CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Qualitative data regarding CGM use
研究概览
简要总结
Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.
详细描述
The prevalence of type 2 diabetes (T2D) is rising in young adults and is associated with increased complications and reduced life expectancy. Poor adherence to diabetes self-management behaviors is common in young adulthood, often leading to poor glycemic control, and existing self-management interventions have had limited effectiveness in this age group. Continuous glucose monitors (CGMs) provide real-time glucose data that can support behavior change and reduce common self-management barriers such as glycemic unawareness, but their use in younger adults is limited. As "digital natives," young adults are well-poised to benefit from CGM interventions, particularly if they reduce barriers of standard self-management education (e.g., time burden). Qualitative data has shown that young adults are interested in CGM use but lack both access to CGMs and understanding of how to best utilize CGM data. The purpose of this proposal is to utilize a mixed-methods, community-engaged approach to generate pilot data for the development of a self-management intervention that pairs CGM glucose data with behavioral data (e.g., FitBit step count, dietary intake) to improve self-management and glycemic awareness and control. Young adults with T2D will be recruited to participate in a 30-day trial wear of CGMs, during which self-management behaviors will also be assessed. Afterward, qualitative interviews with participants will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns, and preferences for a CGM-based intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult 18-45 years of age
- •diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record
- •no prior use or experience with wearable CGMs
- •possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app
- •fluency in English or Spanish
排除标准
- •severe mental illness (e.g., psychosis, suicidal ideation);
- •pregnancy or <6 months postpartum
研究组 & 干预措施
CGM Wear
Participants will wear a continuous glucose monitor for 30 days. They will also wear a FitBit activity tracker watch and complete weekly surveys to report diabetes self-management behaviors.
干预措施: Continuous glucose monitor (Device)
结局指标
主要结局
Qualitative data regarding CGM use
时间窗: Immediately after the intervention
Semi-structured qualitative interviews will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns or relationships between glucose and health behaviors, and preferences for a future CGM-based intervention.
次要结局
- Acceptability and feasibility of CGM wear(Immediately after the intervention)
