Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517576
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BlackAfrican Americans or HispanicLatinos 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 BMIweight 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None