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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.

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.

Introduction: While people with T1D report that blood glucose (BG) fluctuations affect their day-to-day functioning, these relationships are poorly understood. Using continuous glucose monitoring (CGM) , accelerometry, and momentary surveys and cognitive tasks, we sought to understand how various BG metrics during sleeping hours impact functioning the following day. Methods: Participants wore a blinded CGM and accelerometer for 10-14 days, during which they completed surveys and cognitive tasks 5-6 times per day. Using dynamic structural equation modeling, we evaluated the within-person impact of overnight BG on the following day’s functioning, while controlling for the prior day’s functioning. BG variables included % time 250 mg/dL, and coefficient of variation (CV) . Functioning variables included cognitive measures of sustained attention and perceptual speed; daily step count; and self-reported fatigue, task performance, and net activity demand. Results: Among 127 adults with T1D (41±15 yrs, 46% male, 39% Latinx, 35% White, 10% Black, 4% Asian, 12% multiethnic/other) , all three BG variables predicted changes in next day functioning. More time 250 predicted more fatigue (0.09) and lower step count (-0.12) (all p Conclusion: Our findings indicate that overnight BG impacts cognition, physical activity, fatigue, and activity engagement the following day. While effect sizes are small, the cumulative impact of these decrements in function should be considered in the context of a life-long disorder. The consistent findings among diverse outcomes, including both objective and self-report measures, strengthen confidence in the overall conclusion that overnight BG has wide-ranging implications for functioning in adults with T1D. Disclosure E. Pyatak: Research Support; Abbott Diabetes. D. Spruijt-Metz: None. S. Schneider: None. J.P. Crandall: Research Support; Abbott Diabetes. A.L. Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust. Stock/Shareholder; Teladoc Health. Other Relationship; Omada Health, Inc. H. Jin: None. S. Agarwal: Advisory Panel; Medtronic. Consultant; Beta Bionics, Inc. L.T. Pham: None. A. Ali: None. C.J. Hoogendoorn: None. G. Crespo-Ramos: None. R. Basile: None. J.S. Gonzalez: Consultant; Virta Health Corp. Funding National Institutes of Health (1R01DK121298-01)

Introduction: Research links self-efficacy and diabetes distress to suboptimal diabetes self-care and blood glucose (BG) regulation. However, most studies rely on between-person comparisons that cannot rule out confounding by unmeasured variables or capture the dynamic interplay among these variables in real time. Pairing continuous glucose monitoring (CGM) with ecological momentary assessment, we sought to illuminate pathways of influence among these variables in a diverse sample of adults with T1D. Methods: Participants (N=127, 41±15 yrs, 53% women, 39% Latino, 35% White, 10% Black) wore blinded CGM for 10-14 days and completed smartphone surveys 5-6 times per day. Using dynamic structural equation modeling, we evaluated within-person pathways shown in Figure 1. Results: Hypothesized pathways were significant, as were indirect effects of:1) morning self-efficacy on that day’s mean BG via diabetes distress and self-care and2) diabetes distress on mean BG via self-care. Similar results were observed for time in range and SD of BG. Conclusion: Our findings provide novel evidence for a sequential pathway of influence of psychological, emotional, and behavioral variables on BG regulation, observed over time and within individuals. These results provide a roadmap for interventions that target self-efficacy, diabetes distress, and self-care to improve BG regulation among adults with T1D. Disclosure J.S.Gonzalez: Consultant; Virta Health Corp. H.Jin: None. L.T.Pham: None. A.Ali: None. P.Lee: None. V.F.Ruelas: n/a. R.Basile: None. E.Pyatak: Research Support; Abbott Diabetes. D.Spruijt-metz: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. J.P.Crandall: Research Support; Abbott Diabetes. G.Crespo-ramos: None. H.Mendez-rodriguez: None. C.J.Hoogendoorn: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc. Funding National Institutes of Health (1R01DK121298-01; P30 DK111022)

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]). 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 (p0.0001); this effect was only significant for somatic symptoms. Diabetes distress was associated with lower adherence (p=0.0001) and self-management (p0.0001); 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.

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 DERR1-10.2196/30901

Background: YA with T1D of non-Hispanic Black and Hispanic race-ethnicity face unique challenges to diabetes self-management, yet little research acknowledges potentially distinct lived experiences and needs between these racial/ethnic groups. Methods: We recruited Black and Hispanic YA with T1D from adult and pediatric diabetes centers at Montefiore Medical Center in the Bronx, NY to conduct individual semi-structured interviews focusing on barriers and facilitators to diabetes self-management. Interviews were performed telephonically or in person, and recorded and transcribed. A modified inductive coding approach was used to analyze the data for common themes until thematic saturation was achieved. Results: We interviewed 39 YA with T1D (18-25 yrs, 26% Black, 74% Hispanic, mean HbA1c 10.3%). Common T1D self-management barriers between Black and Hispanic YA centered on normative development, including competing priorities and peer acceptance of T1D. Differences in self-management barriers were related to culture and lived experience. Black YA reported major challenges related to social determinants of health, such as food insecurity, insurance lapses, and racial bias in the healthcare system. Meanwhile, Hispanic YA reported challenges related to culture and family, such as difficulty incorporating ethnic food into diabetes dietary guidelines and navigating household intergenerational conflict on management of T1D. Conclusions: Black and Hispanic YA with T1D share common challenges to T1D self-management related to stage of development, but key differences exist between these racial/ethnic groups that should inform future interventions. For Black YA with T1D, addressing social determinants of health is an urgent initial need to help support diabetes self-management while for Hispanic YA, family and food-related conflict management is a priority. Disclosure M. Finnan: None. G. Crespo-ramos: None. S. Agarwal: None. Funding National Institutes of Health (K23DK115896)

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

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

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

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

Objective: Telemedicine has gained popularity as an approach to improve health outcomes by enhancing care delivery to vulnerable populations. However, research is lacking on minority patient preferences for telemedicine, to whom these interventions would likely be offered. In this study, we explored opinions of ethnically diverse, underserved YA with T1D on the use of telemedicine videoconferencing for medical visits. Methods: We conducted semi-structured interviews in 41 YA, ages 18-25, at a major diabetes center in the Bronx, NY. We audio-recorded, transcribed, and coded interviews using content analysis. We achieved thematic saturation. Results: YA participants (53% female, 96% Black or Hispanic, 88% Medicaid) were 21±2.4 yrs, with T1D duration 11±2.3 yrs and mean HbA1c 9.6±1.2%. We found that the overwhelming majority of participants preferred to meet with their healthcare provider in person. Participants cited 3 major reasons for preference of in-person over telemedicine visits: 1) in-person visits felt more personal; 2) meeting in clinic helped YA feel more focused and accountable for past and future diabetes management (particularly if they liked their provider); and 3) it was easier to communicate diabetes issues person-to-person. Few stated a preference for telemedicine visits, however noted convenience and not having to navigate transportation as benefits. Notably, some participants would consider virtual communication with providers between visits, but preferred standard visits to remain in clinic. Conclusions: In this sample of ethnically diverse, underserved YA with T1D, telemedicine visits were not well-accepted. Participants suggested that virtual visits would not provide the same comfort and investment in care as in-person visits. Future interventions using telemedicine as a new mode of care delivery in YA with T1D should consider minority patient preferences. Disclosure P.V. Commissariat: None. G. Crespo-Ramos: None. A. Jang: None. S. Agarwal: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK115896 to S.A.), (P30DK036836 to P.V.C.)

Recent advances in technology facilitate new ways of examining dynamic relationships between experiences, behavior, and glycemic variability that occur over time among individuals with diabetes. These technologies can also be used to guide “just-in-time” adaptive interventions. This chapter provides an overview of the importance of modeling individual trajectories in experience and behavior as related to glycemic variability and discusses how recent developments have simplified assessment of these relationships in the day-to-day life of people with diabetes. We propose that ecological momentary assessment is at the center of tracking patient-reported outcomes (PROs), behavior, and context on a daily basis. This approach allows for new ways to studycomplex associations between peoples’ experiences, mood, behavior, and glycemic control, and examine the role of contextual factors on these associations. However, big data generated by using new assessment technologies to track glucose and PROs pose new challenges for researchers, clinicians, and individuals with diabetes that need to be addressed in order to make these data useful for clinical practice. The insights generated with this approach contribute to the development and advancement of individualized and patient-centered assessment and treatments to improve diabetes outcomes.

BackgroundDiabetes-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 procedureWe 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.ResultsAfter coding, inter-rater reliability (Cohen’s κ) ranged from 0.73 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 the 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.ConclusionsDRS 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.