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February 1, 2025BMJ Open16 citationsOpen Access

Cross-sectional design and protocol for Artificial Intelligence Ready and Equitable Atlas for Diabetes Insights (AI-READI)

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COCynthia OwsleyDMDawn S MatthiesGMGerald McGwin

Key Result

The AI-READI project is a cross-sectional study protocol targeting 4,000 participants aged ≥40 to collect multimodal data for artificial intelligence research in type 2 diabetes.

Study Design

Type

Cross-Sectional (n=4,000)

Multicenter

Yes

PICO

P
Population
Target enrollment of 4,000 adults aged ≥40, balanced by race/ethnicity, T2DM status, and sex, for a cross-sectional multimodal data collection protocol.
E
Exposure / Comparator
Multimodal data collection (AI-READI)

Abstract

INTRODUCTION: Artificial Intelligence Ready and Equitable for Diabetes Insights (AI-READI) is a data collection project on type 2 diabetes mellitus (T2DM) to facilitate the widespread use of artificial intelligence and machine learning (AI/ML) approaches to study salutogenesis (transitioning from T2DM to health resilience). The fundamental rationale for promoting health resilience in T2DM stems from its high prevalence of 10.5% of the world's adult population and its contribution to many adverse health events. METHODS: AI-READI is a cross-sectional study whose target enrollment is 4000 people aged 40 and older, triple-balanced by self-reported race/ethnicity (Asian, black, Hispanic, white), T2DM (no diabetes, pre-diabetes and lifestyle-controlled diabetes, diabetes treated with oral medications or non-insulin injections and insulin-controlled diabetes) and biological sex (male, female) (Clinicaltrials.org approval number STUDY00016228). Data are collected in a multivariable protocol containing over 10 domains, including vitals, retinal imaging, electrocardiogram, cognitive function, continuous glucose monitoring, physical activity, home air quality, blood and urine collection for laboratory testing and psychosocial variables including social determinants of health. There are three study sites: Birmingham, Alabama; San Diego, California; and Seattle, Washington. ETHICS AND DISSEMINATION: AI-READI aims to establish standards, best practices and guidelines for collection, preparation and sharing of the data for the purposes of AI/ML, including guidance from bioethicists. Following Findable, Accessible, Interoperable, Reusable principles, AI-READI can be viewed as a model for future efforts to develop other medical/health data sets targeted for AI/ML. AI-READI opens the door for novel insights in understanding T2DM salutogenesis. The AI-READI Consortium are disseminating the principles and processes of designing and implementing the AI-READI data set through publications. Those who download and use AI-READI data are encouraged to publish their results in the scientific literature.

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Cite This Study

Owsley et al. (2025) conducted a cross-sectional in Type 2 diabetes mellitus (n=4,000). Multimodal data collection (AI-READI) was evaluated. The AI-READI project is a cross-sectional study protocol targeting 4,000 participants aged ≥40 to collect multimodal data for artificial intelligence research in type 2 diabetes.

synapsesocial.com/papers/6aa46524ccf6357485977c5ehttps://doi.org/10.1136/bmjopen-2024-097449
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