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Enrolling by Invitation

NCT Number: NCT06517576

Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawndale Christian Health Center

Chicago, Illinois, 60623, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood glucose monitor with Digital Platform and Health Coaching

Device

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

Other names: Bluetooth Blood Glucose Monitor, 3011065399

Continuous Glucose Monitor

Device

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

Other names: Dexcom G7 Continuous Glucose Monitoring System, 3004753838

Usual Care

Other

Usual care for type 2 diabetes

Primary outcomes

  1. Glycated Hemoglobin

    Time frame: Baseline and at 4 Months

    HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.

  2. Blood Glucose

    Time frame: 4 Months

    Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).

  3. Engagement with digital platform with a daily submission of blood glucose

    Time frame: 4 Months

    Daily blood glucose measurements from blood glucose monitor submitted to the digital platform

  4. Implementation - Acceptability of Intervention Measure (AIM)

    Time frame: Baseline and at 4 Months

    Self-reported perception among patients that this service is agreeable, palatable, or satisfactory with a likert scale of disagree to agree.

  5. Implementation - Intervention Appropriateness Measure (IAM)

    Time frame: Baseline and at 4 Months

    Self-reported perception among patients that this service is fit, relevant, and compatible with a likert scale of disagree to agree.

  6. Implementation - Feasibility of Intervention Measure (FIM)

    Time frame: Baseline and at 4 Months

    Self-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.

  7. The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use

    Time frame: Baseline and at 4 Months

    Self-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 outcomes

  1. Weight

    Time frame: Baseline and at 4 Months

    Weight in pounds

  2. Height

    Time frame: Baseline and at 4 Months

    Height in inches

  3. Estimated glomerular filtration rate

    Time frame: Baseline and at 4 Months

    The eGFR based on blood test.

  4. Low-density lipoprotein Cholesterol

    Time frame: Baseline and at 4 Months

    The LDL cholesterol based on blood test.

  5. Blood Pressure

    Time frame: Baseline and at 4 Months

    The systolic and diastolic blood pressure using blood pressure monitor.

  6. Clinic Visit

    Time frame: 4 Months

    The total count of clinic visits both virtually and on-site.

  7. Hospitalizations

    Time frame: 4 Months

    The total count of hospital admissions.

  8. Costs of Implementation

    Time frame: 4 Months

    Total estimated costs of implementing interventions using a budget impact analysis

Sponsors and collaborators

Lead sponsor

Lawndale Christian Health Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Northwestern University
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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