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Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults with T1D

改善血糖

基本信息

批准号：
10277165
负责人：
KOREY K HOOD
金额：
$ 72.77万
依托单位：
JOSLIN DIABETES CENTER
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-25 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10277165
关键词：
Adolescent Adolescent and Young Adult Age American Anger Area Attitude Behavior Behavioral Boston COVID-19 pandemic Caring Childhood Clinic Clinical Collaborations Complex Control Groups Data Development Devices Diabetes Mellitus Distress Ensure Frustration Funding Glucose Glycosylated hemoglobin A Health Individual Insulin-Dependent Diabetes Mellitus International Intervention Left Link Longevity Measures Medical Mental Health Meta-Analysis Monitor Moods National Institute of Diabetes and Digestive and Kidney Diseases Nature Occupational Outcome Parents Participant Patient Outcomes Assessments Perception Persons Plant Roots Population Randomized Randomized Clinical Trials Research Research Personnel Risk Sampling San Francisco Schedule Schools Self Care Societies Subgroup Surveys Symptoms Technology Testing Time Visit active method age group aged base behavioral outcome care burden care delivery clinically significant college depression prevention depressive symptoms diabetes control diabetes distress diabetes education diabetes management diabetes self-management evidence base experience glucose monitor glycemic control group intervention high risk high risk population improved improved outcome intervention participants medical appointment post intervention primary endpoint primary outcome programs psychoeducational intervention psychosocial recruit remote visit routine screening secondary endpoint secondary outcome skill acquisition treatment as usual uptake usual care arm virtual young adult

项目摘要

PROJECT SUMMARY/ABSTRACT Adolescents and young adults (AYA) with type 1 diabetes (T1D) are especially at risk for missed diabetes visits and suboptimal self-care behaviors, as evidenced by their poor glycemic control with very high A1c levels. Further, diabetes distress is common in AYA with T1D and contributes to their suboptimal self-care behaviors and outcomes. The American Diabetes Association (ADA) recommends routine screening for diabetes distress and, when identified, referral for diabetes education or mental health treatment. Persons experiencing diabetes distress are at increased risk for missed medical appointments and deficient diabetes self-management. This is concerning because, without intervention, diabetes distress does not remit and either remains stable or intensifies over time. Further, AYAs may not adequately access or use advanced diabetes technologies due to perceptions of possible increases in self-care burden and diabetes distress when, in fact, such technologies could aid in their efforts to enhance self-care and improve glycemic control. Thus, there is an urgent need to develop practical and widely accessible interventions that target diabetes distress, self-care, and glycemic control and include face-to-face and remote visits to facilitate uptake. In the proposed 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress, increase acceptance of self-care behaviors (with or without diabetes technologies), and improve glycemic outcomes in AYAs with T1D. As a group, AYAs with T1D represent the subpopulation of all persons with T1D across the lifespan that has the poorest glycemic control, reaching a peak mean A1c value >9% at age ~19. AYAs with T1D often experience diabetes distress, which is linked to poor glycemic control, making them ideal participants for the proposed study. We will recruit 180 AYAs (ages 14-25) with T1D duration of at least 1 year and suboptimal diabetes control (A1c 8-13%). Participants will be randomly assigned to a usual care control condition or the intervention group. The intervention group will participate in monthly intervention sessions with a study interventionist during the first year. Of the monthly sessions, 4 will focus on improving glycemic outcomes in face-to-face sessions and 8 will focus on reducing diabetes distress in remote, virtual sessions to limit study burden (and in recognition of paradigm changes in care delivery during SARS- CoV-2 pandemic). To ensure adequate recruitment and retention, the control group will receive a delayed intervention and participate in the monthly sessions during the second year of the study. Both groups will use continuous glucose monitoring (CGM) for 14 days every 3 months and complete surveys every 6 months. A1c will also be measured centrally every 6 months. We will compare the two groups on the primary glycemic outcome of percent time-in-range (TIR) of 70-180 mg/dL assessed by CGM and on the secondary outcomes of diabetes distress and A1c from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent TIR, diabetes distress, and A1c compared with the usual care control group.

项目总结/摘要患有1型糖尿病（T1 D）的青少年和年轻人（AYA）尤其有错过糖尿病就诊的风险和次优的自我护理行为，如他们的血糖控制不良和非常高的A1 c水平所证明的。此外，糖尿病困扰在患有T1 D的AYA中很常见，并导致他们的自我护理行为不佳和结果。美国糖尿病协会（ADA）建议对糖尿病患者进行常规筛查并在确定后，转介糖尿病教育或心理健康治疗。糖尿病患者抑郁症患者错过医疗预约和糖尿病自我管理不足的风险增加。这是关注，因为如果不进行干预，糖尿病困扰不会缓解，要么保持稳定，要么随着时间的推移而加剧。此外，AYA可能无法充分获得或使用先进的糖尿病技术，对自我护理负担和糖尿病痛苦可能增加的看法，事实上，这些技术可以帮助他们努力提高自我护理和改善血糖控制。因此，迫切需要针对糖尿病患者的痛苦、自我护理和血糖控制，控制并包括面对面和远程访问，以促进吸收。在拟定的2年随机临床试验，我们将实施和评估行为/心理教育干预的影响，以减少糖尿病困扰，增加自我护理行为的接受度（有或没有糖尿病技术），以及改善患有T1 D的AYA的血糖结果。作为一个群体，患有T1 D的AYA代表了所有在整个生命周期内血糖控制最差的T1 D患者，达到峰值平均A1 c值 19岁时>9%。患有T1 D的AYA通常会经历糖尿病困扰，这与血糖控制不良有关，使他们成为拟议研究的理想参与者。我们将招募180名患有T1 D的AYA（14-25岁）持续时间至少1年，糖尿病控制欠佳（A1 c 8-13%）。参与者将被随机分配到一个常规护理控制条件或干预组。干预组将参加每月一次的在第一年与研究干预者进行干预会议。在每月的会议中，4次会议将侧重于改善面对面会议的血糖结果，8将侧重于减少糖尿病痛苦，虚拟会议，以限制研究负担（并认识到在SARS期间护理提供的范式变化- CoV-2大流行）。为了确保足够的招募和保留，对照组将接受延迟的在研究的第二年，参与干预并参加每月会议。两组将使用连续血糖监测（CGM），每3个月14天，每6个月完成一次调查。A1c 还将每6个月进行一次集中测量。我们将比较两组的主要血糖 CGM评估的70-180 mg/dL的范围内时间百分比（TIR）结局和以下次要结局从基线至1年的糖尿病窘迫和A1 c。我们假设干预组会有一个与常规护理对照组相比，TIR百分比、糖尿病痛苦和A1 c改善。