Promoting Resilience in Stress Management for Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.

Importance: Type 1 diabetes (T1D) requires demanding self-management health behaviors, and adolescents with T1D are at risk for poor psychosocial and medical outcomes. Developing resilience skills may help adolescents with T1D and elevated distress navigate common stressors and achieve positive outcomes. Objective: To test the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention on levels of hemoglobin A1c (HbA1c), diabetes distress, self-management behaviors, resilience, and quality of life among adolescents. Design, Setting, and Participants: This phase 3, parallel, 1:1 randomized clinical trial that followed up 172 participants for 12 months was conducted from January 1, 2020, to November 30, 2022, at each of 2 children's hospitals, in Seattle, Washington, and Houston, Texas. Participants were ages 13 to 18 years with T1D for at least 12 months and elevated diabetes distress. Intervention: PRISM, a manualized, skills-based, individual intervention program that teaches stress management, goal setting, reframing, and meaning-making, facilitated by a coach and accompanied by a digital app, was delivered in three 30- to 60-minute sessions approximately 2 weeks apart. Main Outcomes and Measures: The 2 primary outcomes, diabetes distress and HbA1c levels, and 3 secondary outcomes, resilience, quality of life, and engagement in self-management behaviors, were assessed at baseline and 6 and 12 months after baseline. Linear mixed-effects regression models were used to evaluate associations between PRISM or usual care (UC) and these outcomes at both time points for the intention-to-treat population. Results: Among 172 adolescents (mean [SD] age, 15.7 [1.6] years), 96 were female (56%), and their baseline mean (SD) HbA1c level was 8.7% (2.0%). No differences were evident between PRISM and UC recipients in HbA1c levels (ß, -0.21 [95% CI, -0.65 to 0.22]; P = .33) or diabetes distress (ß, -2.71 [95% CI, -6.31 to 0.90]; P = .14) or any participant-reported outcome (eg, ß, 2.25 [95% CI, -0.30 to 4.80]; P = .08 for self-management behaviors) at 6 months. At 12 months, there was no statistically significant difference between arms in HbA1c levels (ß, -0.26 [95% CI, -0.72 to 0.19]; P = .25); however, PRISM recipients reported significantly greater amelioration of diabetes distress (ß, -4.59 [95% CI, -8.25 to -0.94]; P = .01) and improvement in self-management behaviors (ß, 3.4 [95% CI, 0.9 to 5.9]; P = .01) compared with UC recipients. Conclusions and Relevance: The findings in this randomized clinical trial of psychosocial and behavioral improvements associated with PRISM at 12 months illustrate the value of a strengths-based intervention. Integrating resilience skills-building with traditional diabetes care may be a promising approach for improving outcomes among adolescents with T1D and elevated diabetes distress. Trial Registration: ClinicalTrials.gov number: NCT03847194.

Young Adults with Type 1 Diabetes.

Young adults experience multiple developmental transitions across social, educational, vocational, residential, and financial life domains. These transitions are potential competing priorities to managing a chronic condition such as type 1 diabetes and can contribute to poor psychosocial and medical outcomes. In this narrative review, we describe population outcomes of young adult populations and the unique considerations associated with managing type 1 diabetes in young adulthood. We provide an overview of the current evidence-based strategies to improve care for young adults with type 1 diabetes and recommendations for future directions in the field.

Satisfaction With Participation in the First STEPS Behavioral Intervention: Experiences of Parents of Young Children With Newly Diagnosed Type 1 Diabetes.

OBJECTIVE: Parents of young children with new-onset type 1 diabetes (T1D) often experience significant distress and struggle with T1D management during a challenging developmental stage. The First STEPS (Study of Type 1 in Early childhood and Parenting Support) trial evaluated a stepped-care behavioral intervention comprising increasingly intensive intervention steps (peer parent coach, cognitive-behavioral counseling, consultations with diabetes educator and psychologist) based on need. The intervention improved parental depressive symptoms compared to usual care. Subsequently, we examined parent satisfaction with the intervention to guide potential implementation and refinement for future trials. METHODS: Participants were 157 parents of young children newly diagnosed with T1D. At 9 months post randomization, n = 153 completed satisfaction questionnaires and n = 17 completed qualitative interviews. Satisfaction ratings about trial procedures and each intervention step were summarized. We used thematic analysis with the interview transcripts to generate themes related to participants' experiences in the trial overall and intervention specifically. We explored differences in themes between participants who did versus did not respond to the intervention and among those who experienced different intervention steps. RESULTS: Most participants in both arms rated study participation and methods positively (>95%), and those completing interviews described high satisfaction with study procedures overall, retention incentives, and contact with study staff. Intervention participants' satisfaction ratings were high across steps. Two qualitative themes reflected satisfaction with the intervention enhancing self-efficacy and social support. CONCLUSIONS: High satisfaction suggests implementing a stepped-care behavioral intervention as part of routine clinical care following T1D diagnosis would be well received.

Twelve-month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes.

AIM: Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard-CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks. METHODS: CGM + FBI (n = 45), Standard-CGM (n = 42) and BGM-Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups. RESULTS: The BGM-Crossover group reported improved diabetes burden (Δ -6.9, 95% CI [-11.3, -2.6], p = 0.003), fear of hypoglycaemia (Δ -6.4, CI [-10.1, -2.6], p = 0.002) and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6, 14.0], p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate. CONCLUSIONS: Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short- and long-term.

Parent Perspectives of School/Daycare Experiences in Young Children Newly Diagnosed With Diabetes.

OBJECTIVE: A central part of family adjustment to a new diagnosis of type 1 diabetes (T1D) is integrating T1D management into the child's school/daycare. This may be particularly challenging for young children who rely on adults for their diabetes management. This study aimed to describe parent experiences with school/daycare during the first 1.5 years following a young child's T1D diagnosis. METHODS: As part of a randomized controlled trial of a behavioral intervention, 157 parents of young children with new-onset (<2 months) T1D reported on their child's school/daycare experience at baseline and at 9- and 15-month post-randomization. We used a mixed-methods design to describe and contextualize parents' experiences with school/daycare. Qualitative data were collected via open-ended responses, and quantitative data were collected from a demographic/medical from. RESULTS: While most children were enrolled in school/daycare at all time points, over 50% of parents endorsed that T1D affected their child's enrollment, rejection, or removal from school/daycare at 9 or 15 months. We generated five themes related to parents' school/daycare experiences: Child factors, Parent factors, School/Daycare factors, Cooperation between Parents and Staff, and Socio-historical factors. Parents of younger children and those with lower subjective socioeconomic status were significantly more likely to endorse challenges with school/daycare enrollment. CONCLUSIONS: School/daycare settings present challenges for parents of young children with T1D. Changes may need to occur across contexts to support early childhood education, including advocacy resources for parents to navigate school policies, increased training for school staff, and healthcare team outreach initiatives to parents and schools.

Psychosocial, Medical, and Demographic Variables Associated with Parent Mealtime Behavior in Young Children Recently Diagnosed with Type 1 Diabetes.

OBJECTIVE: Managing young children's mealtime concerns can be challenging after type 1 diabetes (T1D) diagnosis because of developmental factors and diabetes management demands. To identify potential intervention targets, we evaluated medical, psychosocial, and demographic factors in relation to parents' engagement in problem mealtime behaviors (e.g., pressure to eat, restriction). METHOD: Parents (N = 157) of young children (age 1-6 years) reported on psychosocial variables (parent fear of hypoglycemia, family functioning, parent problem solving, and parents' problem mealtime behavior frequency and perceptions of being problematic) within 2 months after T1D diagnosis. Hierarchical regression analyses examined associations among psychosocial variables, demographics (child sex, parent race/ethnicity), child continuous glucose monitor (CGM) use, and parents' problem mealtime behaviors. RESULTS: Parents of children using CGMs reported parents' mealtime behaviors as more problematic than nonusers, but there were no differences for other medical or demographic variables. Models predicting parents' problem mealtime behavior frequency and problem perceptions that included psychosocial variables, demographic variables, and CGM use led to significant R 2 of 0.14 and 0.16, respectively. CGM use and parent problem solving were significantly associated with parent mealtime behaviors being perceived as more problematic. CONCLUSION: Shortly after T1D diagnosis in young children, medical and parent psychosocial factors related to how frequently parents engaged in problem mealtime behaviors and the degree to which parents perceived them as problematic. Other factors may further explain the complexities of mealtime management. Considering parents' problem-solving skills and child treatment regimens may help guide interventions targeting mealtime challenges during the new diagnosis period.

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.

OBJECTIVES: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia. STUDY DESIGN: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology. RESULTS: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%). CONCLUSION: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.

Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes.

BACKGROUND: Adolescents with type 1 diabetes (T1D) are at high risk for elevated diabetes distress, which greatly impacts diabetes management, glycemic outcomes and overall quality of life. Developing protective skills and "resilience resources" to navigate adversity and manage diabetes distress has high potential to help adolescents with T1D achieve optimal behavioral, psychological, and health outcomes. The "Promoting Resilience in Stress Management" (PRISM) program is a manualized, brief, skills-based intervention delivered over 6 months via two 45-60 min one-on-one sessions and a family meeting with a PRISM coach, and supplemented by booster calls and a digital app. This trial (PRISM versus usual care)is designed to:: (1) assess PRISM's impact on glycemic outcomes and diabetes distress among adolescents with T1D, and (2) explor PRISM's impact on resilience, self-reported adherence, and quality of life. METHODS: We describe the protocol for a multi-site randomized controlled trial designed for adolescents ages 13-18 with elevated diabetes distress. The primary trial outcomes are glycemic outcomes and diabetes distress 6 months post-randomization. Secondary outcomes include resilience, self-reported adherence, and QOL 6 months post-randomization. Our hypothesis is that youth in the PRISM group will demonstrate better glycemic outcomes and improved diabetes distress, adherence, resilience, and QOL compared to usual care. CONCLUSIONS: This study will provide methodologically rigorous data and evidence regarding a novel intervention to promote resilience among adolescents with T1D and elevated diabetes distress. This research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group. TRIAL REGISTRATION: Prospectively registered at Clinicaltrials.gov (NCT03847194).

11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes-2023.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

7. Diabetes Technology: Standards of Care in Diabetes-2023.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2023.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes-2023.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.