Clinical trial NCT06040463: Improving Diabetes Equity and Advancing Care Study
Official title: Improving Diabetes Equity and Advancing Care Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: implementation science
optimization study
Lead sponsor: Sinai Health System
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in A1c
timeFrame: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
Secondary outcomes:
measure: Active Usage of RGM
timeFrame: Data will be exported from the Glooko application monthly for the full 18 months of the trial period.
measure: DSMT Attendance
timeFrame: Attendance data will be collected throughout the entire study period (18 months)
measure: CHW Support Adherence
timeFrame: After rerandomization period (starting at 6 months post enrollment)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mount Sinai Hospital
state: Illinois
Study officials:
References: