ECHO Diabetes FQHC

February 10, 2026 updated by: University of Florida

Extension for Community Health Outcomes (ECHO) Diabetes Federally Qualified Health Centers (FQHCs)

Extension for Community Health Outcomes Diabetes FQHC will provide tele-education to primary care providers (PCP) in Federally Qualified Health Centers in the U.S. using the "hub" and "spoke" training model established in the Project ECHO model. Participating FQHCs (called "spokes") will receive twice monthly tele-education sessions delivered by UF's "hub" team in a 6-month program. The program will be evaluated using pre/posttest provider-level surveys and center-level aggregate data in a stepped-wedge trial design with 3 cohorts of FQHCs. The primary outcomes are the proportion of people >9% HbA1c and technology use (CGM and insulin pump).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We will implement a national ECHO Diabetes FQHC program by offering a 6-month tele-education intervention that includes: (1) a virtual orientation and onboarding for FQHCs (2) one-hour tele-ECHO sessions twice monthly with continuing medical education (CME) credits provided (3) real-time support with complex medical decision-making and (4) access to an online repository of diabetes resources for PCPs. The 'hub' team delivering the ECHO Diabetes FQHC program are a nationally recognized multidisciplinary team of adult and pediatric endocrinologists, a clinical health psychologist, Certified Diabetes Care and Education Specialists (CDCES), a registered dietitian, a Certified Exercise Physiologist (CEP), a medical sociologist, PCPs, and health services researchers.

We will evaluate the ECHO Diabetes FQHC program with a stepped-wedge design. This proposal will leverage and expand on key community partnerships established through ECHO Diabetes with two Health Center Controlled Networks (HCCNs), HealthChoiceNetwork (HCN) and AllianceChicago (AC) to accomplish both specific aims. These two Health Center Controlled Networks (HCCNs) have over 100 FQHCs in 29 different states and hold a central data repository for over 7 million unduplicated patients seen for care across these locations. 18 new "spokes" will be recruited from HCN and AC's national network. Covariate-constrained randomization will be used to assign spokes to three cohorts that will have staggered and phased entry into the program in 6-month intervals. Pre- and post-intervention data will be collected at the provider-level and center-level (i.e., "spoke-level") and housed using REDCap® as a central data repository. Provider-level data will include pre and post surveys assessing confidence and knowledge in diabetes care as well as self-reported diabetes care practices. Spoke-level data will include aggregate Health Effectiveness Data and Information Set (HEDIS) metrics for diabetes, Uniform Data System (UDS) metrics for diabetes, mean HbA1c for demographic subgroups, diabetes technology use (CGM and insulin pumps), and referrals for GLP1 and SGL2 medications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ashby F Walker, Ph.D.
  • Phone Number: 352-273-8278
  • Email: afwalker@ufl.edu

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33172
        • Recruiting
        • Health Choice Network
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All people 18 and older with diabetes (T1D, T2D) seen for care at participating Federally Qualified Health Centers.

Description

Inclusion Criteria: Federally Qualified Health centers (spokes) are eligible to participate that are part of Health Choice Network (HCN) or Alliance Chicago (AC). All people living with diabetes 18 and older are included in aggregate data sharing to evaluate outcomes.

-

Exclusion Criteria:

  • Non FQHC, not part of HCN or AC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs
Behavioral: ECHO Diabetes tele-education
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs
Cohort 2
6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs
Behavioral: ECHO Diabetes tele-education
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs
Cohort 3
6-8 FQHCs that participate in the ECHO Diabetes tele-education program for PCPs
Behavioral: ECHO Diabetes tele-education
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HEDIS >9% HbA1c
Time Frame: From baseline to 12-months following
Proportion of FQHC population with >9% HbA1c
From baseline to 12-months following
Technology Use
Time Frame: From baseline to 12-months following
CGM and Pump Use
From baseline to 12-months following

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashby F Walker, Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202501386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregate data will be shared upon reasonable requests made to project PIs

IPD Sharing Time Frame

Upon publication of data or per request of journals via the publication process

IPD Sharing Access Criteria

Any one making a reasonable request for data -- all data is aggregated and do not include PHI or identifiers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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