Diabetes Mellitus, Type 2NCT05000840
Integrating Abbott Point-of-Care Technologies and the Community Scientist Model to Support HbA1c Testing Per ADA
An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Enrollment in existing SDRI diabetes education programs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 7.5%) for increased risk for poor outcomes from COVID-19 (unpublished data).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- Enrollment in existing SDRI diabetes education programs
- Keywords
- Minority Health;, Type 2 Diabetes, Hispanic/Latino, Especialistas, Community Scientists, Community Health Workers, Social determinants of health
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enrollment in existing SDRI diabetes education programsBehavioural
Education will be based on a modification of the existing Ocho Pasos education program provided by SDRI.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 3 months for participants with HbA1c ≥ 7.5%
HbA1c value at 3 months
Measured: 3 months
HbA1c at 6 months for participants with HbA1c ≥ 7.5%
HbA1c value at 6 months
Measured: 6 months
HcA1c at 6 months for participants with HbA1c < 7.5%
HbA1c value at 6 months
Measured: 6 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 and/or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start20 Oct 2021
- Primary completion31 Aug 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, DexCom, Inc.
- Responsible party
- Principal investigator, Kristin Castorino, DO, Sansum Diabetes Research Institute
- Investigators
- Ashley Thorsell, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000840
- Sponsor's protocol ID
- CMI-IIS-002
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05000840
- Acronym / sponsor ID
- CMI-IIS-002
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Abbott, DexCom, Inc.
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HbA1c <7.5% | – | Behavioral: Enrollment in existing SDRI diabetes education programsFor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enrollment in existing SDRI diabetes education programsEducation will be based on a modification of the existing Ocho Pasos education program provided by SDRI. | Behavioural | HbA1c <7.5% |
Primary outcome
HbA1c at 3 months for participants with HbA1c ≥ 7.5%
Time frame: 3 months
HbA1c value at 3 months
HbA1c at 6 months for participants with HbA1c ≥ 7.5%
Time frame: 6 months
HbA1c value at 6 months
HcA1c at 6 months for participants with HbA1c < 7.5%
Time frame: 6 months
HbA1c value at 6 months
4 secondary outcomes
Changes in HbA1c over time- Patient-Reported Variable #1
Time frame: 3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #2
Time frame: 3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #3
Time frame: 3 and/or 6 months
Changes in HbA1c over time- Patient-Reported Variable #4
Time frame: 3 and/or 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Thorsell, MD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at 3 months for participants with HbA1c ≥ 7.5% (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.