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Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes

Randomized Controlled Trial Using Remote Monitoring With an Automated Patient Engagement System and a Self-Monitoring Program With Continuous Glucose Monitors to Address Health Disparities in Type 2 Diabetes

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06517576
Enrollment
150
Registered
2024-07-24
Start date
2024-12-01
Completion date
2025-09-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes, Remote Patient Monitoring

Brief summary

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.

Detailed description

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.

Interventions

DEVICEBlood glucose monitor with Digital Platform and Health Coaching

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

DEVICEContinuous glucose monitor

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

OTHERUsual Care

Usual care for type 2 diabetes

Sponsors

Northwestern University Feinberg School of Medicine
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Chicago
CollaboratorOTHER
Lawndale Christian Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Glycated HemoglobinBaseline and at 4 MonthsHbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.
Blood Glucose4 MonthsBlood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).
Engagement with digital platform with a daily submission of blood glucose4 MonthsDaily blood glucose measurements from blood glucose monitor submitted to the digital platform
Implementation - Acceptability of Intervention Measure (AIM)Baseline and at 4 MonthsSelf-reported perception among patients that this service is agreeable, palatable, or satisfactory with a likert scale of disagree to agree.
Implementation - Intervention Appropriateness Measure (IAM)Baseline and at 4 MonthsSelf-reported perception among patients that this service is fit, relevant, and compatible with a likert scale of disagree to agree.
Implementation - Feasibility of Intervention Measure (FIM)Baseline and at 4 MonthsSelf-reported perception among patients that this service is successfully used or carried out within a primary care setting with a likert scale of disagree to agree.
The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare useBaseline and at 4 MonthsSelf-reported perception among patients of eating behavior, medication adherence, glucose monitoring, physical activity, and healthcare use with a likert scale of applies to me very much, applies to me a considerable degree, applies to some degree, and does not apply to me.

Secondary

MeasureTime frameDescription
WeightBaseline and at 4 MonthsWeight in pounds
HeightBaseline and at 4 MonthsHeight in inches
Estimated glomerular filtration rateBaseline and at 4 MonthsThe eGFR based on blood test.
Low-density lipoprotein CholesterolBaseline and at 4 MonthsThe LDL cholesterol based on blood test.
Blood PressureBaseline and at 4 MonthsThe systolic and diastolic blood pressure using blood pressure monitor.
Clinic Visit4 MonthsThe total count of clinic visits both virtually and on-site.
Hospitalizations4 MonthsThe total count of hospital admissions.
Costs of Implementation4 MonthsTotal estimated costs of implementing interventions using a budget impact analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026