Continuous Glucose Monitoring for Heart Failure

KM
Overseen ByKasra Moazzami, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Oral antidiabetics, GLP1-RAs, Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether real-time continuous glucose monitoring (rt-CGM) can reduce hospital readmissions for people with heart failure (HF) who also have diabetes. The researchers aim to determine if maintaining steady blood sugar levels, rather than checking them a few times a day, can improve heart health. Participants will use either a traditional blood sugar meter or the new rt-CGM device. Ideal participants are adults hospitalized for heart failure and managing diabetes with diet, pills, or insulin.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart health management for others with similar conditions.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it includes patients with diabetes treated with diet, oral antidiabetic agents, GLP1-RAs, or insulin, suggesting you may continue these treatments.

What prior data suggests that real-time continuous glucose monitoring is safe for heart failure patients?

Research has shown that real-time continuous glucose monitoring (rt-CGM) is generally safe for people with diabetes. Studies have found that rt-CGM can help reduce hospital visits for heart problems in this population, suggesting it could be a useful tool for managing both diabetes and heart-related issues.

However, some studies have noted that these devices might not always be accurate, particularly in critically ill patients after surgery. While the device is usually safe, its readings may not always be perfect in certain situations.

Overall, rt-CGM is well-tolerated, and many people with diabetes use it successfully to manage their blood sugar levels. This makes it a promising option for those with heart failure and diabetes who seek to improve their health.12345

Why are researchers excited about this trial?

Researchers are excited about using Real-time Continuous Glucose Monitoring (rt-CGM) for heart failure patients because it provides continuous, real-time data on blood sugar levels, setting it apart from traditional glucose monitoring methods. Unlike standard care, which typically involves periodic fingerstick tests with a glucose meter, rt-CGM offers automatic readings and alerts for high or low blood sugar, allowing for more precise and timely adjustments to insulin therapy. This innovative approach could lead to better glucose control, potentially improving heart health and overall quality of life for patients with heart failure.

What evidence suggests that real-time continuous glucose monitoring is effective for heart failure?

Research has shown that real-time continuous glucose monitoring (rt-CGM) can significantly aid people with diabetes in managing their blood sugar levels. In this trial, participants in the CGM group will wear a Libre 2 rt-CGM, which provides immediate information and allows for quick treatment adjustments. Studies have found that using rt-CGM devices, like the Libre, is linked to a 78% decrease in hospital visits due to heart problems in people with diabetes. This is crucial because controlling blood sugar may lower the chances of returning to the hospital for heart issues. This technology could be especially beneficial for those with both diabetes and heart failure, as it helps maintain stable blood sugar levels and reduces the risk of serious complications.12367

Who Is on the Research Team?

KM

Kasra Moazzami, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Adults aged 18 to 90 with acute decompensated heart failure (ADHF) and diabetes, treated with diet, oral antidiabetic agents, GLP1-RAs, or insulin. They must be experiencing NYHA class II-IV symptoms of heart failure.

Inclusion Criteria

I am between 18 and 90 years old, admitted for acute heart failure, and have moderate to severe symptoms.
I manage my diabetes with diet, pills, GLP1-RAs, or insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hospitalization and Initial Monitoring

Participants are monitored during their hospital stay using rt-CGM and POC glucose meters

Duration of hospital stay
Continuous monitoring during hospital stay

Post-Discharge Monitoring

Participants are monitored for glycemic control and hypoglycemia events using rt-CGM for 12 weeks after discharge

12 weeks
Regular follow-up visits and remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Real-time Continuous Glucose Monitoring (rt-CGM)
Trial Overview The trial is testing if real-time continuous glucose monitoring (rt-CGM), which checks blood sugar every few minutes, can improve health outcomes compared to standard blood glucose tests in patients with heart failure and diabetes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Real Time CGM (RT-CGM)Experimental Treatment1 Intervention
Group II: POC glucose meter with Blinded CGM (Control/standard of care)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Abbott Diabetes Care

Industry Sponsor

Trials
67
Recruited
25,600+

Robert B. Ford

Abbott Diabetes Care

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Dr. Mahmood Kazemi

Abbott Diabetes Care

Chief Medical Officer

Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco

Citations

Diabetes and Heart Risk: Two Battles, One DeviceLibre technology is linked with reduced cardiovascular disease-related hospitalization for people with diabetes.
Abbott's Libre® Technology is First Continuous Glucose ...New data reveal a 78% reduction in cardiovascular disease-related hospitalizations for people living with Type 1 diabetes with prior severe ...
Efficacy of Real-Time Continuous Glucose Monitoring in ...Real-time continuous glucose monitoring (RT-CGM) provides dynamic data to optimize management, although its efficacy in T2D remains debated.
Study Details | NCT07045298 | CGM Use in Heart FailureThis pilot study will examine the potential benefits of remote glucose monitoring by rt-CGM-driven decisions for the hospital and post-discharge management ...
Real-time continuous glucose monitoring vs self ...Congestive heart failure ... A significant strength of this study was the use of clinical effectiveness data from a United States–based real-world ...
The Effect of Congestive Heart Failure on Sensor Accuracy ...This study compares the accuracy of CGM by CHF status within insulin-requiring hospitalized non–intensive care unit patients with type 2 diabetes.
Accuracy of Freestyle Libre continuous glucose monitoring ...Our study demonstrated the relatively low accuracy of Freestyle Libre CGM for critical patients after cardiac surgery.
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