Type 2 Diabetes MellitusNCT07538505
Testing a Diabetes Care Program in Rural and Low-Income Clinics
A study testing Community Health Worker-led diabetes program in people with Type 2 Diabetes Mellitus, run by The University of Texas Medical Branch, Galveston.
Trial summary
The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team. The study aims to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Community Health Worker-led diabetes program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 31 Dec 2031
- Phase
- Interventional
- 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
Who may be able to join
- Self-identified Hispanic Ethnicity
- Spanish-speaking
- Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent
Who cannot join
- Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
- Severe mental illness or cognitive impairment that would preclude participation in group activities
- Pregnancy during the intervention period
- Type 1 diabetes mellitus
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementing a Diabetes Intervention in Rural and Low-Income Clinics: A Feasibility Study
The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team.
The study aims to answer the following questions:
- Does the CHW program improve diabetes-related health outcomes, such as blood sugar control?
- What is the sustainability of the program?
- Is the program feasible and acceptable?
Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.
Read the detailed description
Background:
Type 2 diabetes disproportionately affects low-income and Hispanic populations, who face barriers such as limited literacy, poverty, and lack of insurance. Prevalence is projected to rise, worsening disparities and increasing healthcare costs. Community Health Workers (CHWs) have been shown to improve diabetes outcomes by bridging patients and healthcare systems. Tele-mentoring CHWs allows interventions to be scaled geographically, but effectiveness in real-world clinics remains to be evaluated.
Objective \& Aims:
This 12-month, single-arm study implements a CHW-delivered diabetes intervention in community clinics distant from the parent research team.
Aim 1: Evaluate participant clinical outcomes (primary: HbA1c; secondary: blood pressure, cholesterol, BMI, and ADA adherence measures).
Aim 2: Monitor program sustainability through 36 months at the clinic level.
Aim 3: Assess implementation outcomes, including CHW knowledge, participant satisfaction, and attrition.
Inclusion/Exclusion:
Inclusion: Hispanic, Spanish-speaking adults ≥18 with type 2 diabetes and recent HbA1c.
Exclusion: Conditions affecting HbA1c, severe cognitive/mental illness, pregnancy, type 1 diabetes.
Study Design \& Procedures:
Design: Single-arm study; all consenting participants receive the intervention. Recruitment: Clinic database search (ICD-10 E11.x) and provider referrals; verbal consent obtained.
Intervention Phases:
Clinic readiness assessment CHW training via telehealth Tele-mentored CHW delivery of 12-month program (group classes, weekly mHealth coaching, participant-clinician feedback loop)
Sustainability assessment through month 36
CHWs: Hispanic, Spanish-fluent, trained and certified; supported by experienced CHW instructors.
Safety: CHWs identify urgent issues for clinicians; standard diabetes care guidelines followed; HIPAA compliance ensured.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Community Health Worker-led diabetes program
- Keywords
- Community health workers, Type 2 diabetes mellitus, Rural, Hispanic, telehealth, mentor, low-income, implementation, education, access to care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker-led diabetes programBehavioural
The intervention consists of four phases: (1) clinic readiness assessment, (2) CHW training, (3) tele-mentoring CHWs to deliver the 12-month diabetes program, and (4) sustainability assessment through 36 months.
| Study group | Role | What they receive |
|---|---|---|
| CHW-led diabetes program | Experimental | Not described Receives: Behavioral: Community Health Worker-led diabetes program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c)
Change in glycemic control measured by hemoglobin A1c (HbA1c). HbA1c values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention HbA1c levels.
Measured: baseline to 12 months
Secondary outcomes (5)
Change in Blood Pressure
Change in systolic and diastolic blood pressure measured using standard clinical procedures. Blood pressure readings will be obtained at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention values.
Measured: baseline to 12 months
Change in Cholesterol Levels
Change in lipid profile including total cholesterol, LDL, HDL, and triglycerides. Laboratory values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention levels.
Measured: baseline to 12 months
Change in Body Weight
Change in body weight measured in kilograms using a calibrated scale. Measurements will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention weight.
Measured: baseline to 12 months
Change in Body Mass Index (BMI)
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²). BMI will be assessed at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention BMI.
Measured: baseline to 12 months
Adherence to American Diabetes Association (ADA) Standards of Care
Adherence to ADA Standards of Care will be assessed based on predefined clinical indicators (e.g., HbA1c monitoring, blood pressure control, lipid management, and recommended screenings). Adherence will be evaluated using medical record review and/or standardized assessment tools.
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Mar 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth M. Vaughan, DO, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538505
- Sponsor's protocol ID
- 25-0360
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.
PubMed 35132555Vaughan EM, Virani S, Al Rifai M, Cardenas VJ Jr, Johnston CA, Porterfield L, Santiago Delgado Z, Samson SL, Schick V, Naik AD. Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study. BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819.
PubMed 37898484Vaughan EM, Cardenas VJ Jr, Chan W, Amspoker AB, Johnston CA, Virani SS, Ballantyne CM, Naik AD. Implementation and Evaluation of a mHealth-Based Community Health Worker Feedback Loop for Hispanics with and at Risk for Diabetes. J Gen Intern Med. 2024 Feb;39(2):229-238. doi: 10.1007/s11606-023-08434-7. Epub 2023 Oct 6.
PubMed 37803098Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320.
PubMed 34385148Vaughan EM, Naik AD, Lewis CM, Foreyt JP, Samson SL, Hyman DJ. Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes. Telemed J E Health. 2020 Feb;26(2):244-250. doi: 10.1089/tmj.2018.0313. Epub 2019 Mar 6.
PubMed 30839244Vaughan EM, Moreno JP, Hyman D, Chen TA, Foreyt JP. Efficacy of oral versus insulin therapy for newly diagnosed diabetes in low-income settings. Arch Gen Intern Med. 2017;1(2):17-22.
PubMed 29517061Vaughan EM, Johnston CA, Cardenas VJ, Moreno JP, Foreyt JP. Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Diabetes Educ. 2017 Dec;43(6):589-599. doi: 10.1177/0145721717737742. Epub 2017 Oct 19.
PubMed 29047326Vaughan EM, Hyman DJ, Naik AD, Samson SL, Razjouyan J, Foreyt JP. A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial. J Gen Intern Med. 2021 Feb;36(2):455-463. doi: 10.1007/s11606-020-06017-4. Epub 2020 Jul 22.
PubMed 32700217
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Diabetes Intervention in Rural and Low-Income Clinics: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07538505
- Acronym / sponsor ID
- 25-0360
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Community health workers, Type 2 diabetes mellitus, Rural, Hispanic, telehealth, mentor, low-income, implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Apr 2026 (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.
The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team.
The study aims to answer the following questions:
- Does the CHW program improve diabetes-related health outcomes, such as blood sugar control?
- What is the sustainability of the program?
- Is the program feasible and acceptable?
Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.
Detailed description
Background:
Type 2 diabetes disproportionately affects low-income and Hispanic populations, who face barriers such as limited literacy, poverty, and lack of insurance. Prevalence is projected to rise, worsening disparities and increasing healthcare costs. Community Health Workers (CHWs) have been shown to improve diabetes outcomes by bridging patients and healthcare systems. Tele-mentoring CHWs allows interventions to be scaled geographically, but effectiveness in real-world clinics remains to be evaluated.
Objective \& Aims:
This 12-month, single-arm study implements a CHW-delivered diabetes intervention in community clinics distant from the parent research team.
Aim 1: Evaluate participant clinical outcomes (primary: HbA1c; secondary: blood pressure, cholesterol, BMI, and ADA adherence measures).
Aim 2: Monitor program sustainability through 36 months at the clinic level.
Aim 3: Assess implementation outcomes, including CHW knowledge, participant satisfaction, and attrition.
Inclusion/Exclusion:
Inclusion: Hispanic, Spanish-speaking adults ≥18 with type 2 diabetes and recent HbA1c.
Exclusion: Conditions affecting HbA1c, severe cognitive/mental illness, pregnancy, type 1 diabetes.
Study Design \& Procedures:
Design: Single-arm study; all consenting participants receive the intervention. Recruitment: Clinic database search (ICD-10 E11.x) and provider referrals; verbal consent obtained.
Intervention Phases:
Clinic readiness assessment CHW training via telehealth Tele-mentored CHW delivery of 12-month program (group classes, weekly mHealth coaching, participant-clinician feedback loop)
Sustainability assessment through month 36
CHWs: Hispanic, Spanish-fluent, trained and certified; supported by experienced CHW instructors.
Safety: CHWs identify urgent issues for clinicians; standard diabetes care guidelines followed; HIPAA compliance ensured.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHW-led diabetes program | Experimental | Behavioral: Community Health Worker-led diabetes program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Hispanic Ethnicity
- Spanish-speaking
- Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent
Key exclusion criteria (4 listed)
- Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
- Severe mental illness or cognitive impairment that would preclude participation in group activities
- Pregnancy during the intervention period
- Type 1 diabetes mellitus
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 |
|---|---|---|
| Community Health Worker-led diabetes programThe intervention consists of four phases: (1) clinic readiness assessment, (2) CHW training, (3) tele-mentoring CHWs to deliver the 12-month diabetes program, and (4) sustainability assessment through 36 months. | Behavioural | CHW-led diabetes program |
Primary outcome
Change in Hemoglobin A1c (HbA1c)
Time frame: baseline to 12 months
Change in glycemic control measured by hemoglobin A1c (HbA1c). HbA1c values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention HbA1c levels.
5 secondary outcomes
Change in Blood Pressure
Time frame: baseline to 12 months
Change in Cholesterol Levels
Time frame: baseline to 12 months
Change in Body Weight
Time frame: baseline to 12 months
Change in Body Mass Index (BMI)
Time frame: baseline to 12 months
Adherence to American Diabetes Association (ADA) Standards of Care
Time frame: baseline to 12 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 14 Aug 2026.
- Background: PubMed 35132555Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.
- Background: PubMed 37898484Vaughan EM, Virani S, Al Rifai M, Cardenas VJ Jr, Johnston CA, Porterfield L, Santiago Delgado Z, Samson SL, Schick V, Naik AD. Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study. BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819.
- Background: PubMed 37803098Vaughan EM, Cardenas VJ Jr, Chan W, Amspoker AB, Johnston CA, Virani SS, Ballantyne CM, Naik AD. Implementation and Evaluation of a mHealth-Based Community Health Worker Feedback Loop for Hispanics with and at Risk for Diabetes. J Gen Intern Med. 2024 Feb;39(2):229-238. doi: 10.1007/s11606-023-08434-7. Epub 2023 Oct 6.
- Background: PubMed 34385148Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320.
- Background: PubMed 30839244Vaughan EM, Naik AD, Lewis CM, Foreyt JP, Samson SL, Hyman DJ. Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes. Telemed J E Health. 2020 Feb;26(2):244-250. doi: 10.1089/tmj.2018.0313. Epub 2019 Mar 6.
- Background: PubMed 29517061Vaughan EM, Moreno JP, Hyman D, Chen TA, Foreyt JP. Efficacy of oral versus insulin therapy for newly diagnosed diabetes in low-income settings. Arch Gen Intern Med. 2017;1(2):17-22.
- Background: PubMed 29047326Vaughan EM, Johnston CA, Cardenas VJ, Moreno JP, Foreyt JP. Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Diabetes Educ. 2017 Dec;43(6):589-599. doi: 10.1177/0145721717737742. Epub 2017 Oct 19.
- Background: PubMed 32700217Vaughan EM, Hyman DJ, Naik AD, Samson SL, Razjouyan J, Foreyt JP. A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial. J Gen Intern Med. 2021 Feb;36(2):455-463. doi: 10.1007/s11606-020-06017-4. Epub 2020 Jul 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth M. Vaughan, DO, MPH principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker-led diabetes program in people with Type 2 Diabetes Mellitus, run by The University of Texas Medical Branch, Galveston.
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 4 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Valeria Lescano Ventura (409-772-2222, valescan@UTMB.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (HbA1c) (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538505, which also lists 8 linked publications.
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 14 Aug 2026.