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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Blood glucose monitor with Digital Platform and Health Coaching (Device)
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.
干预措施: Continuous glucose monitor (Device)
Usual care group receiving standard care
Participants in this group will receive standard care for diabetes.
干预措施: Usual Care (Other)
结局指标
主要结局
Glycated Hemoglobin
时间窗: Baseline and at 4 Months
HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.
Blood Glucose
时间窗: 4 Months
Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).
Engagement with digital platform with a daily submission of blood glucose
时间窗: 4 Months
Daily blood glucose measurements from blood glucose monitor submitted to the digital platform
Implementation - Acceptability of Intervention Measure (AIM)
时间窗: 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.
Implementation - Intervention Appropriateness Measure (IAM)
时间窗: 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.
Implementation - Feasibility of Intervention Measure (FIM)
时间窗: 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.
The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use
时间窗: 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.
次要结局
- Weight(Baseline and at 4 Months)
- Height(Baseline and at 4 Months)
- Estimated glomerular filtration rate(Baseline and at 4 Months)
- Low-density lipoprotein Cholesterol(Baseline and at 4 Months)
- Blood Pressure(Baseline and at 4 Months)
- Clinic Visit(4 Months)
- Hospitalizations(4 Months)
- Costs of Implementation(4 Months)
研究者
Andrew Wang
Population Health Director
Lawndale Christian Health Center