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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]

Aim: Undiagnosed diabetes is more prevalent among racial/ethnic minorities in the United States (U.S.). Despite the proliferation of risk scores, few have been validated in Hispanics populations. The aim of this study is to systematically review published studies that developed risk scores to identify undiagnosed Type 2 Diabetes Mellitus based on self-reported information that were validated for Hispanics in the U.S.Methods: The search included PubMed, EMBASE, Cochrane and CINAHL from inception to 2016 without language restrictions. Risk scores whose main outcome was undiagnosed Type 2 diabetes reporting performance measures for Hispanics were included.Results: We identified three studies that developed and validated risk scores for undiagnosed diabetes based on questionnaire data. Two studies were conducted in Latin America and one in the U.S. All three studies reported adequate performance (area under the receiving curve (AUC) range between0.68and 0.78). The study conducted in the U.S. reported a higher sensitivity of their risk score for Hispanics than whites. The limited number of studies, small size and heterogeneity of the combined cohorts provide limited evidence of the validity of risk scores for Hispanics.Conclusions: Efforts to develop and validate risk prediction models in Hispanic populations in the U.S are needed, particularly given the diversity of thisfast growing population. Healthcare professionals should be aware of the limitations of applying risk scores developed for the general population on Hispanics. [ABSTRACT FROM AUTHOR]

We examined emotional distress in relation to metformin adherence, overall diabetes self-management, and glycemic control among adults with early type 2 diabetes (T2DM) enrolled in the GRADE study. Linear regression models examined cross-sectional associations of baseline depression symptoms and diabetes distress with adherence to metformin, self-management, and HbA1c, adjusting for covariates. Cognitive-affective (e.g., sadness) and somatic (e.g., sleep/appetite disturbance) depression symptoms and diabetes distress subscales were also examined. This substudy of 1,739 GRADE participants (56 % Non-Hispanic White, 18 % Non-Hispanic Black, 17 % Hispanic, 68 % male, mean[SD] age = 57.96[10.22] years, diabetes duration = 4.21[2.81] years, and HbA1c = 7.51[0.48]) found that the prevalence of clinically significant depression and diabetes distress was 8.7 % and 25 %, respectively. Fully adjusted models showed that depression symptoms were associated with lower self-management (p < 0.0001); this effect was only significant for somatic symptoms. Diabetes distress was associated with lower adherence (p = 0.0001) and self-management (p < 0.0001); effects were significant for all subscales, except physician-related distress. No significant relationships of total depression symptom severity or diabetes distress with HbA1c were found. Depression symptoms and diabetes distress were robustly associated with problematic diabetes self-management among participants in GRADE. These findings highlight the need for routine assessment of depression symptoms and diabetes distress early in T2DM care. [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]

Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6–12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology. [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: 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]

Background: Spouses often attempt to influence patients' diabetes self-care. Spousal influence has been linked to beneficial health outcomes in some studies, but to negative outcomes in others.Purpose: We aimed to clarify the conditions under which spousal influence impedes glycemic control in patients with type 2 diabetes. Spousal influence was hypothesized to associate with poorer glycemic control among patients with high diabetes distress and low relationship quality.Methods: Patients with type 2 diabetes and their spouses (N = 63 couples) completed self-report measures before patients initiated a 7-day period of continuous glucose monitoring. Mean glucose level and coefficient of variation (CV) were regressed on spousal influence, diabetes distress, relationship quality, and their two- and three-way interactions.Results: The three-way interaction significantly predicted glucose variability, but not mean level. Results revealed a cross-over interaction between spousal influence and diabetes distress at high (but not low) levels of relationship quality, such that spousal influence was associated with less variability among patients with low distress, but more among those with high distress. Among patients with high distress and low relationship quality, a 1 SD increase in spousal influence predicted a difference roughly equivalent to the difference between the sample mean CV and a CV in the unstable glycemia range.Conclusions: This was the first study to examine moderators of the link between spousal influence and glycemic control in diabetes. A large effect was found for glucose variability, but not mean levels. These novel results highlight the importance of intimate relationships in diabetes management. [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.

Depressive symptoms are prevalent among people with type 2 diabetes (T2D) and, even at low severity levels, are associated with worse diabetes outcomes. Carbohydrate restriction is an effective treatment for T2D but its long-term impacts on depressive symptoms are unclear. In the current study we explored changes in depressive symptoms over 2 years among 262 primarily non-depressed T2D patients participating in a continuous remote care intervention emphasizing carbohydrate restriction. Subclinical depressive symptoms decreased over the first 10 weeks and reductions were maintained out to 2 years. Increased frequency of blood ketone levels indicative of adherence to low carbohydrate eating predicted decreases in depressive symptoms. Concerns have been raised with recommending restrictive diets due to potential negative impacts on quality-of-life factors such as mood; however, results of the current study support positive rather than negative long-term impacts of closely monitored carbohydrate restriction on depressive symptoms. [ABSTRACT FROM AUTHOR]

Aims: Elevated depressive symptoms are common among adults with type 2 diabetes (T2D). In a secondary analysis from an RCT of a diabetes self-management support intervention that did not target depressive symptoms, we sought to determine if depressive symptoms were reduced by the intervention (i.e., depressive symptoms an outcome) or, alternatively, if intervention effects on hemoglobin A1c were lesser among persons with clinically elevated depressive symptoms (i.e., depressive symptoms an effect modifier).Methods: We evaluated a text messaging intervention, REACH, in a diverse (half non-white, half underinsured) sample of N = 506 adults with T2D. Participants completed the Patient Health Questionnaire-8 (PHQ) and A1c tests at baseline and 6 months. We conducted a factor analysis to identify somatic- and cognitive-affective symptoms on the PHQ. We tested our hypotheses with regression models, using interaction terms and subgroup analyses.Results: REACH improved depressive symptoms among participants with lower baseline A1c (<8.5%; β = -0.133, p = .007; cognitive β = -0.107, p = .038; somatic β = -0.131, p = .014) but not among participants with higher baseline A1c (≥8.5%; β = 0.040, p = .468). Baseline depressive symptoms did not modify the effect on A1c.Conclusions: We found support for the hypothesis that depressive symptoms - both somatic- and cognitive-affective - may be an outcome, rather than an effect modifier, of effective diabetes self-management support interventions. [ABSTRACT FROM AUTHOR]

Background: Conflicting research emphasizes depression, diabetes distress, or well-being in relation to diabetes self-care and risk for poor health outcomes.Purpose: The purpose of this study was to test whether a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being predicts a latent variable of diabetes self-care and to examine evidence for unique effects once shared effects are adjusted for.Methods: Adults with suboptimally controlled diabetes were recruited from the South Bronx, NY, for a telephonic diabetes self-management support trial. Baseline diabetes self-care, medication adherence, depression symptoms, diabetes distress, and well-being were measured by validated self-report. Structural equation modeling specified a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being. Diabetes self-care was a latent variable indicated by diet, glucose self-monitoring, and medication adherence.Results: Participants (N = 627, 65% female) were predominantly ethnic minority (70% Hispanic; 45% Black) and 77% reported household income <$20K/year. Mean (standard deviation) age = 56 (12) years; A1c = 9.1% (1.9%); body mass index = 32 (8) kg/m2. The latent variable for psychological distress was a robust predictor of poorer diabetes self-care (coefficient = -0.59 [confidence interval = -0.71, -0.46], p < .001) with good model fit. Unique paths from depression symptoms, diabetes distress, and well-being (all ps > .99) to self-care were not observed.Conclusions: In this population of disadvantaged adults with suboptimally controlled diabetes, general psychological distress was strongly associated with poorer diabetes self-care and fully accounted for the effects of depression, diabetes distress, and positive well-being. This suggests that general distress may underlie previously reported associations between these constructs and diabetes self-care. [ABSTRACT FROM AUTHOR]

Depression and anxiety have been linked to increased somatic symptoms among individuals with type 2 diabetes (T2D), but their independent effects and role in symptom attributions remain unclear. This study examined depression and anxiety in relation to total symptoms and symptom attributions in a diverse sample of 120 adults with T2D. Multiple linear regression tested associations after controlling for medical comorbidities and insulin use. Clinician-rated depression (β =.53, p <.001), self-reported depression (β =.59, p <.001) and self-reported anxiety (β =.62, p <.001) were positively associated with total somatic symptoms. Models adjusting for depression and anxiety revealed significant independent effects for each, regardless of measurement method. In attribution models, only self-reported depression (β =.27, p =.003) was significantly associated with greater attribution to diabetes, whereas clinician-rated depression (β =.19, p =.047), self-reported depression (β =.38, p <.001) and anxiety (β =.28, p =.004) were associated with increased attribution to medications. In models adjusting for depression and anxiety, self-reported depression was a significant independent predictor of diabetes (β =.29, p =.023) and medication (β =.38, p =.004) attribution; anxiety was a significant predictor of medication attribution (β =.25, p =.039). Findings suggest depression and anxiety are implicated in overall increases in somatic symptom complaints and an increased tendency to attribute these symptoms to diabetes and side-effects of diabetes medications among adults with T2D. [ABSTRACT FROM AUTHOR]

Objective: Anticholinergic/sedative drug use, measured by the Drug Burden Index (DBI), is linked to cognitive impairment in older adults. Yet, studies on the DBI's association with neuropsychological functioning are lacking, especially in underserved groups at increased risk of cognitive impairment. We examined cross-sectional relationships between total DBI (DBIT ) and an age-adjusted analogue (Adj DBIT ) with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) in diverse adults with type 2 diabetes mellitus (T2DM). Based on results of a prior study, we anticipated higher DBIs would be associated with worse memory at older ages.Methods: One hundred five adults with T2DM (age = 57 ± 9 years, 65% female, 62% Black, 27% Hispanic/Latino, HbA1c = 7.8 ± 1.8) participated. Although memory outcomes were normally distributed, DBIT values were positively skewed. Spearman correlations assessed their bivariate relationships with RBANS. Adjusting for comorbidities, polypharmacy, HbA1c , and education, we tested the moderating effect of age on DBI-RBANS associations at mean ±1 standard deviations of age.Results: One third of the participants endorsed current sedative/anticholinergic use. Mean DBIT was 0.385, and mean Adj DBIT was 0.393 (ranges = 0.00-4.22). Drug burden negatively correlated with RBANS Immediate Memory (DBIT rs = -0.237, P = .013; Adj DBIT rs = -0.239, P = .014) but no other indices. There was a significant DBI*Age interaction; the negative effect of drug burden on Immediate Memory was significant for ages greater than or equal to 55 years old.Conclusions: Sedative/anticholinergic drug exposure was prevalent in these diverse T2DM patients. Adjusting for covariates, greater drug burden was associated with worse memory acquisition among older adults only. Prospective studies should examine these relationships over time and assess whether dementia biomarkers affect the interaction. [ABSTRACT FROM AUTHOR]

People with type 2 diabetes (T2DM) have an increased risk of cardiovascular disease (CVD). We examined depressive symptoms (DS) and diabetes distress (DD) in relation to the estimated 10-year risk of CVD in adults with T2DM enrolled in the GRADE Emotional Distress Substudy. Linear regression models examined the associations of baseline DS and DD with estimated 10-year risk of CVD using the Atherosclerotic Cardiovascular Disease (ASCVD) risk score, adjusting for age, sex, race/ethnicity, education, income, diabetes duration, diabetes-related complications, and HbA1c. A total of 1,605 GRADE participants were included: 54% Non-Latino (NL) White, 18% Latino, 19% NL-Black, 66% male, mean age 57.5 (SD = 10.25) years, diabetes duration 4.2 (SD = 2.8) years, and HbA1c 7.5% (SD = 0.5%). After incorporating covariates, only DS, especially cognitive-affective symptoms, were associated with ASCVD risk (estimate = 0.15 [95% CI: 0.04, 0.025], p = 0.006). Higher DS remained significantly associated with higher ASCVD risk when adding DD to covariates (estimate = 0.19 [95% CI: 0.07, 0.30], p = 0.002). DD was not associated with ASCVD risk when accounting for covariates. Depressive symptoms, particularly cognitive-affective symptoms, are associated with increased 10-year predicted ASCVD risk among adults with early T2DM. Diabetes distress is not significantly associated with the predicted ASCVD risk when accounting for covariates. [ABSTRACT FROM AUTHOR]

Aims: Research suggests differential effects for somatic and cognitive-affective depressive symptoms in predicting health outcomes. This study evaluated differential relations with medication non-adherence among disadvantaged, and predominantly immigrant adults with sub-optimally controlled type 2 diabetes (T2D).Methods: Health plan members taking oral diabetes medication and who had A1c ≥ 7.5% were recruited for a trial of telephonic self-management support. A subset (n = 376; age, M = 55.6 ± 7.2 years; A1c M = 9.1% ± 1.6) completed the Patient Health Questionnaire-8 (PHQ-8). Diabetes medication adherence was measured by self-report and claims-based records. Multivariable logistic regression modeled depressive symptoms and odds of non-adherence using pre-intervention data.Results: A positive PHQ-8 screen (OR = 2.72 [95%CI: 1.56-4.73]) and each standard deviation increase in PHQ-8 score (OR = 1.40 [95%CI: 1.11-1.75]) were associated with non-adherence, with no independent effects for somatic versus cognitive-affective symptoms. Exploration of individual symptoms identified three significantly associated with non-adherence in covariate-adjusted models; after adjustment for likely presence of clinical depression, only fatigue was independently associated with non-adherence (OR = 1.71 [95%CI: 1.06-2.77]).Conclusions: Findings support depression symptom severity as a significant correlate of medication non-adherence among disadvantaged adults with T2D. Support was limited for differential associations for symptom dimensions, but findings suggest that fatigue may be associated with non-adherence independent of the likely presence of depression. [ABSTRACT FROM AUTHOR]

Introduction: Scalable self-management interventions are necessary to address suboptimal diabetes control, especially among minority populations. The study tested the effectiveness of a telephone behavioral intervention in improving glycemic control among adults with diabetes in the New York City A1c Registry.Design: RCT comparing a telephone intervention to print-only intervention in the context of the A1c Registry program.Setting/participants: Nine hundred forty-one adults with diabetes and hemoglobin A1c (A1c) >7% from a low-income, predominantly Latino population in the South Bronx were recruited from the A1c Registry.Intervention: All study participants were mailed print diabetes self-management materials at baseline and modest lifestyle incentives quarterly. Only the telephone participants received four calls from health educators evenly spaced over 1 year if baseline A1c was >7%-9%, or eight calls if baseline A1c was >9%. Medication adherence was the main behavioral focus and, secondarily, nutrition and exercise.Main Outcome Measures: Primary outcome was difference between two study arms in change in A1c from baseline to 1 year. Secondary outcomes included diabetes self-care activities, including self-reported medication adherence. Data were collected in 2008-2012 and analyzed in 2012-2014.Results: Participants were predominantly Latino (67.7%) or non-Latino black (28%), with 69.7% foreign-born and 55.1% Spanish-speaking. Among 694 (74%) participants with follow-up A1c, mean A1c decreased by 0.9 (SD=0.1) among the telephone group compared with 0.5 (SD=0.1) among the print-only group, a difference of 0.4 (95% CI=0.09, 0.74, p=0.01). The intervention had significant effect when baseline A1c was >9%. Both groups experienced similar improvements in self-care activities, medication adherence, and intensification.Conclusions: A telephone intervention delivered by health educators can be a clinically effective tool to improve diabetes control in diverse populations, specifically for those with worse metabolic control identified using a registry. This public health approach could be adopted by health systems supported by electronic record capabilities. CLINICALTRIALS.Gov Registration: NCT00797888. [ABSTRACT FROM AUTHOR]

Aims: We examined the impact of memory complaints on the concordance between self-report (SR) and electronically monitored (EM) medication adherence, independent of depression symptoms, among adults with type 2 diabetes (T2D).Methods: Adults (N = 104, age = 56.6 ± 9.2; 64% female) completed a prospective and retrospective memory questionnaire (PRMQ) and a depression symptom interview at baseline. EM was tracked over 3 months and participants rated adherence using SR. Multiple linear regression evaluated PRMQ as a moderator of the relationship between EM and SR, adjusting for depression and other covariates.Results: PRMQ was correlated with lower SR (r = -0.31, p = 0.001), but not with EM. PRMQ moderated the relationship between SR and EM, independent of depression symptoms. At low levels of PRMQ, SR and EM were closely related (β = 0.76, p < 0.001); at high levels of PRMQ the relationship was weaker (β = 0.28, p = 0.02). Participants who under-reported their adherence (SR < EM) had higher PRMQ scores than more concordant reporters (p = 0.016).Conclusions: SR and EM measures were less concordant among adults with T2D who endorsed higher PRMQ scores. Memory complaints may contribute to under-reporting of medication adherence in adults with T2D. [ABSTRACT FROM AUTHOR]

Aims: To evaluate whether diabetes and prediabetes are associated with impaired cognitive performance among older adults and examine depressive symptoms as a mediator.Methods: We used cross-sectional data from the Einstein Aging Study, a systematically recruited, community-based cohort study of diverse older adults (N = 794; Age Mean (SD) = 78.9 (5.3); 64.4% Non-Hispanic White, 28.7% Non-Hispanic Black, 5.7% Hispanic). Diabetes status was established via self-reported diagnosis, prescribed medications, and fasting blood glucose. Depressive symptoms were assessed using the Geriatric Depression Scale. Cognitive tests included Digit Symbol, Trails-B, Free Recall, Category Fluency, Boston Naming, and Block Design. Linear regression and mediation analyses were applied.Results: Compared to those without diabetes, diabetes was associated with worse performance on all cognitive tests (ps < 0.05), except Trails-B (p = 0.53), and increased depressive symptoms (p < 0.01). For diabetes, mediation via increased depressive symptoms was observed for Free Recall (p = 0.044), Category Fluency (p = 0.033), and Boston Naming (p = 0.048).Conclusions: Diabetes was consistently associated with worse cognitive performance and increased depressive symptoms among this older cohort, while prediabetes was not. Mediation findings suggest depressive symptoms may be a biobehavioral pathway linking diabetes and cognition, though the temporal sequence is unclear. If causal, addressing both diabetes and depressive symptoms among older adults may protect cognitive function. [ABSTRACT FROM AUTHOR]

Emotional distress, including depression and diabetes-specific distress (e.g., feeling overwhelmed by living with diabetes, feelings of failure related to diabetes self-care), is a significant and prevalent problem for patients with type 2 diabetes. Both depression and diabetes distress have been associated with metabolic/glycemic control, diabetes complications, mortality, and quality of life. Recent findings further suggest that risk for emotional distress is influenced by diabetes treatment. The GRADE Study (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is generating prospective data that will provide a unique opportunity to examine the relationships between emotional distress, diabetes treatment, and outcomes in an experimental design. The GRADE study is a randomized clinical trial that will compare the metabolic effects of four common anti-hyperglycemic drugs when combined with metformin. This sub-study recruited a subset (n = 1739) of GRADE participants and will examine patient-level variation in baseline emotional distress as a predictor of glycemic control and other health outcomes, independent of treatment effects. The study will also provide an experimental examination of treatment regimen effects on emotional distress over time as part of the overall evaluation of comparative effectiveness. Evaluation of emotional distress using validated measures will allow us to disentangle the roles of depressive symptoms and diabetes distress, factors that share significant overlap but require distinct approaches to screening and treatment. Study findings may directly influence practice decisions regarding screening and treatment for emotional distress as part of diabetes care. ClinicalTrials.gov Identifier: NCT01794143 [ABSTRACT FROM AUTHOR]