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NCT05000840

Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA

Sponsor: Sansum Diabetes Research Institute

View on ClinicalTrials.gov

Summary

In the United States, the growing Hispanic/Latino population is at high risk for type 2 diabetes and associated complications, yet underserved in healthcare and underrepresented in research. The purpose of this Sansum Diabetes Research Institute (SDRI) study is to create an HbA1c testing and support closed-loop system for U.S. Hispanic/Latino families. This loop will integrate Abbott's point-of-care (POC) technology with SDRI's Community Scientist Model to contact, test, intervene, and monitor Latinos with or at risk of type 2 diabetes for HbA1c levels. This study is built on prior work using specially trained Hispanic/Latino Community Scientists/Especialistas to support engagement with and encourage adherence to American Diabetes Association guidelines for HbA1c testing among Hispanic/Latino adults with type 2 diabetes. The study is an unblinded, nonrandomized, two arm self-controlled single center study. It is anticipated to run over 24 months and enroll 750 participants, in whom HbA1c will be measured over 6 months. This study will provide unique data on the burden of type 2 diabetes for Hispanic/Latino adults in Santa Barbara County, CA. In addition, the closed-loop approach will provide proof-of-concept evidence for scaling this approach to the larger Hispanic/Latino community to reduce the risk of poor outcomes due to type 2 diabetes and now COVID-19.

Official title: Integrating Abbott Point-of-Care Technologies and the SDRI Community Scientist Model to Support HbA1c Testing Per the American Diabetes Association Guidelines for U.S. Latino Adults With or at Risk of Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

750

Start Date

2021-10-20

Completion Date

2025-03-31

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Enrollment in existing SDRI diabetes education programs

Education will be based on a modification of the existing Ocho Pasos education program provided by SDRI.

Locations (1)

Sansum Diabetes Research Institute

Santa Barbara, California, United States