NCT05000840Active, not recruiting
Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 21 Jul 2021
- Start date
- 20 Oct 2021
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Sansum Diabetes Research Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT05000840
What you commit to
- Study type: Observational
- Planned participants: 750
- From 20 Oct 2021 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.
Other
- Language barriers precluding comprehension of study activities and informed consent.
Who the study is looking for
- Hispanic/Latino individuals ≥ 18 years of age at enrollment with known or suspected T2D.
- Ability to provide informed consent before any study-related activities. Study-related activities are any procedure that would not have been performed during normal management of the subject.
- Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sansum Diabetes Research Institute Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.