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临床试验/NCT07065721
NCT07065721招募中不适用

CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults

San Diego State University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月2日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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