Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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This will be conducted at a Lawndale Christian Health Center, a community health center in the West Side of Chicago that serves a largely Black or African American and Hispanic or Latino population. To accomplish this objective, Aim 1 will study the impact on patients with uncontrolled Type 2 diabetes on insulin by comparing an intervention group that features remote patient monitoring with an automated patient engagement system and health coaching using blood glucose meters compared to a group that features a self-monitoring program using continuous glucose monitoring devices and a usual care group with standard care, and Aim 2 will examine the feasibility of implementing these interventions and financial impact of each treatment group at a community health center. To understand the effect of this study on health outcomes, patient level data will be examined including primary outcomes for health measurements such as HbA1c, blood glucose, BMI/weight, estimated glomerular filtration rate (eGFR), patient-reported outcomes including medication adherence, daily activities, diabetes self-management activities, and secondary outcomes for health measurements such as LDL cholesterol, systolic and diastolic blood pressures, as well as implementation outcomes such as acceptability, appropriateness, and feasibility. The costs of implementation and delivery will be examined using a budget impact analysis. This study will be essential for informing the impact on health disparities through remote monitoring with automated patient engagement compared to self-monitoring when providing care for underinsured and underserved populations.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blood glucose monitor with Digital Platform and Health Coaching

Intervention Type DEVICE

Blood glucose monitors will be used daily to measure blood glucose measurements.

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.

Group Type EXPERIMENTAL

Continuous glucose monitor

Intervention Type DEVICE

Continuous glucose monitors will be used daily to measure blood glucose measurements.

Usual care group receiving standard care

Participants in this group will receive standard care for diabetes.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care for type 2 diabetes

Interventions

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Blood glucose monitor with Digital Platform and Health Coaching

Blood glucose monitors will be used daily to measure blood glucose measurements.

Intervention Type DEVICE

Continuous glucose monitor

Continuous glucose monitors will be used daily to measure blood glucose measurements.

Intervention Type DEVICE

Usual Care

Usual care for type 2 diabetes

Intervention Type OTHER

Other Intervention Names

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Bluetooth Blood Glucose Monitor 3011065399 Dexcom G7 Continuous Glucose Monitoring System 3004753838

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Have an assigned primary care provider
* Diagnosis of Type 2 diabetes
* Medication use is insulin
* HbA1c of 8.0% or higher

Exclusion Criteria

* Diagnosis of chronic kidney disease at Stage 4 or higher
* Diagnosis of pregnancy
* Diagnosis of behavioral health conditions including serious mental illness or severe depression in the past 6 months.
* All participants must have a smartphone that is able to access internet services.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No