AI Ready and Exploratory Atlas for Diabetes Insights

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Washington
Study ID
NCT06002048
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 19, 2023
Status verified
Apr 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
4,000 participants (estimated)

Arms

  • Arm: Healthy
    Participants who do not have Type 1 or Type 2 Diabetes
  • Arm: Pre-diabetes/Diet Controlled
    Participants with pre-Type 2 Diabetes and those with Type 2 Diabetes whose blood sugar is controlled by diet
  • Arm: Oral Medication and/or Non-insulin-injectable Medication Controlled
    Participants with Type 2 Diabetes whose blood sugar is controlled by oral or injectable medications other than insulin
  • Arm: Insulin Dependent
    Participants with Type 2 Diabetes whose blood sugar is controlled by insulin

Primary Outcome Measure

Best-corrected visual acuity [ Time Frame: July 19, 2023-January 1, 2027 ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35233-
UC San DiegoSan DiegoCalifornia92093-
University of WashingtonSeattleWashington98109-

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