Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

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.

Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial.

BACKGROUND/OBJECTIVE: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D). METHODS: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed. Analysis focused on the treatment subgroup (n = 21) who received the much more reliable CamAPS FX hardware iteration and their contemporaneous control group (n = 24). Lifetime complications and costs were simulated via an updated Sheffield T1D policy model. RESULTS: Within-trial, both groups had indistinguishable and statistically unchanged health-related quality of life, and statistically similar hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis (DKA) event rates. Total health care utilization was higher in the treatment group. Both the overall treatment group and CamAPS FX subgroup exhibited improved HbA1C (-0.32%, 95% CI: -0.59 to -0.04; P = .02, and -1.05%, 95% CI: -1.43 to -0.67; P < .001, respectively). Modeling projected increased expected lifespan of 5.36 years and discounted quality-adjusted life years (QALYs) of 1.16 (U.K. tariffs) and 1.52 (U.S. tariffs) in the CamAPS FX subgroup. Estimated ICERs for the subgroup were £19 324/QALY (United Kingdom) and -$3917/QALY (United States). For subgroup patients already using continuous glucose monitors (CGM), ICERs were £10 096/QALY (United Kingdom) and -$33 616/QALY (United States). Probabilistic sensitivity analysis generated mean ICERs of £19 342/QALY (95% CI: £15 903/QALY to £22 929/QALY) (United Kingdom) and -$28 283/QALY (95% CI: -$59 607/QALY to $1858/QALY) (United States). CONCLUSIONS: For children and adolescents with T1D on insulin pump therapy, AID using the Cambridge algorithm appears cost-effective below a £20 000/QALY threshold (United Kingdom) and cost saving (United States).

Patient reported outcomes (PROs) and user experiences of young children with type 1 diabetes using t:slim X2 insulin pump with control-IQ technology.

OBJECTIVE: Examine patient-reported outcomes (PROs) after the use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children with type 1 diabetes. METHODS: Children with type 1 diabetes, ages 2 to < 6 years (n = 102), were randomly assigned 2:1 to either CIQ or standard care (SC) with pump or multiple daily injections (MDI) plus continuous glucose monitoring (CGM) for 13 weeks. Both groups were offered to use CIQ for an additional 13 weeks after the randomized control trial's (RCT) completion. Guardians completed PRO questionnaires at baseline, 13-, and 26-weeks examining hypoglycemia concerns, quality of life, parenting stress, and sleep. At 26 weeks, 28 families participated in user-experience interviews. Repeated measures analyses compared PRO scores between systems used. RESULT: Comparing CIQ vs SC, responses on all 5 PRO surveys favored the CIQ group, showing that CIQ was superior to SC at 26 weeks (p values < 0.05). User-experience interviews indicated significant benefits in optimized glycemic control overall and nighttime control (28 of 28 families endorsed). All but 2/28 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their children to continue using CIQ. CONCLUSIONS: Families utilizing CIQ experienced glycemic benefits coupled with substantial benefits in PROs, documented in surveys and interviews. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate the benefit of CIQ in young children with type 1 diabetes that goes beyond documented glycemic benefit.

Satisfaction with diabetes involvement: Exploring parent and adolescent perspectives.

AIMS: Both parent and adolescent involvement in type 1 diabetes management are critical during adolescence. The current study sought to understand the factors associated with parent and adolescent satisfaction with their own and one another's involvement in diabetes management. METHODS: Cross-sectional baseline data from 157 parent-adolescent dyads enrolled in an RCT were used. Adolescent ages ranged from 12 to 19 (Mage = 14.7, SD = 1.89) and were balanced by gender (50.3% male). Paired t-tests examined concordance between parent and adolescent satisfaction, bivariate correlations identified correlates, and regressions examined unique associations. RESULTS: Roughly, 43% of adolescents and 29% of parents were very satisfied with adolescent involvement in diabetes management, whereas 71% of adolescents and 26.1% of parents were very satisfied with parent involvement. Indicators of better glycaemic health (via higher percent time-in-range and lower HbA1c and percent time in hyperglycaemia) and psychosocial functioning (less diabetes distress and depression) were correlated with higher satisfaction. Parent satisfaction with adolescent involvement was higher among older adolescents (R = 0.198, p = 0.013). Non-Hispanic white youth were more satisfied with their own involvement than youth of colour (t(149) = -2.783, p = 0.003). Both percent time-in-range and one's own diabetes distress uniquely related to parent and adolescent satisfaction with adolescent involvement. Conversely, parent satisfaction with their own involvement was only uniquely associated with parent diabetes distress. CONCLUSION: Both adolescent and parents' satisfaction with adolescents' involvement in self-management are indicators of both glycaemic control and psychosocial well-being, whereas parents' self-evaluations are more closely tied to diabetes-specific distress.

"It changed everything we do": A mixed methods study of youth and parent experiences with a pilot exercise education intervention following new diagnosis of type 1 diabetes.

AIMS: This pilot study delivered a comprehensive exercise education intervention to youth with new-onset type 1 diabetes (T1D) and their parents to increase knowledge and confidence with physical activity (PA) shortly after diagnosis. METHODS: Youth initiated continuous glucose monitoring (CGM) and PA trackers within 1 month of diagnosis. Youth and their parents received the 4-session intervention over 12 months. Participants completed self-report questionnaires at baseline, 6- and 12-months. Surveys were analyzed using linear mixed effects models. Semi-structured interviews and focus groups explored experiences with the exercise education intervention. Groups and interviews were audio-recorded, transcribed, and analyzed using content analysis. RESULTS: A total of 16 parents (aged 46 ± 7 years; 88 % female; 67 % non-Hispanic White) and 17 youth (aged 14 ± 2 years; 41 % female; 65 % non-Hispanic White) participated. Worry about hypoglycemia did not worsen throughout the study duration. Parents and youth reported increased knowledge and confidence in managing T1D safely and preventing hypoglycemia during PA following receiving the tailored exercise education intervention. CONCLUSION: This study assessed a novel structured exercise education program for youth and their parents shortly following T1D diagnosis. These results support the broad translation and acceptability of a structured exercise education program in new-onset T1D.

Diabetic Ketoacidosis at Diagnosis in Youth with Type 1 Diabetes Is Associated with a Higher Hemoglobin A1c Even with Intensive Insulin Management.

Introduction: Diabetic ketoacidosis (DKA) at diagnosis is associated with short- and long-term complications. We assessed the relationship between DKA status and hemoglobin A1c (A1c) levels in the first year following type 1 diabetes (T1D) diagnosis. Research Design and Methods: The Pilot Teamwork, Targets, Technology, and Tight Control (4T) study offered continuous glucose monitoring to youth with T1D within 1 month of diagnosis. A1c levels were compared between historical (n = 271) and Pilot 4T (n = 135) cohorts stratified by DKA status at diagnosis (DKA: historical = 94, 4T = 67 versus without DKA: historical = 177, 4T = 68). A1c was evaluated using locally estimated scatter plot smoothing. Change in A1c from 4 to 12 months postdiagnosis was evaluated using a linear mixed model. Results: Median age was 9.7 (interquartile range [IQR]: 6.6, 12.7) versus 9.7 (IQR: 6.8, 12.7) years, 49% versus 47% female, 44% versus 39% non-Hispanic White in historical versus Pilot 4T. In historical and 4T cohorts, DKA at diagnosis demonstrated higher A1c at 6 (0.5% [95% confidence interval (CI): 0.21-0.79; P < 0.01] and 0.38% [95% CI: 0.02-0.74; P = 0.04], respectively), and 12 months (0.62% [95% CI: -0.06 to 1.29; P = 0.07] and 0.39% [95% CI: -0.32 to 1.10; P = 0.29], respectively). The highest % time in range (TIR; 70-180 mg/dL) was seen between weeks 15-20 (69%) versus 25-30 (75%) postdiagnosis for youth with versus without DKA in Pilot 4T, respectively. Conclusions: Pilot 4T improved A1c outcomes versus the historical cohort, but those with DKA at diagnosis had persistently elevated A1c throughout the study and intensive diabetes management did not mitigate this difference. DKA prevention at diagnosis may translate into better glycemic outcomes in the first-year postdiagnosis. Clinical Trial Registration: clinicaltrials.gov: NCT04336969.

Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial.

OBJECTIVE: Evaluate whether the Body Project prevention program adapted for young women with type 1 diabetes (Diabetes Body Project) reduces eating disorder (ED) risk factors and symptoms. METHODS: Young women (aged 15-30) at high-risk for EDs due to having type 1 diabetes and body image concerns (N = 55) were randomized to virtually delivered Diabetes Body Project groups or an educational control condition, completing measures at pretest, posttest, and 3-month follow-up. RESULTS: Diabetes Body Project versus the control participants showed significantly greater reductions in thin-ideal internalization, body dissatisfaction, diabetes distress, diabetes eating pathology, and ED symptoms by posttest, and greater reductions in diabetes eating pathology and ED symptoms, and greater improvements in quality of life by 3-month follow-up, which were medium to large effects (d's ranged from -0.43 to -0.90). Although control participants showed a worsening of glycemic control (time in range) verses Diabetes Body Project participants, this difference was non-significant (d = 0.26). CONCLUSIONS: Virtually delivered Diabetes Body Project decreased ED risk factors and symptoms in young women with type 1 diabetes. A well powered randomized controlled trial is warranted to evaluate this intervention over longer follow-up.

Comprehensive Telehealth Model to Support Diabetes Self-Management.

Importance: As the number of patients with diabetes continues to increase in the United States, novel approaches to clinical care access should be considered to meet the care needs for this population, including support for diabetes-related technology. Objective: To evaluate a virtual clinic to facilitate comprehensive diabetes care, support continuous glucose monitoring (CGM) integration into diabetes self-management, and provide behavioral health support for diabetes-related issues. Design, Setting, and Participants: This cohort study was a prospective, single-arm, remote study involving adult participants with type 1 or type 2 diabetes who were referred through community resources. The study was conducted virtually from August 24, 2020, to May 26, 2022; analysis was conducted at the clinical coordinating center. Intervention: Training and education led by a Certified Diabetes Care and Education Specialist for CGM use through a virtual endocrinology clinic structure, which included endocrinologists and behavioral health team members. Main Outcomes and Measures: Main outcomes included CGM-measured mean glucose level, coefficient of variation, and time in range (TIR) of 70 to 180 mg/dL, time with values greater than 180 mg/dL or 250 mg/dL, and time with values less than 70 mg/dL or 54 mg/dL. Hemoglobin A1c was measured at baseline and at 12 and 24 weeks. Results: Among the 234 participants, 160 had type 1 diabetes and 74 had type 2 diabetes. The mean (SD) age was 47 (14) years, 123 (53%) were female, and median diabetes duration was 20 years. Median (IQR) CGM use over 6 months was 96% (91%-98%) for participants with type 1 diabetes and 94% (85%-97%) for those with type 2 diabetes. Mean (SD) hemoglobin A1c (HbA1c) in those with type 1 diabetes decreased from 7.8% (1.6%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (1.0%) at 6 months (mean change from baseline to 6 months, -0.6%, 95% CI, -0.8% to -0.5%; P < .001), with an 11% mean TIR increase over 6 months (95% CI, 9% to 14%; P < .001). Mean HbA1c in participants with type 2 diabetes decreased from 8.1% (1.7%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (0.9%) at 6 months (mean change from baseline to 6 months, -1.0%; 95% CI, -1.4% to -0.7%; P < .001), with an 18% TIR increase over 6 months (95% CI, 13% to 24%; P < .001). In participants with type 1 diabetes, mean percentage of time with values less than 70 mg/dL and less than 54 mg/dL decreased over 6 months by 0.8% (95% CI, -1.2% to -0.4%; P = .001) and by 0.3% (95% CI, -0.5% to -0.2%, P < .001), respectively. In the type 2 diabetes group, hypoglycemia was rare (mean [SD] percentage of time <70 mg/dL, 0.5% [0.6%]; and <54 mg/dL, 0.07% [0.14%], over 6 months). Conclusions and Relevance: Results from this cohort study demonstrated clinical benefits associated with implementation of a comprehensive care model that included diabetes education. This model of care has potential to reach a large portion of patients with diabetes, facilitate diabetes technology adoption, and improve glucose control.

Utility and precision evidence of technology in the treatment of type 1 diabetes: a systematic review.

BACKGROUND: The greatest change in the treatment of people living with type 1 diabetes in the last decade has been the explosion of technology assisting in all aspects of diabetes therapy, from glucose monitoring to insulin delivery and decision making. As such, the aim of our systematic review was to assess the utility of these technologies as well as identify any precision medicine-directed findings to personalize care. METHODS: Screening of 835 peer-reviewed articles was followed by systematic review of 70 of them (focusing on randomized trials and extension studies with ≥50 participants from the past 10 years). RESULTS: We find that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c, time in range, and glycemic variability, while reducing hypoglycemia risk. Several studies included person-reported outcomes, allowing assessment of the burden or benefit of the technology in the lives of those with type 1 diabetes, demonstrating positive results or, at a minimum, no increase in self-care burden compared with standard care. Important limitations of the trials to date are their small size, the scarcity of pre-planned or powered analyses in sub-populations such as children, racial/ethnic minorities, people with advanced complications, and variations in baseline glycemic levels. In addition, confounders including education with device initiation, concomitant behavioral modifications, and frequent contact with the healthcare team are rarely described in enough detail to assess their impact. CONCLUSIONS: Our review highlights the potential of technology in the treatment of people living with type 1 diabetes and provides suggestions for optimization of outcomes and areas of further study for precision medicine-directed technology use in type 1 diabetes.

In the last decade, there have been significant advances in how technology is used in the treatment of people living with type 1 diabetes. These technologies primarily aim to help manage blood sugar levels. Here, we reviewed research published over the last decade to evaluate the impact of such technologies on type 1 diabetes treatment. We find that various types of novel technologies, such as devices to monitor blood sugar levels continuously or deliver insulin, improve important diabetes-related measures and can reduce the risk of having low blood sugar levels. Importantly, several studies showed a positive impact of technologies on quality of life in people living with diabetes. Our findings highlight the benefits of novel technologies in the treatment of type 1 diabetes and identify areas for further research to optimize and personalize diabetes care.

The Promising Success of Project Extension for Community Healthcare Outcomes (ECHO) Diabetes: Case Series.

BACKGROUND: In the United States, there are over 37 million people with diabetes but only 8000 endocrinologists. Therefore, many people with diabetes receive care exclusively from primary care providers (PCPs). To democratize knowledge regarding insulin-requiring diabetes through tele-education, Stanford University and the University of Florida developed Project Extension for Community Healthcare Outcomes (ECHO) Diabetes. OBJECTIVE: ECHO Diabetes uses a Hub and Spoke model connecting specialists (the "Hub") with PCPs (the "Spokes"). One-hour, weekly sessions include Hub diabetes didactic presentations and Spoke deidentified case presentations. Lessons learned during these sessions target provider knowledge and confidence surrounding diabetes management and patient care. METHODS: Spokes were asked to provide short descriptions of people with diabetes whose diabetes management improved directly or indirectly from their providers' participation or their involvement with a Diabetes Support Coach (DSC). We provide a case series to describe individuals and outcomes. Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry. RESULTS: A case series of 11 people with diabetes was compiled from 10 PCPs and 1 DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to people with diabetes. In all cases, people with diabetes reported increased engagement and improved diabetes management. Several cases reflected increased access to diabetes technology, improvement in glycemic outcomes, and positive trends in mental health measures. CONCLUSIONS: This case series elucidates the potential value of the ECHO Diabetes program to people with diabetes who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in hemoglobin A1c and mental health outcomes.

Expanding the use of patient-reported outcomes (PROs): Screening youth with type 1 diabetes from underrepresented populations.

AIM: Youth from lower socioeconomic status (SES) have suboptimal type 1 diabetes (T1D) outcomes. Patient reported outcomes (PROs) measure psychosocial states and are associated with T1D outcomes, however are understudied in low SES youth. We aimed to evaluate associations between PROs and public insurance status, a proxy for low SES. METHODS: We analyzed survey data from 129 youth with T1D (age 15.7 ± 2.3 years, 33 % publicly insured) screened with PROMIS Global Health (PGH, measuring global health) and Patient Health Questionnaire (PHQ-9, measuring depressive symptoms) during diabetes appointments. Correlation and regression analyses evaluated differences in PGH and PHQ-9 by insurance status. RESULTS: For youth with public insurance, lower global health correlated with lower self-monitoring blood glucose (SMBG; r = 0.38,p = 0.033) and older age (r = -0.45,p = 0.005). In youth with private insurance, lower global health correlated with lower SMBG (r = 0.27,p = 0.018) and female sex (rho = 0.26,p = 0.015). For youth with private insurance, higher depressive symptoms correlated with higher body mass index (r = 0.22,p = 0.03) and fewer SMBG (r = -0.35,p = 0.04). In multivariate regression analyses, public insurance was inversely associated with global health (p = 0.027). CONCLUSION: PGH is a particularly salient PRO in youth with public insurance. Global health may be an important psychosocial factor to assess in youth with T1D from low SES backgrounds.

DiabetesWise: An innovative approach to promoting diabetes device awareness.

BACKGROUND: DiabetesWise is an unbranded, data-driven online resource that tailors device recommendations based on preferences and priorities of people with insulin-requiring diabetes. The objective of this study is to examine whether DiabetesWise increases uptake of diabetes devices, which are empirically supported to improve glycemic and psychosocial outcomes. METHODS: The sample included 458 participants (Mage = 37.1, SD = 9.73; 66% female; 81% type 1 diabetes) with insulin-requiring diabetes and minimal diabetes device use at enrollment. Participants used DiabetesWise and completed online surveys. Chi-square and t tests evaluated requests for a device prescription, receiving a prescription, and starting a new device at 1 and 3 months post use. Baseline predictors of these variables and past use of continuous glucose monitors (CGMs) and changes in diabetes distress post use were also examined. RESULTS: Within the first month of interacting with DiabetesWise 19% of participants asked for a prescription for a diabetes device. This rate rose to 31% in the first 3 months. These requests resulted in 16% of the sample starting a new device within the first 3 months. Whereas several factors were associated with prior CGM use, receiving a prescription, and starting a new device, more diabetes distress (t(343) = -3.13, p = .002) was the only factor associated with asking for a prescription. Diabetes distress decreased after interacting with DiabetesWise within 1 month (t(193) = 3.51, p < .001) and 3 months (t(180) = 5.23, p < .001). CONCLUSIONS: Within 3 months of interacting with DiabetesWise, one in three participants had requested a prescription for a new diabetes device and average distress levels were reduced, indicating benefit from this low-intensity online platform.

Disparities in Hemoglobin A1c Levels in the First Year After Diagnosis Among Youths With Type 1 Diabetes Offered Continuous Glucose Monitoring.

Importance: Continuous glucose monitoring (CGM) is associated with improvements in hemoglobin A1c (HbA1c) in youths with type 1 diabetes (T1D); however, youths from minoritized racial and ethnic groups and those with public insurance face greater barriers to CGM access. Early initiation of and access to CGM may reduce disparities in CGM uptake and improve diabetes outcomes. Objective: To determine whether HbA1c decreases differed by ethnicity and insurance status among a cohort of youths newly diagnosed with T1D and provided CGM. Design, Setting, and Participants: This cohort study used data from the Teamwork, Targets, Technology, and Tight Control (4T) study, a clinical research program that aims to initiate CGM within 1 month of T1D diagnosis. All youths with new-onset T1D diagnosed between July 25, 2018, and June 15, 2020, at Stanford Children's Hospital, a single-site, freestanding children's hospital in California, were approached to enroll in the Pilot-4T study and were followed for 12 months. Data analysis was performed and completed on June 3, 2022. Exposures: All eligible participants were offered CGM within 1 month of diabetes diagnosis. Main Outcomes and Measures: To assess HbA1c change over the study period, analyses were stratified by ethnicity (Hispanic vs non-Hispanic) or insurance status (public vs private) to compare the Pilot-4T cohort with a historical cohort of 272 youths diagnosed with T1D between June 1, 2014, and December 28, 2016. Results: The Pilot-4T cohort comprised 135 youths, with a median age of 9.7 years (IQR, 6.8-12.7 years) at diagnosis. There were 71 boys (52.6%) and 64 girls (47.4%). Based on self-report, participants' race was categorized as Asian or Pacific Islander (19 [14.1%]), White (62 [45.9%]), or other race (39 [28.9%]); race was missing or not reported for 15 participants (11.1%). Participants also self-reported their ethnicity as Hispanic (29 [21.5%]) or non-Hispanic (92 [68.1%]). A total of 104 participants (77.0%) had private insurance and 31 (23.0%) had public insurance. Compared with the historical cohort, similar reductions in HbA1c at 6, 9, and 12 months postdiagnosis were observed for Hispanic individuals (estimated difference, -0.26% [95% CI, -1.05% to 0.43%], -0.60% [-1.46% to 0.21%], and -0.15% [-1.48% to 0.80%]) and non-Hispanic individuals (estimated difference, -0.27% [95% CI, -0.62% to 0.10%], -0.50% [-0.81% to -0.11%], and -0.47% [-0.91% to 0.06%]) in the Pilot-4T cohort. Similar reductions in HbA1c at 6, 9, and 12 months postdiagnosis were also observed for publicly insured individuals (estimated difference, -0.52% [95% CI, -1.22% to 0.15%], -0.38% [-1.26% to 0.33%], and -0.57% [-2.08% to 0.74%]) and privately insured individuals (estimated difference, -0.34% [95% CI, -0.67% to 0.03%], -0.57% [-0.85% to -0.26%], and -0.43% [-0.85% to 0.01%]) in the Pilot-4T cohort. Hispanic youths in the Pilot-4T cohort had higher HbA1c at 6, 9, and 12 months postdiagnosis than non-Hispanic youths (estimated difference, 0.28% [95% CI, -0.46% to 0.86%], 0.63% [0.02% to 1.20%], and 1.39% [0.37% to 1.96%]), as did publicly insured youths compared with privately insured youths (estimated difference, 0.39% [95% CI, -0.23% to 0.99%], 0.95% [0.28% to 1.45%], and 1.16% [-0.09% to 2.13%]). Conclusions and Relevance: The findings of this cohort study suggest that CGM initiation soon after diagnosis is associated with similar improvements in HbA1c for Hispanic and non-Hispanic youths as well as for publicly and privately insured youths. These results further suggest that equitable access to CGM soon after T1D diagnosis may be a first step to improve HbA1c for all youths but is unlikely to eliminate disparities entirely. Trial Registration: ClinicalTrials.gov Identifier: NCT04336969.

Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System.

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.

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System.

AIMS: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System. METHODS: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses. RESULTS: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen). CONCLUSIONS: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D. CLINICAL TRIALS REGISTRATION NUMBER: NCT04196140.

Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents.

AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

Posttraumatic stress disorder in pediatric patients with implantable cardioverter-defibrillators and their parents.

BACKGROUND: An implantable cardioverter-defibrillator (ICD) in the pediatric patient (and the precipitating events that led to ICD placement) can be traumatic for patients and their families and may lead to posttraumatic stress disorder (PTSD). OBJECTIVES: This study aimed to estimate the prevalence of PTSD in pediatric patients with an ICD and their parents and identify the factors associated with PTSD incidence. METHODS: Pediatric participants with an ICD aged 8-21 years and parents of children aged 0-21 years completed surveys that included demographic characteristics and PTSD measures. Pediatric participants completed additional psychosocial measures, such as anxiety and depression self-report questionnaires. RESULTS: Fifty youth (30% female) and 43 parents (70% female) completed the measures. Six of 50 youth (12%) met the screening criteria for a likely PTSD diagnosis, while 20 of 43 parents (47%) met the cutoff for PTSD on the screening measure. Children with PTSD were more likely to have had a secondary prevention ICD (83% vs 17%; P = .021), meet the clinical cutoff for depression (67% vs 16%; P = .005), and had higher shock anxiety scores (31.7 vs 17.9; P = .003) than children without PTSD. Female gender (57% vs 23%; P = .043) and patient depression (31% vs 5%; P = .042) were associated with PTSD in parents. CONCLUSION: Parents were found to be more likely to meet the criteria for PTSD than youth. In youth, PTSD was associated with medical and psychosocial factors, whereas PTSD in parents was associated with being female and child depression. Clinic-based screenings and management planning of emotional functioning are warranted to address psychological distress in patients and parents.

Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.

Background: Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. Methods: In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. Findings: 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA1c]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period. Interpretation: Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.