Clinical trial NCT06643936: E3 Diabetes - Closing the Gap in Diabetes Control
Official title: E3 Diabetes - Closing the Gap in Diabetes Control
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
self-monitoring
adherence
social determinants of health
health care system trust
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2024-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Health Care System Distrust
timeFrame: 6 months and 12 months
measure: Diabetes Self Management
timeFrame: 6 months and 12 months
measure: Medication Adherence
timeFrame: 6 months and 12 months
measure: Primary Care Visit Attendance
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: