跳至主要内容
临床试验/NCT06002048
NCT06002048Enrolling By Invitation不适用

AI Ready and Exploratory Atlas for Diabetes Insights

University of Washington3 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2023年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
4,000
试验地点
3
主要终点
Contrast Sensitivity

研究概览

简要总结

The study will collect a cross-sectional dataset of 4000 people across the US from diverse racial/ethnic groups who are either 1) healthy, or 2) belong in one of the three stages of diabetes severity (pre-diabetes/diet controlled, oral medication and/or non-insulin-injectable medication controlled, or insulin dependent), forming a total of four groups of patients. Clinical data (social determinants of health surveys, continuous glucose monitoring data, biomarkers, genetic data, retinal imaging, cognitive testing, etc.) will be collected. The purpose of this project is data generation to allow future creation of artificial intelligence/machine learning (AI/ML) algorithms aimed at defining disease trajectories and underlying genetic links in different racial/ethnic cohorts. A smaller subgroup of participants will be invited to come for a follow-up visit in year 4 of the project (longitudinal arm of the study). Data will be placed in an open-source repository and samples will be sent to the study sample repository and used for future research.

详细描述

The Artificial Intelligence Ready and Exploratory Atlas for Diabetes Insights (AI-READI) project seeks to create a flagship ethically-sourced dataset to enable future generations of artificial intelligence/machine learning (AI/ML) research to provide critical insights into type 2 diabetes mellitus (T2DM), including salutogenic pathways to return to health. The ability to understand and affect the course of complex, multi-organ diseases such as T2DM has been limited by a lack of well-designed, high quality, large, and inclusive multimodal datasets. The AI-READI team of investigators will aim to collect a cross-sectional dataset of 4,000 people and longitudinal data from 10% of the study cohort across the US. The study cohort will be balanced for self-reported race/ethnicity, gender, and diabetes disease stage. Data collection will be specifically designed to permit downstream pseudo-time manifold analysis, an approach used to predict disease trajectories by collecting and learning from complex, multimodal data from participants with differing disease severity (normal to insulin-dependent T2DM). The long-term objective for this project is to develop a foundational dataset in T2DM, agnostic to existing classification criteria or biases, which can be used to reconstruct a temporal atlas of T2DM development and reversal towards health (i.e., salutogenesis). Six cross-disciplinary project modules involving teams located across eight institutions will work together to develop this flagship dataset. Data will be optimized for downstream AI/ML research and made publicly available. This project will also create a roadmap for ethical and equitable research that focuses on the diversity of the research participants and the workforce involved at all stages of the research process (study design and data collection, curation, analysis, and sharing and collaboration).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥ 40 years old)
  • Patients with and without type 2 diabetes
  • Able to provide consent
  • Must be able to read and speak English

排除标准

  • Adults older than 85 years of age
  • Pregnancy
  • Gestational diabetes
  • Type 1 diabetes

结局指标

主要结局

Contrast Sensitivity

时间窗: July 19, 2023-January 1, 2027

Both photopic and mesopic for right and left eyes individually

fluorescence lifetime imaging ophthalmoscopy (FLIO)

时间窗: July 19, 2023-January 1, 2027

Continuous Glucose Monitoring

时间窗: July 19, 2023-January 1, 2027

Participants wear the Dexcom G6 Pro for 10 days

Home humidity

时间窗: July 19, 2023-January 1, 2027

Volatile Organic Compounds (VOC) in home

时间窗: July 19, 2023-January 1, 2027

Best-corrected visual acuity

时间窗: July 19, 2023-January 1, 2027

Both photopic and mesopic for right and left eyes individually

fundus photography

时间窗: July 19, 2023-January 1, 2027

Home temperature

时间窗: July 19, 2023-January 1, 2027

measured in Fahrenheit

Fine particulate matter that are 2.5 microns or less in diameter (PM2. 5) in home

时间窗: July 19, 2023-January 1, 2027

Montreal Cognitive Assessment (MoCA)

时间窗: July 19, 2023-January 1, 2027

Testing memory and cognitive function. Scores range from 0-30, with scores above 26 indicating normal functioning.

Optical coherence tomography (OCT)

时间窗: July 19, 2023-January 1, 2027

optical coherence tomography angiography (OCTA)

时间窗: July 19, 2023-January 1, 2027

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aaron Y Lee

Associate Professor, Department of Ophthalmology

University of Washington

研究点 (3)

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