Remote Monitoring for Type 2 Diabetes

Overseen By Andrew Wang, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawndale Christian Health Center

Must be taking: Insulin

Disqualifiers: Chronic kidney disease, Pregnancy, Behavioral health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different diabetes management tools can assist individuals with Type 2 diabetes, focusing on Black or African American and Hispanic or Latino populations. It compares three approaches: standard care, self-monitoring with continuous glucose monitors, and remote monitoring with an automated patient engagement system using blood glucose meters. The researchers aim to determine which method is most effective and financially viable for managing diabetes in underserved communities. Individuals may be a good fit if they have Type 2 diabetes, use insulin, and struggle to keep their HbA1c (a measure of blood sugar control) below 8%. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diabetes care for diverse communities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on insulin. It seems likely that you will continue your insulin treatment during the study.

What prior data suggests that remote monitoring with automated patient engagement systems is safe for managing Type 2 diabetes?

Previous studies have shown promising results for remote patient monitoring (RPM) in diabetes care. Research indicates that RPM can enhance the safety of treatment plans and improve patient adherence. Users of these systems often experience better mobility and overall health, managing their blood sugar levels more effectively.

For those using continuous glucose monitors (CGMs), studies have demonstrated significant benefits. Patients report better blood sugar control and even lower mortality rates. CGMs provide real-time information, aiding users in making informed health decisions. Users also report feeling healthier and more satisfied with their diabetes management.

Overall, both remote monitoring and CGMs are user-friendly and offer clear benefits in managing Type 2 diabetes, providing a safe option for those considering a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote monitoring for type 2 diabetes because it offers a fresh approach to managing the condition. Unlike the usual care, which often relies on periodic check-ups, this method uses continuous glucose monitors and digital platforms to keep track of blood sugar levels in real-time. What's unique is the automated patient engagement system, which not only provides constant monitoring but also offers personalized health coaching. This can help patients make more informed decisions daily and potentially improve their overall diabetes management.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research shows that remote monitoring with automated systems, one of the treatment options in this trial, can help people with diabetes manage their condition more effectively. Studies have found that checking blood sugar levels remotely can lower HbA1c levels, an important measure of blood sugar control. This method keeps patients engaged and improves diabetes management.

Another treatment arm in this trial involves continuous glucose monitors (CGMs). These devices are effective for people with uncontrolled diabetes. Patients using CGMs often achieve better blood sugar control and spend more time within their target range. For those with Type 2 diabetes who use insulin, CGMs can enhance quality of life, making these devices a valuable part of ongoing diabetes care. ^{4 6 7 8 9}

Who Is on the Research Team?

Andrew Wang

Principal Investigator

Lawndale Christian Health Center

Are You a Good Fit for This Trial?

This trial is for Black or African American and Hispanic or Latino adults over 18 with Type 2 diabetes, an HbA1c of 8.0% or higher, using insulin, and who have a primary care provider. It aims to help those at community health centers on Chicago's West Side.

Inclusion Criteria

My HbA1c level is 8.0% or higher.

I use insulin for my condition.

I have a primary care doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are divided into groups receiving remote patient monitoring with automated patient engagement or self-monitoring with continuous glucose monitors, and a usual care group.

16 weeks

Regular virtual and on-site visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Monitoring with Automated Patient Engagement System
• Self-monitoring program with Continuous Glucose Monitor
• Usual Care

Trial Overview The study compares usual diabetes care against two tech-assisted methods: one uses a blood glucose monitor with digital platform and health coaching; the other uses a continuous glucose monitor. The goal is to see which method improves patient outcomes more.

How Is the Trial Designed?

Group I: Self-monitoring program with continuous glucose monitors Experimental Treatment 1 Intervention

Participants in this group will receive continuous glucose monitors and will self monitor their blood glucose measurements with support by their care team.

Group II: Remote patient monitoring and automated patient engagement system with blood glucose monitors Experimental Treatment 1 Intervention

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.

Group III: Usual care group receiving standard care Active Control 1 Intervention

Participants in this group will receive standard care for diabetes.

Who Is Running the Clinical Trial?

Lawndale Christian Health Center

Lead Sponsor

Trials

3

Recruited

1,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

The implementation of a remote patient monitoring (RPM) program for diabetes and hypertension in partnership with community health centers has successfully enrolled over 1350 patients, primarily from underserved populations, leading to improved chronic disease management.

More than 30% of patients continued to regularly transmit glucose readings after one year, and over 90% of patients provided hemoglobin A1c data at 6 and 12 months, indicating the program's effectiveness in engaging patients and monitoring their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of Remote Patient Monitoring: An Academic-Community Primary Care Partnership in South Carolina. Kirkland, EB., Dericke, D., Bays, CC., et al.[2023]

Patients showed high initial acceptance of automated telephonic assessment (ATA) calls for depression monitoring, with 89.6% willing to use them at 6 months, but this willingness decreased to 51.0% by 18 months, indicating a decline in perceived usefulness over time.

Key factors influencing long-term acceptance of ATA calls included perceptions of privacy/security and the ongoing usefulness of the system, suggesting that maintaining patient engagement requires continuous adaptation to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Remote Monitoring of Depression: Acceptance Among Low-Income Patients in Diabetes Disease Management. Ramirez, M., Wu, S., Jin, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988428/

Diabetes Management Through Remote Patient Monitoring This study used mixed methods to assess program enrollment and attrition in a large RPM program serving patients with type 2 diabetes (T2D). 2.

2. withpower.com withpower.com/trial/remote-monitoring-for-type-2-diabetes-121b1

Remote Monitoring for Type 2 Diabetes · Info for Participants Current advancements in remote patient monitoring and self-monitoring have been observed to be effective in facilitating improvement in diabetes outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589936825000118

Remote glucose monitoring and HbA1c improvement ... Remote glucose monitoring was associated with improved HbA1c among newly diagnosed patients with Type II diabetes.

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1355792/full

Measuring the effectiveness of hybrid diabetes care over ... The present study highlights the results of a hybrid care model, integrating in-clinic and remote monitoring components, with promising 90 days ...

5. ctv.veeva.com ctv.veeva.com/study/using-remote-monitoring-to-address-health-disparities-in-type-2-diabetes

Using Remote Monitoring to Address Health Disparities in ... Current advancements in remote patient monitoring and self-monitoring have been observed to be effective in facilitating improvement in diabetes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8914599/

Remote Patient Monitoring in Diabetes: How to Acquire, ... In this article, the authors outline several steps to facilitate the acquisition, management, and meaningful use of digital diabetes data.

7. nature.com nature.com/articles/s41746-024-01182-w

A systematic review of the impacts of remote patient ... RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and ...

8. mdpi.com mdpi.com/2227-9032/13/7/698

Diabetes Management Through Remote Patient Monitoring This study used mixed methods to assess program enrollment and attrition in a large RPM program serving patients with type 2 diabetes (T2D). 2. Materials and ...

9. aafp.org aafp.org/pubs/afp/issues/2022/0300/p281.html

Telemedicine in Diabetes Care Telemedicine can be useful for the management of diabetes mellitus. Remote monitoring of glucose levels improves A1C levels in people with poor glucose control.