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NCT05000840 · ClinicalTrials.gov registry record
Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA
A clinical trial of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, sponsored by Sansum Diabetes Research Institute.
- Active
- Registry status
- 750
- Enrollment target
- 1
- Study location
NCT05000840: Active study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, sponsored by Sansum Diabetes Research Institute.
NCT05000840 is a study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases that is active but no longer recruiting, run by Sansum Diabetes Research Institute. The registered enrollment target is 750 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05000840, a study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, is active but no longer recruiting, sponsored by Sansum Diabetes Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- 750 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
HbA1c value at 3 months
Conditions Studied
Interventions
- BEHAVIORAL Enrollment in existing SDRI diabetes education programs
Study Locations (1)
California
- Sansum Diabetes Research Institute - Santa Barbara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2025-03-31 |
What the registry record for NCT05000840 still lists
NCT05000840 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Enrollment in existing SDRI diabetes education programs is the first listed.
NCT05000840 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05000840 about?
NCT05000840 is a clinical study titled "Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA". 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...
What is the current status of trial NCT05000840?
This trial is currently active not recruiting. The enrollment target is 750 participants. The study started on 2021-10-20. Estimated completion is 2025-03-31.
What conditions does trial NCT05000840 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases.
What interventions are being tested in trial NCT05000840?
The interventions under investigation include: Enrollment in existing SDRI diabetes education programs (BEHAVIORAL).
Who is sponsoring clinical trial NCT05000840?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05000840 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05000840's enrollment target sits among peer trials
750 51st of 348 higher than 298 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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