Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Ecological Momentary Assessment (EMA) methods for measuring depression
研究概览
简要总结
This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes for at least six months
- •Fluent in spoken and written English
- •Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
- •Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period
排除标准
- •Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
- •Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
- •Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
- •Currently pregnant or plan to become pregnant during participation in the study
结局指标
主要结局
Ecological Momentary Assessment (EMA) methods for measuring depression
时间窗: Home monitoring (days 1-14)
Depression score via EMA
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress
时间窗: Home monitoring (days 1-14)
Diabetes distress score via EMA
Ecological Momentary Assessment (EMA) methods for measuring anxiety
时间窗: Home monitoring (days 1-14)
Anxiety score via EMA
次要结局
- Hemoglobin A1c(Baseline)
- Glycemic Outcomes(Home monitoring (days 1-14))
研究者
Jennifer Iyengar
Clinical Assistant Professor
University of Michigan