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

NCT05000840 | Active Not Recruiting

• 1 other identifier: CMI-IIS-002
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Minority Health;; Type 2 Diabetes; Hispanic/Latino; Especialistas; Community Scientists; Community Health Workers; Social determinants of health

Outcome Measures

Primary Outcomes (3)

• HbA1c at 3 months for participants with HbA1c ≥ 7.5%

  HbA1c value at 3 months

  3 months

• HbA1c at 6 months for participants with HbA1c ≥ 7.5%

  HbA1c value at 6 months

  6 months

• HcA1c at 6 months for participants with HbA1c < 7.5%

  HbA1c value at 6 months

  6 months

Secondary Outcomes (4)

• Changes in HbA1c over time- Patient-Reported Variable #1

  3 and/or 6 months

• Changes in HbA1c over time- Patient-Reported Variable #2

  3 and/or 6 months

• Changes in HbA1c over time- Patient-Reported Variable #3

  3 and/or 6 months

• Changes in HbA1c over time- Patient-Reported Variable #4

  3 and/or 6 months

Study Arms (2)

HbA1c <7.5%

For participants with HbA1c ≥ 7.5%, Community Scientists will offer enrollment in existing SDRI diabetes education programs and will schedule a follow-up contact for 3 and 6 months later for repeat testing. Study participation for each participant will end upon completion of 6 month follow up.

Behavioral: Enrollment in existing SDRI diabetes education programs

HbA1c ≥7.5%

For participants with HbA1c \< 7.5%, Community Scientists will schedule a follow-up contact 6 months later. Study participation for each participant will end upon completion of 6 month follow up.

Interventions

Enrollment in existing SDRI diabetes education programs BEHAVIORAL

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

HbA1c <7.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be selected from Santa Barbara County and surrounding communities or satellite sites, with the help of the partnering care providers. In Santa Barbara County, Hispanic/Latino adults make up 46% of the population of almost 450,000. Data published by SDRI based on a community screening program reported that 16% of 593 Hispanic/Latino adults had an HbA1c in the diabetes range. In a cohort of Hispanic/Latino adults with known T2D, only 30% had an HbA1c less than 7%, with 31% having values greater than 9%. Currently in our Mil Familias cohort, 46% have an HbA1c above the threshold (\> 7.5%) for increased risk for poor outcomes from COVID-19 (unpublished data).

You may qualify if:

• 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.

You may not qualify if:

• Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.
• Language barriers precluding comprehension of study activities and informed consent.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Abbott: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ashley Thorsell, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP, Clinical Research and Senior Investigator

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 11, 2021
• Study Start: October 20, 2021
• Primary Completion: August 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)