Improving Diabetes Equity and Advancing Care Study

RECRUITING

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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.

Conditions:

🦠 Diabetes 🦠 Diabetes Mellitus 🦠 Diabetes Mellitus, Type 1 🦠 Diabetes Mellitus, Type 2

🗓️ Study Start (Actual) 23 October 2023

🗓️ Primary Completion (Estimated) 31 March 2025

✅ Study Completion (Estimated) 31 March 2025

👥 Enrollment (Estimated) 270

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

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 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)

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

First Submitted 7 September 2023
First Submitted that Met QC Criteria 13 September 2023
First Posted 15 September 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 30 November 2023
Last Update Posted 7 December 2023
Last Verified September 2023