Outcomes of New York City Care Calls: A Prospective Randomized Controlled Effectiveness Trial of Telephone-Delivered Type 2 Diabetes Self-Management Support.

PURPOSE: The purpose of the 12-month randomized controlled trial was to evaluate the effectiveness of a Telephonic Self-Management Support (T-SMS) program among adults with type 2 diabetes (T2D). METHODS: Eight hundred twelve adults with T2D participated in NYC Care Calls (mean age = 59.2, SD = 10.8; female = 57%; mean A1C = 9.3, SD = 1.8; Latino = 86%) and were randomly assigned to T-SMS or enhanced usual care (EUC). A1C (primary outcome), blood pressure, and body mass index (secondary outcomes) were extracted from electronic medical records. Secondary patient-reported outcomes, including depressive symptoms, diabetes distress, medication adherence, and self-management activities, were assessed by telephone in English or Spanish. For T-SMS, the number of assigned phone calls was based on baseline A1C, depressive symptoms, and/or diabetes distress. Analyses were conducted under the intention-to-treat principle. RESULTS: A1C decreased over 12 months in both T-SMS (0.72% percentage points; 95% CI, 0.53-0.91) and EUC (0.66% percentage points; 95% CI, 0.46-0.85; Ps < .001). Diabetes distress and self-management also improved over time in both arms (Ps < .05). Compared to EUC, participants in the T-SMS arm did not differ in outcomes. CONCLUSIONS: The T-SMS and EUC groups were found not to have an appreciable outcome difference. It is unclear whether improvements in A1C across both conditions represent a secular trend or indicate that print-based educational intervention may have a positive impact on self-management and well-being.

Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

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.

Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

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.

Does Emotional Distress Predict Worse Glycemic Control Over Time? Results From the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

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.

Rethinking dehumanization, empathy, and burnout in healthcare context.

Dehumanization has been characterized as common in medical settings, despite limited work directly examining this. In this context, everyday dehumanization is believed to be largely unconscious and unintentional, resulting from a variety of factors often related to structural and organizational aspects of healthcare. This article adopts the patients' and the healthcare providers' perspective to explore how dehumanization can have helpful and hurtful effects on patient outcomes and provider well-being. Future directions include more direct assessment of dehumanization in healthcare settings, centering the needs and experiences of people with mental illness and comorbid conditions, and improving our understanding of dehumanization relative to emotion regulation processes.

Within-person relationships of sleep duration with next-day stress and affect in the daily life of adults with Type-1 diabetes.

OBJECTIVE: The objective of this study is to examine the within-person relationships between sleep duration and next-day stress and affect in the daily life of individuals with T1D. METHODS: Study participants were recruited in the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) study. Sleep duration was derived by synthesizing objective (actigraphy) and self-report measures. General and diabetes-specific stress and positive and negative affect were measured using ecological momentary assessment. Multilevel regression was used to examine the within-person relationships between sleep duration and next-day stress and affect. Cross-level interactions were used to explore whether gender and baseline depression and anxiety moderated these within-person relationships. RESULTS: Adults with T1D (n = 166) completed measurements for 14 days. The average age was 41.0 years, and 91 participants (54.8%) were female. The average sleep duration was 7.3 h (SD = 1.2 h). Longer sleep was significantly associated with lower general stress (p < 0.001) but not diabetes-specific stress (p = 0.18) on the next day. There were significant within-person associations of longer sleep with lower levels on next-day negative affect (overall, p = 0.002, disappoint, p = 0.05; sad, p = 0.05; tense, p < 0.001; upset, p = 0.008; anxious, p = 0.04). There were no significant associations with positive affect. Examination of the interaction effects did not reveal significant differential relationships for men and women and for individuals with and without depression or anxiety at baseline. CONCLUSION: Findings from this study suggest optimizing sleep duration as an important interventional target for better managing general stress and improving daily emotional wellbeing of individuals with T1D.

Emotional distress and cardiovascular disease risk among participants enrolled in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study.

AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Impact of Overnight Glucose on Next-Day Functioning in Adults With Type 1 Diabetes: An Exploratory Intensive Longitudinal Study.

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.

Glycemic Risk Index Profiles and Predictors Among Diverse Adults With Type 1 Diabetes.

BACKGROUND: The Glycemia Risk Index (GRI) was introduced as a single value derived from the ambulatory glucose profile that identifies patients who need attention. This study describes participants in each of the five GRI zones and examines the percentage of variation in GRI scores that is explained by sociodemographic and clinical variables among diverse adults with type 1 diabetes. METHODS: A total of 159 participants provided blinded continuous glucose monitoring (CGM) data over 14 days (mean age [SD] = 41.4 [14.5] years; female = 54.1%, Hispanic = 41.5%). Glycemia Risk Index zones were compared on CGM, sociodemographic, and clinical variables. Shapley value analysis examined the percentage of variation in GRI scores explained by different variables. Receiver operating characteristic curves examined GRI cutoffs for those more likely to have experienced ketoacidosis or severe hypoglycemia. RESULTS: Mean glucose and variability, time in range, and percentage of time in high, and very high, glucose ranges differed across the five GRI zones (P values < .001). Multiple sociodemographic indices also differed across zones, including education level, race/ethnicity, age, and insurance status. Sociodemographic and clinical variables collectively explained 62.2% of variance in GRI scores. A GRI score ≥84.5 reflected greater likelihood of ketoacidosis (area under the curve [AUC] = 0.848), and scores ≥58.2 reflected greater likelihood of severe hypoglycemia (AUC = 0.729) over the previous six months. CONCLUSIONS: Results support the use of the GRI, with GRI zones identifying those in need of clinical attention. Findings highlight the need to address health inequities. Treatment differences associated with the GRI also suggest behavioral and clinical interventions including starting individuals on CGM or automated insulin delivery systems.

Within-person Relationships of Sleep Duration with Next-Day Stress and Affect in the Daily Life of Adults with Type-1 Diabetes.

Objective: The objective of this study is to examine the within-person relationships between sleep duration and next-day stress and affect in the daily life of individuals with T1D. Methods: Study participants were recruited in the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) study. Sleep duration was derived by synthesizing objective (actigraphy) and self-report measures. General and diabetes-specific stress and positive and negative affect were measured using ecological momentary assessment. Multilevel regression was used to examine the within-person relationships between sleep duration and next-day stress and affect. Cross-level interactions were used to explore whether gender and baseline depression and anxiety moderated these within-person relationships. Results: Adults with T1D (n=166) completed measurements for 14 days. The average age was 40.99 years, and 91 participants (54.82%) were female. The average sleep duration was 7.29 hours (SD=1.18 hours). Longer sleep was significantly associated with lower general stress (p<0.001) but not diabetes-specific stress (p=0.18) on the next day. There were significant within-person associations of longer sleep with lower levels on next-day negative affect (overall, p=0.002, disappoint, p=0.05; sad, p=0.05; tense, p<0.001; upset, p=0.008; anxious, p=0.04). There were no significant associations with positive affect. Examination of the interaction effects did not reveal significant differential relationships for men and women and for individuals with and without depression or anxiety at baseline. Conclusion: Findings from this study suggest optimizing sleep duration as an important interventional target for better managing general stress and improving daily emotional wellbeing of individuals with T1D.

Diabetes-Related Quality of Life: Learning From Individuals Making Lifestyle Changes to Improve Type 2 Diabetes Control.

PURPOSE: The purpose of this study was to explore how treatment adherence and lifestyle changes required for glycemic control in type 2 diabetes (T2D) are related to quality of life (QoL) among predominantly ethnic minority and socioeconomically disadvantaged adults engaged in making changes to improve T2D self-management. METHODS: Adults with T2D in New York City were recruited for the parent study based on recent A1C (≥7.5%) and randomly assigned to 1 of 2 arms, receiving educational materials and additional self-management support calls, respectively. Substudy participants were recruited from both arms after study completion. Participants (N = 50; 62% Spanish speaking) were interviewed by phone using a semistructured guide and were asked to define QoL and share ways that T2D, treatment, self-management, and study participation influenced their QoL. Interviews were analyzed using thematic analysis. RESULTS: QoL was described as a multidimensional health-related construct with detracting and enhancing factors related to T2D. Detracting factors included financial strain, symptom progression and burden, perceived necessity to change cultural and lifestyle traditions, and dietary and medical limitations. Enhancing factors included social support, diabetes education, health behavior change, sociocultural connection. CONCLUSION: QoL for diverse and socioeconomically disadvantaged adults with T2D is multifaceted and includes aspects of health, independence, social support, culture, and lifestyle, which may not be captured by existing QoL measures. Findings may inform the development of a novel QoL measure for T2D.

Emotional distress, self-management, and glycemic control among participants enrolled in the glycemia reduction approaches in diabetes: A comparative effectiveness (GRADE) study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Depressive symptoms mediate the relationship between diabetes and cognitive performance in a community-based sample of older adults.

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.

Memory complaints moderate the concordance between self-report and electronically monitored adherence in adults with type 2 diabetes.

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 (ß = 0.76, p < 0.001); at high levels of PRMQ the relationship was weaker (ß = 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.

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study.

BACKGROUND: Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D. OBJECTIVE: The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely. METHODS: The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits. RESULTS: The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection. CONCLUSIONS: Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30901.

Distress and Type 2 Diabetes Self-Care: Putting the Pieces Together.

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.

Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support.

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.

Glycemic control and self-rated health among ethnically diverse adolescents with type 1 diabetes.

OBJECTIVE: Patient-reported outcomes have received increased attention as treatment outcomes and indicators of wellbeing. A1c has been criticized as lacking patient-centered relevance because individuals are often unaware of their A1c, and studies also often fail to show a benefit of intensive control on quality of life. The goal of the present study was to examine self-rated health (SRH) in relation to diabetes self-care behaviors, socioeconomic factors, treatment regimen characteristics, and glycemic control among predominately Hispanic and African American adolescents with type 1 diabetes (T1D). METHODS: Adolescents with T1D (N = 84) were recruited for a cross-sectional study evaluating psychosocial factors and identity development. SRH, self-care behaviors, treatment regimen, and demographic variables were collected through self-report while glycemic control (A1c) was determined through chart review. RESULTS: Participants were predominantly racial and ethnic minorities (48% Hispanic, 27% African American; 52% female, M age 15.9, M diabetes duration 6.8, M A1c 10% [86 mmol/mol]). Significant bivariate relationships emerged between SRH and sex, A1c, self-care behavior, and insulin delivery method. Covariate-adjusted regression models showed only A1c was significantly and independently related to SRH. Mediation analyses illustrated a significant indirect effect for A1c between self-care and SRH. CONCLUSION: These findings suggest glycemic control is associated with self-ratings of health among ethnically diverse adolescents with T1D. SRH appears to be an appropriate patient-reported outcome that is sensitive to glycemic control in this population.

Assessing the association of depression and anxiety with symptom reporting among individuals with type 2 diabetes.

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 (ß = .53, p < .001), self-reported depression (ß = .59, p < .001) and self-reported anxiety (ß = .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 (ß = .27, p = .003) was significantly associated with greater attribution to diabetes, whereas clinician-rated depression (ß = .19, p = .047), self-reported depression (ß = .38, p < .001) and anxiety (ß = .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 (ß = .29, p = .023) and medication (ß = .38, p = .004) attribution; anxiety was a significant predictor of medication attribution (ß = .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.

Anticholinergic/sedative drug burden predicts worse memory acquisition in older racially/ethnically diverse patients with type 2 diabetes mellitus.

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.