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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000840
• Other study ID #: CMI-IIS-002
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Sansum Diabetes Research Institute
• Contact: Arianna Larez
• Phone: 805-682-7640
• Email: alarez[@]sansum.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (3)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Abbott, DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c at 3 months for participants with HbA1c = 7.5%	HbA1c value at 3 months	3 months
Primary	HbA1c at 6 months for participants with HbA1c = 7.5%	HbA1c value at 6 months	6 months
Primary	HcA1c at 6 months for participants with HbA1c < 7.5%	HbA1c value at 6 months	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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