E3 Diabetes - Closing the Gap in Diabetes Control

NCT06643936 | Active Not Recruiting

• 1 other identifier: 24062508
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; self-monitoring; adherence; social determinants of health; health care system trust

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 6 months, 12 months

Secondary Outcomes (4)

• Health Care System Distrust

  6 months and 12 months

• Diabetes Self Management

  6 months and 12 months

• Medication Adherence

  6 months and 12 months

• Primary Care Visit Attendance

  6 months and 12 months

Study Arms (2)

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.

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.

Behavioral: E3 Self-Guided Type 2 Diabetes Education

Interventions

E3 Multidisciplinary Team BEHAVIORAL

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.

Diabetes Team-Based Group

E3 Self-Guided Type 2 Diabetes Education BEHAVIORAL

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.

Diabetes Self-Guided Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: November 18, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)