Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS: In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).

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.

Parent, child, and adolescent lived experience using the insulin-only iLet Bionic Pancreas.

OBJECTIVE: Automated insulin delivery (AID) systems show great promise for improving glycemic outcomes and reducing disease burden for youth with type 1 diabetes (T1D). The current study examined youth and parent perspectives after using the insulin-only iLet Bionic Pancreas (BP) during the 13-week pivotal trial. METHODS: Parents and youth participated in focus group interviews, with questions assessing participants' experiences in a variety of settings and were grounded in the Unified Theory of Acceptance and Use of Technology. Qualitative analysis was completed by 3 authors using a hybrid thematic analysis approach. RESULTS: Qualitative analysis of focus groups revealed a total of 19 sub-themes falling into 5 major themes (Diabetes Burden, Freedom and Flexibility, Daily Routine, Managing Glucose Levels, and User Experience). Participants' overall experience was positive, with decreased burden and improved freedom and flexibility. Some participants reported challenges in learning to trust the system, adjusting to the user interface, and the system learning their body. CONCLUSION: This study adds to the growing literature on patient perspectives on using AID systems and was among the first to assess caregiver and youth experiences with the BP system over an extended period (13 weeks). Patient feedback on physical experiences with the device and experiences trusting the device to manage glucose should inform future development of technologies as well as approaches to education for patients and their families.

Diabetes distress in urban Black youth with type 1 diabetes and their caregivers: associations with glycemic control, depression, and health behaviors.

OBJECTIVES: Adolescents with type 1 diabetes (T1D) and their caregivers endorse high diabetes distress (DD). Limited studies have documented the impact of DD on Black youth. The aims of the present study were to (1) describe DD among a sample of Black adolescents with T1D and their caregivers, (2) compare their DD levels with published normative samples, and (3) determine how DD relates to glycemic outcomes, diabetes self-management, parental monitoring of diabetes, and youth depressive symptoms. METHODS: Baseline data from a multicenter clinical trial were used. Participants (N = 155) were recruited from 7 Midwestern pediatric diabetes clinics. Hemoglobin A1c (HbA1c) and measures of DD, parental monitoring of diabetes care, youth depression and diabetes management behaviors were obtained. The sample was split into (1) adolescents (ages 13-14; N = 95) and (2) preadolescents (ages 10-12; N = 60). Analyses utilized Cohen's d effect sizes, Pearson correlations, t-tests, and multiple regression. RESULTS: DD levels in youth and caregivers were high, with 45%-58% exceeding either clinical cutoff scores or validation study sample means. Higher DD in youth and caregivers was associated with higher HbA1c, lower diabetes self-management, and elevated depressive symptoms, but not with parental monitoring of diabetes management. CONCLUSIONS: Screening for DD in Black youth with T1D and caregivers is recommended, as are culturally informed interventions that can reduce distress levels and lead to improved health outcomes. More research is needed on how systemic inequities contribute to higher DD in Black youth and the strategies/policy changes needed to reduce these inequities.

The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes.

OBJECTIVE: Due to systemic inequities, Black adolescents with type 1 diabetes are more likely to have suboptimal glycemic control and high rates of diabetes distress, but tailored interventions for this population are lacking. In primary outcomes of a randomized clinical trial, a family-based eHealth intervention improved glycemic control in Black adolescents with type 1 diabetes and elevated depressive symptoms. The present study is a secondary analysis of these clinical trial data examining the moderating effect of diabetes distress on the efficacy of the intervention. METHODS: Using secondary data from a multicenter randomized clinical trial (Clinicaltrials.gov [NCT03168867]), caregiver-adolescent dyads were randomly assigned to either up to three sessions of an eHealth parenting intervention (n = 75) or a standard medical care control group (n = 74). Black adolescents (10 years, 0 months to 14 years, 11 months old) with type 1 diabetes and a caregiver willing to participate were eligible. Adolescents reported their diabetes distress at baseline, and hemoglobin A1c (HbA1c) data were collected at baseline, 6-, 13-, and 18-month follow-up. RESULTS: No between-group contrasts emerged in a linear mixed-effects regression (p's > .09). Within-group contrasts emerged such that adolescents assigned to the intervention who reported high diabetes distress had lower HbA1c at the 18-month follow-up relative to baseline (p = .004); the 18-month decrease in HbA1c was -1.03%. CONCLUSIONS: Black adolescents with type 1 diabetes and high levels of diabetes distress showed significant decreases in HbA1c following a family-based eHealth intervention, suggesting diabetes distress may be a key moderator of intervention efficacy within this population.

Cost considerations for adoption of diabetes technology are pervasive: A qualitative study of persons living with type 1 diabetes and their families.

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 subthemes 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.

Psychometric properties of the diabetes skills checklist for adolescents with type 1 diabetes and their parents.

OBJECTIVE: Among adolescents with type 1 diabetes, research has found that their perception of their diabetes management is an important predictor of actual diabetes management. There is a need for measures that assess adolescents' perception of their ability to independently complete daily diabetes self-care tasks. The current study examined the psychometric properties of the Diabetes Skills Checklist Teen-Report (DSC-T) and DSC Parent of Teen-Report (DSC-PT), which assess perceived independence in diabetes self-care skills. RESEARCH DESIGN AND METHODS: Data were from 1450 adolescents aged 12 to 18 years and their parents who participated in the Diabetes Camp Matters Study. Families completed the DSC as well as other questionnaires online assessing demographic and diabetes-related information, diabetes strengths, and diabetes-specific emotional distress. RESULTS: Exploratory factor analysis revealed a 14-item DSC-T and 12-item DSC-PT, both with excellent internal consistency and concurrent validity. Both the DSC-T and DSC-PT were found to be positively correlated with diabetes strengths and negatively correlated with HbA1c, and the DSC-PT was significantly correlated with parent-reported diabetes distress. Adolescents who used insulin pumps and continuous glucose monitoring reported higher perceived independence in diabetes self-care skills compared to adolescents who used insulin pens/syringes or blood glucose meters. No differences were found based on demographic characteristics. CONCLUSIONS: The DSC-T and DSC-PT have strong potential to be used during diabetes clinic visits to spark discussion regarding adolescents' self-care, which would allow for a more successful transfer of diabetes care from parent to adolescent, and eventually, the transition from pediatric to adult healthcare.

Effects of family and neighborhood risks on glycemic control among young black adolescents with type 1 diabetes: Findings from a multi-center study.

While individual and family risk factors that contribute to health disparities in children with type 1 diabetes have been identified, studies on the effects of neighborhood risk factors on glycemic control are limited, particularly in minority samples. This cross-sectional study tested associations between family conflict, neighborhood adversity and glycemic outcomes (HbA1c) in a sample of urban, young Black adolescents with type 1 diabetes(mean age = 13.4 ± 1.7), as well as whether neighborhood adversity moderated the relationship between family conflict and HbA1c. Participants (N = 128) were recruited from five pediatric diabetes clinics in two major metropolitan US cities. Diabetes-related family conflict was measured via self-report questionnaire (Diabetes Family Conflict Scale; DFCS). Neighborhood adversity was calculated at the census block group level based on US census data. Indictors of adversity were used to calculate a neighborhood adversity index (NAI) for each participant. Median family income was $25,000, suggesting a low SES sample. In multiple regression analyses, DFCS and NAI both had significant, independent effects on glycemic control (ß = 0.174, P = 0.034 and ß = 0.226 P = 0.013, respectively) after controlling for child age, family socioeconomic status and insulin management regimen. Tests of effects of the NAI and DFCS interaction on HbA1c found no significant moderating effects of neighborhood adversity. Even within contexts of significant socioeconomic disadvantage, variability in degree of neighborhood adversity predicts diabetes-related health outcomes in young Black adolescents with type 1 diabetes. Providers should assess social determinants of health such as neighborhood resources that may impact adolescents' ability to maintain optimal glycemic control.

Optimizing Recruitment of Black Adolescents into Behavioral Research: A Multi-Center Study.

OBJECTIVES: Adolescents of color are underrepresented in behavioral health research. Study aims were to quantify the amount and types of outreach effort needed to recruit young Black adolescents with type 1 diabetes and their primary caregiver into a clinical trial evaluating a parenting intervention and to determine if degree of recruitment difficulty was related to demographic, diabetes-related, or family characteristics. METHODS: Data were drawn from a multi-center clinical trial. Participants (N = 155) were recruited from seven pediatric diabetes clinics. Contact log data were used to quantify both number/type of contacts prior to study enrollment as well as length of time to enrollment. Families were coded as having expedited recruitment (ER) or prolonged recruitment (PR). Baseline study data were used to compare ER and PR families on sociodemographic factors, adolescent diabetes management and health status and family characteristics such as household organization and family conflict. RESULTS: Mean length of time to recruit was 6.6 months and mean number of recruitment contacts was 10.3. Thirty-nine percent of the sample were characterized as PR. These families required even higher levels of effort (mean of 9.9 months to recruit and 15.4 contacts). There were no significant between-group differences on any baseline variable for ER and PR families, with the exception of family income. CONCLUSIONS: Researchers need to make persistent efforts in order to successfully enroll adolescents of color and their caregivers into clinical trials. Social determinants of health such as family resources may differentiate families with prolonged recruitment within such samples.

Diabetes distress and HbA1c in racially/ethnically and socioeconomically diverse youth with type 1 diabetes.

BACKGROUND: Diabetes distress, the emotional burden of caring for the chronic demands of diabetes, has not been well described in children and preadolescents with type 1 diabetes (T1D). This gap is particularly evident among youth of lower socioeconomic status (SES) and/or racial/ethnic minorities. Since these groups are more likely to have disparities in health outcomes and healthcare related to their diabetes, factors that could potentially improve glycemic and other diabetes-related outcomes should be studied closely. OBJECTIVE: We hypothesized that (a) diabetes distress levels would be elevated in children with markers of lower SES and those of racial/ethnic minorities, and (b) higher HbA1c would be predicted by higher diabetes distress levels, when controlling for race/ethnicity, SES, and clinical covariates. METHODS: One hundred and eighty-seven youth age 9 to 13 with T1D completed age-appropriate Problem Areas in Diabetes (PAID) questionnaires using a web-based portal during routine diabetes care visits. RESULTS: PAID scores were significantly elevated in youth who had surrogate markers of lower SES and who were from racial/ethnic minority backgrounds. In multivariate models including race/ethnicity or the SES variables and controlling for clinical covariates, the factor most predictive of higher HbA1c was elevated PAID score. CONCLUSIONS: Diabetes distress is elevated in a younger population of children with T1D who are from racial/ethnic minority backgrounds or have markers of lower SES. Interventions that target distress and/or expand the safety net in these populations could potentially improve glycemic outcomes.

Patient-Reported and Parent Proxy-Reported Outcomes in Pediatric Medical Specialty Clinical Settings: A Systematic Review of Implementation.

OBJECTIVE: Youth with chronic illness are at higher risk for psychosocial difficulties, leading to a call for screening via patient-reported outcomes (PROs). The purpose of the current review is to summarize PRO implementation in pediatric medical specialty settings. A literature review of PRO implementation in these settings, conceptual issues, value and approach, legal and ethical concerns, as well as a case example of PROA in type 1 diabetes are presented. METHODS: A systematic review was conducted to identify relevant articles published since the most recent Journal of Pediatric Psychology Special Issue on Evidence-Based Assessment in Pediatric Psychology (2008). RESULTS: Thirty-two articles were identified and reviewed. The majority of studies reported that PROA was feasible, did not disrupt clinic flow, identified psychosocial issues warranting intervention, and was acceptable to families and providers. Response to elevated scores and impact on behavioral health referrals varied. CONCLUSION: While many evidenced-based assessment measures are well-validated within pediatric chronic illness groups, the literature regarding implementation of PROs is still emerging. Research findings are promising, with PROs being feasible, acceptable, and leading to increased discussion of psychosocial issues when integrated into pediatric medical settings. Additional research is needed to evaluate the longitudinal impact of PROs and the optimal manner of responding to assessment data, particularly when clinically-elevated. Ultimately, identifying psychosocial issues in pediatric medical settings can promote optimal health and well-being of youth with chronic illness and their families.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial.

BACKGROUND: Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care. METHODS: Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models. RESULTS: Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups. CONCLUSIONS: The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.

Diabetes camp still matters: Relationships with diabetes-specific distress, strengths, and self-care skills.

OBJECTIVE: Prior studies suggest diabetes camps improve psychosocial well-being in youth with type 1 diabetes but these studies suffer from variable levels of rigor. The present study assessed associations between camp participation and diabetes distress, perceived independence in diabetes self-care, and diabetes strengths in a large sample of children, adolescents, and their parents across 44 camps in the United States. Analyses compared viewpoints of study participants, identified moderators of change, and assessed perceived benefits of camp participation. METHODS: There were 2488 youth and 2563 parents consented for participation in the online survey. Participants reported diabetes distress and perceived independence in youth care, their new experiences and best parts of camp, and changes in behavior following camp. T-tests, regressions, Cohen's d, and relative frequencies were used as appropriate to assess baseline differences between reporters, pre-post outcome differences, and moderators of change. RESULTS: Parents as compared to youth reported higher pre-camp distress and lower perception of youth independence in self-care. Youth experienced a statistically significant decrease in distress and increase in independence in self-care. Diabetes strengths did not change. Higher A1c prior to camp was associated with higher levels of distress across camp participation. Campers and their parents endorsed a high frequency of positive firsts, bests, and benefits of camp. CONCLUSIONS: Data from a large sample youth with type 1 diabetes across multiple camps showed broad-based psychosocial benefits of camp participation.

Assessing strengths of children with type 1 diabetes: Validation of the Diabetes Strengths and Resilience (DSTAR) measure for ages 9 to 13.

BACKGROUND: Adaptive diabetes-specific attitudes and behaviors, known as diabetes strengths, relate to positive self-management and quality of life outcomes in type 1 diabetes (T1D), but have not been studied in preadolescence. To facilitate strengths-based care and research on this topic, we developed and evaluated the psychometric properties of a measure of diabetes strengths for children age 9 to 13. METHODS: Participants were 187 children receiving care for T1D at a tertiary care children's hospital. They completed the 12-item self-report Diabetes Strengths and Resilience scale for children (DSTAR-Child), which we adapted from a measure validated for adolescents. Youth completed the DSTAR-Child twice, and measures of relevant constructs at baseline: general and diabetes-related quality of life, depressive symptoms, and diabetes distress. Parents rated children's engagement in self-management behaviors and general resilience. We extracted HbA1c from the medical record. RESULTS: The DSTAR-Child total score demonstrated reliability, including internal consistency and stability across two time points. The total score was significantly associated in expected directions with psychosocial measures and glycemic control but not self-management behaviors. In confirmatory factor analyses, the best-fitting structure contained two latent factors tapping intrapersonal and interpersonal strengths. Resulting subscale scores also appeared reliable and valid. CONCLUSIONS: This brief, practical measure of diabetes strengths demonstrated sound psychometric properties. Diabetes strengths appeared unrelated to self-management behaviors, perhaps because of the primary role of adult caregivers in T1D management for preadolescents. As a research and clinical tool, the DSTAR-Child can facilitate greater understanding of diabetes strengths and inform strengths-based strategies to foster resilient T1D outcomes.

Psychometric Properties of the Parent and Child Problem Areas in Diabetes Measures.

OBJECTIVE: Children with type 1 diabetes and their parents face daily self-care demands, leading to diabetes-specific emotional distress. A standardized measure of diabetes distress can guide clinical care and prevent negative outcomes. METHODS: This study evaluated the psychometric properties of child- and parent-report measures of the Problem Areas in Diabetes Scale, adapted for children ages 8-12 (PAID-C) and their parents (P-PAID-C). Participants were from 42 diabetes camps in the United States. Children (N = 804; mean age = 10.3 ± 1.1) and parents (N = 968) completed measures of diabetes distress, diabetes-related strengths, and self-care skills. Half of the sample was used for exploratory factor analyses (EFA) with direct oblimin rotation and the other half for confirmatory factor analyses (CFAs). RESULTS: For the PAID-C, EFA and CFAs supported an 11-item two-factor measure, Cronbach's α = .91, accounting for 54.6% of the variance. For the P-PAID-C, analyses resulted in a 16-item measure, Cronbach's α = .92, accounting for 51.9% of the variance. PAID-C and P-PAID-C scores were positively correlated with HbA1c (rchild = .08, p = .04; rparent = .18, p < .001), and negatively correlated with diabetes-related strengths (rchild = -.38, p < .001, rparent = -.29, p < .001) and parent report of child self-care skills (rparent = -.13, p < .001; rchild = -0.07, p = ns). CONCLUSIONS: Initial psychometrics suggest that the PAID-C and P-PAID-C reliably and validly capture diabetes-specific emotional distress for children and their parents. Associations with glycemic control, self-care, and diabetes strengths demonstrate criterion validity. Both measures have potential applications for routine, clinic-based assessments of diabetes distress and may guide clinical decision-making.

Family-Based Interventions Targeting Improvements in Health and Family Outcomes of Children and Adolescents with Type 1 Diabetes: a Systematic Review.

PURPOSE OF REVIEW: A systematic review was conducted of family-based interventions to improve glycemic control, adherence, and psychosocial outcomes in children and adolescents with type 1 diabetes (T1D). Electronic databases were searched for randomized controlled trials (RCTs) published since the seminal Diabetes Control and Compliance Trial (DCCT). Interventions are summarized and findings reviewed to help guide clinical practice and future research. RECENT FINDINGS: Twenty-five RCTs are reviewed. The majority of studies (n = 15) focused on interventions targeting both children and adolescents and their caregivers and were delivered in diabetes clinics, outpatient settings, mental health clinics, or participants' homes. Family-based interventions for youth with T1D appear effective at improving diabetes and family-centered outcomes. Additional research is needed to examine the pathways to improvement in glycemic control, as outcomes were mixed. Future research should also involve measures beyond HbA1c given new markers for sustained health improvement and outcomes are being explored.

Screening and support for emotional burdens of youth with type 1 diabetes: Strategies for diabetes care providers.

Multiple sources of burden for youth with type 1 diabetes (T1D) impact key outcomes including quality of life, self-management, and glycemic control. Professional diabetes organizations recommend diabetes care providers screen for psychosocial and behavioral challenges and implement strategies to support youth with T1D. The purpose of this article is to review the literature and recommend practical strategies medical providers can use for screening and behavioral support for youth with diabetes and their families. As part of their routine medical care, diabetes care providers are well-positioned to identify and intervene to address emotional distress related to the burdens of living with diabetes. In collaboration with multidisciplinary team members, including psychologists and mental health professionals, medical providers may be able to successfully implement brief behavioral strategies for screening and providing emotional support.

Psychometric Properties of the Problem Areas in Diabetes: Teen and Parent of Teen Versions.

Objective: This study adds to the literature on the psychometric properties of the Problem Areas in Diabetes-Teen (PAID-T) and Parent (P-PAID-T) Versions. It also aims to shorten the measures of diabetes-specific distress, determine construct validity, and establish cutoff scores. Methods: Data are from two independent studies (N = 1,265). Adolescent-caregiver dyads completed measures of emotional distress, diabetes strengths, hemoglobin A1c, blood glucose checks, and average blood glucose. Exploratory and confirmatory factor analyses assessed factor structures for each measure. Correlational analyses provided support for concurrent validity. Receiver-operating characteristic curves identified cutoff scores based on clinically meaningful groups identified with latent profile analysis. Results: Analyses supported a 14-item PAID-T and a 15-item P-PAID-T, with preliminary cutoff scores ≥44 and ≥54, respectively. Measures were associated with emotional and health outcomes as hypothesized. Conclusions: The PAID-T and P-PAID-T are valid, reliable, and useful measures of diabetes-specific distress for teenagers with type 1 diabetes and parents of teenagers.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings.

Young adult solid organ transplant recipients who transfer from pediatric to adult care experience poor outcomes related to decreased adherence to the medical regimen. Our pilot trial for young adults who had heart transplant (HT) who transfer to adult care tests an intervention focused on increasing HT knowledge, self-management and self-advocacy skills, and enhancing support, as compared to usual care. We report baseline findings between groups regarding (1) patient-level outcomes and (2) components of the intervention. From 3/14 to 9/16, 88 subjects enrolled and randomized to intervention (n = 43) or usual care (n = 45) at six pediatric HT centers. Patient self-report questionnaires and medical records data were collected at baseline, and 3 and 6 months after transfer. For this report, baseline findings (at enrollment and prior to transfer to adult care) were analyzed using Chi-square and t-tests. Level of significance was p < 0.05. Baseline demographics were similar in the intervention and usual care arms: age 21.3 ± 3.2 vs 21.5 ± 3.3 years and female 44% vs 49%, respectively. At baseline, there were no differences between intervention and usual care for use of tacrolimus (70 vs 62%); tacrolimus level (mean ± SD = 6.5 ± 2.3 ng/ml vs 5.6 ± 2.3 ng/ml); average of the within patient standard deviation of the baseline mean tacrolimus levels (1.6 vs 1.3); and adherence to the medical regimen [3.6 ± 0.4 vs 3.5 ± 0.5 (1 = hardly ever to 4 = all of the time)], respectively. At baseline, both groups had a modest amount of HT knowledge, were learning self-management and self-advocacy, and perceived they were adequately supported. Baseline findings indicate that transitioning HT recipients lack essential knowledge about HT and have incomplete self-management and self-advocacy skills.

Diabetes camp matters: Assessing families' views of their diabetes camp experience.

BACKGROUND: Camp offers a safe and fun environment for learning new information about diabetes care and for trying new self-care skills. It is a place where children and teens are able to meet with others who also have diabetes and who share their experiences. MATERIALS AND METHODS: This study assessed self-reports before and after attending diabetes camp on diabetes-specific emotional distress, diabetes-specific quality of life, and self-care behaviors by surveying campers and their parents from over 42 diabetes-specific summer camps across the United States. Parents (N = 413), Teenagers (N = 154), and Children (N = 116) completed both pre- and post-camp surveys. RESULTS: Parents reported higher levels of diabetes-specific emotional distress than their campers did. Both parents and children reported significant improvements in their own distress after camp. Teens reported improvements in distress but they were not statistically significant. Youth report higher levels of self-care skills than parents believe their children possess. Parents, Teens, and Children all reported significant improvements in the camper's self-care skills after camp. First time campers' and their parents' perspectives regarding self-care skills are consistent with veteran campers after attending camp. Self-reports post-camp reveals that campers and their parents see camp as a place where youth feel they are with others who really understand what it is like to live with diabetes. Respondents also report that camp is a place where youth are exposed to new technologies and where campers can try new self-care tasks.