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 — DEVICEBlood glucose monitors will be used daily to measure blood glucose measurements.
- Continuous glucose monitor — DEVICEContinuous glucose monitors will be used daily to measure blood glucose measurements.
- Usual Care — OTHERUsual 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 monitorsParticipants 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 monitorsParticipants 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 careParticipants in this group will receive standard care for diabetes.
Primary Outcome Measure
Glycated Hemoglobin [ Time Frame: Baseline and at 4 Months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lawndale Christian Health Center | Chicago | Illinois | 60623 | - |
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