Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes
NCT Number: NCT06517576
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: DEVICE: Blood glucose monitor with Digital Platform and Health Coaching|DEVICE: Continuous glucose monitor|OTHER: Usual Care
Sponsor: Lawndale Christian Health Center
Collaborators: Northwestern University Feinberg School of Medicine|University of Chicago|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-06

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.

Primary Outcome Measures: 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: 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