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Objective: People with diabetes have an increased risk of depression, intentional self-injury and self-harm (ISI), and suicide compared with the general population. This study aimed to explore experiences and awareness of health care professionals (HCPs) regarding depression, ISI, and suicide, and understand resource use and needs among HCPs who care for persons with diabetes (PWD). Methods: Health care professionals who see children and/or adults with type 1 diabetes or type 2 diabetes anonymously completed an online survey about their experiences, opinions, barriers, and needs surrounding identification and care of PWD with depression, ISI, and suicide. Results: One hundred twenty-nine HCPs participated. The majority were medical doctors (MDs) or advanced practice providers (APPs). Only a quarter of MDs and APPs felt very comfortable asking about ISI or suicidal ideation (SI), whereas 20% felt they had received appropriate training to support those with ISI or SI. The primary needs reported include more training on how to ask, respond, and support those expressing ISI and SI. Health care professionals reported wanting better access to resources for PWD. Discussion: The HCPs tend to underestimate SI in the diabetes population and rates of training were low. Areas to address include providing education and training to HCPs to improve identification and management of ISI and suicide risk. These data can inform the development of mechanisms to improve discussions of depression and suicide and of resources to help HCPs support PWD.

BACKGROUND: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. METHODS: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. RESULTS: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were “I decided to try something else” (27.8%) followed by “It just didn't help as much as I thought it would” (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. CONCLUSIONS: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).

Objective: To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. Research Design and Methods: A prospective real-world observational study was conducted, which included 558 adults and children (age range 1–71 years, mean HbA1c 6.8% ± 1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months. Results: Mean time-in-range 70–180 mg/dL (TIR) increased from 67% ± 16% at baseline (before starting Loop) to 73% ± 13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval [CI] 5.9%–7.4%; P

OBJECTIVE Disparities in type 1 diabetes related to use of technologies like continuous glucose monitors (CGMs) and utilization of diabetes care are pronounced based on socioeconomic status (SES), race, and ethnicity. However, systematic reports of perspectives from patients in vulnerable communities regarding barriers are limited. RESEARCH DESIGN AND METHODS To better understand barriers, focus groups were conducted in Florida and California with adults ≥18 years old with type 1 diabetes with selection criteria including hospitalization for diabetic ketoacidosis, HbA1c >9%, and/or receiving care at a Federally Qualified Health Center. Sixteen focus groups were conducted in English or Spanish with 86 adults (mean age 42 ± 16.2 years). Transcript themes and pre–focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology and endocrinology care included 1) provider level (negative provider encounters), 2) system level (financial coverage), and 3) individual level (preferences). RESULTS Over 50% of participants had not seen an endocrinologist in the past year or were only seen once including during hospital visits. In Florida, there was less technology use overall (38% used CGMs in FL and 63% in CA; 43% used pumps in FL and 69% in CA) and significant differences in pump use by SES (P = 0.02 in FL; P = 0.08 in CA) and race/ethnicity (P = 0.01 in FL; P = 0.80 in CA). In California, there were significant differences in CGM use by race/ethnicity (P = 0.05 in CA; P = 0.56 in FL) and education level (P = 0.02 in CA; P = 0.90 in FL). CONCLUSIONS These findings provide novel insights into the experiences of vulnerable communities and demonstrate the need for multilevel interventions aimed at offsetting disparities in diabetes.

Background: Diabetes technology use is associated with favorable type 1 diabetes (T1D) outcomes. American youth with public insurance, a proxy for low socioeconomic status, use less diabetes technology than those with private insurance. We aimed to evaluate the role of insurance-mediated provider implicit bias, defined as the systematic discrimination of youth with public insurance, on diabetes technology recommendations for youth with T1D in the United States. Methods: Multi-disciplinary pediatric diabetes providers completed a bias assessment comprised of a clinical vignette and ranking exercises ( n = 39). Provider bias was defined as providers: (1) recommending more technology for those on private insurance versus public insurance or (2) ranking insurance in the top 2 of 7 reasons to offer technology. Bias and provider characteristics were analyzed with descriptive statistics, group comparisons, and multivariate logistic regression. Results: The majority of providers [44.1 ± 10.0 years old, 83% female, 79% non-Hispanic white, 49% physician, 12.2 ± 10.0 practice-years] demonstrated bias ( n = 33/39, 84.6%). Compared to the group without bias, the group with bias had practiced longer (13.4±10.4 years vs 5.7 ± 3.6 years, P = .003) but otherwise had similar characteristics including age (44.4 ± 10.2 vs 42.6 ± 10.1, p = 0.701). In the logistic regression, practice-years remained significant (OR = 1.47, 95% CI [1.02,2.13]; P = .007) when age, sex, race/ethnicity, provider role, percent public insurance served, and workplace location were included. Conclusions: Provider bias to recommend technology based on insurance was common in our cohort and increased with years in practice. There are likely many reasons for this finding, including healthcare system drivers, yet as gatekeepers to diabetes technology, providers may be contributing to inequities in pediatric T1D in the United States.

Objective: A subset of youth with T1D experience ongoing challenges with diabetes self-management, often due to social risk. This 5-site study examined which social factors were associated with hemoglobin A1c (A1c) , specifically in youth with preexisting high A1c. Methods: Youth with T1D for more than 1 year were included if between 12-17 years old and with at least one A1c value ≥10% in the past year. Chart review captured A1c values, and caregivers reported on social risk- with 16 risk variables (e.g., housing security, employment status) in initial analyses. Multivariable linear regression model included A1c from 1 year prior to enrollment as an outcome and backwards stepwise procedure retained covariates with p Results: Participants (n=130) had a mean age of 14.4 (±1.6) years and mean A1c of 11.1 (±1.7) ; 49% reported male gender; 51% self-identified as Non-Hispanic White. A1c prior to study enrollment was predicted to be 0.68 lower in individuals whose caregiver had at least a college education and 0.65 higher when caregivers were divorced or separated. Conclusion: Findings suggest that, in youth with preexisting difficulty with glycemic variability, caregiver education level and marital status are associated with A1c - and, while not causal, may reflect unique value when screening for risk. This cohort will be followed to determine which factors predict future health concerns and associated need for intervention. Disclosure D.V.Wagner: None. L.Yglecias: None. J.J.Flores garcia: None. E.Salcedo-rodriguez: None. A.Torres sanchez: None. P.Dasika: None. J.Viana: None. D.D.Williams: None. D.Ferro: None. M.A.Harris: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. J.Raymond: None. J.C.Wong: Consultant; Provention Bio, Inc., Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. A.Reed: None. D.Naranjo: None. C.Jenisch: None. C.Cruz: None. S.Mitchell: None. Funding JDRF

Objective: Health disparities exist in diabetes technology access for those youth with T1D who experience high social risk, despite likely benefits. Novel Interventions in Children’s Healthcare (NICH) , designed to improve health for youth with T1D experiencing such disparities, has previously been associated with improved diabetes technology access. This study compares diabetes technology use prior to and after NICH referral, and is the first such study to include a control group. Methods: Youth with T1D served by NICH (n=65) and referred youth (“controls”: n=73) across 3 sites were included. EHR data included DKAs, hospitalizations, ED visits, and presence of diabetes technology 1 year prior and 2 years after NICH initiation. No significant demographic differences. Results: Compared to the controls, NICH youth were significantly more likely to gain a CGM and experience significantly greater reductions in hospital admits, DKAs, and ED visits. After accounting for prior differences, only DKA event reduction and CGM access continued to be significant. Youth in NICH also averaged more years with tech access. Conclusion: This study demonstrates that while youth referred to NICH experience substantial barriers to accessing diabetes technology, youth in NICH were more likely to gain CGM access and have fewer DKA events than controls - and neither group approached national averages in technology access. Disclosure J.Lely: None. M.A.Harris: None. D.Naranjo: None. C.Jenisch: None. A.F.Manabat: None. C.Cruz: None. R.Bensen: None. A.Bonilla ospina: None. D.V.Wagner: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

BACKGROUND: Loop is an open-source automated insulin delivery (AID) system, used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. METHODS: Focus groups revealed 72 new and existing users' perspectives on Loop uptake, use, and persistence. A subsample of participants from a mixed-methods, observational cohort study shared first-hand accounts of their experiences using Loop. Participants were predominately white (95%), male (50%), privately insured (94%), and reported annual household income ≥$100K (73%) and education exceeding a bachelor's degree (87%) with a mean HbA1c of 6.6% ± 0.8%. Data were analyzed and synthesized by a multidisciplinary team. RESULTS: Participants detailed their experiences with (1) Loop technical support and troubleshooting, (2) decreased mental/behavioral burden, (3) technical issues with parts of the system, (4) glycemic control, (5) personalizing settings, and (6) providers while using Loop. Decreased burden was the most endorsed benefit defined by less worry, stress, and cognitive effort and less time spent on diabetes management tasks. Participants highlighted the benefits of Loop overnight and their introduction to “Loop communities” during use. The most discussed challenges involved technical issues. A range of provider attitudes and knowledge about Loop complicated users' clinical experiences and disclosure. CONCLUSIONS: This sample of new and experienced Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components, customizing the system to suit one's lifestyle and habits, and adjusting system settings. Challenges related to system setup and calibrating settings are remediable and, if addressed, may better serve Loop users. Users reported feeling empowered by the customizability of and the educational effects facilitated by the open-source AID system. Loop helped users learn more about their chronic illness and physiology in an acceptable format. Clinical Trial Registration number: NCT03838900.

Background: Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox. Methods: In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test. Results: Among 253 179 diagnostic angiograms and 93 614 PCIs, radial access rates increased over time for both diagnostic (17.5%–60.4%; P P P =0.02) but not PCI (3.4%–2.5%, P =0.20). Femoral access patients had a higher predicted risk for bleeding. Conclusions: A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access.

Pediatric diabetes 23(8), 1322-1340 (2022). doi:10.1111/pedi.13443, Published by Wiley-Blackwell, Oxford [u.a.]

Background: Despite the demonstrated benefits of diabetes device use, uptake of insulin pumps and continuous glucose monitors (CGMs) remains quite low. The current study aimed to identify profiles ...

The State of Washington received a State Innovation Models (SIM) $65 million award from the federal Centers for Medicare & Medicaid Services to improve population health and quality of care and reduce the growth of health care costs in the entire state, which has over 7 million residents. SIM is a "complex intervention" that implements several interacting components in a complex, decentralized health system to achieve goals, which poses challenges for evaluation. Our purpose is to present the state-level evaluation methods for Washington's SIM, a 3-year intervention (2016-2018). We apply the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework to structure our evaluation. We create a conceptual model and a plan to use multiple and mixed methods to study SIM performance in the RE-AIM components from a statewide, population-based perspective.

Background: Closed loop (CL) automated insulin delivery systems are demonstrated to be safe and effective in regulating glucose levels and reducing cognitive burden in people with type 1 diabetes (T1D). However, given the limited market options and the do-it-yourself nature of most systems, it can be difficult for potential users to shape their expectations fitting them into daily lives and management routines. As such, we examined the potential feasibility of a virtual reality (VR) intervention. Methods: A four-part VR intervention was created to expose adults with T1D to expected CL system barriers: body image, perceived hassles of using CL, deskilling fears, and unwanted social attention. Goals of the pilot were to assess feasibility and expose patients to CL. Surveys were conducted pre- and postparticipating in the VR experience. Results: A total of 20 adults with T1D completed the pilot. Average time to complete the experience was 14.1 minutes (8.8-39.9). Reported VR sickness was low. Willingness to use VR was maintained in 90% ( n = 18) and did not change expectations of CL in 95% ( n = 19). Virtual reality changed perceived hassles of CL in 25% ( n = 5) with four concerned over alarms and one connectivity issues: positive diabetes technology attitudes, confidence in managing hypoglycemia, overall perceptions of appearance, and positive affect maintained after the VR intervention. Negative affect significantly decreased after exposure and perceptions of being overweight trended toward significance. Conclusion: This pilot VR intervention demonstrated high potential in addressing expected barriers to uptake and usage of CL systems without decreasing enthusiasm or changing expectations of CL.

Background The transradial approach (TRA) to cardiac catheterization is safer than the traditional transfemoral approach (TFA), with similar clinical effectiveness. However, adoption of TRA remains low, representing less than 50% of catheterization procedures in 2015. Peer coaching is one approach to facilitate implementation; however, the costs of this strategy for cardiac procedures such as TRA are unclear. Methods We conducted an activity-based costing analysis (ABC) of a multi-center, hybrid type III implementation trial of a coaching intervention designed to increase the use of TRA. We identified the key activities of the intervention and determined the personnel, resources, and time needed to complete each activity. The personnel cost per hour and the activity duration were then used to estimate the cost of each activity and the total variable cost of the implementation. Fixed costs related to designing and running the implementation were calculated separately. All costs are reported in 2019 constant US dollars. Results The total cost of the coaching intervention implementation was $374,863. Of the total cost, $367,752 were variable costs due to travel, preparatory work, in-person coaching, post-intervention evaluation, and administrative time. We estimated fixed costs of $7112. The mean marginal cost of implementing the intervention at only one additional medical center was $52,536. Conclusions We provide granular cost estimates of a conceptually rooted implementation strategy designed to increase the uptake of TRA for cardiac catheterization. We estimate that implementation costs stemming from the coaching approach would be offset after the conversion of approximately 409 to 1363 catheterizations from TFA to TRA. Our estimates provide benchmarks of the expected costs of implementing evidence-based, but expertise-intensive, cardiac procedures. Trial registration ISRCTN, ISRCTN66341299. Registered 7 July 2020—retrospectively registered

The Washington State Innovation Models (SIM) $65 million Test Award from the Center for Medicareamp; Medicaid Services' Innovation Center is a statewide intervention expected to improve population health, quality of care, and cost growth through four initiatives: 1) regional accountable communities of health linking health and social services to address local needs; 2) a practice transformation support hub; 3) four value-based payment reform pilot projects mainly in state employee and Medicaid populations; and 4) data and analytic infrastructure development to support system transformation with common measures. We develop a conceptual model based on diffusion theory and apply the RE-AIM evaluation framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to structure our evaluation. We find that in three years (2016-2018), SIM built the infrastructure for system transformation and increased Washington's readiness for health system change in the next decade. However, the initiatives have not spread statewide, which may take over 10 years.

Background: Loop is an open-source do-it-yourself (DIY) automated insulin delivery system that allows users unrivaled control over physiologic settings that effect future glucose prediction. Over 9,000 individuals have adopted Loop, but little is known about those who discontinue. Methods: Twenty Loop users (14 adults and 6 caregivers; 60% female, 85% white, 75% household income >$100k/year, and HbA1c 6.7±1.0%) participated in semi-structured interviews about their experiences with Loop following discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Prominent themes reflected the perception that the stress, effort and/or time required to set up Loop and achieve management goals exceeded potential benefits. Two quotes: “I couldn’t spend any more time trying to work on my settings and trying to make it better,” and “I know I could get an improvement with it, but the problem was the cost of it⋯I couldn’t concentrate anymore at work⋯it felt like fog in my brain.” Technical issues with component devices, connectivity issues, lack of technical support, cost (time, energy, supplies), fear of provider disapproval, concerns related to pregnancy, exercise, hypoglycemia and managing low insulin doses, and desire to try other new technologies were among other reasons for ending use. Participants indicated that improved technical assistance and expert guidance might lead to them to use Loop again in the future. Conclusions: For those who manage to set up Loop there are additional challenges, even among individuals with adequate glycemic control and access to various financial, social, and personal resources. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Disclosure J. J. Wong: None. S. Suttiratana: Employee; Spouse/Partner; CVS Health. M. S. Lanning: None. A. Dunlap: None. S. Hanes: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. D. Naranjo: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Objective: Advancements in technology (insulin pumps, CGMs) for youth with type 1 diabetes (T1D) hold promise for better outcomes, but multiple barriers to access exist, especially for underserved and underrepresented populations. Novel Interventions in Children’s Healthcare (NICH), was designed to improve health for youth with T1D and social vulnerabilities. NICH is associated with improvements in glycemic control and reductions in complications (DKA), but less is known regarding technology access for participating youth. This study aims to 1) identify prevalence of technology use prior to and after NICH initiation and 2) examine the relationship between technology access and NICH outcomes. Methods: Youth with T1D served by NICH (n=65) across three distinct geographical sites were included. EHR review included T1D complications (DKA), HbA1c values, and presence of T1D technology one year prior and two years following initiation of NICH services. Mean age was 15.0 years (SD=3.5); 52% female; 73% non-Hispanic White. Results: Ten percent of youth had access to technology prior to NICH (pump=8%; CGM=2%), and 22% had access to technology 2 years post NICH initiation (pump=17%; CGM=14%). Youth were significantly more likely to gain access to CGMs (p Conclusion: With rates of access hovering around 40% for CGMs and 50% for pumps, this study demonstrates that 1) youth referred to NICH experience substantial barriers to accessing T1D technology, 2) NICH participation is associated with increased access to T1D technology for socially vulnerable youth, and 3) despite program involvement, technology access inequities persist. Disclosure J. Lely: None. M. A. Harris: None. D. Naranjo: None. C. Jenisch: None. W. C. Cadiz: None. R. Bensen: None. J. Viana: None. D. V. Wagner: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; BUILD EXITO Foundation; Central Oregon Health Council

Background: Loop is an open-source AID system used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. Methods: Focus groups illuminated 72 new and experienced users’ perspectives on Loop uptake, use and persistence. Participants were predominately white (95%), male (50%), privately insured (94%), reported annual household income ≥ $100K (73%) and education exceeding a bachelor’s degree (87%) with a mean HbA1c of 6.6±0.8%. Twenty discontinuers who stopped using Loop during the study (60% female, 85% white, 85% privately insured) completed interviews. Qualitative data, collected as part of the larger observational study, were analyzed and synthesized by a multidisciplinary team. Results: High frequency thematic content described experiences with: a) technical support and troubleshooting, b) decreased mental/behavioral burden, c) technical issues with parts of the system, d) glycemic control, e) personalizing settings, and f) providers while using Loop. Users also emphatically highlighted the effects of Loop on overnight experiences and the role that “Loop communities” played during use. Decreased burden was the most endorsed benefit characterized by less worry, stress, and cognitive effort; less time spent on diabetes management tasks, and more space to think about nondiabetes aspects of life. The most discussed drawback was having technical issues with any part of the system including challenges with insulin pumps, CGMs, infusion sites, signal loss, the app, and/or the algorithm. A range of provider attitudes and knowledge about Loop complicated users’ disclosure and experiences. Conclusions: This sample of Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components and adjusting settings. Users reported being empowered by the customizability and educational effects of the open-source AID system. Disclosure S. Suttiratana: Employee; Spouse/Partner; CVS Health. J. J. Wong: None. M. S. Lanning: None. A. Dunlap: None. S. Hanes: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. D. Naranjo: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background: Access to psychosocial services is limited, especially during a pandemic. A Zoom-delivered family-based intervention for adolescents with type 1 diabetes has the potential to enhance access to psychosocial services. Methods: Nine families enrolled in a pilot of a 6-session online (Zoom) intervention for adolescents with type 1 diabetes and their parents during the COVID-19 pandemic. Qualitative and quantitative data were collected via online focus groups and surveys. Results: Teens’ ages ranged from 12-17 years (M=14.9, SD=1.76) and most self-identified as male (78%). All parents self-identified as female and most families self-identified as non-Hispanic white (78%). Qualitative results revealed that participants found the program to be generally helpful and would recommend the program to others. Perceived benefits included increased parental empathy toward teens, enhanced parental involvement in teens’ diabetes management, and decreased parent-teen conflict. Participants conveyed that these benefits were particularly impactful given increased family contact and tensions related to the COVID-19 pandemic. Identified areas for improvement included adding follow-up group sessions with parents to maintain program impact on parenting over time and to target teens in early adolescence, when family dynamics are more malleable. Quantitative results from paired t-tests of pre-post comparisons revealed no significant differences in teen or parental diabetes distress or depression (all p>0.05), but should be interpreted with caution due to small sample size. Conclusions: Adolescents with type 1 diabetes and their parents responded positively to this program and found it particularly relevant during the current pandemic. Zoom delivery of these programs may be instrumental in their feasibility, acceptability, and ultimately dissemination in the future. Disclosure J. J. Wong: None. M. S. Lanning: None. J. Ngo: None. C. A. Wu: None. S. Hanes: None. H. M. Linzmeyer: None. D. Naranjo: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1K23DK121771-01A1)

The Project Extension for Community Healthcare Outcomes (ECHO™) model addresses disparities by empowering primary care provider (PCPs), through tele-education, to meet the needs of underserved communities lacking access to subspecialty care. Given the rapid replication of this model, it is vital to understand the perspectives of participating PCPs to refine program implementation. Project ECHO™ Type 1 Diabetes (T1D) program was piloted in Florida and California with >15 Federally Qualified Health Centers (FQHC). PCPs completed pre/post-test surveys assessing knowledge and confidence in T1D care. Exit surveys and focus groups were conducted to understand their experiences (N=92 providers, 41 from FL and 51 from CA were queried). Qualitative analysis of open-ended survey feedback and thematic analysis of focus group data used the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies five domains that affect intervention implementation - including internal and external factors to the healthcare organization. Pre/post surveys demonstrated significant improvements in providers’ diabetes knowledge; mean ± SD change in score for an 11-item knowledge evaluation from pre/post: (1.0 ± 1.8, [Min: -2, Max: +5], p-value: 0.0003) and increase in overall confidence evaluated on a 4-point likert scale (0.6 ± 0.4 [Min: -0.1, Max: 1.6] p-value Disclosure A. F. Walker: None. S. L. Filipp: None. K. Turner: None. G. L. Zori: None. J. Maizel: None. N. Cuttriss: Consultant; Self; Cecelia Health. L. G. Baer: None. L. Figg: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. M. Basina: None. M. J. Haller: Board Member; Self; SAB Biotherapeutics, Inc., Consultant; Self; MannKind Corporation, Other Relationship; Self; Janssen Pharmaceuticals, Inc., Sanofi. J. J. Wong: None. K. Yabut: None. D. Naranjo: None. E. Lewit: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. E. Sheehan: None. S. C. Westen: None. C. Anez-zabala: None. X. Roque: None. B. C. Fitzgerald: None. A. Bernier: None. M. J. Gurka: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background Cost is a major consideration in the uptake and continued use of diabetes technology. With increasing use of automated insulin delivery systems, it is important to understand the specific cost-related barriers to technology adoption. In this qualitative analysis, we were interested in understanding and examining the decision-making process around cost and diabetes technology use. Materials and methods Four raters coded transcripts of four stakeholder groups using inductive coding for each stakeholder group to establish relevant themes/nodes. We applied the Social Ecological Model in the interpretation of five thematic levels of cost. Results We identified five thematic levels of cost: policy, organizational, insurance, interpersonal, and individual. Equitable diabetes technology access was an important policy-level theme. The insurance-level theme had multiple sub-themes which predominantly carried a negative valence. Participants also emphasized the psychosocial burden of cost specifically identifying diabetes costs to their families, the guilt of diabetes related costs, and frustration in the time and involvement required to ensure insurance coverage. Conclusion We found broad consensus in how cost is experienced by stakeholder groups. Cost considerations for diabetes technology uptake extended beyond finances to include time, cost to society, morality, and interpersonal relationships. Cost also reflected an important moral principle tied to the shared desire for equitable access to diabetes technology. Knowledge of these considerations can help clinicians and researchers promote equitable device uptake while anticipating barriers for all persons living with type 1 diabetes and their families.

OBJECTIVE To assess the association between debt burden and self-reported suicide attempt among US adults. METHODS Data from the National Epidemiologic Survey on Alcohol and Related Conditions-III (2012-2013) were used to estimate the association between self-reported past-year debt burden and past-year and lifetime suicide attempt with logistic regression, controlling for sociodemographic characteristics with known associations with debt burden and suicide attempt. RESULTS Among 36,278 adults aged ≥ 18 years, 13.03% reported past-year debt burden, 0.37% reported past-year suicide attempt, and 5.16% reported lifetime suicide attempt. Self-reported attempt was more likely for persons reporting debt burden than for those without (eg, for past-year suicide attempt: odds ratio [OR] = 7.96 [95% CI, 5.45-11.64; P

Determinando como piedra angular de todo el sistema de información en todos los niveles de atención de salud a una historia clínica de calidad, concordamos que es un tema esencial en nuestra práctica diaria, conceptualizando a una historia clínica adecuadamente confeccionada como la constancia escrita de todos los exámenes médicos, estudios realizados y tratamientos aplicados durante el transcurso de la enfermedad , el obtuvo principal del estudio fue conocer el grado de cumplimentación de la historia clínica en el Servicio de Consulta Externa de una Unidad de Primer Nivel de Atención, para evaluar áreas de mejora. Se realizó un Estudio descriptivo transversal, con análisis del porcentaje de cumplimentación de veinte variables en 147 ingresos atendidos en la consulta externa de la Unidad Anidad Chunchi durante 6 meses. Para el análisis de datos se creó una base de datos en Microsoft Excel 2016. De las 20 variables analizadas en el presente estudio se encontró que, en cuanto a la calidad de la documentación clínica utilizada, los datos clínico-estadísticos y la fecha de atención estaban presentes en el 100%, antecedentes familiares (73%), antecedentes personales de interés (82%), hábitos tóxicos (8%), motivo de consulta (95%), el diagnóstico, las órdenes terapéuticas y los signos vitales (100%). El 96% de las historias incluían las hojas de evolución. El 86% de las historias clínicas tenían realizadas el post consulta por parte de enfermería. El 59% de la documentación revisada es legible sin dificultad y el 41% es legible con alguna dificultad. El 68% de las historias clínicas poseían los formularos llenados de manera correcta de acuerdo con la edad. La calidad del registro es variable, aceptable en codificación diagnóstica, datos estadísticos y fecha de atención y deficitaria en antecedentes personales, hábitos, a pesar de la alta cumplimentación (>95%) de motivo de consulta y juicio clínico, se subraya la relevancia del incumplimiento del llenado documentario en un 41 % con datos legibles y comprensibles.

Aims: This study examined the psychosocial impact of Loop, an open-source automated insulin dosing system that has emerged from the diabetes technology “Do-It-Yourself” (DIY) movement. Methods: Subsamples of 239 adults, 115 children, and 243 parents completed data collection at the time of Loop initiation and 3 and 6 months later. Surveys collected demographic and clinical information, percent time-in-range, HbA1c, and validated psychosocial measures. Analyses included paired t tests and McNemar’s tests to compare psychosocial functioning at 3 and 6 months and regression models to assess baseline predictors of psychosocial outcomes at 6 months. Results: Adults reported significant improvements in diabetes distress ( t = −7.20 P < .001; t = −8.01, P < .001), sleep quality ( t = 6.81, P < .001; t = 2.98, P = .003), fear of hypoglycemia ( t = −4.42, P < .001; t = −4.97, P < .001), and hypoglycemia confidence ( t = 8.68, P < .001; t = 7.96 P < .001) from baseline to 3 months and 6 months, respectively. Significant improvements in parents’ and children’s sleep quality and parents’ fear of hypoglycemia were also observed. Several baseline characteristics were associated with psychosocial outcomes at 6 months. Conclusions: The current findings support the broad and sustained benefits of Loop across multiple aspects of psychosocial well-being. Advancement and dissemination of such technologies has the potential to improve mental and physiological health among people living with type 1 diabetes.

OBJECTIVE Limited research has examined the impact of technology on intimacy and relationships among individuals with type 1 diabetes (T1D). The current study examined the experiences of individuals with T1D and their partners and evaluated the expectations for how advances in technology such as automated insulin delivery systems may impact physical intimacy. METHOD The Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) study is a multisite study examining expectations for automated insulin delivery systems among adults and youth with T1D as well as partners and caregivers. For the current analysis, data regarding the impact of diabetes on relationship intimacy were extracted from focus groups or individual semistructured interviews with adults with T1D (n = 113) and partners of individuals with T1D (n = 55). RESULTS Three independent coders conducted thematic analysis utilizing NVivo software. Two primary themes were identified: vulnerability in romantic relationships because of managing diabetes and the unique challenges of physical intimacy because of the use of diabetes technology. CONCLUSIONS Participants expressed the hope that diabetes technology, and automated insulin delivery systems in particular, will offer opportunities for flexibility in their diabetes management. These options may decrease their sense of vulnerability through provision of greater control over diabetes management and when/whether to disclose diabetes, minimizing discomforts in the context of sexual intimacy, and reduction of fear about diabetes complications. Patient-reported outcomes and expectations for diabetes technology should be incorporated into patient-provider conversations about sensitive issues. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Objective: to explore the self-reported medical and psychological factors associated with sexual health for men with diabetes.Research Design and Methods: an online survey was distributed via social media platforms including Twitter, Facebook and LinkedIn and remained open for four weeks. The survey contained 45 items including free text response questions so that participants could provide further detail to their responses if desired, including the 20-item validated diabetes-related sexual complications items [xx] (see supplementary material for full survey). Descriptive and inferential statistical analyses were conducted using SPSS.24 with content and thematic analyses conducted on free text responses. Results: 100 participants completed the survey, aged 20-73 years (mean 45.4 years) with a diabetes duration of 1-62 years (mean 23.07 years), 90% had type 1 diabetes. 49% reported diabetes had led to a loss of self-esteem, 62% said it had a negative effect on relationships with a partner, 41% felt less attractive and 46% reported it had led to loneliness. Free text responses reflect depth of feeling and considerable negative psychosocial impact of diabetes and associated sexual health issues. Erectile dysfunction was common (66%) however over a third of those participants had not sought help (42%). Oral medications removed spontaneity for half of participants (n=58) who had taken it (n=29).Conclusions: sexual health issues continue to pose challenges for men with diabetes both medically and psychologically. The psychosocial aspects of diabetes and sexuality, including feeling unattractive both physically and emotionally are widely reported by participants, demonstrating the damaging and distressing personal consequences.

Aims Psychosocial screenings are recommended and increasingly common in pediatric subspecialty clinics, though little is known about their acceptability. This study seeks to uncover profiles of acceptability and assess demographic and clinical correlates among adolescents with diabetes. Methods A sample of 124 adolescents (57.7% female) ages 12–21 years (M = 16.2 ± 2.3) completed screenings during routine diabetes appointments. K-means clustering of responses to acceptability items derived profiles; Analysis of Variance (ANOVA) and Chi-square tests assessed correlates. Results Adolescents with the most common profile (72.6%) placed high importance on medical providers’ awareness of their emotions and reported no difficulties/discomfort with the screener. These youth had moderate depressive symptoms, low diabetes distress, and low A1c. Those who fit a less common profile (18.5%) were uncomfortable with the screener and had the highest depressive symptoms and lowest A1c. Youth who fit a smaller profile (6.5%) endorsed technical difficulties and had high depressive symptoms and lowest diabetes distress. The smallest profile (2.4%, N = 3) had difficulty understanding and experienced discomfort with the screening and had the lowest depressive symptoms and the highest diabetes distress and A1c. These differences in depressive symptoms (F = 3.54, p = .017), A1c values (F = 4.03, p = .009), and diabetes distress (F = 3.27, p = .036) were significant though differences in age, gender, and diabetes duration were not. Conclusions Most youth responded favorably to in-clinic psychosocial screenings. Youth who were less satisfied were at increased risk for psychosocial and medical complications. Findings highlight areas of need, such as enhanced support with and an emphasized rationale for screenings, which may improve patient experience in subspecialty care.

Disparities in the use of CGMs and insulin pumps in T1D based on socioeconomic status (SES) and race/ethnicity are pronounced. However, systematic reports of perspectives from patients in vulnerable communities are limited. To better understand barriers, focus groups were conducted in Florida and California with adults with T1D. Selection criteria included hospitalization for DKA, HbA1C >9%, or receiving care at a Federally Qualified Health Center. A total of 16 focus groups were conducted in English or Spanish with 86 adults (Table 1). Transcript themes and pre-focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology included: (1) provider-level (overtly blocked/discouraged by provider) (2) system-level (financial barriers related to coverage) and (3) individual-level (difficulty with use or preference issues). In Florida there was less technology use overall (38% had used CGMs in FL, 63% in CA; 43% had used pumps in FL, 69% in CA) and significant differences in pump use by SES (P=0.02 in FL, P=0.08 in CA) and race/ethnicity (P=0.01 in FL, P=0.80 in CA). In California there were significant differences in CGM use by race/ethnicity (P=0.05 in CA, P=0.56 in FL) and education level (P=0.02 in CA, P=0.90 in FL). These findings provide novel insights and demonstrate the need for multi-level interventions and further research on variations in technology use based on geographic location. Disclosure A.F. Walker: None. N. Cuttriss: None. M.J. Haller: Advisory Panel; Self; SAB Biotherapeutics, Inc. S.L. Filipp: None. K. Yabut: None. C. Anez-Zabala: None. K.K. Hood: Research Support; Self; Dexcom, Inc. Speaker’s Bureau; Self; LifeScan, Inc., MedIQ. X. Roque: None. D. Naranjo: None. G. Aulisio: None. A. Addala: None. S. Look: None. M.J. Gurka: None. D.M. Maahs: Advisory Panel; Self; Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S. Consultant; Self; Abbott, Sanofi. Research Support; Self; Bigfoot Biomedical, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background: Psychosocial screening is recommended and increasingly common, but little is known about youths’ perspectives on screenings. Methods: One hundred and twenty-four adolescents (57.7% female) ages 12-21 years (M=16.2±2.3) completed routine, clinic-integrated screenings. K-means clustering derived profiles and ANOVA assessed correlates profiles. Results: Four distinct profiles emerged (Table 1). Profiles varied by depression (F=3.54, p=0.017), diabetes distress (F=3.27, p=0.036), and A1c values (F=4.03, p=0.009). Majority (72.6%) placed high importance on diabetes teams awareness about their emotions and reported no difficulties/discomfort (Embracers). Those uncomfortable with screening (Avoiders) were most depressed and had lowest A1C. Youth who endorsed difficulties with tablet and placed low importance about team awareness about their emotions (Skeptics) had relatively high depression but least diabetes distress. A small fourth group (Strugglers; n=3) must be interpreted with caution due to size. No differences were found for age, gender, diabetes duration/type, race/ethnicity, self-rated global health, or anxiety. Conclusions: Most youth responded favorably to in-clinic psychosocial screenings. Those less satisfied may have increased mental health risk and may benefit from technical support and an emphasized rationale for screenings. Disclosure J.J. Wong: None. S. Hanes: None. M.S. Lanning: None. M.L. Tanenbaum: None. D. Naranjo: None. K.K. Hood: Research Support; Self; Dexcom, Inc. Speaker’s Bureau; Self; LifeScan, Inc., MedIQ.

The State of Washington received a State Innovation Models (SIM) $65 million award from the federal Centers for MedicareMedicaid Services to improve population health and quality of care and reduce the growth of health care costs in the entire state, which has over 7 million residents. SIM is a "complex intervention" that implements several interacting components in a complex, decentralized health system to achieve goals, which poses challenges for evaluation. Our purpose is to present the state-level evaluation methods for Washington's SIM, a 3-year intervention (2016-2018). We apply the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework to structure our evaluation. We create a conceptual model and a plan to use multiple and mixed methods to study SIM performance in the RE-AIM components from a statewide, population-based perspective.

For people with type 1 diabetes (T1DM), regular exercise can be highly beneficial. Although\ud exercise has been shown to improve quality of life and health for people living with T1DM,\ud there are common barriers. To examine such issues, we explored the perceived impact that\ud automated insulin delivery systems could have on people with T1DM and their families.\ud One common theme found was hopes, expectations and impact on sports and exercise. Four\ud sites (United States: three; UK: one) were involved in this study. Two hundred and eighty-four\ud participants were recruited across all sites; participants comprised: children (9–11 years);\ud adolescents (12–18 years); parents/caretakers of children and adolescents with T1DM; adults\ud with T1DM (18–77 years); and their significant others/partners. Between May and December\ud 2015, focus groups and semi-structured interviews were conducted and analysed using\ud content analysis. Three themes found related to the benefits of automated insulin delivery\ud systems: (a) more freedom and spontaneity in the individual’s ability to exercise; (b) relief\ud from worry of hypoglycaemia as a result of exercise; (c) removing the ‘guesswork’ of\ud adjusting insulin for exercise. Two further themes emerged relating to potential concerns\ud with regard to safely exercising while wearing an automated insulin delivery system. Further\ud research is encouraged with a view to providing accurate algorithms and increasing\ud confidence for those using automated insulin delivery systems and, in turn, for their exercise\ud colleagues and loved ones.

International audience; Glycemic control in type 1 diabetes mellitus (T1DM) remains a challenge for many, despite the availability of modern diabetes technology. While technologies have proven glycemic benefits and may reduce excess mortality in some populations, both mortality and complication rates remain significantly higher in T1DM than the general population. Diabetes technology can reduce some burdens of diabetes self-management, however, it may also increase anxiety, stress, and diabetes-related distress. Additional workload associated with diabetes technologies and the dominant focus on metabolic control may be at the expense of quality-of-life. Diabetes is associated with significantly increased risk of suicidal ideation, self-harm, and suicide. The risk increases for those with diabetes and comorbid mood disorder. For example, the prevalence of depression is significantly higher in people with diabetes than the general population, and thus, people with diabetes are at even higher risk of suicide. The Center for Disease Control and Prevention reported a 24% rise in US national suicide rates between 1999 and 2014, the highest in 30 years. In the United Kingdom, 6000 suicides occur annually. Rates of preventable self-injury mortality stand at 29.1 per 100 000 population. Individuals with diabetes have an increased risk of suicide, being three to four times more likely to attempt suicide than the general population. Furthermore, adolescents aged 15 to 19 are most likely to present at emergency departments for self-inflicted injuries (9.6 per 1000 visits), with accidents, alcohol-related injuries, and self-harm being the strongest risk factors for suicide, the second leading cause of death among 10 to 24 year olds. While we have developed tools to improve glycemic control, we must be cognizant that the psychological burden of chronic disease is a significant problem for this vulnerable population. It is crucial to determine the psychosocial and behavioral predictors to uptake and continued use of technology in order to aid the identification of those individuals most likely to realize benefits of any intervention as well as those individuals who may require more support to succeed with technology.

Background: Diabetes devices such as insulin pumps and continuous glucose monitoring (CGM) are associated with improved health and quality of life in adults with type 1 diabetes (T1D). However, uptake remains low. The aim of this study was to develop different “personas” of adults with T1D in relation to readiness to adopt new diabetes technology. Methods: Participants were 1498 T1D Exchange participants who completed surveys on barriers to uptake, technology attitudes, and other psychosocial variables. HbA1c data was available from the T1D Exchange for 30% of the sample. K-means cluster analyses grouped the sample by device barriers and attitudes. The authors assigned descriptive labels based on cluster characteristics. ANOVAs and chi-square tests assessed group differences by demographic and psychosocial variables (eg, diabetes duration, diabetes distress). Results: Analyses yielded five distinct personas. The d-Embracers (54% of participants) endorsed few barriers to device use and had the highest rates of device use, lowest HbA1c, and were the least distressed. The Free Rangers (23%) had the most negative technology attitudes. The Data Minimalists (10%) used pumps but had lower CGM use and did not want more diabetes information. The Wary Wearers (11%) had lower overall device use, were younger, more distressed, endorsed many barriers, and had higher HbA1c. The High Distress (3%) group members were the youngest, had the shortest diabetes duration, reported the most barriers, and were the most distressed. Conclusion: These clinically meaningful personas of device readiness can inform tailored interventions targeting barriers and psychosocial needs to increase device uptake.

Female sexual health remains a much‐neglected area in diabetes clinical medicine; however, it is important for psychological and social well‐being as well as reproductive function. We aimed to explore the views of women regarding the impact of diabetes on sexual health beyond pregnancy and reproduction. We conducted an online survey distributed via social media platforms including Twitter, Facebook and LinkedIn; the survey remained open for four weeks. Questions addressed a range of medical and psychological factors including body image, self‐esteem and confidence. A total of 258 participants, aged 18–73 years, completed the survey. Results show a significant deterioration over the past 20 years, with issues including negative impact on self‐esteem (68.6%) and relationships (61.6%), feeling less attractive (57.8%), feeling lonely/isolated (66.3%), worries about fertility (52.7%) and pregnancy (69.4%), and worry about diabetes being passed on to children (79.5%). Medical factors included vaginal infections (77.9%), dyspareunia (51.2%), and general orgasmic problems (57.4%). Almost half (49.2%) were unaware that these problems were more common in women with diabetes. Shorter duration of diabetes was negatively associated with self‐esteem (p It was concluded that sexual health issues continue to pose challenges for women with diabetes in terms of medical and psychological challenges. The psychosocial aspects of diabetes and sexuality, including feeling unattractive both physically and emotionally are widely reported by participants, demonstrating the very damaging and distressing personal consequences.

OBJECTIVE The purpose of this study was to rigorously explore psychosocial factors associated with automated insulin delivery systems among people living with type 1 diabetes. RESEARCH DESIGN AND METHODS Across four sites in the U.S. and U.K., 284 participants completed structured interviews or focus groups on expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems. Recorded audio files were transcribed and analyzed using NVivo. RESULTS Three themes were identified as critical for uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption. Children and adolescents with type 1 diabetes primarily identified needs specific to their life stage and social contexts (e.g., school). Adults with type 1 diabetes, parents of youth with type 1 diabetes, and partners of adults with type 1 diabetes were most concerned about the accuracy, adaptability, and algorithm quality alongside expectations that systems stabilize glucose levels and reduce risk for long-term complications. CONCLUSIONS Incorporating stakeholder perspectives on use of automated insulin delivery systems will improve the adoption of devices, quality of life, and likelihood of optimal health. Efforts to build trust in systems, optimize user-system interactions, and provide clear guidance about device capabilities and limitations may help potential users achieve optimal glycemic outcomes.

Background Despite growing attention to diabetes throughout Asia, data from Southeast Asia are limited. This article reports rates of diabetes, hypertension and obesity in Cambodia. Methods Two studies were conducted across different regions of Cambodia: a 2012 screening study across urban, semi-urban and rural areas that used point of care capillary glucose for determination of diabetes (n = 13,997) and a 2005 epidemiological study with random selection from two main urban areas that used oral glucose tolerance tests for determination of diabetes (n = 1,863). Blood pressure and anthropometrics were also measured. Results In the screening study, urban sites showed significantly higher rates of diabetes than rural sites; semi-urban rates were intermediate. There was a significant dose–response effect for urbanicity on overweight, obesity, and waist-to-hip ratio with higher rates for urban vs semi-urban and semi-urban vs rural locales. Rural sites had the lowest hypertension rates followed by urban and then semi-urban. Among persons who screened positive for diabetes, there was a dose–response effect for urbanicity on undiagnosed diabetes; rates of previously undiagnosed diabetes were lowest in urban (51%) vs semi-urban (55%) vs rural locales (67%). Rural participants reported the highest rates of smoking and alcohol use. In the urban epidemiological study, prevalence rates of diabetes and impaired glucose tolerance were approximately 10%, indicating a prevalence of total glucose intolerance of approximately 20%. Conclusions Diabetes rates in Cambodia are high and disproportionately affect urban residents. A public health response is urgently needed; as development continues, rates of diabetes are expected to rise.

Automated closed loop systems will greatly change type 1 diabetes management; user trust will be essential for acceptance of this new technology. This qualitative study explored trust in 32 individuals following a hybrid closed loop trial. Participants described how context-, system-, and person-level factors influenced their trust in the system. Participants attempted to override the system when they lacked trust, while trusting the system decreased self-management burdens and decreased stress. Findings highlight considerations for fostering trust in closed loop systems. Systems may be able to engage users by offering varying levels of controls to match trust preferences.

Purpose The first hybrid closed loop (HCL) system, which automates insulin delivery but requires user inputs, was approved for treatment of type 1 diabetes (T1D) by the US Food and Drug Administration in September 2016. The purpose of this study was to explore the benefits, expectations, and attitudes of individuals with T1D following a clinical trial of an HCL system. Methods Thirty-two individuals with T1D (17 adults, 15 adolescents) participated in focus groups after 4 to 5 days of system use. Content analysis generated themes regarding perceived benefits, hassles, and limitations. Results Some participants felt misled by terms such as “closed loop” and “artificial pancreas,” which seemed to imply a more “hands-off” experience. Perceived benefits were improved glycemic control, anticipated reduction of long-term complications, better quality of life, and reduced mental burden of diabetes. Hassles and limitations included unexpected tasks for the user, difficulties wearing the system, concerns about controlling highs, and being reminded of diabetes. Conclusion Users are willing to accept some hassles and limitations if they also perceive health and quality-of-life benefits beyond current self-management. It is important for clinicians to provide a balanced view of positives and negatives to help manage expectations.