Optimizing Technology Uptake and Use in Hard to Reach Adolescents with Type 1 Diabetes

优化难以接触到的 1 型糖尿病青少年的技术吸收和使用

• 批准号: 10340417
• 负责人: RANDI STREISAND
• 金额: $ 35.7万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10340417
• 关键词: Acute; Address; Adherence; Adolescence; Adolescent; African American; Age; Attention; Behavior Therapy; Behavioral; Black race; Caring; Chronic; Clinical; Communication; Complex; Conflict (Psychology); Data; Deterioration; Development; Devices; Diabetes Mellitus; Diagnosis; Disease; Distress; Education; Ensure; Ethnic Origin; Family; Family health status; Glucose; Goals; Health; Health Personnel; Hispanic; Household; Hyperglycemia; Hypoglycemia; Income; Insulin; Insulin-Dependent Diabetes Mellitus; Insurance; Intervention; Interview; Joints; Knowledge; Low income; Measures; Medical; Motivation; Not Hispanic or Latino; Outcome; Outcome Assessment; Parents; Participant; Personal Satisfaction; Pilot Projects; Population Heterogeneity; Positioning Attribute; Problem Solving; Process; Race; Randomized; Randomized Clinical Trials; Reduce health disparities; Regimen; Reporting; Research; Resources; Risk; Site; Social support; Source; Specialist; Structure; Technology; Telemedicine; Time; Work; Youth; acceptability and feasibility; adolescent health; age group; cost; dashboard; design; diabetes distress; diabetes education; diabetes self-management; efficacy evaluation; eligible participant; ethnic minority; expectation; experience; family support; follow-up; glucose monitor; glycemic control; group intervention; health disparity; high risk; improved; innovation; novel; parent-adolescent communication; participant retention; peer; peer support; pilot trial; primary outcome; psychosocial; public health insurance; racial and ethnic; racial minority; randomized trial; recruit; response; routine care; satisfaction; secondary outcome; skills; standard care; uptake; wearable device

PROJECT SUMMARY/ABSTRACT Young adolescents (ages 10-15) with type 1 diabetes (T1D) are at high risk for deterioration of glycemic control and relatedly poor overall T1D self-management. Continuous glucose monitors (CGM) provide real-time indicators of glucose levels and alert users to hypoglycemia and hyperglycemia. Consistent, informed use of CGM has the potential to improve glycemic control and related T1D health outcomes. However, adolescents with T1D are the least likely age group to utilize CGM and significant health disparities exist in access to and use of CGM among youth from racial and ethnic minority backgrounds and youth with public insurance. Adolescent CGM users also continue to evidence A1c levels above recommended targets, potentially due challenges related to perceived CGM burden and related family functioning. Novel, developmentally targeted interventions delivered early in adolescence could promote optimal uptake and use of CGM and reduce psychosocial barriers to sustained use but must be evaluated in rigorous pilot trials that attend to health disparities. The current study proposes to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges, and weekly adolescent-parent joint review of CGM reports. The intervention also addresses HCP knowledge of health disparities in diabetes technology through interactive education, and boosts family support through connection with peer parent consultants. This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and their parents will be recruited for this pilot randomized trial, randomly assigned to either an immediate intervention group or a delayed intervention group serving as a standard care comparison. Intervention content will be delivered via 3 telemedicine sessions with adolescents and a parent and supported by connection with a peer parent consultant. Medical and psychosocial data (including A1c, CGM indicators, CGM burdens and benefits, diabetes distress, and diabetes-related family conflict) will be collected from adolescents and a parent at baseline and three follow-up time points across the first year after CGM initiation. We will employ quantitative and qualitative analyses to evaluate intervention feasibility, acceptability, and impact. Enhancing CGM access and use at this key developmental juncture provides an excellent opportunity for tailored support and problem- solving, resulting in potentially lasting improvement in diabetes self-management. Results of this pilot trial will directly inform a multi-site randomized clinical trial to evaluate efficacy, with the long term goal of identifying effective behavioral strategies that can be integrated into routine diabetes education and care.

项目总结/摘要 患有1型糖尿病（T1 D）的青少年（10-15岁）处于血糖控制恶化的高风险中 以及相对较差的T1 D整体自我管理。动态血糖监测仪（CGM）提供实时 血糖水平的指示器，并提醒用户低血糖和高血糖。一致、知情地使用 CGM有可能改善血糖控制和相关的T1 D健康结果。然而，青少年 T1 D患者是最不可能使用CGM的年龄组，在获得和使用CGM方面存在显著的健康差异。 在种族和少数民族背景的青年以及有公共保险的青年中使用CGM。 青少年CGM使用者也继续证明A1 c水平高于推荐目标，这可能是由于 与感知的CGM负担和相关家庭功能相关的挑战。新颖，有发展针对性 在青春期早期提供的干预措施可以促进CGM的最佳吸收和使用， 持续使用的心理障碍，但必须在严格的试点试验中进行评估， 差距。目前的研究建议评估一种创新的行为干预， 糖尿病护理和教育专家（CDCES）教授解决问题和沟通技巧， CGM数据和使用，针对与血糖数据相关的双亲T1 D相互作用，个性化CGM 挑战，以及每周家长对CGM报告的联合审查。干预措施还涉及HCP 通过互动教育了解糖尿病技术中的健康差异，并加强家庭支持 通过与同行家长顾问的联系。本研究的目的是评估的初步疗效 行为干预，以提高CGM的使用和由此产生的T1 D健康结果。60名青少年及其 这项试验性随机试验将招募父母，随机分配到立即干预组和立即干预组。 组或延迟干预组作为标准治疗比较。干预内容将是 通过与青少年和一名家长的3次远程医疗会议提供，并通过与同龄人的联系提供支持 家长顾问医疗和心理社会数据（包括A1 c、CGM指标、CGM负担和益处， 糖尿病困扰和糖尿病相关的家庭冲突）将从青少年和父母中收集， 基线和CGM开始后第一年的三个随访时间点。我们将使用定量 和定性分析，以评估干预的可行性，可接受性和影响。加强CGM的访问 并在这一关键发展关头使用，为量身定制的支持和解决问题提供了极好的机会， 解决，导致糖尿病自我管理的潜在持久改善。这项试点试验的结果将 直接通知多中心随机临床试验，以评估疗效，长期目标是确定 有效的行为策略，可以整合到常规的糖尿病教育和护理。