Background:The Hypoglycemia Awareness Restoration Program for people with type 1 diabetes and problematic hypoglycemia with severe episodes persisting despite optimal care (HARPdoc) uniquely focusses on addressing cognitive and motivational barriers to hypoglycemia avoidance associated with impaired awareness to hypoglycemia. We aimed to compare perceptions of acceptability, feasibility, and appropriateness of HARPdoc intervention to an existing program, Blood Glucose Awareness Training (BGAT) and understand how these implementation outcomes relate to cognitive and mental health clinical outcomes. Methods:The HARPdoc trial was a hybrid randomized clinical trial delivered in the United Kingdom and United States between July 2018 and December 2019. Implementation outcomes, including perceived acceptability, appropriateness, and feasibility, were measured using published validated surveys. These surveys were completed by the people with diabetes, healthcare professionals, and relatives of participants. Clinical outcomes, including attitudes to awareness, diabetes distress, anxiety, and depression, were measured using validated self-reported questionnaires. We explored differences of perceived implementation outcomes between HARPdoc and BGAT and associations between implementation and clinical outcomes using quantile and linear regression. We also assessed whether the effect of HARPdoc on cognitive and mental health outcomes were mediated by implementation outcomes. Results:HARPdoc was perceived as more appropriate than BGAT at 12 months, with a median difference of 0.75 (95% CI 0,26,1,24) by both those involved in delivering the programs and the HARPdoc participants. All stakeholder groups also perceived HARPdoc intervention as more acceptable (MD 0.50 95% CI 0.13, 0.87), but as feasible (MD 0.00; 95% CI -0.31, 0.31) as BGAT. Each of perceived acceptability, appropriateness, and feasibility were significantly linked to improvements in clinical outcomes (feasibility- anxiety: Mean Difference: -1.07; 95% CI: -2.03, -0.10); feasibility-depression (MD: -5.25, 95% CI -9.09, -1.41)). No evidence of mediation was observed. Conclusions:HARPdoc compared to BGAT was perceived as more appropriate and acceptable and subsequently higher perceived appropriateness, acceptability and feasibility was linked to better cognitive and mental health outcomes. Our findings provide important insights for the development of an implementation blueprint and the expansion of HARPdoc and BGAT programs into routine healthcare services and highlight the need for larger, better-powered hybrid trials.

OBJECTIVE:We aimed to explore sex differences in type 1 diabetes management and investigate the perceived need for improved diabetes technology to mitigate the effect of the menstrual cycle on glycemic control in females with type 1 diabetes. RESEARCH DESIGN AND METHODS:A REDCap survey was designed to ask adults with type 1 diabetes about demographics, medical history, diabetes management, and, when applicable, the impact of the menstrual cycle on glycemic control and the extent to which currently available diabetes technology is successful at regulating blood glucose levels across cycle phases. RESULTS:A total of 299 respondents completed the survey. Of these, 218 (72.9%) reported being female. No significant sex differences were detected in reported A1C, glycemic time in range, or diabetes technology used (χ2 tests, all P >0.3). One hundred and thirty-six female respondents reported actively menstruating. Of these, 97 (71.3%) indicated the luteal phase of the menstrual cycle to be the cycle phase that most affected their glycemic control, and 102 (75.0%) reported increased exposure to hyperglycemia during this phase. When asked about technology satisfaction, 68 respondents (50.0%) reported that their diabetes technology was not successful at regulating blood glucose levels across the menstrual cycle, and 88 (64.7%) indicated that the technology they used could be better at mitigating cycle-related metabolic variability. CONCLUSION:Most investigated type 1 diabetes management outcomes showed no significant sex differences. Importantly, 65% of female respondents who were actively menstruating indicated the need for improved diabetes technology to stabilize glycemic control across the menstrual cycle.

Introduction and Objective: To evaluate the impact of psychosocial factors, as assessed by the INSPIRE Questionnaire, and perceptions of technology efficacy (TES metrics) on glycemic outcomes and user acceptance of FCL systems in adults with type 1 diabetes. Methods: Data were analyzed from a cohort of 12 adults with T1D who participated in a 1-week at home study of FCL (NCT06041971). Key psychosocial variables, including INSPIRE baseline, TES Benefit, TES Burden, and TES efficacy, were assessed post FCL intervention and examined in relation to its glycemic outcomes, including Time<54, Time Below Range (TBR), Time in Range (TIR), Time Above Range (TAR), and Time>250 in FCL. Pearson correlations identified significant relationships, and insights were drawn regarding the influence of psychosocial factors and perceived efficacy on glycemic control and satisfaction with the FCL system. Results: Higher INSPIRE scores were significantly associated with lower perceived burden (r = -0.587, p < 0.01), better time-in-range (TIR; r = 0.575, p < 0.05) with reduced hypoglycemic exposure (r = -0.716, p < 0.01). TES Benefit strongly correlated with increased TIR (r = 0.805, p < 0.01) and lower hypoglycemic exposure (r = 0.707, p < 0.01), while higher TES Burden was linked to poorer TIR (r = -0.562, p < 0.05) and more hypoglycemic episodes (r = -0.716, p < 0.01). TES benefit strongly associates with overall system acceptance (r = 0.982, p < 0.01). TES efficacy did not correlate significantly with glycemic outcomes. Conclusion: Higher psychosocial engagement, as reflected by INSPIRE scores, and positive perceptions of system benefit are significantly associated with better glycemic outcomes and acceptance of FCL systems. These findings highlight the need for strategies that reduce burden and enhance benefit perception to optimize FCL system adoption, user satisfaction, and clinical outcomes. A. Fernandes Moura B Batista: None. M. Moscoso-Vasquez: Other Relationship; Dexcom, Inc. Research Support; Tandem Diabetes Care, Inc, National Institute of Diabetes and Digestive and Kidney Diseases. S.A. Brown: Research Support; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc, Tolerion, Roche Diabetes Care. Other Relationship; MannKind Corporation. M.D. DeBoer: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc, Medtronic. L. Gonder-Frederick: Other Relationship; HFS-Global LLC. M.D. Breton: Speaker's Bureau; Sinocare Inc, Tandem Diabetes Care, Inc. Consultant; Roche Diabetes Care, Boydsense. National Institutes of Health (NCT06041971)

The technological progress to date with automated insulin delivery (AID) has ushered in a new era of challenges and opportunities for people with diabetes (PWD), spotlighting implementation considerations. Beyond physiologic and technologic variation, cost, access, and health care professional (HCP) endorsement/experience lead to uneven uptake of AID technologies and attenuate universal ease of use. For AID to be broadly implemented, we must prioritize the lived experience for PWD and consider how to alleviate burden to promote physical/functional health, psychological well-being, and social well-being. Expectations and education help HCPs and PWD navigate the similarities and differences between AID devices, and help find common ties: users need to give the system time to work, learn to trust it, and not try to "trick" the system. Despite these learnings, disparities in uptake exist, both in clinical trials and in routine clinical care. Strategies to proactively address AID disparities must be enacted at multiple levels, including recognizing HCP biases, using clinic-based benchmarking efforts, and addressing insurance and policy barriers, all of which increase in importance as AID becomes more common for people with type 2 diabetes. Furthermore, broader implementation will require comprehensive health care system integration efforts, including new data solutions. Overall, the success of AID requires ongoing transformation of clinical paradigms, with lockstep alignment between PWD and their families, health care professionals, researchers, funders, policy makers, and industry partners.

AIM:Studies on decision support systems (DSS) for type 1 diabetes show low user engagement and marginal glycemic benefits. This work investigates the interplay between human factors and DSS use and efficacy. METHODS:Adults using insulin injections or pump and continuous glucose monitoring (CGM) underwent three 2-month interventions, in randomized order: i) no DSS; ii) informative DSS (iDSS), providing summary feedback for decision-making; iii) prescriptive DSS (pDSS), recommending precise treatment actions. DSS advisory modules included tools for smart bolusing and therapy optimization. Primary outcomes were CGM-derived glycemic metrics. Exploratory analyses investigated the association between glycemic outcomes, DSS use, and psychosocial variables. RESULTS:Fifty-three participants (26 injections, 27 pump) completed the study. Glycemic outcomes did not differ between interventions. However, using iDSS vs no DSS reduced average time >180 mg/dl for participants with lower diabetes-related knowledge (-6 %, p < 0.001) and higher hemoglobin A1c (-6 %, p < 0.01). Emotional distress (p < 0.001) and hypoglycemia worry (p < 0.01) were associated with lower DSS engagement. Participants engaged more with their preferred system (p < 0.01); 40 % of them preferred iDSS. CONCLUSIONS:Personalized feedback (iDSS) may offer an important learning tool, especially for individuals with lower diabetes-related knowledge. Addressing diabetes-related distress and hypoglycemia worry could unlock the full potential of DSS technologies.

Older adults with insomnia face considerable challenges accessing treatment given limited availability to first-line therapy (Cognitive-Behavioral Therapy for Insomnia, CBT-I). This study evaluated the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS), a tailored CBT-I internet intervention for older adults with insomnia, in a 3-arm randomized controlled trial (SHUTi OASIS alone, SHUTi OASIS + stepped support, online patient education [PE]). 311 participants (ages 55-95) were randomized to receive SHUTi OASIS (alone n = 105; with stepped support n = 102), with both conditions reporting significant improvements across post, 6-month, and 12-month follow-ups in insomnia severity compared to those receiving PE (n = 104). Clinically meaningful indices of insomnia response and remission were also higher among those receiving SHUTi OASIS. Those who received SHUTi OASIS also significantly outperformed those receiving PE on secondary outcomes, including sleep onset latency, wake after sleep onset, sleep efficiency, number of awakenings, sleep quality, and fatigue, across most timepoints. Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia treatment for this underserved population.

BACKGROUND:Diabetes ranks among the most common chronic conditions in childhood and adolescence. It is unique among chronic conditions, in that clinical outcomes are intimately tied to how the child or adolescent living with diabetes and their parents or carers react to and implement good clinical practice guidance. It is widely recognized that the individual's perspective about the impact of trying to manage the disease together with the burden of self-management should be addressed to achieve optimal health outcomes. Standardized, rigorous assessment of behavioural and mental health outcomes is crucial to aid understanding of person-reported outcomes alongside, and in interaction with, physical health outcomes. Whilst tempting to conceptualize person-reported outcomes as a focus on perceived quality of life, the reality is that health-related quality of life is multi-dimensional and covers indicators of physical or functional health status, psychological well-being and social well- being. METHODS:In this context, this Consensus Statement has been developed by a collection of experts in diabetes to summarize the central themes and lessons derived in the assessment and use of person-reported outcome measures in relation to children and adolescents and their parents/carers, helping to provide a platform for future standardization of these measures for research studies and routine clinical use. RESULTS:This consensus statement provides an exploration of person-reported outcomes and how to routinely assess and incorporate into clincial research.

Introduction & Objective: Academic medical centers have identified disparities in access to diabetes technology. This analysis performed a self-assessment of potential inequities in access to diabetes technology at this medical center, including CGMs, insulin pumps, and insulin pens, to guide our community outreach efforts. Methods: This study analyzed deidentified EMR data using multivariable logistic regressions to determine the association of social determinants (age, sex, race-ethnicity, insurance, and neighborhood socioeconomic disadvantage) with technology use among adults (ages≥18) with T1D. Results: Of 1,480 patients with T1D seen at UVA Health in 2022, 479 accessed CGMs, 370 used pumps, and 133 used insulin pens. For CGMs, older age (80+ years), Non-Hispanic Black (NHB) race-ethnicity, public insurance and uninsured status related to lesser use/access. For pumps, female gender related to higher usage while NHB race-ethnicity and public insurance and uninsured status were associated with less use. Hispanic ethnicity was associated with higher pen use while Medicare/uninsured status related to with less use. (Fig 1.) Conclusion: The majority of center patients do not use advanced technology for diabetes management, indicating that outreach efforts should target all racial-ethnic/SES groups with extra effort focusing on NHB groups and those with public/no insurance. Disclosure M. Hall: None. C. Rodriguez: None. L. Gonder-Frederick: None. Funding Lomar Foundation

Diabetes technologies, including continuous glucose monitors, insulin pumps, and automated insulin delivery systems offer the possibility of improving glycemic outcomes, including reduced hemoglobin A1c, increased time in range, and reduced hypoglycemia. Given the rapid expansion in the use of diabetes technology over the past few years, and touted promise of these devices for improving both clinical and psychosocial outcomes, it is critically important to understand issues in technology adoption, equity in access, maintaining long-term usage, opportunities for expanded device benefit, and limitations of the existing evidence base. We provide a brief overview of the status of the literature—with a focus on psychosocial outcomes—and provide recommendations for future work and considerations in clinical applications. Despite the wealth of the existing literature exploring psychosocial outcomes, there is substantial room to expand our current knowledge base to more comprehensively address reasons for differential effects, with increased attention to issues of health equity and data harmonization around patient-reported outcomes.

As diabetes technologies continue to advance, their use is expanding beyond type 1 diabetes to include populations with type 2 diabetes, older adults, pregnant individuals, those with psychiatric conditions, and hospitalized patients. This review examines the psychosocial outcomes of these technologies across these diverse groups, with a focus on treatment satisfaction, quality of life, and self-management behaviors. Despite demonstrated benefits in glycemic outcomes, the adoption and sustained use of these technologies face unique challenges in each population. By highlighting existing research and identifying gaps, this review seeks to emphasize the need for targeted studies and tailored support strategies to understand and optimize psychosocial outcomes and well-being.

AIMS:To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS:Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS:Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS:Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

The influence of CLC systems on quality-of-life factors is complex. This study investigates the dynamic relationship between diabetes distress and perceived technology burden in CLC users over a 26-wk period. The study utilized data from clinical trial NCT03563313, in which individuals with T1D used CLC systems. Diabetes distress and technology burden were assessed at three-time points: baseline (wk 0), mid-study (wk 13), and study end (wk 26). Cross-lagged panel models were tested in structural equations to explore the temporal dynamics between diabetes distress and technology burden throughout the research. The structural equation model shown in Figure 1 demonstrated a good fit to the data, with a non-significant chi-square (p = 0.18), Comparative Fit Index of 0.99, Tucker-Lewis Index of 0.98, and Root Mean Square Error of Approximation of 0.07. The model and significant autoregressive and cross-lagged paths indicate that increases in perceived technology burden are associated with subsequent increased diabetes distress. These results show that rising technology burden from CLC predicts higher diabetes distress, impacting life quality and CLC continuation. M. Ganjiarjenaki: None. A. Fernandes Moura B Batista: None. L. Gonder-Frederick: None.