Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05000840

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. HbA1c at 3 months for participants with HbA1c ≥ 7.5%

    Time frame: 3 months

    HbA1c value at 3 months

  2. HbA1c at 6 months for participants with HbA1c ≥ 7.5%

    Time frame: 6 months

    HbA1c value at 6 months

  3. HcA1c at 6 months for participants with HbA1c < 7.5%

    Time frame: 6 months

    HbA1c value at 6 months

Secondary outcomes

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

    Time frame: 3 and/or 6 months

    Single point-in-time assessment of patient-reported variable: Socio-demographics including age, gender, race/ethnicity, insurance

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

    Time frame: 3 and/or 6 months

    Single point-in-time assessment of patient-reported variable: Contact Information, including smartphone ownership

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

    Time frame: 3 and/or 6 months

    Single point-in-time assessment of patient-reported variable: Diabetes type and duration

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

    Time frame: 3 and/or 6 months

    Single point-in-time assessment of patient-reported variable: Concurrent diabetes medications via visual inspection

Sponsors and collaborators

Lead sponsor

Sansum Diabetes Research Institute

Other

Collaborators

  • Abbott
  • DexCom, Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 11, 2021
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.