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.

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 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.

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.

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.

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.

Solutions to Address Inequity in Diabetes Technology Use in Type 1 Diabetes: Results from Multidisciplinary Stakeholder Co-creation Workshops.

Background: Racial-ethnic inequity in type 1 diabetes technology use is well documented and contributes to disparities in glycemic and long-term outcomes. However, solutions to address technology inequity remain sparse and lack stakeholder input. Methods: We employed user-centered design principles to conduct workshop sessions with multidisciplinary panels of stakeholders, building off of our prior study highlighting patient-identified barriers and proposed solutions. Stakeholders were convened to review our prior findings and co-create interventions to increase technology use among underserved populations with type 1 diabetes. Stakeholders included type 1 diabetes patients who had recently onboarded to technology; endocrinology and primary care physicians; nurses; diabetes educators; psychologists; and community health workers. Sessions were recorded and analyzed iteratively by multiple coders for common themes. Results: We convened 7 virtual 2-h workshops for 32 stakeholders from 11 states in the United States. Patients and providers confirmed prior published studies highlighting patient barriers and generated new ideas by co-creating solutions. Common themes of proposed interventions included (1) prioritizing more equitable systems of offering technology, (2) using visual and hands-on approaches to increase accessibility of technology and education, (3) including peer and family support systems more, and (4) assisting with insurance navigation and social needs. Discussion: Our study furthers the field by providing stakeholder-endorsed intervention ideas that propose feasible changes at the patient, provider, and system levels to reduce inequity in diabetes technology use in type 1 diabetes. Multidisciplinary stakeholder engagement in disparities research offers unique insight that is impactful and acceptable to the target population.

"I Didn't Really Have a Choice": Qualitative Analysis of Racial-Ethnic Disparities in Diabetes Technology Use Among Young Adults with Type 1 Diabetes.

Background: Racial-ethnic disparities in diabetes technology use are well documented in young adults (YA) with type 1 diabetes (T1D), but modifiable targets for intervention still need to be identified. Our objective was to explore YA perspectives on technology access and support in routine clinical care. Materials and Methods: Participants were YA with T1D of Hispanic or non-Hispanic Black race-ethnicity from pediatric and adult endocrinology clinics in the Bronx, NY. We conducted semistructured individual interviews to explore how health care and personal experiences affected technology use. Interviews were audio-recorded and transcribed for analysis. We used a modified inductive coding approach with two independent coders and iterative coding processes to improve data reliability and validity. Results: We interviewed 40 YA with T1D: mean age 22 years; 62% female; 72% Medicaid insured; 72% Hispanic; 28% non-Hispanic Black; and mean hemoglobin A1C 10.3%. Themes were categorized into potentially exacerbating and alleviating factors of racial-ethnic disparities in technology use. Exacerbating factors included perceptions that providers were gatekeepers of information and prescription access to technology, providers did not employ shared decision making for use, and YA biases against technology were left unaddressed. Alleviating factors included provider optimism and tailoring of technology benefits to YA needs, and adequate Medicaid insurance coverage. Conclusions: Our results reveal potential intervention targets at the provider level to increase technology uptake among underrepresented YA with T1D. Diabetes health care providers need to be aware of inadvertent withholding of information and prescription access to technology. Provider approaches that address YA technology concerns and promote shared decision making help to mitigate racial/ethnic disparities in technology use.

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.

"They called me a terrorist": Social and Internalized Stigma in Latino Youth with Type 1 Diabetes.

BACKGROUND: Diabetes-related stigma (DRS) globally affects patients' lives. Over a third of adolescents with type 1 diabetes (T1D) in Puerto Rico reported concerns of others knowing about their diabetes and about being different. PARTICIPANTS AND PROCEDURES: We examined DRS among 65 T1D Latino youth (aged 12-17). During a depression-treatment study screening, they answered open-ended questions about diabetes-related concerns/difficulties and issues bothering them while interacting with peers, family, and healthcare professionals because of T1D. Using content analysis, we classified responses into Social Stigma (SS), Internalized Stigma (IS), and No Stigma. Four SS and IS sub-categories were developed. RESULTS: After coding, inter-rater reliability (Cohen's kappa) ranged from .73 to .1.00 (p≤.001). Forty-four youth (67.69%) reported at least one DRS verbalization, and 25 reported more than one. Both SS and IS were identified in 32 (49.23%) adolescents. Among SS experiences were: "they call me a junkie [because of insulin shots]"; "they call me a terrorist [because of insulin pump]". IS verbalizations included: "I've never wanted to accept that I have T1D, so I don't practice good self-care"; "at times I do not feel the same as others". We found more stigma-related verbalizations among those from urban zones or larger families. DRS was related to increased depressive symptoms and risk of a depressive disorder. Peers were the main source of SS. CONCLUSION: DRS was common, pervasive, and linked to depression. This study innovatively examines DRS in an exclusively T1D Latino and adolescent sample. Understanding its extent and nature is essential for developing interventions to address DRS.