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

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

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.

Do baseline resilience profiles moderate the effects of a resilience-enhancing intervention for adolescents with type I diabetes?

OBJECTIVE: Resilience processes include modifiable individual and family-based skills and behaviors and are associated with better health and emotional outcomes for youth with Type I diabetes (T1D). There is likely heterogeneity among adolescents with T1D based on differing profiles of resilience processes. At-risk adolescents with lower levels of modifiable skills and assets may benefit more from psychosocial skill-building interventions, compared to adolescents who already have strong resilience processes. This article identified whether there are subgroups of adolescents with T1D based on resilience process profiles and assessed differences in glycemic control, diabetes management behaviors, and distress at baseline. It also evaluated subgroups as moderators of the efficacy of a psychosocial skill-building program. METHOD: Two hundred sixty-four adolescents with T1D (14 to 18 years) were randomly assigned to a resilience-promoting program (N = 133) or diabetes education control (N = 131). Data were collected at seven time points over 3 years and analyzed with latent profile analysis and latent growth curve modeling. RESULTS: There were two subgroups with high- versus low-resilience processes. The low-resilience subgroup exhibited more distress, higher HbA1c, less glucose monitoring, and fewer diabetes management behaviors at baseline. Differences persisted over 3 years. Subgroup membership did not moderate the efficacy of a resilience-promoting program compared to control. The resilience program resulted in lower distress regardless of subgroup. CONCLUSIONS: There is heterogeneity in resilience process profiles, which are associated with clinically meaningful differences in distress, diabetes management, and glycemic control. Findings can be used to identify at-risk teenagers and inform a targeted approach to care. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

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.

Cost, Hassle, and On-Body Experience: Barriers to Diabetes Device Use in Adolescents and Potential Intervention Targets.

Background: Adolescents with diabetes have the highest A1cs of all age groups. Diabetes devices (insulin pumps and continuous glucose monitors [CGM]) can improve glycemic outcomes, and although the uptake of devices has increased, they remain underutilized in this population. This study characterizes adolescent-reported barriers to diabetes device use to determine targets for clinician intervention. Methods: We surveyed 411 adolescents with type 1 diabetes (mean age 16.30 ± 2.25 years) on barriers to diabetes device use, technology use attitudes (general and diabetes specific), benefits and burdens of CGM, self-efficacy for diabetes care, diabetes distress, family conflict, and depression. We characterize barriers to device uptake; assess demographic and psychosocial differences in device users, discontinuers, and nonusers; and determine differences in device use by gender and age. Results: The majority of adolescents used an insulin pump (n = 307, 75%) and more than half used CGM (n = 225, 55%). Cost/insurance-related concerns were the most commonly endorsed barrier category (61%) followed by wear-related issues (58.6%), which include the hassle of wearing the device (38%) and dislike of device on the body (33%). Adolescents who endorsed more barriers also reported more diabetes distress (P = 0.003), family conflict (P = 0.003), and depressive symptoms (P = 0.014). Pump and CGM discontinuers both endorsed more barriers and more negative perceptions of technology than current users, but reported no difference from device users in diabetes distress, family conflict, or depression. Gender was not related to the perceptions of devices. Conclusions: Clinicians can proactively assess attitudes toward diabetes technology and perceptions of benefits/burdens to encourage device uptake and potentially prevent device discontinuation among adolescents.

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.

Correlates of health care use among White and minority men and women with diabetes: An NHANES study.

AIMS: The current study sought to identify patient-level factors related to health care use among White and minority men and women with diabetes. METHODS: A sample of 447 of non-pregnant individuals with diabetes, ages 18-64, was drawn from the 2015-2016 National Health and Nutrition Examination Surveys dataset. Poisson regression models tested associations between health care use and self-rated health, depression, medical comorbidities, body mass index, marital status, number of children, income, insurance coverage, and age, stratified by gender and racial/ethnic minority status. RESULTS: Poorer self-rated health was the only significant correlate of increased health care use among White men with diabetes whereas income and insurance were significant correlates of increased use among minority men. Among White and minority women, higher levels of depression and being single were correlated with greater health care use. Comorbid medical conditions and insurance coverage were also related to use among minority women. CONCLUSIONS: Among individuals with diabetes, health care use among White men appeared to be driven by subjective health whereas financial factors were critical among minority men. Family structure and mental health were instrumentally associated with health care use among all women. These factors can be targeted to promote equitable access to care.

From Wary Wearers to d-Embracers: Personas of Readiness to Use Diabetes Devices.

BACKGROUND: Diabetes devices such as insulin pumps and continuous glucose monitoring (CGM) are associated with improved health and quality of life in adults with type 1 diabetes (T1D). However, uptake remains low. The aim of this study was to develop different "personas" of adults with T1D in relation to readiness to adopt new diabetes technology. METHODS: Participants were 1498 T1D Exchange participants who completed surveys on barriers to uptake, technology attitudes, and other psychosocial variables. HbA1c data was available from the T1D Exchange for 30% of the sample. K-means cluster analyses grouped the sample by device barriers and attitudes. The authors assigned descriptive labels based on cluster characteristics. ANOVAs and chi-square tests assessed group differences by demographic and psychosocial variables (eg, diabetes duration, diabetes distress). RESULTS: Analyses yielded five distinct personas. The d-Embracers (54% of participants) endorsed few barriers to device use and had the highest rates of device use, lowest HbA1c, and were the least distressed. The Free Rangers (23%) had the most negative technology attitudes. The Data Minimalists (10%) used pumps but had lower CGM use and did not want more diabetes information. The Wary Wearers (11%) had lower overall device use, were younger, more distressed, endorsed many barriers, and had higher HbA1c. The High Distress (3%) group members were the youngest, had the shortest diabetes duration, reported the most barriers, and were the most distressed. CONCLUSION: These clinically meaningful personas of device readiness can inform tailored interventions targeting barriers and psychosocial needs to increase device uptake.

Mobile Momentary Assessment and Biobehavioral Feedback for Adolescents with Type 1 Diabetes: Feasibility and Engagement Patterns.

BACKGROUND: Integration of momentary contextual and psychosocial factors within self-management feedback may provide more specific, engaging, and personalized targets for problem solving. METHODS: Forty-four youth ages 13-19 with type 1 diabetes (T1D) were provided a Bluetooth meter and completed the 30-day protocol. Participants were randomized to "app + meter" or "meter-only" groups. App + meter participants completed mealtime and bedtime assessment each day. Assessments focused on psychosocial and contextual information relevant for self-management. Graphical feedback integrated self-monitored blood glucose (SMBG), insulin, and Bluetooth-transmitted blood glucose data with the psychosocial and contextual data. App + meter participants completed an interview to identify data patterns. RESULTS: The median number of momentary assessments per participant was 80.0 (range 32-120) with 2.60 per day. By 2 weeks participants had an average of 40.77 (SD 12.23) assessments. Dose-response analyses indicated that the number of app assessments submitted were significantly related to higher mean daily SMBG (r = -0.44, P < 0.05) and to lower% missed mealtime SMBG (r = -0.47, P < 0.01). Number of feedback viewing sessions was also significantly related to a lower% missed mealtime SMBG (r = -0.44, P < 0.05). Controlling for baseline variables, mixed-effects analyses did not indicate group × time differences in mean daily SMBG. Engagement analyses resulted in three trajectory groups distinguished by assessment frequencies and rates of decline. Engagement group membership was significantly related to gender, mean daily SMBG, and HbA1c values. CONCLUSIONS: Momentary assessment combined with device data provided a feasible means to provide novel personalized biobehavioral feedback for adolescents with T1D. A 2-week protocol provided sufficient data for self-management problem identification. In addition to feedback, more intensive intervention may need to be integrated for those patients with the lowest self-management at baseline.

Implementation of Depression Screening and Global Health Assessment in Pediatric Subspecialty Clinics.

PURPOSE: Adolescents with chronic illness face greater risk of psychosocial difficulties, complicating disease management. Despite increased calls to screen for patient-reported outcomes, clinical implementation has lagged. Using quality improvement methods, this study aimed to investigate the feasibility of standardized screening for depression and assessment of global health and to determine recommended behavioral health follow-up, across three pediatric subspecialty clinics. METHODS: A total of 109 patients aged 12-22 years (median = 16.6) who were attending outpatient visits for treatment of diabetes (80% type 1), inflammatory bowel disease, or cystic fibrosis completed the 9-item Patient Health Questionnaire (PHQ-9) depression and Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health measures on electronic tablets. Patients screening positive on the PHQ-9 received same-day behavioral health assessment and regular phone check-ins to facilitate necessary follow-up care. RESULTS: Overall, 89% of 122 identified patients completed screening during a 6-month window. Patients completed measures in a timely manner (within 3 minutes) without disruption to clinic flow, and they rated the process as easy, comfortable, and valuable. Depression scores varied across disease type. Patients rated lower global health relative to a previously assessed validation cohort. Depression and global health related significantly to certain medical outcomes. Fifteen percent of patients screened positive on the PHQ-9, of whom 50% confirmed attending behavioral health appointments within 6 months of screening. CONCLUSIONS: A standardized depression and global health assessment protocol implemented across pediatric subspecialties was feasible and effective. Universal behavioral health screening for adolescents and young adults living with chronic disease is necessary to meet programmatic needs in pediatric subspecialty clinics.

The emerging diabetes online community.

BACKGROUND: Diabetes self-management is complex and demanding, and isolation and burnout are common experiences. The Internet provides opportunities for people with diabetes to connect with one another to address these challenges. The aims of this paper are to introduce readers to the platforms on which Diabetes Online Community (DOC) participants interact, to discuss reasons for and risks associated with diabetes-related online activity, and to review research related to the potential impact of DOC participation on diabetes outcomes. METHODS: Research and online content related to diabetes online activity is reviewed, and DOC writing excerpts are used to illustrate key themes. Guidelines for meaningful participation in DOC activities for people with diabetes, families, health care providers, and industry are provided. RESULTS: Common themes around DOC participation include peer support, advocacy, self-expression, seeking and sharing diabetes information, improving approaches to diabetes data management, and humor. Potential risks include access to misinformation and threats to individuals' privacy, though there are limited data on negative outcomes resulting from such activities. Likewise, few data are available regarding the impact of DOC involvement on glycemic outcomes, but initial research suggests a positive impact on emotional experiences, attitudes toward diabetes, and engagement in diabetes management behaviors. CONCLUSION: The range of DOC participants, activities, and platforms is growing rapidly. The Internet provides opportunities to strengthen communication and support among individuals with diabetes, their families, health care providers, the health care industry, policy makers, and the general public. Research is needed to investigate the impact of DOC participation on self-management, quality of life, and glycemic control, and to design and evaluate strategies to maximize its positive impact.

Psychosocial assessment of artificial pancreas (AP): commentary and review of existing measures and their applicability in AP research.

AIM: This study aimed to systematically review the evidence base for the use of existing psychological and psychosocial measures suitable for use in artificial pancreas (AP) research. MATERIALS AND METHODS: This systematic review of published literature, gray literature, previous systematic reviews, and qualitative and economic studies was conducted using terms and abbreviations synonymous with diabetes, AP, and quality of life (QoL). RESULTS: Two hundred ninety-two abstracts were identified that reported psychosocial assessment of diabetes-related technologies. Of these, nine met the inclusion criteria and were included. Only four of 103 ongoing trials evaluated psychosocial aspects as an outcome in the trial. Of these, treatment satisfaction, acceptance and use intention of AP, fear of hypoglycemia episodes, satisfaction with AP, and an unspecified QoL measure were used. CONCLUSIONS: A better understanding of the psychosocial side of AP systems and the extent to which human factors play a role in the uptake and efficient use of these systems will ultimately lead to the most benefit for people with diabetes.

From caregiver psychological distress to adolescent glycemic control: the mediating role of perceived burden around diabetes management.

OBJECTIVE: To examine whether perceived caregiver burden around diabetes management mediated the relationship between caregivers' psychological distress and adolescents' glycemic control. METHODS: Across three visits spanning 9 months, caregivers of 147 adolescents with type 1 diabetes completed measures of anxiety and depressive symptoms and a measure of perceived burden specific to diabetes management. Adolescents' glycemic control was also measured. RESULTS: Perceived burden mediated the relationship between caregiver depressive symptoms and adolescents' glycemic control. The overall model was significant, F(10,132) = 5.0, p < .001, R(2) = 0.27. Fifty percent of the relationship was explained by diabetes-specific burden. The relationship between caregiver anxiety symptoms and adolescent glycemic control was partially mediated by diabetes-specific burden, F(10,133) = 5.7, p < .001, R(2) = 0.30, explaining 26% of this relationship. DISCUSSION: A variable linking caregiver psychological distress to adolescent glycemic control is perceived caregiver burden around diabetes management. Implications for clinical practice include targeting caregiver psychological functioning and reducing global and diabetes-specific distress.

A meta-systems approach to evidence-based practice for children and adolescents.

Improving outcomes for children and adolescents with mental health needs demands a broad meta-systemic orientation to overcome persistent problems in current service systems. Improving outcomes necessitates inclusion of current and emerging evidence about effective practices for the diverse population of youth and their families. Key components of the meta-system for children with emotional or behavioral needs include families, cultural norms and values, and service sectors such as schools, pediatric health centers, specialty mental health systems, juvenile justice systems, child protection services, and substance use treatment systems. We describe each component of the meta-system, noting challenges to the provision of evidence-based practice (EBP) and highlighting ways to optimize outcomes. Our focus is on the inclusion of evidence-based assessment and interventions, including prevention, within a developmentally driven and culturally responsive contextual model. Recommendations for addressing disparities in research funding and essential steps to foster communication and coordination of EBP across settings are provided.

Sociodemographic and psychosocial factors associated with continuous subcutaneous insulin infusion in adolescents with type 1 diabetes.

OBJECTIVE: To examine the role of sociodemographic factors and psychosocial adjustment in continuous subcutaneous insulin infusion (CSII) use among adolescents with type 1 diabetes. METHODS: A total of 150 adolescents with type 1 diabetes and their caregivers completed measures of general psychological functioning, diabetes functioning, and stressful life events. Blood glucose monitoring (BGM) frequency and glycemic control were also assessed. Logistic regression was used to determine associations between CSII use and sociodemograpic and psychosocial factors. RESULTS: All logistic regression models were significant, indicating a large proportion of the variance in CSII use was associated with sociodemographic, diabetes-specific and psychosocial variables. Final models showed higher frequency of BGM and having private insurance as significant correlates of CSII use. CSII use was also associated with adolescent and caregiver reports of sharing of responsibilities around diabetes management and negative affect regarding BGM. CONCLUSIONS: Adolescents currently prescribed CSII therapy evidenced key differences from their counterparts using multiple daily injections (MDI) in insurance status, diabetes management behavior, and family functioning related to diabetes. Efforts to understand the role of family factors in the maintenance of CSII therapy with clinical indicators of CSII use may inform treatment effectiveness.

Updated and revised Diabetes Family Conflict Scale.

OBJECTIVE: The purpose of this study was to update the Diabetes Family Conflict Scale (DFCS) in the era of intensive diabetes management and provide an indication of its psychometric properties. RESEARCH DESIGN AND METHODS: The revised DFCS and measures of negative emotions around blood glucose monitoring (BGM), quality of life, and perceived parental burden from diabetes management were completed by 202 children and adolescents with type 1 diabetes and their primary caregivers. Insulin regimen, adherence, and glycemic control were also assessed. RESULTS: The revised DFCS demonstrated strong psychometric properties. There was acceptable internal consistency for child and caregiver forms of the DFCS. Factor analysis revealed two factors related to direct and indirect management tasks. Both child (r = 0.27, P < 0.01) and caregiver (r = 0.26, P < 0.01) DFCS scores were correlated with A1C values. Multivariate analysis of factors usually associated with A1C values showed an additive, independent contribution of diabetes-specific family conflict to the prediction of glycemic control: F (12,189) = 6.17, P < 0.01, R2 = 0.28. Conflict around direct management tasks (e.g., BGM) was a more important predictor of higher A1C levels than conflict around indirect management tasks (e.g., telling friends about diabetes). CONCLUSIONS: The revised and updated DFCS demonstrates strong psychometric properties and can be used as a tool for measuring the level of diabetes-specific conflict in families with children and adolescents with type 1 diabetes.