E3 Diabetes - Closing the Gap in Diabetes Control (E3Diabetes)

December 9, 2025 updated by: Rush University Medical Center
This study aims to decrease the racial gap in type 2 diabetes control in African American and Latinx patients in Rush University Medical Center clinics.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in the US as well as in Chicago. Risk factors for CVD include hypertension, diabetes, and lifestyle factors such as smoking, diet, and obesity. Among the critical social and structural determinants of cardiovascular health are food access, neighborhood safety, education, poverty, and chronic stress. Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden, contributing to stark racial gaps in cardiometabolic disease mortality. Life expectancy is as high as 84 years on Chicago's North Side, but only 68 years on the West Side - a gap of 16 years. Cardiometabolic disease accounts for 40 to 50% of this lifespan gap. The diabetes-related death rate is 70% higher among Chicago's African Americans than among non-African Americans. In Rush primary care clinics, under conditions of usual clinical care, African American and Latinx patients with diabetes have worse glycemic control than white patients, raising the question whether modifying the model of diabetes care from intermittent clinic-based care to more frequent home-based care remote monitoring might reduce these stubborn disparities. We are proposing a feasibility trial of a remote diabetes monitoring, social care, medication adherence and dietary intervention to improve diabetes control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racial/ethnic disparity in diabetes control. The proposed feasibility trial will use a randomized-control, four-pronged approach to improve glycemic control. The intervention group will receive the following: 1) remote glucose monitoring, 2) a multidisciplinary team to address social needs, 3) medication titration and adherence support, and 4) culturally tailored diabetes self-management and dietary education. The control group will receive standard of care diabetes primary care in addition to dietary education around diabetes through written materials. We hypothesize that E3 Diabetes program participants will achieve a change in A1c of 0.5 in at least 30% of the participants in 6 months, and will be a greater percentage than seen with the propensity matched control of African American and Latinx patients receiving usual care for Diabetes.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years and older
  • African American and/or Latinx
  • Uncontrolled Type 2 Diabetes, A1C >/= 8.0 within the last 3 months
  • Following with Rush primary care provider in eligible Rush primary care clinics
  • Access to cellphone

Exclusion Criteria:

  • Patient has Type 1 Diabetes
  • Patient is already participating in another remote diabetes monitoring program
  • Patient is not interested in participating in the program
  • Patient has already participated in the E3 hypertension program

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes Team-Based Group
A multidisciplinary team composed of a pharmacist, social worker, community health worker, and dietician will provide glucose monitoring, medication titration, diet education and reinforcement, and referrals for social needs. The pharmacist will remind patients to get A1C readings at 3 months and 6 months. The team will interact with the patients predominantly via tele-health remotely for 6 months.
Behavioral: E3 Multidisciplinary Team
The E3 Multidisciplinary team is composed of a remote pharmacist, social worker, community health worker, and dietician working together to overcome barriers to diabetes control via behavioral change, medication adherence and titration, diet and lifestyle education and resource referrals for social needs.
Active Comparator: Diabetes Self-Guided Group
A registered nurse will ensure patients have glucose monitors and supplies on enrollment and will call to remind patients to obtain A1C readings at 3 months and 6 months. Patients will continue with standard clinical care for type 2 diabetes in addition to receiving timed, mailed educational materials on type 2 diabetes monitoring and diabetes diet and lifestyle recommendations for 6 months.
Behavioral: E3 Self-Guided Type 2 Diabetes Education
Patients will receive timed, mailed educational materials on diabetes monitoring, diet and lifestyle modifications to supplement usual clinic based type 2 diabetes care with their primary care doctor. A registered nurse will ensure patients have glucometers and supplies, and remind patients to obtain A1C readings at 3 months and 6 months via phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: baseline, 6 months, 12 months
We hypothesize that the E3 Multidisciplinary team group patients will achieve a change in A1c of 0.5 in at least 30% of participants in 6 months compared to baseline, and this will be a greater percentage than seen with Self-guided group of African American and Latinx patients receiving usual care for Diabetes with educational materials. A1C will be measured at 12 months to check for persistence in A1C improvement as compared to 6 months and baseline.
baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Care System Distrust
Time Frame: 6 months and 12 months
To test the hypothesized mechanisms of change of the intervention by assessing the relationship between change in the following intervening behavioral targets and change in glycemic control at 6 and 12 months: perceived trust in healthcare system
6 months and 12 months
Diabetes Self Management
Time Frame: 6 months and 12 months
To test the hypothesized mechanisms of change of the intervention by assessing the relationship between change in the following intervening behavioral targets and change in glycemic control at 6 and 12 months: diabetes self management skills (e.g. monitoring blood glucose levels, food intake, physical activity)
6 months and 12 months
Medication Adherence
Time Frame: 6 months and 12 months
To test the hypothesized mechanisms of change of the intervention by assessing the relationship between change in the following intervening behavioral targets and change in glycemic control at 6 and 12 months: daily medication adherence
6 months and 12 months
Primary Care Visit Attendance
Time Frame: 6 months and 12 months
To test the hypothesized mechanisms of change of the intervention by assessing the relationship between change in the following intervening behavioral targets and change in glycemic control at 6 and 12 months: attending primary care visits at 3 and 6 months after enrollment.
6 months and 12 months

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Collaborators

Novartis Pharmaceuticals

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)

November 18, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24062508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data will not be shared, however aggregate patient data may be shared with other researchers

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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