Type 2 DiabetesE3DiabetesNCT06643936
E3 Diabetes - Closing the Gap in Diabetes Control
A study testing E3 Multidisciplinary Team and E3 Self-Guided Type 2 Diabetes Education in people with Type 2 Diabetes, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- E3 Multidisciplinary Team and E3 Self-Guided Type 2 Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 31 Dec 2026
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- E3 Multidisciplinary Team, E3 Self-Guided Type 2 Diabetes Education
- Keywords
- Type 2 Diabetes, self-monitoring, adherence, social determinants of health, health care system trust
- 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.
E3 Multidisciplinary TeamBehavioural
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.
E3 Self-Guided Type 2 Diabetes EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Team-Based Group | Experimental | 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. Receives: Behavioral: E3 Multidisciplinary Team |
| Diabetes Self-Guided Group | Active comparator | 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. Receives: Behavioral: E3 Self-Guided Type 2 Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
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.
Measured: baseline, 6 months, 12 months
Secondary outcomes (4)
Health Care System Distrust
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
Measured: 6 months and 12 months
Diabetes Self Management
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)
Measured: 6 months and 12 months
Medication Adherence
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
Measured: 6 months and 12 months
Primary Care Visit Attendance
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start18 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643936
- Sponsor's protocol ID
- 24062508
- Acronym
- E3Diabetes
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared, however aggregate patient data may be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E3 Diabetes - Closing the Gap in Diabetes Control
- ClinicalTrials.gov ID
- NCT06643936
- Acronym / sponsor ID
- E3Diabetes / 24062508
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, self-monitoring, adherence, social determinants of health, health care system trust
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Team-Based Group | Experimental | Behavioral: E3 Multidisciplinary TeamA 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. |
| Diabetes Self-Guided Group | Active comparator | Behavioral: E3 Self-Guided Type 2 Diabetes EducationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| E3 Multidisciplinary TeamThe 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. | Behavioural | Diabetes Team-Based Group |
| E3 Self-Guided Type 2 Diabetes EducationPatients 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. | Behavioural | Diabetes Self-Guided Group |
Primary outcome
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.
4 secondary outcomes
Health Care System Distrust
Time frame: 6 months and 12 months
Diabetes Self Management
Time frame: 6 months and 12 months
Medication Adherence
Time frame: 6 months and 12 months
Primary Care Visit Attendance
Time frame: 6 months and 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 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared, however aggregate patient data may be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E3 Multidisciplinary Team and E3 Self-Guided Type 2 Diabetes Education in people with Type 2 Diabetes, run by Rush University Medical Center 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 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 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?
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?
Hemoglobin A1C (time frame: baseline, 6 months, 12 months). 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 15 Oct 2026.