Improving Diabetes Equity and Advancing Care Study

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Behavioral: Diabetes Self-Management Training (DSMT); Behavioral: Remote Glucose Monitoring (RGM); Behavioral: Community Health Worker tailored support

• Registration Number: NCT06040463
• Lead Sponsor: Sinai Health System

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-15
• Study Start: 2023-10-23
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)	Diabetes Self-Management Training (DSMT)	Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support.
Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)	Remote Glucose Monitoring (RGM)	Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.
Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)	Diabetes Self-Management Training (DSMT)	Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.
Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)	Remote Glucose Monitoring (RGM)	Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.
Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)	Community Health Worker tailored support	Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support.
Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)	Community Health Worker tailored support	Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.
Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)	Diabetes Self-Management Training (DSMT)	Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT).
Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM)	Remote Glucose Monitoring (RGM)	Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group.
Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)	Remote Glucose Monitoring (RGM)	Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT).
Diabetes Self-Management Training > Standard of Care (DSMT->SOC)	Diabetes Self-Management Training (DSMT)	Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care.

Primary Outcome Measures

Name	Time	Method
Change in A1c	Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)	Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.

Secondary Outcome Measures

Name	Time	Method
Active Usage of RGM	Data will be exported from the Glooko application monthly for the full 18 months of the trial period.	Active usage will be defined as at least one upload of data within a 30-day period and at least 16 blood glucose entries within a 30-day period.
CHW Support Adherence	After rerandomization period (starting at 6 months post enrollment)	Adherence to CHW engagement will include completing the initial education session with a CHW, competing a SDoH screener and at least three phone or in-person touchpoints over the 6-month intervention period.
DSMT Attendance	Attendance data will be collected throughout the entire study period (18 months)	We will collect # and proportion of attended DSMT classes by participant.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 Chicago, Illinois, United States