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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]

Objective: We conducted comprehensive assessments of emotional distress to examine relations with diabetes medication adherence over time.Research Design and Methods: Ethnically and socioeconomically diverse adults treated for type 2 diabetes completed validated self-reports (SRs) for diabetes distress and depression, were administered semistructured depression interviews, and provided blood samples for A1C. Medication adherence among 104 participants was electronically monitored (EM) over the subsequent 3 months; validated SRs of medication adherence were also obtained. Hierarchical linear regression evaluated independent effects of diabetes distress and depression on adherence.Results: Mean ± SD 3-month medication adherence was 76.1% ± 25.7% for EM and 83.7% ± 21.9% for SR. Higher levels of SR (P < 0.001) and interview-based (P < 0.05) depressive symptom severity (P < 0.05) and diabetes-related distress (P < 0.01) showed a significant bivariate association with EM and SR nonadherence. Regression models showed baseline diabetes distress was a significant independent predictor of EM (β = -0.29; P = 0.001) and SR adherence (β = -0.24; P < 0.02) at follow-up. SR depression was an independent predictor of EM and SR adherence and reduced the effects of diabetes distress to nonsignificance. Subsequent models indicated this effect was driven by somatic rather than cognitive-affective symptoms of depression. Results were consistent but weaker for interview-based depressive symptoms.Conclusions: Findings support diabetes-related distress and depression symptom severity as risk factors for type 2 diabetes medication nonadherence. Somatic symptoms captured by depression measures, but not cognitive-affective symptoms, independently predict nonadherence and should be further investigated as a potential link between emotional distress and nonadherence. [ABSTRACT FROM AUTHOR]

Type 2 diabetes is a chronic, progressive disease, and its management results in a high emotional burden on patients. Eventually many patients require and can benefit from the use of insulin. This article reports results of a survey of patients and health care providers regarding their experiences of and challenges with the use of basal insulin. Health care providers can play a key role in helping people with type 2 diabetes overcome the challenges associated with the use of basal insulin, including connecting with their emotional needs and understanding the stressors associated with managing diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE To test cognitive behavioral therapy for adherence and depression (CBT-AD) in type 2 diabetes. We hypothesized that CBT-AD would improve adherence; depression; and, secondarily, hemoglobin A1c (A1C). RESEARCH DESIGN AND METHODS Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual (ETAU), including medication adherence, self-monitoring of blood glucose (SMBG), and lifestyle counseling; a provider letter documented psychiatric diagnoses. Those randomized to the intervention arm also received 9-11 sessions of CBT-AD. RESULTS Immediately after acute treatment (4months), adjusting for baseline, CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap (95% CI - 231.14 to -10.22, P = 0.000); 30.2 percentage points greater SMBG adherence through glucometer downloads (95% CI -42.95 to -17.37, P = 0.000); 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale (95% CI 2.33-10.56, P = 0.002); 0.74 points lower on the Clinical Global Impression (95% CI 0.16-1.32, P = 0.01); and 0.72 units lower A1C (95% CI 0.29-1.15, P = 0.001) relative to ETAU. Analyses of 4-, 8-, and 12-month follow-up time points indicated that CBT-AD maintained 24.3 percentage points higher medication adherence (95% CI-38.2 to -10.3, P = 0.001); 16.9 percentage points greater SMBG adherence (95% CI-33.3 to -20.5, P = 0.043); and 0.63 units lower A1C (95% CI 0.06-1.2, P = 0.03) after acute treatment ended. For depression, there was some evidence of continued improvement posttreatment, but no between-group differences. CONCLUSIONS CBT-AD is an effective intervention for adherence, depression, and glycemic control, with enduring and clinically meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To assess the validity of self-report measures of diabetes medication adherence and evaluate the effect of depression on the validity of these reports. RESEARCH DESIGN AND METHODS--Adults with type 2 diabetes, treated with oral medications, completed a set of medication adherence self-reports that varied response scales and time frames, were administered structured clinical interviews for depression, and provided blood samples for HbA1c as part of a screening for an intervention study. A subsample of participants with HbA1c ≥7.0% and clinically significant depression received Medication Event Monitoring System (MEMS) bottle caps to record adherence. Analyses examined relationships between adherence measures and HbA1c and, in the subsample, MEMS. Moderated linear regression evaluated whether depression severity modified relationships with HbA1c. RESULTS--Participant (n = 170, 57% men, 81% white, mean HbA1c 8.3% [SD, 1.7]) adherence self-reports were significantly (r =20.18 to 20.28; P,0.03) associated with lower HbA1c. In the subsample (n = 88), all self-reports were significantly (r = 0.35 to 0.55; P ≤ 0.001) associated with MEMS-measured adherence. Depression significantly moderated the relationship between three of six self-reports and HbA1c; at high levels of depression, associations with HbA1c became nonsignificant. CONCLUSIONS--Results support the validity of easily administered self-reports for diabetes medication adherence. One-month, percentage-based ratings of adherence had the strongest associations with MEMS and HbA1c; those requiring the report of missed doses had weaker associations. One-week self-ratings and measures that require respondents to record the number of missed doses appear to be vulnerable to bias from depression severity. [ABSTRACT FROM AUTHOR]

A commentary on the prevalence of depression in diabetes is presented. According to the authors, adults with diabetes have a higher risk of developing clinical depression or major depressive disorder (MDD). They claimed that there is little evidence indicating a longitudinal association between MDD and hyperglycemia. They believed that there is too much overapplication of the MDD conceptual model.

OBJECTIVE -- Depression is common in patients with diabetes and is associated with worse treatment outcomes. Its relationship to treatment adherence, however, has not been systematically reviewed. We used meta-analysis to examine the relationship between depression and treatment nonadherence in patients with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS -- We searched MEDLINE and PsycINFO databases for all studies published by June 2007 and reviewed references of published articles. Meta-analytic procedures were used to estimate the effect size r in a random effects model. Significance values, weighted effect sizes, 95% CIs, and tests of homogeneity of variance were calculated. RESULTS -- Results from 47 independent samples showed that depression was significantly associated with nonadherence to the diabetes treatment regimen (z = 9.97, P < 0.0001). The weighted effect size was near the medium range (r = 0.21, 95% CI 0.17-0.25). Moderator analyses showed that the effect was significantly larger in studies that measured self-care as a continuous versus categorical variable (P = 0.001). Effect sizes were largest for missed medical appointments and composite measures of self-care (r values = 0.31, 0.29). Moderation analyses suggest that effects for most other types of self-care are also near the medium range, especially in studies with stronger methodologies. CONCLUSIONS-- These findings demonstrate a significant association between depression and treatment nonadherence in patients with diabetes. Studies that used stronger methodologies had larger effects. Treatment nonadherence may represent an important pathway between depression and worse diabetes clinical outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- We examined the association between depression, measured as either a continuous symptom severity score or a clinical disorder variable, with self-care behaviors in type 2 diabetes. RESEARCH DESIGN AND METHODS -- We surveyed 879 type 2 diabetic patients from two primary care clinics using the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), the Summary of Diabetes Self-Care Activities, and self-reported medication adherence. RESULTS -- Of the patients, 19% met the criteria for probable major depression (HANDS score ±9), and an additional 66.5% reported at least some depressive symptoms. After controlling for covariates, patients with probable major depression reported significantly fewer days' adherent to diet, exercise, and glucose self-monitoring regimens (P < 0.01) and 2.3-fold increased odds of missing medication doses in the previous week (95% CI 1.5-3.6, P < 0.001) compared with all other respondents. Continuous depressive symptom severity scores were better predictors of nonadherence to diet, exercise, and medications than categorically defined probable major depression. Major depression was a better predictor of glucose monitoring. Among the two-thirds of patients not meeting the criteria for major depression (HANDS score < 9, n = 709), increasing HANDS scores were incrementally associated with poorer self-care behaviors (P < 0.01). CONCLUSIONS -- These findings challenge the conceptualization of depression as a categorical risk factor for nonadherence and suggest that even low levels of depressive symptomatology are associated with nonadherence to important aspects of diabetes self-care. Interventions aimed at alleviating depressive symptoms, which are quite common, could result in significant improvements in diabetes self-care. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- Using the common-sense model of illness behavior, we developed and validated a self-report instrument for assessment of patients' cognitive and emotional representations of diabetic peripheral neuropathy (DPN) influencing foot self-care. RESEARCH DESIGN AND METHODS -- The Patient Interpretation of Neuropathy (PIN) questionnaire, generated from discussions with clinicians and interviews with patients with DPN, was administered to patients with DPN attending U.K. (n = 325) and U.S. (n = 170) diabetes centers. Psychometric tests of the PIN questionnaire comprised factor analysis, internal consistency, and test-retest reliability. Partial correlations and multivariate regressions established construct and criterion-related validity. The associations of PIN scales to past foot ulceration and foot self-care behaviors were compared with those using a generic measure of illness perception and emotion, the Revised Illness Perception Questionnaire (IPQ-R), which was adapted to neuropathy. RESULTS -- Factor analysis of the PIN questionnaire produced 11 scales, which explained 69% of item variance. Nine factors measured patients' common-sense beliefs about DPN and their levels of understanding of DPN-related medical information. Two factors assessed the emotions of worry about potential consequences and anger at practitioners. Most scales demonstrated adequate internal (Cronbach's α = 0.62-0.90) and test-retest reliability (Pearson's rp = 0.51-0.64). Partial correlations between the PIN and IPQ-R scales in corresponding domains were significant but modest (rp = 0.15-0.26). Finally, PIN scales showed significant associations with past foot ulceration and foot self-care behaviors, thereby confirming criterion validity. CONCLUSIONS -- The 39-item PIN questionnaire is a reliable and valid measure of patients' cognitive and emotional representations of neuropathy affecting foot self-care. [ABSTRACT FROM AUTHOR]

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: 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: 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]

The authors trialed a mobile application, DiabetesXcel, which included type 2 diabetes–focused educational videos and modules, in 50 adults of Bronx, NY, a region with a high prevalence of diabetes and diabetes complications. From baseline to 4 months and from baseline to 6 months, there was significantly improved quality of life, self-management, knowledge, self-efficacy, depression, A1C, and LDL cholesterol among those who used DiabetesXcel. There was also a significant decrease in diabetes-related emergency department visits and hospital admissions from baseline to 6 months. This study demonstrates that DiabetesXcel could be beneficial for type 2 diabetes management. [ABSTRACT FROM AUTHOR]

Objective: Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years.Research Design and Methods: We measured inpatient (n = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm.Results: During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97; P < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99; P = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98; P = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A1c during individuals' participation in the 1-year intervention.Conclusions: These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: While there is evidence that functioning, or ability to perform daily life activities, can be adversely influenced by type 1 diabetes, the impact of acute fluctuations in glucose levels on functioning is poorly understood. RESEARCH DESIGN AND METHODS: Using dynamic structural equation modeling, we examined whether overnight glucose (coefficient of variation[CV], percent time <70 mg/dL, percent time >250 mg/dL) predicted seven next-day functioning outcomes (mobile cognitive tasks, accelerometry-derived physical activity, self-reported activity participation) in adults with type 1 diabetes. We examined mediation, moderation, and whether short-term relationships were predictive of global patient-reported outcomes. RESULTS: Overall next-day functioning was significantly predicted from overnight CV (P = 0.017) and percent time >250 mg/dL (P = 0.037). Pairwise tests indicate that higher CV is associated with poorer sustained attention (P = 0.028) and lower engagement in demanding activities (P = 0.028), time <70 mg/dL is associated with poorer sustained attention (P = 0.007), and time >250 mg/dL is associated with more sedentary time (P = 0.024). The impact of CV on sustained attention is partially mediated by sleep fragmentation. Individual differences in the effect of overnight time <70 mg/dL on sustained attention predict global illness intrusiveness (P = 0.016) and diabetes-related quality of life (P = 0.036). CONCLUSIONS: Overnight glucose predicts problems with objective and self-reported next-day functioning and can adversely impact global patient-reported outcomes. These findings across diverse outcomes highlight the wide-ranging effects of glucose fluctuations on functioning in adults with type 1 diabetes. [ABSTRACT FROM AUTHOR]

A correction to the article "A Randomized Controlled Trial of Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Patients With Uncontrolled Type 2 Diabetes" by Steven A. Safren and colleagues that was published in the previous issue is presented.

A large body of research suggests that self-rated health (SRH) is a robust and consistent predictor of morbidity and mortality in various community and chronic illness populations, including patients with diabetes. Even when controlling for potential confounds, respondents rating their health as "poor" have been found to have a 6-fold increased risk of death due to diabetes as compared to respondents who rate their health as "excellent." The aim of the current study was to address the lack of information about the determinants of SRH in patients with diabetes by examining factors predictive of SRH in a sample of 295 patients with diabetic peripheral neuropathy (DPN) using a longitudinal design. Patients (mean age = 62 y; 70% male) rated SRH using a single item from the SF-12. They completed the NeuroQoL to assess neuropathic symptoms of pain, unsteadiness, and reduced feeling and limitations in daily activities due to DPN. The Hospital Anxiety and Depression Scale assessed symptoms of depression and the Big Five Inventory assessed neuroticism. DPN was diagnosed by the Neuropathy Disability Score (NDS; mean = 7.4). Measures were completed at baseline and 18-months. Hierarchical linear regression analyses controlling for demographic variables showed that more medical comorbidities and complications of diabetes at baseline each significantly predicted lower SRH at 18-months (p̠ < .01). Higher NDS scores also significantly predicted lower SRH at follow-up (p̠ < .01). This relationship was mediated by associated increases in symptoms of unsteadiness, which independently predicted lower SRH at follow-up (p̠ < .001). Higher levels of neuroticism, more limitations in daily activities, and more symptoms of depression were each independently predictive of lower SRH at follow-up (all p̠s < .05). The full model of baseline variables accounted for 34% of the variance in SRH 18 months later. These results identify independent predictors of SRH and suggest that objective neuropathy severity influences SRH through the experience of unsteadiness in patients with DPN. ADA-Funded Research [ABSTRACT FROM AUTHOR]

OBJECTIVE -- We examined the association between severity of diabetic peripheral neuropathy and depressive symptoms and investigated the potential mediators of this association. RESEARCH DESIGN AND METHODS -- The Hospital Anxiety and Depression Scale (HADS) was used to assess depressive symptoms in 494 patients (mean age 62 years; 70% male; 72% type 2 diabetic) with diabetic neuropathy diagnosed by the Neuropathy Disability Score (NDS) and the Vibration Perception Threshold (VPT). Diabetic neuropathy symptoms, activities of daily living (ADLs), and social self-perception were measured by the neuropathy and foot ulcer-specific quality-of-life instrument, NeuroQoL; perceptions of diabetic neuropathy symptom unpredictability and the lack of effective treatment were assessed by the revised Illness Perception Questionnaire. RESULTS -- Both the NDS and VPT were significantly associated with the HADS after controlling for demographic and disease variables. Although diabetic neuropathy symptoms mediated this association, with unsteadiness being most strongly associated with HADS, the relationship between foot ulceration and depression was nonsignificant. The association between diabetic neuropathy symptoms and HADS was partially mediated by two sets of psychosocial variables: 1) perceptions of diabetic neuropathy symptom unpredictability and the lack of treatment control and 2) restrictions in ADLs and changes in social self-perception. CONCLUSIONS -- These findings establish the association between diabetic neuropathy and depressive symptoms and identify potential targets for interventions to alleviate depressive symptoms in persons affected by diabetic peripheral neuropathy. [ABSTRACT FROM AUTHOR]

Objective: Young adults with T1D of racial/ethnic minority status suffer adverse outcomes compared with White peers. Diabetes-related stigma (DRS) is common and may contribute to poor outcomes in minority YA, but further study is needed. Methods: We recruited non-Hispanic Black and Hispanic YA with T1D from pediatric and adult diabetes centers at Montefiore Medical Center in the Bronx, NY for a qualitative study to explore YA lived experiences with T1D, challenges to diabetes self-management, and healthcare interactions. We conducted semi-structured individual interviews, which were audio-recorded, transcribed, and analyzed for common themes until thematic saturation was achieved. We coded for DRS in YA responses using the Diabetes Stigma Assessment Scale (DSAS), which includes three domains for stigma due to having diabetes: 1) treated differently, 2) blame and judgment, and 3) identity concerns. Results: We included 41 YA participants for analysis (mean age 21 yrs, 68% female, 73% Hispanic, 27% Black, mean HbA1c 10.3%). Seventy-eight percent of participants (n=32) qualified as having at least one experience consistent with DRS. Of those, approximately half of participants had experiences consistent with one domain of DRS, nine participants with two DRS domains, and three participants with all three domains. Each stigma domain (treated differently, blame and judgment, and identity concerns) was represented equally among participants with DRS experiences. Notably, several Black participants mentioned that they experienced race discrimination from healthcare providers related to diabetes self-management and outcomes. Conclusions: In this sample of minority YA with T1D, DRS prevalence was very high and had some race-specific associations. Greater recognition of DRS and its contribution to poor outcomes among YA with T1D belonging to racial/ethnic minority groups is needed. Disclosure: G. Crespo-ramos: None. M. Finnan: None. J. S. Gonzalez: None. S. Agarwal: None. Funding: National Institutes of Health (K23DK115896) [ABSTRACT FROM AUTHOR]

Recent studies demonstrate wide racial/ethnic disparity in insulin pump and continuous glucose monitor (CGM) use in people with T1D. It remains unknown whether socioeconomic status (SES) or other factors drive disparities. We recruited 300 diverse YA with T1D from 6 diabetes centers across the U.S. (ages 18-28; 33% non-Hispanic White, 32% non-Hispanic Black, 34% Hispanic; 52% public/no insurance; median A1c 9.2%). We used logistic regression to examine how patient-reported and chart-extracted variables, including multiple socioeconomic and individual-level factors, accounted for racial/ethnic disparity in current pump or ever CGM use. Compared with White YA (71/72%), both Black (18/28%) and Hispanic (37/39%) YA had significantly lower pump and CGM use, respectively (p<0.001). Pump and CGM users were more likely to have lower A1c levels, higher attained education, greater household income, lower neighborhood poverty, private insurance, higher diabetes numeracy and literacy, and receive care in a pediatric or combined pediatric-adult center (p<0.001). They were also more likely to report frequent self-monitoring of blood glucose and diabetes medical visit attendance (p<0.001). Full adjustment for these multiple SES, self-management, and care factors did little to explain racial/ethnic disparity. Compared with White YA, Black and Hispanic YA had persistent 50-80% lower odds of insulin pump use and Black YA had 70% lower odds of CGM use (OR (95% CI) Pump: Black 0.125 (0.050, 0.313), Hispanic 0.427 (0.176, 1.035); CGM: Black 0.291 (0.121, 0.702)). In contrast, these variables accounted for more of the CGM disparity between White and Hispanic YA (OR (95% CI) 1.007 (0.409, 2.483)). Exploration of factors other than SES and self-management is needed to examine disparity in diabetes technology use, especially in Black YA. Black and Hispanic YA preferences for technology and provider factors should be considered. Disclosure: S. Agarwal: None. C. Schechter: None. J.S. Gonzalez: None. J.A. Long: None. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (K23DK115896) [ABSTRACT FROM AUTHOR]

Previous research has documented racial/ethnic disparity in continuous glucose monitor and insulin pump use in people with T1D. It remains unknown whether disparities result from socioeconomic status or other factors. We recruited 17 YA with T1D from an underserved area (mean age 22, 5 non-Hispanic Black, 12 Hispanic, 88% Medicaid, duration 11 yrs, median HbA1c 9.6%) and conducted semi-structured individual interviews in English or Spanish. We asked questions about how YA were introduced to diabetes technology and what helped them make decisions for use. We developed a standard codebook to direct content analysis and achieved thematic saturation. Our results revealed 3 main themes surrounding information and decisions on technology use: 1) providers were the gateway for information and access; 2) patients were not typically included in decision-making, but were more likely to accept use when they were; and 3) cost was not an issue. Half of participants reported they were never offered or told about diabetes technology in the past despite long diabetes duration. For those with whom technology was discussed, most stated they were not included in the decision process to receive such technology. Some participants reported that providers refused prescription of technology due to lack of demonstration of self-management skills. Still, no alternative options or goal-setting to obtain technology were offered. Some participants desired to learn more about technology but refused to ever start because of perceived extra burden, skepticism of new equipment, or attachment concerns. Very few participants stated they could not afford the technology. Our results suggest that racial/ethnic disparity in technology use may originate at the patient-provider level. Deeper examination of implicit bias in prescribing practices is needed, as well as understanding of minority YA preferences and promotion of shared decision-making. Disclosure: G. Crespo-Ramos: None. V. Miller: None. J.S. Gonzalez: None. A. Jang: None. S. Agarwal: None. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (K23DK115896) [ABSTRACT FROM AUTHOR]

The article presents the position statement of the American Diabetes Association on psychosocial care for people with diabetes. Topics discussed include the general considerations in psychosocial care, situations that warrant referral of a person with diabetes to a mental health provide for evaluation and treatment, and selected measures for the evaluation of psychosocial constructs in the clinical setting.

This study examined responsiveness (change in scores: baseline (T1) - 18 months) of the NeuroQoL to both baseline levels (lagged effects) and change in clinical indicators of neuropathy severity (baseline (T1) - 9 months). Severity of diabetic peripheral neuropathy (DPN) was defined by the Neuropathy Disability Score (NDS; T1 mean=7.4) and Vibration Perception Threshold (VPT; T1 mean=41 volts). Three NeuroQoL scales measured DPN symptoms (pain, diffuse sensorimotor and reduced feeling in the feet), two assessed psychosocial dysfunction (restrictions in activities of daily living (ADL) and interpersonal-emotional burden) and two single-item scores represented DPN-specific and overall QoL judgments. Two sets of multivariate regression analyses, controlling for T1 outcome values and demographic/disease variables, were performed separately for each NeuroQoL scale, each using as predictors both T1 and change in either NDS or VPT scores. 295 adult DPN patients in the US and UK completed the study (mean age 60 y; 71% male). Change in NeuroQoL diffuse sensorimotor symptoms was sensitive to both T1 and change in both NDS and VPT (NDS: T1 coefficient beta (β)=. 16; p=.001; change β=.11; p=.011; VPT: T1 β=. 16; p=.001; change β=.11; p=.011). Change in NeuroQoL symptoms of reduced feeling was sensitive only to T1 NDS and VPT scores (β=.18; p<.001; β=.16; p=.002). Change in NeuroQoL pain scores was not sensitive to either NDS or VPT. Changes in NeuroQoL ADL and interpersonal-emotional burden were sensitive to T1 levels of NDS (β=.18; p=.001; β=.12; p=.006) and VPT (β=.12; p=.036; β=.097; p=.028). Finally, while changes in NeuroQoL DPN-specific and overall QoL judgments were sensitive to both T1 NDS (β.286; p<.001; β=-. 13; p=.005) and change in NDS (β= -.17; p=.002; β=-.11; p=.012), for VPT only T1 levels predicted changes in these QoL judgrnents (β-.19; p<.001; β=-. 17; p=.001). This study provides further support for the validity of NeuroQoL by demonstrating its sensitivity to both lagged effects of and change in DPN severity. ADA-Funded Research [ABSTRACT FROM AUTHOR]

Objective: We examined the association between depression, measured as either a continuous symptom severity score or a clinical disorder variable, with self-care behaviors in type 2 diabetes.Research Design and Methods: We surveyed 879 type 2 diabetic patients from two primary care clinics using the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), the Summary of Diabetes Self-Care Activities, and self-reported medication adherence.Results: Of the patients, 19% met the criteria for probable major depression (HANDS score >or=9), and an additional 66.5% reported at least some depressive symptoms. After controlling for covariates, patients with probable major depression reported significantly fewer days' adherent to diet, exercise, and glucose self-monitoring regimens (P < 0.01) and 2.3-fold increased odds of missing medication doses in the previous week (95% CI 1.5-3.6, P < 0.001) compared with all other respondents. Continuous depressive symptom severity scores were better predictors of nonadherence to diet, exercise, and medications than categorically defined probable major depression. Major depression was a better predictor of glucose monitoring. Among the two-thirds of patients not meeting the criteria for major depression (HANDS score <9, n = 709), increasing HANDS scores were incrementally associated with poorer self-care behaviors (P < 0.01).Conclusions: These findings challenge the conceptualization of depression as a categorical risk factor for nonadherence and suggest that even low levels of depressive symptomatology are associated with nonadherence to important aspects of diabetes self-care. Interventions aimed at alleviating depressive symptoms, which are quite common, could result in significant improvements in diabetes self-care. [ABSTRACT FROM AUTHOR]

Objective: We examined the association between severity of diabetic peripheral neuropathy and depressive symptoms and investigated the potential mediators of this association.Research Design and Methods: The Hospital Anxiety and Depression Scale (HADS) was used to assess depressive symptoms in 494 patients (mean age 62 years; 70% male; 72% type 2 diabetic) with diabetic neuropathy diagnosed by the Neuropathy Disability Score (NDS) and the Vibration Perception Threshold (VPT). Diabetic neuropathy symptoms, activities of daily living (ADLs), and social self-perception were measured by the neuropathy and foot ulcer-specific quality-of-life instrument, NeuroQoL; perceptions of diabetic neuropathy symptom unpredictability and the lack of effective treatment were assessed by the revised Illness Perception Questionnaire.Results: Both the NDS and VPT were significantly associated with the HADS after controlling for demographic and disease variables. Although diabetic neuropathy symptoms mediated this association, with unsteadiness being most strongly associated with HADS, the relationship between foot ulceration and depression was nonsignificant. The association between diabetic neuropathy symptoms and HADS was partially mediated by two sets of psychosocial variables: 1) perceptions of diabetic neuropathy symptom unpredictability and the lack of treatment control and 2) restrictions in ADLs and changes in social self-perception.Conclusions: These findings establish the association between diabetic neuropathy and depressive symptoms and identify potential targets for interventions to alleviate depressive symptoms in persons affected by diabetic peripheral neuropathy. [ABSTRACT FROM AUTHOR]

Background: YA with T1D of racial-ethnic minority disproportionately experience stress related to social determinants of health (SDOH), which may be associated with hyperglycemia, glycemic variability, and poorer emotional well-being. Mobile EMA methodology uses mobile technology to assess contextually relevant, real-time behavioral and self-report data. Methods: Coupled with real-time CGM for two weeks, we employed mEMA methodology with three times daily cell phone-delivered surveys to study the association of momentary variations in SDOH-related stress with glycemia in YA with T1D from the Bronx, NY. We report our preliminary findings on acceptability, feasibility, and adherence of mEMA methodology in this ongoing study. We evaluated adherence by real-time app tracking of mEMA survey completion, and evaluated acceptability and feasibility by post-study questionnaires and qualitative interviews. Results: Thus far, 18 participants have completed the study: (mean age 23 yrs, 11 Hispanic, 7 non-Hispanic Black, mean HbA1c 8.0%). Adherence to assigned daily surveys was high at 85% (753/887 surveys). There were no differences in survey adherence across timepoints. Acceptability was high: participants reported good understanding of mEMA procedures (mean score 4/5 on Likert scale), high satisfaction (mean score 5/5), high willingness to participate again (mean score 5/5), and were very likely to recommend participation to others (mean score 5/5). For feasibility, the most common barrier cited was mEMA app issues (40%, n=7), specifically dropped survey notifications, which interfered with adherence. Conclusions: YA with T1D of racial-ethnic minority demonstrated high adherence, feasibility, and acceptability of mEMA methods, however there were app-related issues that need closer monitoring. mEMA is a viable tool to study real-time contextual and behavioral factors in minority YA with T1D. Disclosure: S. Leung: None. G. Crespo-ramos: None. M. Finnan: None. J. S. Gonzalez: None. S. Agarwal: None. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (5P30DK111022, K23DK115896) [ABSTRACT FROM AUTHOR]

Background: Black and Hispanic YA with T1D are less likely to use insulin pumps and continuous glucose monitors than White peers, which may be contributing to disparities in glycemic and long-term outcomes. Methods: We conducted a series of interactive focus groups to elicit perspectives on racial/ethnic disparities in diabetes technology use, patient-centered barriers and facilitators, and solutions to enhance uptake. We invited multidisciplinary panels of stakeholders to participate, including YA T1D patients, physicians, nurses, psychologists, and community health workers. Sessions were recorded and analyzed for common themes. Results: We convened 7 virtual 2-hour workshops and recruited 32 stakeholders from 11 states (5 Black and 7 Hispanic YA, 20 other stakeholders). Notably, many patients stated that they had never been offered technology until recent engagement in a specialized YA T1D clinic. Once offered technology, multiple barriers were present across a chronological journey consisting of three phases: 1) learning about and deciding to get technology; 2) initiating use; and 3) managing ongoing problems. Some barriers included a lack of knowledge about devices, mismanaged expectations for device wearability and use, and insurance coverage benefits. Facilitators included family support, T1D peer partnership, and a supportive healthcare team. Co-created solutions to address barriers were categorized into four main themes: 1) more equitable system of offering technology; 2) visual and hands-on education; 3) peer support; and 4) insurance navigation assistance. Discussion: Engaging multiple stakeholders with lived experience of the problem is an important approach to diabetes disparities research. Inadvertent provider bias may be preventing equal access to technology for minority YA with T1D, while extra support for device use through the technology journey is needed to sustain use. Disclosure: S. Agarwal: None. G. Crespo-ramos: None. S. Leung: None. M. Finnan: None. T. Park: None. J. S. Gonzalez: None. J. A. Long: None. Funding: National Institutes of Health (K23DK115896) [ABSTRACT FROM AUTHOR]

Ecological momentary assessment (EMA) captures patients' ongoing experiences in natural settings. In type 2 diabetes (T2D), EMA allows us to connect psychological experiences of illness with behavioral and biological processes. We implemented an EMA protocol to assess emotional distress, physical symptoms and diabetes self-care among predominantly ethnic minority and socioeconomically disadvantaged adults with T2D. We then collected qualitative data about patients' experiences. We recruited 51 English-speaking adults receiving treatment for T2D (M(SD), age = 54.3(9.7), 61% Black and 39% Hispanic, 67% female, HbA1c = 8.6(2.4%)), from an urban academic medical center. Patients completed EMA surveys (3/day) via the MyDay smartphone app and used an electronic pill cap that tracked oral medication adherence over 2 weeks. No feedback was provided from the devices. Semi-structured individual interviews were conducted upon study completion. Patients were asked about their experiences and any differences in their diabetes self-care. Interviews were audio-recorded, transcribed, and analyzed for content. A vast majority (88%) would recommend the MyDay app to others. For 90%, it took less than a few days to feel comfortable with the app. About 69% said the app positively influenced their self-care, via more consistent medication-taking and/or blood-glucose monitoring. Some participants (41%) indicated that they encountered a challenge with app use (e.g., lack of internet access, difficulty recalling instructions) and a few (14%) said they felt overwhelmed by study participation. Results suggest that the app was well-received and considered acceptable by a diverse sample who used it over 2 weeks. For some, using the app may have improved self-care. Future research may explore barriers such as limited internet access or technological literacy. This work provides support for the acceptability of technologies for assessing patients' experience with T2D self-management. Disclosure: V.H. Jonas: None. S.R. Fishman: None. M. Sears: None. R. Fang: None. A.G. Asman: None. C.A. Solon: None. H. Mendez-Rodriguez: None. G. Crespo-Ramos: None. C.J. Hoogendoorn: None. S.A. Mulvaney: None. J.P. Crandall: Research Support; Self; Abbott. J.S. Gonzalez: None. [ABSTRACT FROM AUTHOR]

Aim: Polypharmacy, depression, and disease-specific distress are prevalent in type 2 diabetes (T2D). Polypharmacy may add to the emotional burden of treatment. Our group previously showed that insulin use is linked with increased distress; however, few studies have examined polypharmacy in relation to mental health in T2D. The present study examined cross-sectional relationships between the number of medications and emotional distress in a T2D sample. Method: Adults with T2D (N=120, age=56(9.7), 64% female, 25% Hispanic/Latino) self-reported medication regimens and diabetes distress; depression was assessed by clinical interview. Due to severely skewed and kurtotic outcome variables, we used logistic regression with emotional distress dichotomized at clinical cutoffs. Independent relationships were assessed between the total number of medications (oral + insulin) and emotional distress, adjusting for age, sex, presence of diabetes complications, and insulin (yes/no). The moderating effect of insulin was examined. Results: Number of prescribed medications (M=6.5(3.8)) was not associated with depression (OR=1.09 [95% CI: 0.97-1.21]), diabetes (OR=0.97 [95% CI: 0.88-1.07]) or regimen (OR=0.97 [95% CI: 0.88-1.08]) distress. In multivariate models, age was negatively associated with higher odds of depression (OR=0.95 [95% CI: 0.91-0.99]), diabetes (OR= 0.95 [95% CI: 0.91-0.99]) and regimen (OR=0.94 [95% CI: 0.90-0.99]) distress. Diabetes complications were associated with 3.08-fold increased odds (95% CI: 1.28-7.40) of depression. Insulin use did not moderate the relationship between number of medications and emotional distress. Conclusion: The number of prescribed medications was not associated with depression or diabetes distress, suggesting that polypharmacy alone does not account for psychological aspects of perceived disease burden. As age was a notable predictor, younger individuals may be at more risk for the negative psychological impact of T2D and its treatment. Disclosure: C.A. Solon: None. M.Z. Sears: None. C.J. Hoogendoorn: None. E.K. Seng: Consultant; Self; Eli Lilly and Company, GlaxoSmithKline plc. Other Relationship; Self; Haymarket Media. S.A. Margolis: None. J.S. Gonzalez: None. [ABSTRACT FROM AUTHOR]

A correction notice is presented for the article "Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association."

A correction to the article “Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association." that was published in a 2016 issue is presented.