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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Blood glucose monitor with Digital Platform and Health Coaching; Device: Continuous glucose monitor; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60623
      • Lawndale Christian Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Blood glucose monitor with Digital Platform and Health Coaching; Blood glucose monitors will be used daily to measure blood glucose measurements.; Other Names: Bluetooth Blood Glucose Monitor; 3011065399
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.	Device: Continuous glucose monitor; Continuous glucose monitors will be used daily to measure blood glucose measurements.; Other Names: Dexcom G7 Continuous Glucose Monitoring System; 3004753838
Active Comparator: Usual care group receiving standard care; Participants in this group will receive standard care for diabetes.	Other: Usual Care; Usual care for type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Hemoglobin	HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.	Baseline and at 4 Months
Blood Glucose	Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).	4 Months
Engagement with digital platform with a daily submission of blood glucose	Daily blood glucose measurements from blood glucose monitor submitted to the digital platform	4 Months
Implementation - Acceptability of Intervention Measure (AIM)	Self-reported perception among patients that this service is agreeable, palatable, or satisfactory with a likert scale of disagree to agree.	Baseline and at 4 Months
Implementation - Intervention Appropriateness Measure (IAM)	Self-reported perception among patients that this service is fit, relevant, and compatible with a likert scale of disagree to agree.	Baseline and at 4 Months
Implementation - Feasibility of Intervention Measure (FIM)	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.	Baseline and at 4 Months
The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use	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.	Baseline and at 4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight in pounds	Baseline and at 4 Months
Height	Height in inches	Baseline and at 4 Months
Estimated glomerular filtration rate	The eGFR based on blood test.	Baseline and at 4 Months
Low-density lipoprotein Cholesterol	The LDL cholesterol based on blood test.	Baseline and at 4 Months
Blood Pressure	The systolic and diastolic blood pressure using blood pressure monitor.	Baseline and at 4 Months
Clinic Visit	The total count of clinic visits both virtually and on-site.	4 Months
Hospitalizations	The total count of hospital admissions.	4 Months
Costs of Implementation	Total estimated costs of implementing interventions using a budget impact analysis	4 Months

Collaborators and Investigators

• Sponsor: Lawndale Christian Health Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Chicago; Northwestern University Feinberg School of Medicine
• Investigators: Principal Investigator: Andrew Wang, Lawndale Christian Health Center

Publications and helpful links

General Publications

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
• Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
• Weinstock RS, Aleppo G, Bailey TS, Bergenstal RM, Fisher WA, Greenwood DA, Young LA. The Role of Blood Glucose Monitoring in Diabetes Management. Arlington (VA): American Diabetes Association; 2020 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK566165/

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Remote Patient Monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: LCHC-ID-10; P30DK092949 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes