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CGM Use in Heart Failure

Real-Time Continuous Glucose Monitoring for the Management of Patients With Type 2 Diabetes and Acutely Decompensated Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the use of a continuous glucose monitor, a device that checks blood sugar as often as every 5 minutes, in adults with heart failure and diabetes. Researchers want to learn whether better blood sugar control and fewer low blood sugar episodes could reduce repeat hospital stays for heart failure. Participants are followed during their hospital stay and for 3 months after they leave.

Heart failure (HF) is a major cause of hospital admissions in the US, with over 6 million hospital days annually. More than 40% of hospitalized patients with HF have diabetes mellitus (DM), which increases the risk of recurrent hospitalizations for HF with reduced and preserved ejection fraction by more than two-fold. Current methods for assessing glycemic control do not consider fluctuations in blood glucose levels, known as glycemic variability. High glycemic variability is a poor prognostic marker for HF re-hospitalizations. Given the significant prevalence and impact of DM in individuals with HF, it is crucial to examine whether improving glycemic control and avoiding hypoglycemia could lead to a decrease in HF readmissions. Real-time continuous glucose monitoring (rt-CGM), which provides glucose measurements as frequently as every 5 minutes, has improved glycemic control in insulin-treated adults with DM compared to the standard of care, capillary point-of-care blood glucose testing (POC). Researchers will monitor participants during their hospital stay and 3 months after discharge.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 90.
  • In the hospital for suddenly worsening heart failure, with symptoms during activity or at rest (NYHA class II, III, or IV). For the part after leaving the hospital, you must still have this diagnosis.
  • Have diabetes treated after leaving the hospital with diet alone, diabetes pills, GLP-1 medicines, or insulin.

Who can't join

  • Younger than 18 or older than 90, or have a history of type 1 diabetes.
  • Have a mental condition that keeps you from understanding the study and its possible effects.
  • Use a device that helps the heart pump blood.
  • Have had a heart transplant or are on a heart transplant waiting list.
  • Had heart surgery within 90 days before joining, or plan to have a heart procedure in the next 6 months.
  • Are pregnant or breastfeeding when joining.
  • Are in hospice care or are expected to live less than 6 months.
  • Are expected to need an MRI scan during the hospital stay or after leaving.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults 18 to 90 years admitted with a diagnosis of acute decompensated heart failure (ADHF), New York Heart Association (NYHA) class II, III, or IV symptoms (Aim 1) and discharged with a clinical diagnosis of ADHF (Aim 2). * Patients with diabetes treated with diet alone or oral antidiabetic agents, Glucagon-like peptide-1 receptor agonists (GLP1-RAs), or insulin after discharge Exclusion Criteria: * Age \< 18 or \> 90 years; * Patients with a history of type 1 diabetes; * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; * Patients on ventricular assist devices; * History of a heart transplant or listed for a heart transplant; * History of cardiac surgery (within 90 days before enrollment) or planned cardiac interventions within the following 6 months; * Female participants who are pregnant or breastfeeding at the time of enrollment into the study; * Hospice care or expected life expectancy of less than 6 months; * Patients who are expected to require Magnetic Resonance Imaging (MRI) procedures during hospitalization or after discharge.

Study sites (1)

GA