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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

BACKGROUND: We tested the safety and performance of the insulin-only configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points. METHOD: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis. RESULTS: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time

Aims: Psychosocial impacts of early continuous glucose monitoring (CGM) initiation in youth soon after type 1 diabetes diagnosis are underexplored. We report parent/guardian and youth patient‐reported outcomes (PROs) that measure psychosocial states for families in 4T Study 1. Materials and Methods: Of the 133 families in the 4T Study 1, 132 parent/guardian and 66 youth (≥11 years) were eligible to complete PROs. PROs evaluated included diabetes distress, global health, diabetes technology attitudes and CGM benefits/burden scales. Temporal trends of PROs were assessed via generalised linear mixed effects regression. Sociodemographic and clinical characteristics associated with PROs were evaluated. Psychosocial associations were evaluated by regressing parental distress on youth distress. Results: PRO completion rates were 85.6% and varied between parent/guardian and youth. Throughout the study, parent/guardian and youth distress remained low and youth had increased technology acceptance (p = 0.046). Each additional month of CGM use was associated with a 14% decrease in the odds of experiencing diabetes distress (aOR = 0.86, 95% CI [0.76, 0.99], p = 0.029). Additionally, higher time‐in‐range was associated with decreased diabetes distress (p = 0.048). Age, diabetic ketoacidosis at diagnosis, gender, ethnicity, insurance status and language spoken were not associated with PROs. Conclusions: Initiation of CGM shortly after type 1 diabetes diagnosis does not have unintended negative psychological consequences. Longer duration of CGM use was associated with decreased youth distress and technology acceptance increased throughout the study. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The Project Extension for Community Healthcare Outcomes (ECHO) model is used in 180 countries to address chronic disease care through a provider empowerment, tele-education approach. Few studies have rigorously evaluated the impact of the program on patient outcomes using randomized designs. RESEARCH DESIGN AND METHODS: Implementation of an ECHO Diabetes program was evaluated using a stepped-wedge design with recruitment of 20 federally qualified health centers (FQHCs) across California and Florida with randomized, phased-in intervention entry. Participating FQHCs (referred to as "spokes") provided aggregate data, including the Healthcare Effectiveness Data and Information Set (HEDIS) and diabetes technology use. Patients were recruited from spokes, and data collection involved historical and prospective HbA1c measures, HEDIS markers, and pre/post surveys. Linear mixed models were used to generate patient-level monthly HbA1c estimates and evaluate change over time; Poisson regression was used tomodel clinic-level technology use. RESULTS: The spoke-level cohort included 32,796 people with type 1 diabetes (T1D; 3.4%) and type 2 diabetes (T2D; 96.6%), of whom 72.7% were publicly insured or uninsured. The patient-level cohort included 582 adults with diabetes (33.0% with T1D, 67.0% with T2D). Their mean age was 51.1 years, 80.7% were publicly insured or uninsured, 43.7% were non-HispanicWhite, 31.6% were Hispanic, 7.9% were non-Hispanic Black, and 16.8% were in other race/ethnicity categories. At the spoke level, there were statistically significant reductions before and after the intervention in the proportion of people with HbA1c >9% (range 31.7% to 26.7%; P = 0.033). At the patient level, there were statistically significant increases in those using continuous glucose monitoring (range 25.1% to 36.8%; P < 0.0001) and pump use (range 15.3% to 18.3%; P < 0.001) before and after the intervention. CONCLUSIONS: The ECHO model demonstrates promise for reducing health disparities in diabetes and contributes to our understanding of programbenefits beyond the provider level. [ABSTRACT FROM AUTHOR]

Background: The objective was to examine patient-reported outcomes (PROs) associated with access to a virtual clinic model for diabetes care. Methods: Adults with diabetes (N = 234) received virtual care, including support for continuous glucose monitoring (CGM) over a 6-month study period. Care was led by a Certified Diabetes Care and Education Specialist and focused on optimizing self-management skills and response to glucose values observed on CGM. After 6 months of CGM use and access to diabetes education, participants could opt in to another 6 months of follow-up with access to the virtual care team. Participants completed PRO surveys and had health and glycemic measures collected at baseline, 3, 6, and 12 months. Results: Participants with type 1 diabetes (N = 160) were 44 ± 14 years and had mean baseline HbA1c of 61 mmol/mol (7.7%). Participants with type 2 diabetes (N = 74) were 52 ± 12 years and had mean baseline HbA1c of 66 mmol/mol (8.2%). Compared with baseline levels, at 6 months participants experienced less depression, diabetes distress, and hypoglycemic fears while also experiencing greater satisfaction with glucose monitoring, diabetes technology and specifically with CGM, and confidence for managing hypoglycemic (p < 0.05). For participants with type 1 diabetes, more time in the target range for glucose levels (70–180 mg/dL) was associated with less depression, diabetes distress, and hypoglycemic fears. Conclusions: PROs improved for adults with diabetes utilizing virtual diabetes care, including support for CGM use. Paired with the glycemic improvements observed in this virtual clinic study, there were robust benefits on the quality of life of adults with diabetes. ClinicalTrials.gov Identifier: NCT04765358. [ABSTRACT FROM AUTHOR]

ObjectivesThe primary objective was to investigate the mediating effects of diabetes management in the relationship between diabetes symptoms and generic health-related quality of life (HRQOL) in adolescents and young adults (AYAs) with type 1 diabetes. The secondary objective explored patient health communication and perceived treatment adherence barriers as mediators in a serial multiple mediator model.MethodsThe PedsQL 3.2 Diabetes Module 15-item diabetes symptoms summary score, 18-item diabetes management summary score, and PedsQL 4.0 generic core scales were completed in a 10-site national field test study by 418 AYA aged 13 to 25 years with type 1 diabetes. Diabetes symptoms and diabetes management were tested for bivariate and multivariate linear associations with overall generic HRQOL. Mediational analyses were conducted to test the hypothesized mediating effects of diabetes management as an intervening variable between diabetes symptoms and generic HRQOL.ResultsThe predictive effects of diabetes symptoms on HRQOL were mediated in part by diabetes management. In predictive analytics models utilizing multiple regression analyses, demographic and clinical covariates, diabetes symptoms, and diabetes management significantly accounted for 53% of the variance in generic HRQOL (P

ObjectiveThe objective of the study was to report on the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for children, adolescents, and young adults with type 1 diabetes.Research design and methodsThe 33-item PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were completed in a 10-site national field test study by 656 families of patients ages 2-25 years with type 1 diabetes.ResultsThe 15-item Diabetes Symptoms Summary Score and 18-item Diabetes Management Summary Score were derived from the factor analysis of the items. The Diabetes Symptoms and Diabetes Management Summary Scores evidenced excellent reliability (patient self-report α = 0.88-0.90; parent proxy report α = 0.89-0.90). The Diabetes Symptoms and Diabetes Management Summary Scores demonstrated construct validity through medium to large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.43-0.67, P < 0.001). HbA1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = -0.21 to -0.29, P < 0.001). Minimal clinically important difference scores ranged from 5.05 to 5.55.ConclusionsThe PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary Scores demonstrated excellent measurement properties and may be useful as standardized patient-reported outcomes of diabetes symptoms and diabetes management in clinical research, clinical trials, and practice in children, adolescents, and young adults with type 1 diabetes.

Aim: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children. Materials and Methods: This 3‐month single‐arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0–5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes—diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well‐being (World Health Organization 5 Well‐Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use. Results: Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes‐related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well‐being (World Health Organization 5 Well‐Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001). Conclusions: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management. [ABSTRACT FROM AUTHOR]

Aims: Continuous glucose monitoring (CGM) systems are standard of care for youth with type 1 diabetes with the goal of spending >70% time in range (TIR; 70–180 mg/dL, 3.9–10 mmol/L). We aimed to understand paediatric CGM user experiences with TIR metrics considering recent discussion of shifting to time in tight range (TITR; >50% time between 70 and 140 mg/dL, 3.9 and 7.8 mmol/L). Methods: Semi‐structured interviews and focus groups with adolescents with type 1 diabetes and parents of youth with type 1 diabetes focused on experiences with TIR goals and reactions to TITR. Groups and interviews were audio‐recorded, transcribed and analysed using content analysis. Results: Thirty participants (N = 19 parents: age 43.6 ± 5.3 years, 79% female, 47% non‐Hispanic White, 20 ± 5 months since child's diagnosis; N = 11 adolescents: age 15.3 ± 2 years, 55% female, 55% non‐Hispanic White, 16 ± 3 months since diagnosis) attended. Participants had varying levels of understanding of TIR. Some developed personally preferred glucose ranges. Parents often aimed to surpass 70% TIR. Many described feelings of stress and disappointment when they did not meet a TIR goal. Concerns about TITR included increased stress and burden; risk of hypoglycaemia; and family conflict. Some participants said TITR would not change their daily lives; others said it would improve their diabetes management. Families requested care team support and a clear scientific rationale for TITR. Conclusions: The wealth of CGM data creates frequent opportunities for assessing diabetes management and carries implications for management burden. Input from people with type 1 diabetes and their families will be critical in considering a shift in glycaemic goals and targets. [ABSTRACT FROM AUTHOR]

The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents. [ABSTRACT FROM AUTHOR]

Type 1 diabetes (T1D) is a chronic illness that requires complex behaviors and routines for daily self-management tasks, including daily blood glucose monitoring and insulin administration. With advances, technology has [...], 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. Public Significance Statement The present study identifies expectations among those with type 1 diabetes and their partners about how new diabetes technologies may impact intimacy. As these new technologies become more common, it is anticipated these results will be useful to care providers and clinicians when discussing how technology may impact a couple&apos;s physical relationship along with the benefits and challenges these technologies provide with their patients. Keywords: type 1 diabetes, intimacy, automated insulin delivery systems, qualitative analysis

Few studies have explored durability of insulin pump use, and none have explored the link between depression and pump discontinuation. To examine the relationship between depressive symptoms [measured by the Children's Depression Inventory (CDI)], method of insulin delivery, and hemoglobin A1c (A1c), mixed models were used with data from 150 adolescents with type 1 diabetes (T1D) and visits every 6 months for 2 years. Of the 63% who used a pump, compared with multiple daily injections (MDI) at baseline, there were higher proportions who were non-minorities, had caregivers with a college degree, private insurance, and two caregivers in the home (p ≤ 0.01). After adjusting for time, sex, age, T1D duration, frequency of blood glucose monitoring, ethnicity, insurance, and caregiver number and education, baseline pump use was associated with -0.79% lower mean A1c [95% confidence interval (CI): -1.48, -0.096; p = 0.03]. For those using a pump at baseline, but switching to MDI during the study (n = 9), mean A1c was 1.38% higher (95% CI: 0.68, 2.08; p < 0.001) than that for those who did not switch method of delivery. A 10-point increase in CDI was associated with a 0.39% increase in A1c (95% CI: 0.16, 0.61; p = 0.001), independent of pump use. Regarding the temporal relationship between CDI score and changing method of insulin delivery, prior higher CDI score was associated with switching from pump to MDI (odds ratio = 1.21; 95% CI: 1.05, 1.39; p = 0.007). Clinicians should be aware of the associations between depressive symptoms, change in insulin delivery method, and the effect on glycemic control.

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. [ABSTRACT FROM AUTHOR]

OBJECTIVE - To establish minimal clinically important difference (MCID) scores representing the smallest detectable change in quality of life (QOL), using the Pediatric Quality of Life Inventory (PedsQL) Generic Core and Diabetes Module among youth with ia

OBJECTIVE: Although substantial literature has reported regional cerebral blood flow (rCBF) abnormalities in adults with depression, these studies commonly necessitated the injection of radioisotopes into subjects. The recent development of arterial spin labeling (ASL), however, allows noninvasive measurements of rCBF. Currently, no published ASL studies have examined cerebral perfusion in adolescents with depression. Thus, the aim of the present study was to examine baseline cerebral perfusion in adolescent depression using a newly developed ASL technique: pseudocontinuous arterial spin labeling (PCASL). METHOD: A total of 25 medication-naive adolescents (13-17 years of age) diagnosed with major depressive disorder (MDD) and 26 well-matched control subjects underwent functional magnetic resonance imaging. Baseline rCBF was measured via a novel PCASL method that optimizes tagging efficiency. RESULTS: Voxel-based whole brain analyses revealed significant frontal, limbic, paralimbic, and cingulate hypoperfusion in the group with depression (p < .05, corrected). Hyperperfusion was also observed within the subcallosal cingulate, putamen, and fusiform gyrus (p < .05, corrected). Similarly, region-of-interest analyses revealed amygdalar and insular hypoperfusion in the group with depression, as well as hyperperfusion in the putamen and superior insula (p < .05, corrected). CONCLUSIONS: Adolescents with depression and healthy adolescents appear to differ on rCBF in executive, affective, and motor networks. Dysfunction in these regions may contribute to the cognitive, emotional, and psychomotor symptoms commonly present in adolescent depression. These findings point to possible biomarkers for adolescent depression that could inform early interventions and treatments, and establishes a methodology for using PCASL to noninvasively measure rCBF in clinical and healthy adolescent populations.

OBJECTIVE - Youth with diabetes are at increased risk for depression. The objectives of this study were to provide preliminary evidence that this at-risk status for depression is associated with metabolic and inflammatory markers and to inform future, more

To test models of unidirectional and bidirectional change between treatment adherence and glycemic control in youth with type 1 diabetes.We conducted a 2-year longitudinal, multisite study of 225 youth with type 1 diabetes recruited at the cusp of adolesce

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. [ABSTRACT FROM AUTHOR]