Citations

Importance Effective interventions are needed to support the cocreation of diabetes care plans that are sensible, desirable, and feasible for the people living with diabetes (ie, care that fits). Objective To investigate whether an agenda-setting kit (ASK) added to usual primary care improves fit of care and glycemic control in adults with type 2 diabetes (T2D). Design, Setting, and Participants This single-center, clinician-level cluster randomized clinical trial was conducted from February 16, 2023, to July 26, 2024, with a 6-month follow-up, at a federally qualified health center in New Haven, Connecticut. Eligible clinicians were primary care physicians, nurse practitioners, and physician assistants who prescribed medication to treat patients with T2D. Eligible patients were English- or Spanish-speaking adults aged 18 years or older with T2D and hemoglobin (Hb) A 1c level greater than 8%. Patients were excluded if their clinician determined that an HbA 1c level 8% or lower was inconsistent with goals of care. Data were analyzed from November 7, 2024, to August 13, 2026. Intervention Clinicians were randomized 1:1 to the ASK plus usual primary care group (intervention group) or usual primary care only (control group). The ASK intervention consisted of 14 conversation cards about life with diabetes and its treatment. Prior to the clinical encounter, patients were asked to select 0 to 3 cards they wanted to prioritize for discussion. Main Outcomes and Measures The primary outcome was the 6-month change from baseline in illness intrusiveness measured with the Illness Intrusiveness Ratings Scale (IIRS; range: 13-91, with higher scores indicating greater intrusiveness) and HbA 1c level. Secondary outcomes included changes in treatment burden measured with the Treatment Burden Questionnaire (TBQ; range: 0-150, with higher scores indicating greater burden), diabetes distress measured with the 17-Item Diabetes Distress Scale (DDS-17; scores: indicate little or no distress [<2.0], moderate distress [2.0-2.9], and high distress [≥3.0]), and visit satisfaction. Results Eleven clinicians (6 [54.5%] female) were included in the trial along with 143 of their patients. The mean (SD) patient age was 56 (12) years; 87 participants (60.8%) were female and 88 (61.5%) reported Spanish as their primary language. Six-month survey data were available for 65 of 74 patients (87.8%) in the intervention group and 58 of 69 (84.0%) in the control group; data on HbA 1c level were available for 71 (95.9%) and 65 (94.2%), respectively. At 6 months, mean (SD) IIRS scores were 32.1 (15.1) and 37.1 (18.7) in the intervention and control groups (adjusted mean difference, −3.9; 95% CI, −10.4 to 2.6). The mean (SD) HbA 1c levels were 8.8% (1.8) in the intervention group and 9.1% (1.8) in the control group (adjusted mean difference, −0.2%; 95% CI, −0.9% to 0.5%). Mean (SD) TBQ scores in the intervention and control groups were 41.2 (44.8) and 46.8 (44.4) (adjusted mean difference, 1.0; 95% CI, −16.6 to 18.6), and mean (SD) DDS-17 scores were 2.0 (1.0) and 2.3 (1.0) (adjusted mean difference, −0.1; 95% CI, −0.4 to 0.2). Clinician-reported satisfaction was greater in the intervention group; patient satisfaction did not differ between groups. Conclusions and Relevance In this cluster randomized clinical trial of adults with T2D, use of the ASK with usual primary care was associated with greater clinician satisfaction but not with improvements in patients’ fit of care or glycemic control over 6 months. Larger studies should evaluate interventions that not only identify patients’ priorities and treatment burdens but also better support clinicians in addressing them. Trial Registration ClinicalTrials.gov Identifier: NCT05553912

Abstract Context. Thyroid nodule ultrasound findings are crucial in guiding management decisions for patients with thyroid nodules. However, the frequency with which ultrasound images are discussed and reviewed with patients during clinical visits is not well understood. Objective. To assess how often thyroid ultrasound images are shown and discussed with patients during consultations, and to identify predictors of image review during clinical visits. Design and setting. Secondary analysis of a multicenter pilot randomized clinical trial conducted at two academic medical centers in the United States. Participants. Adults undergoing evaluation for thyroid nodules. Intervention. Participants were randomized to receive either usual care or care enhanced with a conversation aid. Main Outcome Measures. The primary outcome was the frequency of thyroid nodule imaging review evaluated as a binary outcome. Secondary outcomes included evaluation of predictors of image discussion. Results. Eighty-five patients were evaluated. Most participants were women (80%), mean age (60 years, SD 16), and White (86%), undergoing new patient visits (84%). Thyroid nodule ultrasound images were reviewed with patients in 53% of visits (45/85), and in all cases, clinicians initiated the imaging discussion. Predictors of image review included type of consultation (new patient visit) (OR 10.6, 95% CI: 1.79, 62.3). Age, sex, study arm, thyroid nodule size or cancer risk and plan of care (e.g., completing a biopsy) were not statistically associated with review of clinical images. Conclusions. Review of thyroid ultrasound images during clinical visits is relatively common, with consultation type serving as significant predictor.

ABSTRACT Objective Women carry disproportionate shares of caregiving and other life demands that may compound the work of diabetes self-management. We sought to examine gender differences in overall and digital treatment burden and their key contributors. Research Design and Methods Cross-sectional analysis of two cohorts of adults with type 1 or type 2 diabetes attending outpatient endocrinology visits who completed the Treatment Burden Questionnaire Plus Digital (TBQ+D) (n=472). Multivariable regression estimated gender differences in overall and digital treatment burden, ability to live a normal life, and sustainability of current self- care effort, adjusting for age, diabetes type, insulin intensity, HbA1c, and cohort. Item-level analyses identified contributors to observed differences. Results Compared to men, women reported higher median overall treatment burden (33 vs 20, adjusted mean difference 10.6 points, 95% CI 5.1–16.3; p <.0001) and digital treatment burden (13 vs 7, adjusted mean difference 3.5 points, 95% CI 1.1–6.1; p =.009). They also had higher odds of not living a normal life (OR 1.77, 95% CI 1.18–2.67; p =0.006) and difficulty sustaining current self-care efforts indefinitely (OR 2.01, 95% CI 1.10–3.66; p =0.023). Digital burden differences were concentrated in annoyance, precautions, and time and effort required to use digital medicine tools, whereas contributors to differences in overall burden varied, with relationships, self-monitoring, and injections contributing most. Conclusions After adjusting for treatment intensity and other factors, women living with diabetes were twice as likely to be overwhelmed by diabetes care than men. Their greater vulnerability to treatment burden demands healthcare service redesign and individualization of plans of care that minimally disrupt patients’ and caregivers’ lives. ARTICLE HIGHLIGHTS Why did we undertake this study? Women may experience greater treatment burden across chronic conditions, reflecting competing (caregiving) demands that reduce capacity for self-management. Gender differences in diabetes, especially digital burden, remain unclear. What is the specific question we wanted to answer? Do women with diabetes experience greater overall and digital treatment burden than men? What did we find? Women reported greater overall and digital burden and more difficulty living a normal life and sustaining care than men. Differences were larger for digital annoyance, precautions, and effort, plus relationships, self-monitoring, and injections. What are the implications? Treatment burden cannot be inferred from treatment intensity alone. Diabetes care should consider whether treatment work fits within each patient’s life and can be sustained. Women with diabetes may be particularly vulnerable to becoming overwhelmed by the work of diabetes care.

Background Intensive care units are high-acuity environments characterized by time pressure, medical complexity, and organizational demands. These conditions may influence clinicians’ ability to provide patient-centered care and contribute to forms of care perceived as fragmented or dehumanizing. Objective To examine how ICU clinicians describe and make sense of the pressures shaping everyday critical care practice, and how these pressures give rise to interacting patterns of care, including those described as hurry, blur, burden, and cruelty. Methods We conducted a qualitative study using focus groups with ICU clinicians from a large academic health system. Discussions were informed by the concept of the pathologies of care as sensitizing concepts. Four focus groups were held with physicians, nurses, advanced practice nurses, and a social worker ( N = 14). Transcripts were analyzed using directed content analysis with both deductive and inductive coding. Results Clinicians described these patterns not as discrete phenomena but as interrelated, context-dependent processes shaped by shared operational pressures such as time constraints, workload, and information demands. These dynamics were often viewed as inherent to the structure and culture of ICU care and were described as co-occurring and compounding. Communication emerged as both a contributor to and a potential mechanism for mitigation, alongside system-level strategies such as reducing documentation burden and leveraging artificial intelligence to support care delivery. Conclusions Patterns reflected in hurry, blur, burden, and cruelty are best understood as emergent properties of complex care systems. Addressing these dynamics may require system-level approaches to improve communication, reduce workload pressures, and support more patient-centered, humanizing care.

Importance Continuous glucose monitoring (CGM), initially recommended primarily for people with type 1 diabetes, has rapidly expanded to patients with type 2 diabetes and, more recently, even to individuals without diabetes. This broadening use underscores the importance of critically examining the evidence supporting CGM across populations, clarifying where benefits are established, where they are modest, and where they remain uncertain. Observations We reviewed systematic reviews and meta-analyses of randomized trials and clinical guidelines evaluating CGM use beyond type 1 diabetes, with particular attention to glycemic outcomes, hypoglycemia, patient-reported outcomes, and potential unintended consequences in nonpregnant adults. In adults with type 2 diabetes, evidence from randomized trials consistently demonstrated that CGM use was associated, on average, with a modest yet consistent reduction in hemoglobin A 1c of approximately 0.3% compared with finger-stick monitoring or usual care; some patients benefited considerably more. Only limited and indirect evidence supported the adoption of CGM in people with type 2 diabetes not receiving glucose-lowering therapy or in those with prediabetes or obesity. Conclusions and Relevance CGM should be deployed in response to a specific patient problem rather than as a default intervention. Deliberate, equitable deployment of CGM that is aligned with patient goals, clinical context, and system capacity will be necessary to ensure that those most likely to benefit are not left behind, while avoiding overuse in populations for whom benefit remains unproven.

OBJECTIVE To examine kidney disease outcomes associated with dipeptidyl peptidase 4 inhibitors (DPP-4i). RESEARCH DESIGN AND METHODS In this target trial emulation, claims data from enrollees in commercial, Medicare Advantage, and traditional Medicare health plans were used to identify adults ≥21 years old with type 2 diabetes, with moderate cardiovascular risk, and without stage 3 or worse chronic kidney disease (CKD) initiating alogliptin, linagliptin, saxagliptin, or sitagliptin between 2014 and 2021. The primary outcome was a composite of incident CKD stages 3–5, kidney failure, or kidney replacement therapy. Random treatment assignment was emulated using propensity scores, estimated using the super learner ensemble method and incorporated as inverse probability of treatment weights into proportional hazards models. RESULTS The weighted study cohort included 3,026 individuals starting alogliptin, 38,213 starting linagliptin, 14,934 starting saxagliptin, and 115,091 starting sitagliptin. One year after treatment initiation, the primary outcome occurred in 1.4%, 2.7%, 2.2%, and 2.4% of patients initiating alogliptin, linagliptin, saxagliptin, and sitagliptin, respectively, increasing to 3.2%, 6.2%, 5.0%, and 5.4%, respectively, at 3 years. Alogliptin was associated with lower risk of stage 3 or worse CKD than linagliptin (hazard ratio [HR] 0.50; 95% CI 0.37–0.69), saxagliptin (HR 0.63; 95% CI 0.45–0.86), and sitagliptin (HR 0.58; 95% CI 0.42–0.79), while saxagliptin was associated with lower risk than linagliptin (HR 0.80; 95% CI 0.73–0.87). Conversely, linagliptin was associated with higher risk than sitagliptin (HR 1.15, 95% CI 1.10–1.21). CONCLUSIONS Alogliptin was associated with lower risk of moderate-to-severe kidney disease than other DPP-4i, while linagliptin was associated with higher risk. Limitations include lack of laboratory data and potential unmeasured confounding.

Objective Digital health applications (health apps) are increasingly integrated in clinical care. Yet the information describing these apps varies across curated app repositories supporting prescription. We aimed to identify the information items used to describe health apps in repositories; and to quantify the completeness of publicly displayed app-entry information across repositories. Methods We conducted a cross-sectional study of seven national or international curated health app repositories: mHealthBelgium, DiGA, AppThera, ORCHA, GGD AppStore, MIND, and AppGuide. In January 2025, we randomly selected 140 health apps, with 20 apps per repository. For each app, one reviewer extracted the publicly available information displayed in the repository entry and inductively identified the information items reported (i.e., atomic information elements used to describe apps). These information items were then grouped into categories by an expert committee. We calculated, for each repository, the median number of items reported across apps, overall and by category. Results Health apps were described by 32 information items grouped into 10 categories: general information, regulatory information, compatibility, costs, indication, functions, evidence, user experience, data governance and security, and change history. The median number of items reported in repositories ranged from a median of 9/32 items, IQR 9 to 11 in MIND to 27/32, IQR 26 to 28 in DiGA. Only, three repositories (AppThera, DiGA and AppGuide) systematically reported information on the evidence supporting the apps for all listed apps. Conclusions Curated health app repositories differed in the information items presented to clinicians and patients. Incomplete reporting of clinically relevant information, particularly evidence and data governance, may limit informed app selection and prescription. Minimum reporting standards are needed to enable safe prescription and reliable integration of health apps into clinical practice.

Abstract Aim This study aims to assess the treatment burden and health‐related quality of life (HRQoL) in young adults with type 1 diabetes (T1D). Methods Online survey on experienced treatment burden (Treatment Burden Questionnaire, TBQ, 0–150, higher scores indicate higher burden) and HRQoL (Type 1 Diabetes and Life questionnaire for ages 18–25 and 26–45, T1DAL, 0–100, higher scores indicate better HRQoL) among Dutch young adults with T1D (aged 18–30). Results In total, 294 young adults with T1D completed the survey. Mean TBQ score was 59.5 (SD = 24.9). Regular medical care reminding participants of their health problems scored highest. Mean T1DAL scores were 55.9 (SD = 12.9) for ages 18–25, and 62.1 (SD = 13.2) for ages 26–30. Lowest scores were in the subcategory ‘Emotional experiences and daily activities’ (18–25: median = 41.7, IQR = 24.9; 26–30: median = 47.8, IQR = 22.5). TBQ was strongly negatively correlated with T1DAL ( r = −0.69, 95% CI [−0.74, −0.62], p < 0.001). Characteristics associated with higher treatment burden and lower HRQoL included female gender, lower time in range and dissatisfaction with diabetes management approach. Conclusion Young adults with T1D report considerable treatment burden and moderate HRQoL, suggesting a high impact of diabetes care on their lives. Treatment burden is particularly affected by regular medical care activities, whereas diabetes affects the daily functioning and emotional experiences domains of HRQoL. Further research is needed to understand how young adults make care fit and to improve care for these patients, resulting in minimally disruptive care plans. While cautiously interpreted, this may be especially relevant for women and those with adverse clinical outcomes.

Introduction To assess the within-class variation in kidney outcomes following initiation of sulfonylurea therapy. Research design and methods We used claims data of enrollees in commercial, Medicare Advantage, and traditional Medicare health plans between 2014 and 2021 to emulate a target trial including adults ≥21 years with type 2 diabetes at moderate cardiovascular risk to compare initiation of glimepiride, glipizide, or glyburide on the incidence of chronic kidney disease (CKD) stage 3 or worse, including initiation of kidney replacement therapy (primary outcome); secondary outcomes examined incident CKD stages 3-4, kidney failure (including kidney replacement therapy), all-cause mortality, and hypoglycemia requiring emergency department or hospital care. Random treatment assignment was emulated using propensity scores, estimated using the super learner ensemble method, and incorporated as inverse probability of treatment weights into proportional hazards models. Results The weighted study cohort included 295 092 individuals starting glimepiride (n=134 926), glipizide (n=145 984), and glyburide (n=14 182). One year after treatment initiation, stage 3 or worse CKD developed in 2.1% of patients in the glimepiride group, 2.2% in the glipizide group, and 1.8% in the glyburide group. Glyburide was associated with a lower risk of kidney complications compared with both glimepiride (HR 0.84, 95% CI 0.76 to 0.92) and glipizide (HR 0.81, 95% CI 0.73 to 0.89), despite a higher risk of severe hypoglycemia (HR 1.47, 95% CI 1.27 to 1.71 vs glipizide and HR 1.22, 95% CI 1.05 to 1.42 vs glimepiride). In contrast, the risk of kidney complications was modestly increased with glipizide compared with glimepiride use (HR 1.04, 95% CI 1.00 to 1.07). Conclusions Glyburide was associated with a modestly lower risk of kidney complications, despite a higher risk of hypoglycemia, while glipizide was associated with a higher risk of kidney complications. These hypothesis-generating findings suggest important within-class differences that warrant consideration in clinical decision-making and future research. Despite rigorous prespecified causal inference analytic methods, the risk of unmeasured confounding and bias by indication with the use of observational data remains. Trial registration number NCT05214573 .