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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Enrollment in existing SDRI diabetes education programs

Detailed Description

Hypothesis: Adoption of the SDRI Community Scientist/Especialista model will improve adherence to ADA recommended guidelines for HbA1c testing for Hispanic/Latino adults with T2D.

Participants known to have or considered to have diabetes by the Principal Investigator (PI) will be offered enrollment in the study, and their HbA1c will be tested using the Afinion HbA1c point-of-care analyzer. The subjects will be stratified into two groups: HbA1c <7.5 and HbA1c ≥7.5%. All other potential participants (unknown diabetes diagnosis) will be tested for HbA1c as the site standard practice. All participants with HbA1c <7.5 will be followed up at 6 months; those with HbA1c ≥7.5% will be followed up at 3 months and again at 6 months post enrollment. Participants with HbA1c ≥7.5% will be invited to participate in SDRI's existing educational programs.

Therapy will be provided as per standard of care by the participant's treating physician and is out of the scope of this proposal. Those with an HbA1c at or above 7.5% will be offered diabetes education and support through the tele-health platform and/or in person. Participants not known to have diabetes but with an HbA1c result >6.4% will be referred to a local provider for further evaluation and possible diagnosis of diabetes.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

1. Hispanic/Latino individuals ≥ 18 years of age at enrollment with known or suspected T2D.
2. 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.
3. Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Education will be based on a modification of the existing Ocho Pasos education program provided by SDRI.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HbA1c over time- Patient-Reported Variable #1	Single point-in-time assessment of patient-reported variable: Socio-demographics including age, gender, race/ethnicity, insurance	3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #2	Single point-in-time assessment of patient-reported variable: Contact Information, including smartphone ownership	3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #3	Single point-in-time assessment of patient-reported variable: Diabetes type and duration	3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #4	Single point-in-time assessment of patient-reported variable: Concurrent diabetes medications via visual inspection	3 and/or 6 months

Collaborators and Investigators

• Sponsor: Sansum Diabetes Research Institute
• Collaborators: Abbott; DexCom, Inc.
• Investigators: Principal Investigator: Ashley Thorsell, MD, Sansum Diabetes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Community Health Workers; Hispanic/Latino; Social determinants of health; Minority Health;; Especialistas; Community Scientists
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cardiovascular Diseases
• Other Study ID Numbers: CMI-IIS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes