Type 2 DiabetesNCT05734989
Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD
An observational study of Type 2 Diabetes and Chronic Kidney Diseases, run by Duke University at 1 site in United States.
Trial summary
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Diseases
- What is being tested?
- BP, HbA1c and PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 4 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Aim 1: Adults in the Durham, NC Hispanic/Latinx community at risk for hypertension and/or CKD
Who may be able to join
- Age 18 or older at time of screening
- Self-identifying as Hispanic/Latinx ethnicity.
Who cannot join
- Unable to be reached by telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27708
About this study
Official title: Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP.
In Aim 2, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes.
Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) and Black patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.
Read the detailed description
The goal of Aim 1 was to increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events. Aim 1 included adult Hispanic individuals in the Durham community screened for CKD. Urine protein/glucose screening, blood pressure measurements, and BMI measures were conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk were referred to PCP for follow up/treatment.
The goal of Aim 2 was to pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx and Black patients with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipated the study would identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx and Black individuals.
Electronic health record (EHR) information obtained to identify Hispanic and non-Hispanic Black individuals with T2D at two Duke clinics with an upcoming PCP appointment. A clinical champion (nurse practitioner) at each clinic site queried the information obtained from the EHR for all potentially eligible patients. Queries identified 1) if the patient was prescribed a RAAS inhibitor (yes/no), 2) if the patient was prescribed an SGLT2i or GLP-1 RA (yes/no), and 3) if the patient had received guideline concordant UACR screening (yes/no). Patients were not considered eligible for the intervention and were placed in the "optimal care" group if: 1) They met the "yes" criteria to all three queries above; 2) Had an up to date UACR screen and were determined not to be eligible for either of the medication groups (based on history of adverse events to the medication or contraindications as determined by the clinical champion). Patients were considered eligible for the intervention and were assigned to the "screening/treatment" group if they: 1) Did not have a UACR within 1-year prior to T0; 2) were not on either a RAAS inhibitor or a SGLT2i/GLP-1 RA and were determined by the clinical champion to be eligible, based on the most updated KDIGO and ADA guidelines. The clinical champions would then make recommendations to a pharmacy champion (one at each site) on our study team on whether the patient should get a UACR and/or one or more of the medication classes at visit T0. The pharmacy champion reviewed these recommendations, and if in agreement, delivered them via electronic message, including specific medication names and doses, in the EHR to the PCPs, prior to the upcoming appointment T0.
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Being tested
- BP, HbA1c, PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPDiagnostic test
Blood pressure measurements and HbA1c tests will be conducted to identify participants with or at risk for high blood pressure and/or Type 2 Diabetes. Those identified will be referred to PCP for follow up/treatment.
HbA1cDiagnostic test
HbA1c will screen to identify patients with Type 2 diabetes
PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKDBehavioural
Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic/Latinx patients at risk for CKD | Adult patients in the Hispanic/Latinx Durham community screened for CKD Receives: Diagnostic Test: BP; Diagnostic Test: HbA1c | |
| PCPs caring for Hispanic Latinx patients screened for CKD in the Durham Community | Primary Care Providers (PCPs) caring for Hispanic Latinx patients who agree to use the study guidelines and interventions for screening and monitoring their patients for CKD. Receives: Behavioral: PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit
Measured: up to 3 months after screening
Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening
Measured: Within three months of T0 (primary care appointment)
Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA)
Measured: Within three months of T0 (primary care appointment)
Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi)
Measured: Within three months of T0 (primary care appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start18 May 2023
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Matthew Sinclair, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734989
- Sponsor's protocol ID
- Pro00112455
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2023
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05734989
- Acronym / sponsor ID
- Pro00112455
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP.
In Aim 2, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes.
Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) and Black patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.
Detailed description
The goal of Aim 1 was to increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events. Aim 1 included adult Hispanic individuals in the Durham community screened for CKD. Urine protein/glucose screening, blood pressure measurements, and BMI measures were conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk were referred to PCP for follow up/treatment.
The goal of Aim 2 was to pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx and Black patients with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipated the study would identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx and Black individuals.
Electronic health record (EHR) information obtained to identify Hispanic and non-Hispanic Black individuals with T2D at two Duke clinics with an upcoming PCP appointment. A clinical champion (nurse practitioner) at each clinic site queried the information obtained from the EHR for all potentially eligible patients. Queries identified 1) if the patient was prescribed a RAAS inhibitor (yes/no), 2) if the patient was prescribed an SGLT2i or GLP-1 RA (yes/no), and 3) if the patient had received guideline concordant UACR screening (yes/no). Patients were not considered eligible for the intervention and were placed in the "optimal care" group if: 1) They met the "yes" criteria to all three queries above; 2) Had an up to date UACR screen and were determined not to be eligible for either of the medication groups (based on history of adverse events to the medication or contraindications as determined by the clinical champion). Patients were considered eligible for the intervention and were assigned to the "screening/treatment" group if they: 1) Did not have a UACR within 1-year prior to T0; 2) were not on either a RAAS inhibitor or a SGLT2i/GLP-1 RA and were determined by the clinical champion to be eligible, based on the most updated KDIGO and ADA guidelines. The clinical champions would then make recommendations to a pharmacy champion (one at each site) on our study team on whether the patient should get a UACR and/or one or more of the medication classes at visit T0. The pharmacy champion reviewed these recommendations, and if in agreement, delivered them via electronic message, including specific medication names and doses, in the EHR to the PCPs, prior to the upcoming appointment T0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hispanic/Latinx patients at risk for CKD | – | Diagnostic Test: BP, Diagnostic Test: HbA1cAdult patients in the Hispanic/Latinx Durham community screened for CKD |
| PCPs caring for Hispanic Latinx patients screened for CKD in the Durham Community | – | Behavioral: PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKDPrimary Care Providers (PCPs) caring for Hispanic Latinx patients who agree to use the study guidelines and interventions for screening and monitoring their patients for CKD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1: Adults in the Durham, NC Hispanic/Latinx community at risk for hypertension and/or CKD
Key inclusion criteria (2 listed)
- Age 18 or older at time of screening
- Self-identifying as Hispanic/Latinx ethnicity.
Key exclusion criteria (1 listed)
- Unable to be reached by telephone
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 |
|---|---|---|
| BPBlood pressure measurements and HbA1c tests will be conducted to identify participants with or at risk for high blood pressure and/or Type 2 Diabetes. Those identified will be referred to PCP for follow up/treatment. | Diagnostic test | Hispanic/Latinx patients at risk for CKD |
| HbA1cHbA1c will screen to identify patients with Type 2 diabetes | Diagnostic test | Hispanic/Latinx patients at risk for CKD |
| PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKDGuidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD. | Behavioural | PCPs caring for Hispanic Latinx patients screened for CKD in the Durham Community |
Primary outcome
Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit
Time frame: up to 3 months after screening
Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening
Time frame: Within three months of T0 (primary care appointment)
Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA)
Time frame: Within three months of T0 (primary care appointment)
Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi)
Time frame: Within three months of T0 (primary care appointment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Matthew Sinclair, MD principal investigator
Duke University
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 Type 2 Diabetes and Chronic Kidney Diseases, run by Duke University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit (time frame: up to 3 months after screening). The study lists 4 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 24 Apr 2026.