetes., Trial Registration Number: NCT00597922., Competing Interests: Competing interests: HK, ES and KJL work under contract with the Centers for Medicare & Medicaid Services to develop publicly reported quality measures. In the past three years, HK received expenses and/or personal fees from UnitedHealth, IBM Watson Health, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing. He is an owner of Refactor Health and Hugo Health, and had grants and/or contracts from the Centers for Medicare & Medicaid Services, Medtronic, the U.S. Food and Drug Administration, Johnson & Johnson, and the Shenzhen Center for Health Information. HB receives research funding from the Instituto de Salud Carlos III, Spain (PIE16/00021 & PI17/01799), Astra-Zeneca, BMS, Janssen and Novartis; has received consulting fees from Astra-Zeneca, Bayer, BMS-Pfizer, Novartis and speaking fees or support for attending scientific meetings from Astra-Zeneca, Bayer, BMS-Pfizer, Novartis and MEDSCAPE-the heart.org. JAS is supported by grants from Bayer, serves as a consultant for Janssen, Bayer, Novartis, AstraZeneca and holds the copyright for the Seattle Angina Questionnaire with royalties paid. KJL is also supported by the National Institute on Aging and the American Federation of Aging Research through the Paul Beeson Career Development Award (K23AG04835)., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Current diabetes quality measures are agnostic to patient clinical complexity and type of treatment required to achieve it. Our objective was to introduce a patient-centered indicator of appropriate diabetes therapy indicator (ADTI), designed for patients with type 2 diabetes, which is based on hemoglobin A1c (HbA1c) but is also contextualized by patient complexity and treatment intensity., Research Design and Methods: A draft indicator was iteratively refined by a multidisciplinary Delphi panel using existing quality measures, guidelines, and published literature. ADTI performance was then assessed using OptumLabs Data Warehouse data for 2015. Included adults (n=206 279) with type 2 diabetes were categorized as clinically complex based on comorbidities, then categorized as treated appropriately, overtreated, or undertreated based on a matrix of clinical complexity, HbA1c level, and medications used. Associations between ADTI and emergency department/hospital visits for hypoglycemia and hyperglycemia were assessed by calculating event rates for each treatment intensity subset., Results: Overall, 7.4% of patients with type 2 diabetes were overtreated and 21.1% were undertreated. Patients with high complexity were more likely to be overtreated (OR 5.60, 95% CI 5.37 to 5.83) and less likely to be undertreated (OR 0.65, 95% CI 0.62 to 0.68) than patients with low complexity. Overtreated patients had higher rates of hypoglycemia than appropriately treated patients (22.0 vs 6.2 per 1000 people/year), whereas undertreated patients had higher rates of hyperglycemia (8.4 vs 1.9 per 1000 people/year)., Conclusions: The ADTI may facilitate timely, patient-centered treatment intensification/deintensification with the goal of achieving safer evidence-based care., Competing Interests: Competing interests: RGM also receives support from the Mayo Clinic Center for Health Equity and Community Engagement Research. In the past 36 months, KJL also received support from the National Institute on Aging and the American Federation of Aging Research through the Paul Beeson Career Development Award (K23AG048359), the Yale Claude D. Pepper Older Americans Independence Center (P30AG021342), and from CMS to develop and maintain publicly reported quality measures. In the past 36 months, NDS has received research support through Mayo Clinic from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (1U19HS024075; R01HS025164; R01HS025402; R03HS025517); the National Heart, Lung and Blood Institute of the National Institutes of Health (R56HL130496; R01HL131535); the National Science Foundation; and the Patient Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet)., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Whether the use of generic vs brand levothyroxine affects thyrotropin levels remains unclear., Objective: To compare the effectiveness of generic vs brand levothyroxine in achieving and maintaining normal thyrotropin levels among new users., Design, Setting, and Participants: This retrospective, 1:1 propensity score-matched longitudinal cohort study used the OptumLabs Data Warehouse administrative claims database linked to laboratory results from commercially insured and Medicare Advantage enrollees throughout the United States. Eligible patients were adults (aged ≥18 years) with thyrotropin levels ranging from 4.5 to 19.9 mIU/L who initiated use of generic or brand-name levothyroxine from January 1, 2008, to October 1, 2017. Data were analyzed from August 13, 2018, to October 25, 2019., Exposure: Patients received generic or brand-name levothyroxine., Main Outcomes and Measures: Proportion of patients with normal vs markedly abnormal thyrotropin levels (<0.1 or >10 mIU/L) within 3 months and with stable thyrotropin levels within 3 months after the thyrotropin value fell into the normal range., Results: A total of 17 598 patients were included (69.0% female; 74.0% White; mean [SD] age, 55.1 [16.0] years), of whom 15 299 filled generic and 2299 filled brand-name levothyroxine prescriptions during the study period. Among 4570 propensity score-matched patients (mean [SD] age, 50.3 [13.8] years; 3457 [75.6%] female; 3510 [76.8%] White), the proportion with normal thyrotropin levels within 3 months of filling levothyroxine prescriptions was similar for patients who received generic vs brand-name levothyroxine (1722 [75.4%; 95% CI, 71.9%-79.0%] vs 1757 [76.9%; 95% CI, 73.4%-80.6%]; P = .23), as was the proportion with markedly abnormal levels (94 [4.1%; 95% CI, 3.4%-5.0%] vs 88 [3.9%; 95% CI, 3.1%-4.7%]; P = .65). Among 1034 propensity score-matched patients who achieved a normal thyrotropin value within 3 months of initiation of levothyroxine, the proportion maintaining subsequent normal thyrotropin levels during the next 3 months was similar for patients receiving generic vs brand-name levothyroxine (427 [82.6%] vs 433 [83.8%]; P = .62)., Conclusions and Relevance: Initiation of generic vs brand-name levothyroxine formulations was associated with similar rates of normal and stable thyrotropin levels. These results suggest that generic levothyroxine as initial therapy for mild thyroid dysfunction is as effective as brand-name levothyroxine.

Although cardiologists have long treated patients with coronary artery disease (CAD) and concomitant type 2 diabetes mellitus (T2DM), T2DM has traditionally been considered just a comorbidity that affected the development and progression of the disease. Over the past decade, a number of factors have shifted that have forced the cardiology community to reconsider the role of T2DM in CAD. First, in addition to being associated with increased cardiovascular risk, T2DM has the potential to affect a number of treatment choices for CAD. In this document, we discuss the role that T2DM has in the selection of testing for CAD, in medical management (both secondary prevention strategies and treatment of stable angina), and in the selection of revascularization strategy. Second, although glycemic control has been recommended as a part of comprehensive risk factor management in patients with CAD, there is mounting evidence that the mechanism by which glucose is managed can have a substantial impact on cardiovascular outcomes. In this document, we discuss the role of glycemic management (both in intensity of control and choice of medications) in cardiovascular outcomes. It is becoming clear that the cardiologist needs both to consider T2DM in cardiovascular treatment decisions and potentially to help guide the selection of glucose-lowering medications. Our statement provides a comprehensive summary of effective, patient-centered management of CAD in patients with T2DM, with emphasis on the emerging evidence. Given the increasing prevalence of T2DM and the accumulating evidence of the need to consider T2DM in treatment decisions, this knowledge will become ever more important to optimize our patients' cardiovascular outcomes.

Purpose: To examine the proportion of diabetes-focused clinical encounters in primary care and endocrinology practices where the evaluation for hypoglycemia is documented; and when it is, identify clinicians' stated actions in response to patient-reported events., Methods: A total of 470 diabetes-focused encounters among 283 patients nonpregnant adults (≥18 years) with type 1 or type 2 diabetes mellitus in this retrospective cohort study. Participants were randomly identified in blocks of treatment strategy and care location (95 and 52 primary care encounters among hypoglycemia-prone medications (i.e. insulin, sulfonylurea) and others patients, respectively; 94 and 42 endocrinology encounters among hypo-treated and others, respectively). Documentation of hypoglycemia and subsequent management plan in the electronic health record were evaluated., Results: Overall, 132 (46.6%) patients had documentation of hypoglycemia assessment, significantly more prevalent among hypo-treated patients seen in endocrinology than in primary care (72.3% vs. 47.4%; P = 0.001). Hypoglycemia was identified by patient in 38.2% of encounters. Odds of hypoglycemia assessment documentation was highest among the hypo-treated (OR 13.6; 95% CI 5.5-33.74, vs. others) and patients seen in endocrine clinic (OR 4.48; 95% CI 2.3-8.6, vs. primary care). After documentation of hypoglycemia, treatment was modified in 30% primary care and 46% endocrine clinic encounters; P = 0.31. Few patients were referred to diabetes self-management education and support (DSMES)., Conclusions: Continued efforts to improve hypoglycemia evaluation, documentation, and management are needed, particularly in primary care. This includes not only screening at-risk patients for hypoglycemia, but also modifying their treatment regimens and/or leveraging DSMES.

Introduction: Glycemic targets and glucose-lowering regimens should be individualized based on multiple factors, including the presence of comorbidities. We examined contemporary patterns of glycemic control and use of medications known to cause hypoglycemia among adults with diabetes across age and multimorbidity., Research Design and Methods: We retrospectively examined glycosylated hemoglobin (HbA 1c ) levels and rates of insulin/sulfonylurea use as a function of age and multimorbidity using administrative claims and laboratory data for adults with type 2 diabetes included in OptumLabs Data Warehouse, 1 January 2014 to 31 December 2016. Comorbidity burden was assessed by counts of any of 16 comorbidities specified by guidelines as warranting relaxation of HbA 1c targets, classified as being diabetes concordant (diabetes complications or risk factors), discordant (unrelated to diabetes), or advanced (life limiting)., Results: Among 194 157 patients with type 2 diabetes included in the study, 45.2% had only concordant comorbidities, 30.6% concordant and discordant, 2.7% only discordant, and 13.0% had ≥1 advanced comorbidity. Mean HbA 1c was 7.7% among 18-44 year-olds versus 6.9% among ≥75 year-olds, and was higher among patients with comorbidities: 7.3% with concordant only, 7.1% with discordant only, 7.1% with concordant and discordant, and 7.0% with advanced comorbidities compared with 7.4% among patients without comorbidities. The odds of insulin use decreased with age (OR 0.51 (95% CI 0.48 to 0.54) for age ≥75 vs 18-44 years) but increased with accumulation of concordant (OR 5.50 (95% CI 5.22 to 5.79) for ≥3 vs none), discordant (OR 1.72 (95% CI 1.60 to 1.86) for ≥3 vs none), and advanced (OR 1.45 (95% CI 1.25 to 1.68) for ≥2 vs none) comorbidities. Conversely, sulfonylurea use increased with age (OR 1.36 (95% CI 1.29 to 1.44) for age ≥75 vs 18-44 years) but decreased with accumulation of concordant (OR 0.76 (95% CI 0.73 to 0.79) for ≥3 vs none), discordant (OR 0.70 (95% CI 0.64 to 0.76) for ≥3 vs none), but not advanced (OR 0.86 (95% CI 0.74 to 1.01) for ≥2 vs none) comorbidities., Conclusions: The proportion of patients achieving low HbA 1c levels was highest among older and multimorbid patients. Older patients and patients with higher comorbidity burden were more likely to be treated with insulin to achieve these HbA 1c levels despite potential for hypoglycemia and uncertain long-term benefit., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Severe hypoglycemia is a serious and potentially preventable complication of diabetes, with some of the most severe episodes requiring emergency department (ED) care or hospitalization. A variety of health conditions increase the risk of hypoglycemia. People with diabetes often have multiple comorbidities, and the association of such multimorbidity with hypoglycemia risk in the context of other risk factors is uncertain., Objective: To examine the associations of age, cumulative multimorbidity, glycated hemoglobin (HbA1c) level, and use of glucose level-lowering medication with hypoglycemia-related ED visits and hospitalizations., Design, Setting, and Participants: Cohort study of claims and laboratory data from OptumLabs Data Warehouse, an administrative claims database of commercially insured and Medicare Advantage beneficiaries in the United States. Participants were adults (aged ≥18 years) with diabetes who had an available HbA1c level result in 2015. Data from January 1, 2014, to December 31, 2016, were analyzed. Final analyses were conducted from December 2017 to September 2018., Main Outcomes and Measures: This study calculated rates of hypoglycemia-related ED visits and hospitalizations during the year after the index HbA1c level was obtained, stratified by patient demographic characteristics, diabetes type, comorbidities (from 16 guideline-specified high-risk conditions), index HbA1c level, and glucose level-lowering medication use. The association of each variable with hypoglycemia-related ED and hospital care was examined using multivariable Poisson regression analysis overall and by diabetes type., Results: The study cohort was composed of 201 705 adults with diabetes (mean [SD] age, 65.8 [12.1] years; 102 668 [50.9%] women; 118 804 [58.9%] white; mean [SD] index HbA1c level, 7.2% [1.5%]). Overall, there were 9.06 (95% CI, 8.64-9.47) hypoglycemia-related ED visits and hospitalizations per 1000 persons per year. The risk of hypoglycemia-related ED visits and hospitalizations was increased by age 75 years or older (incidence rate ratio [IRR], 1.56 [95% CI, 1.23-2.02] vs 18-44 years), black race/ethnicity (IRR, 1.30 [95% CI, 1.16-1.46] vs white race/ethnicity), lower annual household income (IRR, 0.63 [95% CI, 0.53-0.74] for ≥$100 000 vs <$40 000), number of comorbidities (increasing from IRR of 1.66 [95% CI, 1.42-1.95] in the presence of 2 comorbidities to IRR of 4.12 [95% CI, 3.07-5.51] with ≥8 comorbidities compared with ≤1), prior hypoglycemia-related ED visit or hospitalization (IRR, 6.60 [95% CI, 5.77-7.56]), and glucose level-lowering treatment regimen (IRR, 6.73 [95% CI, 4.93-9.22] for sulfonylurea; 12.53 [95% CI, 8.90-17.64] for basal insulin; and 27.65 [95% CI, 20.32-37.63] for basal plus bolus insulin compared with other medications). Independent of these factors, having type 1 diabetes was associated with a 34% increase in the risk of hypoglycemia-related ED visits or hospitalizations (IRR, 1.34 [95% CI, 1.15-1.55]). The index HbA1c level was associated with hypoglycemia-related ED visits and hospitalizations when both low (IRR, 1.45 [95% CI, 1.12-1.87] for HbA1c level ≤5.6% vs 6.5%-6.9%) and high (IRR, 1.24 [95% CI, 1.02-1.50] for HbA1c level ≥10%)., Conclusions and Relevance: In this cohort study of adults with diabetes, the risk of an ED visit or hospitalization for hypoglycemia appeared to be highest among patients with type 1 diabetes, multiple comorbidities, prior severe hypoglycemia, and sulfonylurea and/or insulin use. At-risk patients may benefit from individualized treatment regimens to decrease their risk of hypoglycemia.

Importance: Among older individuals with type 2 diabetes, those with poor health have greater risk and derive less benefit from tight glycemic control with insulin., Objective: To examine whether insulin treatment is used less frequently and discontinued more often among older individuals with poor health compared with those in good health., Design, Setting, and Participants: This longitudinal cohort study included 21 531 individuals with type 2 diabetes followed for up to 4 years starting at age 75 years. Electronic health record data from the Kaiser Permanente Northern California Diabetes Registry was collected to characterize insulin treatment and glycemic control over time. Data were collected from January 1, 2009, through December 31, 2017, and analyzed from February 2, 2018, through June 30, 2019., Exposures: Health status was defined as good (<2 comorbid conditions or 2 comorbidities but physically active), intermediate (>2 comorbidities or 2 comorbidities and no self-reported weekly exercise), or poor (having end-stage pulmonary, cardiac, or renal disease; diagnosis of dementia; or metastatic cancer)., Main Outcomes and Measures: Insulin use prevalence at age 75 years and discontinuation among insulin users over the next 4 years (or 6 months prior to death if <4 years)., Results: Of 21 531 patients, 10 396 (48.3%) were women, and the mean (SD) age was 75 (0) years. Nearly one-fifth of 75-year-olds (4076 [18.9%]) used insulin. Prevalence and adjusted risk ratios (aRRs) of insulin use at age 75 years were higher in individuals with poor health (29.4%; aRR, 2.03; 95% CI, 1.87-2.20; P < .01) and intermediate health (27.5%; aRR, 1.85; 95% CI, 1.74-1.97; P < .01) relative to good health (10.5% [reference]). One-third (1335 of 4076 [32.7%]) of insulin users at age 75 years discontinued insulin within 4 years of cohort entry (and at least 6 months prior to death). Likelihood of continued insulin use was higher among individuals in poor health (aRR, 1.47; 95% CI, 1.27-1.67; P < .01) and intermediate health (aRR, 1.16; 95% CI, 1.05-1.30; P < .01) compared with good health (reference). These same prevalence and discontinuation patterns were present in the subset with tight glycemic control (hemoglobin A1c <7.0%)., Conclusions and Relevance: In older individuals with type 2 diabetes, insulin use was most prevalent among those in poor health, whereas subsequent insulin discontinuation after age 75 years was most likely in healthier patients. Changes are needed in current practice to better align with guidelines that recommend reducing treatment intensity as health status declines.

Importance: Differences in readmission rates among racial and ethnic minorities have been reported, but data among people with diabetes are lacking despite the high burden of diabetes and its complications in these populations., Objectives: To examine racial/ethnic differences in all-cause readmission among US adults with diabetes and categorize patient- and system-level factors associated with these differences., Design, Setting, and Participants: This retrospective cohort study includes 272 758 adult patients with diabetes, discharged alive from the hospital between January 1, 2009, and December 31, 2014, and stratified by race/ethnicity. An administrative claims data set of commercially insured and Medicare Advantage beneficiaries across the United States was used. Data analysis took place between October 2016 and February 2019., Main Outcomes and Measures: Unplanned all-cause readmission within 30 days of discharge and individual-, clinical-, economic-, index hospitalization-, and hospital-level risk factors for readmission., Results: A total of 467 324 index hospitalizations among 272 758 adults with diabetes (mean [SD] age, 67.7 [12.7]; 143 498 [52.6%] women) were examined. The rates of 30-day all-cause readmission were 10.2% (33 683 of 329 264) among white individuals, 12.2% (11 014 of 89 989) among black individuals, 10.9% (4151 of 38 137) among Hispanic individuals, and 9.9% (980 of 9934) among Asian individuals (P < .001). After adjustment for all factors, only black patients had a higher risk of readmission compared with white patients (odds ratio, 1.05; 95% CI, 1.02-1.08). This increased readmission risk among black patients was sequentially attenuated, but not entirely explained, by other demographic factors, comorbidities, income, reason for index hospitalization, or place of hospitalization. Compared with white patients, both black and Hispanic patients had the highest observed-to-expected (OE) readmission rate ratio when their income was low (annual household income <$40 000 among black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; among Hispanic patients: OE ratio, 1.11; 95% CI, 1.07-1.16) and when they were hospitalized in nonprofit hospitals (black patients: OE ratio, 1.10; 95% CI, 1.08-1.12; among Hispanic patients: OE ratio, 1.08; 95% CI, 1.05-1.12), academic hospitals (black patients: OE ratio, 1.16; 95% CI, 1.13-1.20; Hispanic patients: OE ratio, 1.12; 95% CI, 1.06-1.19), or large hospitals (ie, with ≥400 beds; black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; Hispanic patients: OE ratio, 1.09; 95% CI, 1.04-1.14)., Conclusions and Relevance: In this study, black patients with diabetes had a significantly higher risk of readmission than members of other racial/ethnic groups. This increased risk was most pronounced among lower-income patients hospitalized in nonprofit, academic, or large hospitals. These findings reinforce the importance of identifying and addressing the many reasons for persistent racial/ethnic differences in health care quality and outcomes.

Background Diabetes mellitus increases the risk of mortality after acute myocardial infarction (AMI). However, little is known about the association of diabetes mellitus with post-AMI health status outcomes (symptoms, functioning, and quality of life) in younger adults. Methods and Results We investigated the association between diabetes mellitus and health status during the first 12 months after AMI, using data from 3501 adults with AMI (42.6% with diabetes mellitus) aged 18 to 55 years enrolled in the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study. Health status was measured with Seattle Angina Questionnaire (SAQ), 12-item Short-Form Health Survey, and EuroQol-Visual Analogue Scale at baseline hospitalization, 1-month, and 12-months post-AMI. At baseline, patients with diabetes mellitus had significantly worse SAQ-angina frequency (81±22 versus 86±19), SAQ-physical limitations (77±28 versus 85±23), SAQ-quality of life (55±25 versus 57±23), 12-item Short-Form Health Survey mental (44±13 versus 46±12)/physical functioning (41±12 versus 46±12), and EuroQol-Visual Analogue Scale (61±22 versus 66±21) than those without diabetes mellitus. Over time, both groups (with and without diabetes mellitus) improved considerably and the differences in health status scores progressively narrowed (except for 12-item Short-Form Health Survey physical functioning). In the linear-mixed effects models, adjusted for sociodemographics, cardiovascular risk factors, comorbidities, clinical characteristics, psychosocial factors, healthcare use, and AMI treatment, diabetes mellitus was associated with worse health status at baseline but not after discharge, and the association did not vary by sex. Conclusions At baseline, young adults with diabetes mellitus had poorer health status than those without diabetes mellitus. After AMI, however, they experienced significant improvements and diabetes mellitus was not associated with worse angina, SAQ-physical limitations, mental functioning, and quality of life, after adjustment for baseline covariates. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00597922.

Context: Generic drugs account for 9 out of 10 prescriptions dispensed in the United States but for a lower proportion of commonly prescribed thyroid hormone replacement therapies., Objective: Characterize temporal patterns of generic and brand-name thyroid hormone drug use, including patient and prescriber characteristics associated with brand-name use., Design and Setting: Cross-sectional longitudinal analysis of national data from a large administrative claims database from January 2007 through December 2016., Patients: Adults with insurance coverage through commercial, Medicare Advantage, and Medicare Part D health plans., Main Outcome Measures: Generic and brand-name thyroid hormone drug use., Results: From 2007 to 2016, the annual number of thyroid hormone treatment pharmacy fills increased from 8,905,836 in 2007 to 11,613,923 in 2016, 73.6% of which were for generic levothyroxine, 23.4% for brand-name levothyroxine, and the remaining for other formulations. Dispensing of generic thyroid hormone drugs increased from 59.8% in 2007 to 84.9% in 2016 and was consistently higher among Medicare Advantage and Medicare Part D when compared with the commercial beneficiary population. For all three beneficiary populations, use of brand-name products was less common among older adults and more common among women and those receiving prescriptions from endocrinologists and was more common among those of white race and with greater household income for the Medicare Advantage and commercial beneficiary populations (P < 0.001)., Conclusions: Brand-name thyroid hormone product use declined from 2007 to 2016 among three large, national insurer beneficiary populations. Although certain patient characteristics were associated with brand-name use, prescriber specialty was the strongest predictor., (Copyright © 2019 Endocrine Society.)

Background: A key quality metric for Accountable Care Organizations (ACOs) is the rate of hospitalization among patients with heart failure (HF). Among this patient population, non-HF-related hospitalizations account for a substantial proportion of admissions. Understanding the types of admissions and the distribution of admission types across ACOs of varying performance may provide important insights for lowering admission rates., Methods: We examined admission diagnoses among 220 Medicare Shared Savings Program ACOs in 2013. ACOs were stratified into quartiles by their performance on a measure of unplanned risk-standardized acute admission rates (RSAARs) among patients with HF. Using a previously validated algorithm, we categorized admissions by principal discharge diagnosis into: HF, cardiovascular/non-HF, and noncardiovascular. We compared the mean admission rates by admission type as well as the proportion of admission types across RSAAR quartiles (Q1-Q4)., Results: Among 220 ACOs caring for 227,356 patients with HF, the median (IQR) RSAARs per 100 person-years ranged from 64.5 (61.7-67.7) in Q1 (best performers) to 94.0 (90.1-99.9) in Q4 (worst performers). The mean admission rates by admission types for ACOs in Q1 compared with Q4 were as follows: HF admissions: 9.8 (2.2) vs 14.6 (2.8) per 100 person years (P < .0001); cardiovascular/non-HF admissions: 11.1 (1.6) vs 15.9 (2.6) per 100 person-years (P < .0001); and noncardiovascular admissions: 42.7 (5.4) vs 69.6 (11.3) per 100 person-years (P < .0001). The proportion of admission due to HF, cardiovascular/non-HF, and noncardiovascular conditions was 15.4%, 17.5%, and 67.1% in Q1 compared with 14.6%, 15.9%, and 69.4% in Q4 (P < .007)., Conclusions: Although ACOs with the best performance on a measure of all-cause admission rates among people with HF tended to have fewer admissions for HF, cardiovascular/non-HF, and noncardiovascular conditions compared with ACOs with the worst performance (highest admission rates), the largest difference in admission rates were for noncardiovascular admission types. Across all ACOs, two-thirds of admissions of patients with HF were for noncardiovascular causes. These findings suggest that comprehensive approaches are needed to reduce the diverse admission types for which HF patients are at risk., (Copyright © 2018 Elsevier Inc. All rights reserved.)