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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote Monitoring with Automated Patient Engagement System for Type 2 Diabetes?

Research shows that patients with type 2 diabetes who frequently and regularly engage with remote monitoring technology tend to have better control of their blood sugar levels, as indicated by lower HbA1c levels. This suggests that active participation in remote monitoring can improve diabetes management. ^{1 2 3 4 5}

Is remote monitoring for type 2 diabetes safe for humans?

Research on remote monitoring for type 2 diabetes shows it is generally safe, with patients finding it useful and reassuring. It can improve quality of life and help manage blood sugar levels effectively. ^{2 4 6 7 8}

How does the Remote Monitoring with Automated Patient Engagement System treatment for Type 2 Diabetes differ from other treatments?

This treatment is unique because it uses remote monitoring technology to engage patients actively in their diabetes management, which can lead to better blood sugar control. Unlike traditional treatments, it involves frequent data uploads and interaction with healthcare providers through technology, making it more interactive and potentially more effective in managing Type 2 Diabetes. ^{2 4 7 9 10}

What is the purpose of this trial?

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.

Research Team

Andrew Wang

Principal Investigator

Lawndale Christian Health Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Automated Remote Monitoring of Depression: Acceptance Among Low-Income Patients in Diabetes Disease Management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Web-Based Remote Monitoring Systems for Self-Managing Type 2 Diabetes: A Systematic Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Diabetes Management Through Remote Patient Monitoring: The Importance of Patient Activation and Engagement with the Technology. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Telemedicine influence on the follow-up of type 2 diabetes patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of a glucose data-filtering system with automatic response software to reduce the physician workload in managing type 2 diabetes. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of Patient Perceptions About Web Telemonitoring Applied to Artificial Pancreas Use at Home. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dissemination of Remote Patient Monitoring: An Academic-Community Primary Care Partnership in South Carolina. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A remote healthcare monitoring framework for diabetes prediction using machine learning. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly. [2015]