McCoy, Rozalina G.

Introduction To examine within-class sulfonylurea safety, we compared risks of major adverse cardiovascular events (MACE) and severe hypoglycemia among adults with type 2 diabetes (T2D) and moderate cardiovascular risk following sulfonylurea initiation. Research design and methods We conducted a target trial emulation including adults ≥21 years old with T2D and moderate cardiovascular risk who initiated glimepiride, glipizide or glyburide between 2014 and 2021, using claims data from Optum Labs Data Warehouse and the Medicare fee-for-service 100% sample. Study outcomes were MACE (primary), expanded MACE and its components and emergency department or hospital encounters for hypoglycemia, ascertained during follow-up through 2022. Inverse probability of treatment weighting (IPTW) was applied using propensity scores estimated using the super learner ensemble, and outcomes were examined using IPTW Cox proportional hazards models. Results The weighted study cohort comprised 314 699 patients (mean age 66.9 years, 52.0% men, 76.6% non-Hispanic white). At 1 year, MACE was experienced by 2.5%, 2.7% and 2.8% of patients starting glimepiride, glipizide and glyburide, respectively. Compared with glimepiride, glyburide and glipizide were associated with higher risk of MACE (HR 1.10, 95% CI 1.05 to 1.16 for glyburide; HR 1.05, 95% CI 1.03 to 1.07 for glipizide). At 1 year, severe hypoglycemia was experienced by 0.3%, 0.3% and 0.4% of patients starting glimepiride, glipizide and glyburide, respectively. Glyburide was associated with a greater risk of severe hypoglycemia compared with glipizide (HR 1.43, 95% CI 1.23 to 1.65), while glipizide was associated with a lower risk compared with glimepiride (HR 0.82, 95% CI 0.77 to 0.87). Conclusions Among adults with T2D and moderate cardiovascular risk, glimepiride was associated with lowest risk of MACE and glipizide with lowest risk of severe hypoglycemia. These results can help inform treatment selection if sulfonylureas are used for glucose-lowering.

ABSTRACT Background Effective interventions are needed to support co-creation of diabetes care plans that fit patients’ lives. We evaluated the QBSafe agenda-setting kit (14 conversation cards) for its impact on care fit and glycemic control when added to usual primary care. Methods This single-center, clinician-level cluster-randomized, open-label trial was conducted at a federally qualified health center in New Haven, Connecticut ( ClinicalTrials.gov NCT05553912 ). Clinicians and their patients with type 2 diabetes and HbA1c >8% were randomized 1:1 to usual care with or without QBSafe cards. In the intervention arm, patients selected up to 3 cards highlighting concerns about life with diabetes prior to their visit. Primary outcomes were change at 6 months in care fit (Illness Intrusiveness Ratings Scale, IIRS) and HbA1c, analyzed by intention to treat. Secondary outcomes were treatment burden (Treatment Burden Questionnaire, TBQ) and diabetes distress (Diabetes Distress Scale, DDS), and satisfaction with visits. Results Between February 2023 and July 2024, 143 participants (mean age 56 years; 61% female; 73% Hispanic; mean HbA1c 10%) were enrolled: 74 received usual care with QBSafe, 69 usual care alone. At 6 months, there were no significant between-arm differences in changes in IIRS (−3.9 [95% CI -10.4, 2.6]), HbA1c (−0.2% [95% CI -0.9, 0.5]), TBQ (1.0 [95% CI -16.6, 18.6]), or DDS (−0.1 [95% CI -0.4, 0.2]). Clinicians reported greater satisfaction when using QBSafe. Patient satisfaction was high and did not differ across arms. Conclusions QBSafe cards improved clinician satisfaction but did not improve care fit or glycemic control. Future tools should focus on helping clinicians respond effectively to patient-identified challenges.

This cohort study examines the clinical implementation of timely consolidation with antiresorptive therapy to preserve bone mineral density gains and reduce fracture risk.

Abstract Disclosure: N.M. Singh Ospina: None. Y. Chen: None. F. Du: None. J.P. Brito: None. H. Shao: None. Q. Liu: None. R.G. McCoy: None. T. Jiao: None. Background: The levothyroxine dose for patients with hypothyroidism is highly correlated with weight. In patients with hypothyroidism, TSH measurements are used to assess the adequacy of levothyroxine dosing.Since type 2 diabetes (T2D) and obesity are two common comorbidities for patients with hypothyroidism, and the significant weight loss associated with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) therapy, the initiation of GLP-1 RA on levothyroxine users may significant increase the need for levothyroxine dose reduction potentially requiring additional TSH tests to assure control. Objectives: To evaluate the timing and frequency of TSH testing within one year of initiation of GLP-1, or sodium-glucose co-transporter 2 (SGLT-2) inhibitors, in patients with T2D on levothyroxine treatment. Methods: We identified a cohort of T2D patients using 15% of Medicare fee-for-service claims data from 2005 to 2020. Cohort entry was defined by the initiation of GLP-1 or SGLT2. Patients needed to continuously receive the same dose of levothyroxine for >6 months and have at least 1 TSH measurement before the index date. We excluded patients with hyperthyroidism, thyroid cancer, end-stage renal disease, HIV/AIDs, organ transplant, or who received medications that affect thyroid levels before the index date. The primary outcome was the timing and frequency of TSH testing within one year after GLP-1 RA initiation. Demographics, comorbidities, and medication use were balanced using 1:1 propensity score matching based on the index date. Results: After matching, no significant demographic differences were observed among the 2,107 patients in GLP-1 RA and SGLT-2 groups, respectively. Overall, 32.1%, 32.3%, and 35.6% were aged 65-70, 70-74, and over 75, with 69.3% female and 87.9% white. In the year before the index date, the average number of TSH tests was higher in the GLP-1 RA (1.16 ± 1.27) compared to the SGLT2 (1.07 ± 1.18, p-value: 0.001). In the year after the index date, the average number of TSH tests declined to 0.93 ± 1.18 for GLP-1 and 0.89 ± 1.13 for SGLT2 (p-value: 0.03). Most patients (48.6 vs. 49.5%) had no TSH tests, 41.3 vs. 40.6% had 1-2 tests, and 10.1 vs. 9.9% had more than 2 tests in the GLP-1 RA and SGLT-2 group, respectively. Fewer patients (32.3 vs. 33.6%) were tested within 0-6 months while the majority (67.7 vs. 66.5%) waited longer than 6 months. The relative risk of TSH testing between the GLP-1 RA group and the SGLT2 group was 1.03 (95% CI: 0.98 to 1.08) 1-year before the index date and 1.00 (95% CI: 0.94 to 1.06) 1-year after the index date. Conclusions: Despite the potential impact of GLP-1 RA on levothyroxine dosing, on average, half of patients did not receive a TSH test after treatment initiation. There were no significant differences in TSH testing patterns between GLP-1 and SGLT2 groups, with similar test frequencies and timing observed. Presentation: Saturday, July 12, 2025

OBJECTIVE To evaluate the impact of community paramedic (CP)-delivered, in-home diabetes self-management education and support (DSMES) for adults with poorly managed diabetes. RESEARCH DESIGN AND METHODS In a pragmatic, single-arm pilot trial, adults with HbA1c ≥9% and a recent emergency department or hospital visit received a 1-month CP-led DSMES intervention. Outcomes included HbA1c, health care engagement, and patient-reported satisfaction. RESULTS Seventy participants (median age 61 years, 50% rural, 84% with type 2 diabetes) completed the intervention. HbA1c declined from 9.8% to 8.2% at 4 months (P < 0.001). Engagement with primary care, endocrinology, and DSMES improved. Satisfaction was high (mean rating 9 out of 10). CONCLUSIONS CP-led DSMES improved glycemic management and care engagement in underserved populations. This scalable model warrants further study.

Optimal management of hyperglycemia during illness has been hindered by a lack of comprehensive sick-day guidance, particularly for adults with diabetes. Managing glycemia can be challenging during illness because of adaptive counterregulatory hormonal changes, acute stress of illness, altered dietary intake, and effects of medications. People with diabetes may be at risk for severe hypoglycemia and hyperglycemic crisis during illness unless mitigated by close monitoring and medication adjustment. This article provides practical guidance to health care professionals and people with diabetes for safe glycemic management during illness, including considerations for insulin and noninsulin medications, use of insulin technologies, prevention of hypoglycemia and ketoacidosis, steroid use, and pregnancy.

Background Glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) and sodium–glucose cotransporter‐2 inhibitors (SGLT2is) have favorable cardiovascular outcomes compared with dipeptidyl peptidase‐4 inhibitors (DPP4is) and sulfonylureas in adults with type 2 diabetes and high cardiovascular risk. How these benefits vary across lower levels of cardiovascular risk is unknown. Methods We used nationwide claims data to emulate a comparative effectiveness trial and examine the heterogeneity of treatment effects of GLP‐1RAs, SGLT2is, DPP4is, and sulfonylureas on major adverse cardiovascular events (MACEs) among adults with type 2 diabetes and moderate cardiovascular risk (annualized MACE risk 1%–5%, estimated using the annualized claims‐based MACE estimator). Results Among 386 276 included adults with type 2 diabetes, 25.2% had baseline ACME–predicted MACE risk >1% to ≤2% (lower‐risk patients) and 13.3% had ACME–predicted risk >4% to ≤5% (higher‐risk patients). By year 3 of treatment, higher‐risk patients derived greater absolute benefit than lower‐risk patients when treated with GLP‐1RAs versus sulfonylureas (absolute reduction in the estimated rate of MACE of 3.1% in higher‐risk patients and 1.6% in lower‐risk patients), SGLT2is versus sulfonylureas (absolute reduction, 3.9% in higher‐risk patients and 1.3% in lower‐risk patients), and GLP‐1RAs versus DPP4is (absolute reduction, 1.6% in higher‐risk patients and 0.5% in lower‐risk patients). The relative benefits for MACE were also greater in higher‐risk than lower‐risk patients with SGLT2is versus DPP4is (hazard ratio [HR], 0.78 [95% CI, 0.70–0.87] in higher‐risk patients; HR, 0.99 [95% CI, 0.88–1.12] in lower‐risk patients). Conversely, the relative benefits of DPP4is and GLP‐1RAs versus sulfonylureas were greater in lower‐risk patients: HR 0.76 (95% CI, 0.71–0.81) in lower‐risk and HR 0.91 (95% CI, 0.97–0.96) in higher‐risk patients for DPP4is versus sulfonylureas; HR 0.67 (95% CI, 0.58–0.78) in lower‐risk and HR 0.80 (95% CI, 0.70–0.93) in higher‐risk patients for GLP‐1RAs versus sulfonylurea. Benefits of SGLT2is and GLP‐1RAs were comparable across all risk levels. Conclusions Cardiovascular benefits of SGLT2is and GLP‐1RAs exist across all levels of moderate cardiovascular risk, reinforcing the importance of choosing glucose‐lowering therapies that can prevent MACE in all people with type 2 diabetes.

Background Previous studies have demonstrated disparities in the utilization of diabetes technology among youth with type 1 diabetes (T1D) based on race and socioeconomic status (SES). Few studies have examined these differences on a national scale or among youth with commercial health insurance. Aim To investigate differences in the fill rates of insulin pumps and continuous glucose monitors (CGMs) among commercially insured children with T1D across diverse racial and SES groups. Methods Using medical and pharmacy claims included in the OptumLabs Data Warehouse, we calculated the proportion of youth <18 years with T1D who had a fill for an insulin pump or a CGM, overall and stratified by race/ethnicity and annual household income, between 2011 and 2021. Results Among 13,246 youth with T1D, 36.1% had CGM and 30.9% had pump fills. White youth had higher CGM and pump fills than black (CGMs: 35.8% vs 22.5%; pumps: 31.9% vs 21.2%, p<0.001) and Hispanic (CGMs: 35.8% vs 32.6%, p=0.047; pumps: 31.9% vs 25.0%, p<0.001). Youth from households with income <US$40,000 had lower CGM and pump fills than those with income ≥US$200,000 (CGM 25.4% vs 43.8%; pumps: 22.4% vs 38.8%, p<0.001). Within similar incomes <US$40,000, black youth had fewer CGM and pump fills than white youth (CGM: 15.2% vs 27.9%, p=0.006; pumps: 12.9% vs 25.5%, p=0.004). This racial difference disappeared with income ≥US$200,000 (CGMs: 47.5% for black vs 43.1% for white; pumps: 45.9% for black vs 38.3% for white, p=0.45 and p=0.57, respectively). Conclusions In a cohort of commercially insured youth with T1D, both race and income are important factors that can independently influence the use of diabetes technology. Racial disparities decrease with higher income and disappear at incomes ≥US$200,000. Black youth with income <US$40,000 are at the highest exclusion risk from essential technologies. Greater effort is needed at both the system and individual levels to mitigate these disparities.