Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Lawndale Christian Health Center
Study ID
NCT06517576
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood glucose monitor with Digital Platform and Health Coaching — DEVICE
    Blood glucose monitors will be used daily to measure blood glucose measurements.
  • Continuous glucose monitor — DEVICE
    Continuous glucose monitors will be used daily to measure blood glucose measurements.
  • Usual Care — OTHER
    Usual care for type 2 diabetes

Study Details

Patient populations at community health centers, specifically Black or African American and Hispanic or Latino populations with Type 2 diabetes, experience significant health disparities. In particular, they have higher rates of diabetes-related complications and other related conditions such as myocardial infarction, cerebrovascular disease, kidney failure, blindness, neuropathy, and the risk of amputation. Diabetes affects 34 million adults in the US. Achieving a target HbA1c less than 8% can be challenging through diabetes management. Patients are able to monitor their blood glucose levels with devices such as blood glucose meters or continuous glucose monitors to facilitate diabetes management and glycemic control. Past studies have demonstrated that these devices are effective in engaging patients in the improvement of diabetes management. Current advancements in remote patient monitoring and self-monitoring have been observed to be effective in facilitating improvement in diabetes outcomes. However, the effectiveness and financial feasibility of these devices delivered in conjunction with automated patient engagement systems in remote patient monitoring programs is not well understood among underinsured, underserved, and vulnerable minority populations as they face a high-cost barrier particularly with continuous glucose monitors. To better address this gap in knowledge, this pilot study will compare and examine the effectiveness of these interventions on patient outcomes with Type 2 diabetes among populations in the West Side of Chicago. Study the comparative effectiveness among patients with uncontrolled Type 2 diabetes on insulin in an intervention group using remote patient monitoring and automated patient engagement system with blood glucose monitors to a group using a self-monitoring program with continuous glucose monitors and a usual care group receiving standard care. Conduct a feasibility analysis and financial impact of these programs among an underinsured and underserved population of Black/African Americans or Hispanic/Latinos with Type 2 diabetes.

Key Dates

Start date
Dec 1, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Remote patient monitoring and automated patient engagement system with blood glucose monitors
    Participants in this group will receive blood glucose monitors and will check their blood glucose daily with monitoring through a digital platform and provided health coaching.
  • Experimental: Self-monitoring program with continuous glucose monitors
    Participants in this group will receive continuous glucose monitors and will self monitor their blood glucose measurements with support by their care team.
  • Active Comparator: Usual care group receiving standard care
    Participants in this group will receive standard care for diabetes.

Primary Outcome Measure

Glycated Hemoglobin [ Time Frame: Baseline and at 4 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lawndale Christian Health CenterChicagoIllinois60623-

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