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临床试验/NCT05335889
NCT05335889已完成不适用

Feasibility of Using Wearable Sensors and Artificial Intelligence for Carbohydrate Counting in Chinese Americans With Type 2 Diabetes

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Accuracy of Carbohydrate Counting using eButton (absolute error)

研究概览

简要总结

This is a one-group pilot study where Chinese immigrants who are English speaking with T2D from NYU Langone Health and NYU Brooklyn Family Health Center (Sunset Park) will be recruited.

详细描述

To evaluate the estimation accuracy using eButton, researchers will collect carbohydrate data via weighing food by registered dietitian nutritionist (RDN) ("gold standard") (2 days/week at research labs) and food diaries by participants (2 days/week at research labs and 3 days/ week at participant home). Then, the estimated carb grams will be compared head to head among each other. Assessment will be at 0 and 2 weeks, including surveys and qualitative audio interview.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years old
  • Diagnosed with T2D at least one year prior
  • Self-identified as first- or second-generation Chinese immigrants
  • Feel comfortable communicating in English, the reason is that the questionnaires/surveys are validated in English
  • Have a computer and internet connection

排除标准

  • Plan frequent travel or vacations or plan to relocate in the next five weeks
  • Have serious diabetes-related complications, physical illness, or mental illness (e.g., schizophrenia, bipolar disorder, or substance abuse) that would preclude participation
  • Have severe cognitive impairments (e.g., dementia, intellectual disability)

结局指标

主要结局

Accuracy of Carbohydrate Counting using eButton (absolute error)

时间窗: Day 14

The estimated carb grams using the eButton, gold standard, and participants' food diaries will be compared head to head among each other. The absolute error will be computed: the difference between the estimated value and the gold standard (estimated - gold standard). Bland-Altman plots will be used to examine the level of agreement between eButton and gold standard measurements.

Accuracy of Carbohydrate Counting using eButton (relative error)

时间窗: Day 14

The estimated carb grams using the eButton, gold standard, and participants' food diaries will be compared head to head among each other. The relative error will be computed: the percentage difference between the estimated value relative to the gold standard. Relative errors will be reported using boxplots to allow visual comparison of the distribution and variability in errors across all methods. Bland-Altman plots will be used to examine the level of agreement between eButton and gold standard measurements.

Proportion of participants who are fully compliant with eButton use

时间窗: Day 14

Proportion of participants who are fully compliant with eButton use and proportion of meals evaluated using eButton, with 95% confidence intervals will be qualitatively reported. Perceived usefulness and perceived ease of use will be summarized as mean and standard deviation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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