Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.

BACKGROUND: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear. METHODS: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed. RESULTS: A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred. CONCLUSIONS: A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).

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.

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.

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.

BACKGROUND: Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. METHODS: In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. FINDINGS: Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. INTERPRETATION: Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.

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.

Using Peer Power to Reduce Health Disparities: Implementation of a Diabetes Support Coach Program in Federally Qualified Health Centers.

Community health workers (CHWs) provide vital support to underserved communities in the promotion of health equity by addressing barriers related to the social determinants of health that often prevent people living with diabetes from achieving optimal health outcomes. Peer support programs in diabetes can also offer people living with diabetes invaluable support through a shared understanding of the disease and by offsetting diabetes-related stigma. As part of a Project Extension for Community Healthcare Outcomes (ECHO) Diabetes program, participating federally qualified healthcare centers were provided diabetes support coaches (DSCs) to facilitate patient engagement. DSCs hold invaluable expert knowledge, as they live with diabetes themselves and reside in areas they serve, thus combining the CHW role with peer support models. The use of DSCs and CHWs during the coronavirus disease 2019 pandemic and beyond is highly effective at reaching underserved communities with diabetes and promoting health equity.

Predicting optimal use of continuous glucose monitors in adolescents with type 1 diabetes: It's about benefit and burden.

PURPOSE: Youth with type 1 diabetes (T1D) often use Continuous Glucose Monitoring (CGM) devices; however, many do not wear them consistently enough to obtain optimal glycemic benefit. This study aimed to identify demographic and psychosocial predictors of optimal CGM use in adolescents with T1D to inform nurse-led interventions to improve adherence. DESIGN AND METHODS: Cross-sectional survey data from youth (12-19 years) using CGM were analyzed to determine whether perceived benefits/burdens of CGM, self-efficacy, and coping predicted being a "CGM Optimizer" (wearing CGM 6-7 days/week) or "CGM Sub-user." RESULTS: Of 282 adolescents (54% female), 161 were CGM Optimizers and 121 were CGM Sub-Users. Optimizers were younger (15.91 ± 2.17 years vs. 16.79 ± 2.17, p = 0.001), more likely non-Hispanic White (91.9% vs 83.5%, p = 0.029), and more likely to have private insurance (82.0% vs. 69.4%, p = 0.009). Every 1-point increase on Benefits of CGM scale was associated with 2.8 times greater odds of being an Optimizer (OR = 2.82, 95% CI 1.548-5.132, p = 0.001), and every 1-point increase on the Burdens of CGM scale was associated with a 52% decrease in odds (OR = 0.48, 95% CI = 0.283-0.800, p = 0.005), with final logistic regression model (including only these two predictors) explaining 22.3% of variance. CONCLUSION: CGM Optimizing adolescents were more likely to perceive higher benefit and lower burden of CGM. PRACTICAL IMPLICATIONS: Nurse-led interventions to promote benefits of CGM and mitigate burden may help youth increase adherence with CGM to achieve glycemic benefit.

'I was ready for it at the beginning': Parent experiences with early introduction of continuous glucose monitoring following their child's Type 1 diabetes diagnosis.

AIM: This study aimed to capture the experience of parents of youth with recent onset Type 1 diabetes who initiated use of continuous glucose monitoring (CGM) technology soon after diagnosis, which is a new practice. METHODS: Focus groups and individual interviews were conducted with parents of youth with Type 1 diabetes who had early initiation of CGM as part of a new clinical protocol. Interviewers used a semi-structured interview guide to elicit feedback and experiences with starting CGM within 30 days of diagnosis, and the benefits and barriers they experienced when adjusting to this technology. Groups and interviews were audio recorded, transcribed and analysed using content analysis. RESULTS: Participants were 16 parents (age 44.13 ± 8.43 years; 75% female; 56.25% non-Hispanic White) of youth (age 12.38 ± 4.15 years; 50% female; 50% non-Hispanic White; diabetes duration 10.35 ± 3.89 months) who initiated CGM 11.31 ± 7.33 days after diabetes diagnosis. Overall, parents reported high levels of satisfaction with starting CGM within a month of diagnosis and described a high level of reliance on the technology to help manage their child's diabetes. All participants recommended early CGM initiation for future families and were committed to continue using the technology for the foreseeable future, provided that insurance covered it. CONCLUSION: Parents experienced CGM initiation shortly after their child's Type 1 diabetes diagnosis as a highly beneficial and essential part of adjusting to living with diabetes.

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.

Do Youth Want Psychosocial Screenings in Diabetes Clinic? Profiles of Acceptability.

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

Depression in context: Important considerations for youth with type 1 vs type 2 diabetes.

BACKGROUND: Youth with diabetes are at increased risk for depression. However, severity and correlates of depressive symptoms may differ by diabetes type. OBJECTIVE: Associations of depressive symptoms with global health, diabetes duration, and gender were compared between youth with type 1 and type 2 diabetes. METHODS: A sample of 149 youth ages 12 to 21 diagnosed with either type 1 (n = 122) or type 2 (n = 27) diabetes were screened during routine clinic appointments. Regression models were constructed to examine differences by diabetes type. RESULTS: Adolescents with type 2 diabetes had significantly higher depressive symptom scores (4.89 vs 2.99, P = .025) than those with type 1 diabetes. A significant interaction between global health and diabetes type on depressive symptoms revealed inverse associations between global health and depressive symptoms that was stronger among youth with type 2 diabetes (ß = -.98, P < .001) than type 1 (ß = -.48, P < .001). Further probing revealed that among youth with better global health, adolescents with type 1 had more depressive symptoms than those with type 2 diabetes (ß = .33, P = .035). Diabetes duration and depressive symptoms were positively associated among individuals with type 2 (ß = .86, P = .043), but not type 1 diabetes. No gender differences were detected. CONCLUSION: These findings suggest that correlates of depressive symptoms in youth with diabetes differ by diabetes type. Global health appears to be an important correlate among youth with both types, whereas diabetes duration was only a significant factor among those with type 2 diabetes. The current findings can inform future psychosocial intervention efforts within both these populations.

An exploratory assessment of pediatric patient and parent needs after implantable cardioverter defibrillator implant.

BACKGROUND: Placement of an implantable cardioverter defibrillator (ICD) is often accompanied by psychological adjustment issues in pediatric patients and their parents. Although anxiety, depression, and lowered quality of life have been seen in these patients, no studies have investigated patient or parent reported needs. This exploratory study describes the needs of pediatric ICD patients and parents and assesses whether patient factors of age, gender, depression, and anxiety are associated with specific needs. METHODS: ICD patients ages 8-21 years and their parents completed a needs analysis survey assessing various domains of functioning. Patients also completed self-reported measures of depression and anxiety. RESULTS: Thirty-two patients (28% female) and their parents (72% mothers) completed the survey. Patients' most frequently endorsed needs involved educational issues: understanding their cardiac event/diagnosis (34%), medications (34%), and how the ICD would change their lifestyle (31%). Parents' most frequently endorsed needs involved family issues; almost half of parents (47%) were concerned about their children's frustration with their overprotectiveness and 28% were concerned with their child feeling depressed or anxious. Patients who reported feeling overprotected (12.1 ± 3.4 vs 17.4 ± 3.5 years; P = .001) were significantly younger than those who did not. Experiencing peer issues was more frequently endorsed by females than males (33% of females vs 4% of males; P = .026). CONCLUSIONS: ICD patients and parents endorsed markedly different needs. Patients focused on understanding their ICD, whereas parents were more focused on their children's emotional needs. Novel ways of educating patients about their device and clinic-based screenings of emotional functioning may serve to meet these needs.

Diabetes-Specific Self-Compassion: A New Measure for Parents of Youth With Type 1 Diabetes.

OBJECTIVE: Given the high daily demands of managing type 1 diabetes (T1D), parents of youth with T1D can experience high levels of emotional distress, burden, and self-criticism, with implications for parent and child well-being and parent self-efficacy for managing diabetes. Diabetes-specific self-compassion (SC), or being kind to oneself when facing challenges related to managing diabetes, may serve as protective for parents. This study aimed to create and assess the psychometric properties of a new tool, the diabetes-specific Self-Compassion Scale (SCS-Dp), to assess diabetes-specific SC in parents of youth with T1D. METHODS: We adapted a parent diabetes-specific SC measure; surveyed parents (N = 198; parent: 88% female; 95% non-Hispanic White; M age = 44 ± 8.9; child: 46% female; M age = 13 ± 3.4, range 2-18 years; 83% insulin pump users; 40% continuous glucose monitor (CGM) users; HbA1c from clinic data available for 76 participants: M HbA1c = 8.1 ± 1.3%) and conducted confirmatory factor analysis, and reliability and construct validity analyses. Validity measures included diabetes distress, diabetes empowerment, diabetes numeracy, and HbA1c. RESULTS: A bifactor structure provided the best fit, with one general factor and two wording-related group factors (positively and negatively worded items). The final 19-item SCS-Dp demonstrated excellent internal consistency (α =.94; range of item-total correlations: .52-.81) and good construct validity. As predicted, greater SC was associated with lower distress (r = -.68, p < .001) and greater empowerment (r = .43, p < .001) and was not associated with diabetes numeracy (p = .61). Diabetes-specific Self-Compassion Scale was not associated with HbA1c (p = .28). CONCLUSIONS: Results provide initial evidence of good reliability and validity of the SCS-Dp to assess diabetes-specific SC in parents.

Barriers to Continuous Glucose Monitoring in People With Type 1 Diabetes: Clinician Perspectives.

The purpose of this study was to determine clinician attitudes about the distinct barriers to uptake of continuous glucose monitoring (CGM) among people with diabetes. Survey data were collected measuring individual barriers, prerequisites to CGM, confidence in addressing barriers, and clinic staff resources. Results show that clinicians commonly report barriers to using CGM among people with diabetes in their clinic. Furthermore, clinicians who report a high number of barriers do not feel confident in overcoming the barriers to CGM. Interventions that attempt to empower clinicians to address concerns about CGM among people with diabetes may be warranted because low uptake does not appear to be directly related to available resources or prerequisites to starting CGM.

Primary Care Providers in California and Florida Report Low Confidence in Providing Type 1 Diabetes Care.

People with type 1 diabetes may receive a significant portion of their care from primary care providers (PCPs). To understand the involvement of PCPs in delivering type 1 diabetes care, we performed surveys in California and Florida, two of the most populous and diverse states in the United States. PCPs fill insulin prescriptions but report low confidence in providing type 1 diabetes care and difficulty accessing specialty referrals to endocrinologists.

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

Importance: Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective: To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions: Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures: The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results: Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance: Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03263494.

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.

Diabetes management mediating effects between diabetes symptoms and health-related quality of life in adolescents and young adults with type 1 diabetes.

OBJECTIVES: The 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. METHODS: The 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. RESULTS: The 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 < 0.001), demonstrating a large effect size. Patient health communication and perceived treatment adherence barriers were significant mediators in an exploratory serial multiple mediator model. CONCLUSIONS: Diabetes management explains in part the effects of diabetes symptoms on HRQOL in AYA with type 1 diabetes. Patient health communication to healthcare providers and perceived treatment adherence barriers further explain the mechanism in the relationship between diabetes symptoms and overall HRQOL.

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.

Diabetes symptoms predictors of health-related quality of life in adolescents and young adults with type 1 or type 2 diabetes.

OBJECTIVES: The objective was to investigate the patient-reported diabetes symptoms predictors of generic health-related quality of life (HRQOL) in adolescents and young adults (AYA) with type 1 or type 2 diabetes. METHODS: The 15-item PedsQL™ 3.2 Diabetes Module Diabetes Symptoms Summary Score and PedsQL™ 4.0 Generic Core Scales were completed in a 10-site national field test study by 513 AYA ages 13-25 years with type 1 (n = 424) or type 2 (n = 89) diabetes. Diabetes symptoms were tested for bivariate and multivariate linear associations with generic HRQOL. RESULTS: Diabetes symptoms were associated with decreased HRQOL in bivariate analyses. In predictive analytics models utilizing hierarchical multiple regression analyses controlling for relevant demographic and clinical covariates, diabetes symptoms accounted for 38 and 39% of the variance in patient-reported generic HRQOL for type 1 and type 2 diabetes, respectively, reflecting large effect sizes. The diabetes symptoms facets hyperglycemia symptoms, hypoglycemia symptoms, and nonspecific diabetes symptoms individually accounted for a significant percentage of the variance in separate exploratory predictive analytics models after controlling for demographic and clinical covariates, with small-to-large effect sizes. CONCLUSIONS: Diabetes symptoms are potentially modifiable predictors of generic HRQOL in AYA with diabetes. Identifying specific diabetes symptoms or symptoms facets that are the most important predictors from the patient perspective facilitates a patient-centered approach in clinical research, clinical trials, and practice designed to enhance overall generic HRQOL in AYA with diabetes.