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OBJECTIVE: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8–8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate whether baseline levels of depressive symptoms and diabetes-specific distress are associated with glycemic control in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing the metabolic effects of four common glucose-lowering medications when combined with metformin in individuals with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The primary and secondary outcomes were defined as an HbA1c value ≥7%, subsequently confirmed, and an HbA1c value >7.5%, subsequently confirmed, respectively. Separate Cox proportional hazards models assessed the association between baseline levels of each exposure of interest (depressive symptoms measured with the eight-item Patient Health Questionnaire and diabetes distress measured with the Diabetes Distress Scale) and the subsequent risk of metabolic outcomes. RESULTS: This substudy included 1,739 participants (56% of whom were non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic, and 68% male; mean [SD] age 58.0 [10.2] years, diabetes duration 4.2 [2.8] years, and HbA1c 7.5% [0.48%]). A total of 1,157 participants reached the primary outcome, with time to event of 2.1 years on average, while 738 participants reached the secondary outcome at 3 years on average. With adjustment for sex, race/ethnicity, treatment group, baseline age, duration of T2DM, BMI, and HbA1c, there were no significant associations between the depressive symptoms or diabetes distress and the subsequent risk of the primary or secondary outcomes. CONCLUSIONS: The current findings suggest that, at least for individuals with diabetes of relatively short duration, baseline levels of emotional distress are not associated with glycemic control over time. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%–15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments. RESEARCH DESIGN AND METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years' duration, HbA1c 6.8–8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up. RESULTS: Across treatments, diabetes distress (−0.24, P < 0.0001) and depressive symptoms (−0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (−0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (−0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms. CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM. [ABSTRACT FROM AUTHOR]

Background: Adverse social determinants of health (SDoH) have been associated with cardiometabolic disease; however, disparities in cardiometabolic outcomes are rarely the result of a single risk factor., Objective: This study aimed to identify and characterize SDoH phenotypes based on patient-reported and neighborhood-level data from the institutional electronic medical record and evaluate the prevalence of diabetes, obesity, and other cardiometabolic diseases by phenotype status., Methods: Patient-reported SDoH were collected (January to December 2020) and neighborhood-level social vulnerability, neighborhood socioeconomic status, and rurality were linked via census tract to geocoded patient addresses. Diabetes status was coded in the electronic medical record using International Classification of Diseases codes; obesity was defined using measured BMI ≥30 kg/m2. Latent class analysis was used to identify clusters of SDoH (eg, phenotypes); we then examined differences in the prevalence of cardiometabolic conditions based on phenotype status using prevalence ratios (PRs)., Results: Complete data were available for analysis for 2380 patients (mean age 53, SD 16 years; n=1405, 59% female; n=1198, 50% non-White). Roughly 8% (n=179) reported housing insecurity, 30% (n=710) reported resource needs (food, health care, or utilities), and 49% (n=1158) lived in a high-vulnerability census tract. We identified 3 patient SDoH phenotypes: (1) high social risk, defined largely by self-reported SDoH (n=217, 9%); (2) adverse neighborhood SDoH (n=1353, 56%), defined largely by adverse neighborhood-level measures; and (3) low social risk (n=810, 34%), defined as low individual- and neighborhood-level risks. Patients with an adverse neighborhood SDoH phenotype had higher prevalence of diagnosed type 2 diabetes (PR 1.19, 95% CI 1.06-1.33), hypertension (PR 1.14, 95% CI 1.02-1.27), peripheral vascular disease (PR 1.46, 95% CI 1.09-1.97), and heart failure (PR 1.46, 95% CI 1.20-1.79)., Conclusions: Patients with the adverse neighborhood SDoH phenotype had higher prevalence of poor cardiometabolic conditions compared to phenotypes determined by individual-level characteristics, suggesting that neighborhood environment plays a role, even if individual measures of socioeconomic status are not suboptimal., (© Carrie R Howell, Li Zhang, Olivio J Clay, Gareth Dutton, Trudi Horton, Michael J Mugavero, Andrea L Cherrington. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org).)

Healthcare delivery is currently undergoing major structural reform, and the Learning Health System (LHS) has been proposed as an aspirational model to guide healthcare transformation. As efforts to build LHS take considerable investment from health systems, it is critical to understand their leaders' perspectives on the rationale for pursuing an LHS and the potential benefits for doing so. This paper describes the qualitative analysis of semi-structured interviews ( n = 17) with health system leaders about their general perceptions of the LHS, description of key attributes and potential benefits, and perception of barriers to and facilitators for advancing the model. Participants universally endorsed the goal of the local health system aspiring to become an LHS. Participants identified many recognized attributes of LHS, though they emphasized unique attributes and potential benefits. There was also heterogeneity in participants' views on what to prioritize, how to structure the local LHS within existing initiatives, and how new initiatives should be implemented. Improving conceptual clarity of attributes of the LHS would improve its potential in guiding future reform., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AV has a financial relationship (employment) with Heart Rhythm Clinical Research Solutions, LLC and 3PH Alliance, Inc. All other authors have no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.