Improving Diabetes Equity and Advancing Care Study

Last updated: November 30, 2023
Sponsor: Sinai Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetic Foot Ulcers

Diabetic Vitreous Hemorrhage

Treatment

Community Health Worker tailored support

Diabetes Self-Management Training (DSMT)

Remote Glucose Monitoring (RGM)

Clinical Study ID

NCT06040463
23-11
  • Ages > 18
  • All Genders

Study Summary

The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of type 1 or type 2 diabetes
  • 18+ years of age
  • Able to provide consent
  • Identify as African American/Black or Latinx
  • most recent HbA1c > 7%,
  • Have a smartphone compatible with the Glooko application
  • Have completed at least one Center appointment (i.e. current patient)
  • Completed at least 3 months of their assigned study condition

Exclusion

Exclusion Criteria:

  • Already an active user of RGM
  • Actively working with a CHW
  • Diagnosis of gestational diabetes (without type 1 or type 2)
  • Has a Power of Attorney
  • Be suffering from Stage-V renal disease or undergoing dialysis.
  • Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)

Study Design

Total Participants: 270
Treatment Group(s): 3
Primary Treatment: Community Health Worker tailored support
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
March 31, 2025

Study Description

Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 & 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.

Connect with a study center

  • Mount Sinai Hospital

    Chicago, Illinois 60608
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.