CGM Use in Heart Failure

This study is looking at how continuous glucose monitoring (CGM) can help people with heart failure (HF) and diabetes. Researchers want to see if using a Freestyle Libre 2, a small device that measures blood sugar under your skin, can help improve blood sugar control and reduce hospital readmissions for HF. You might be eligible if you are 18-90 years old, have been hospitalized for acute decompensated heart failure, and have diabetes treated with diet, oral medications, GLP1-RAs, or insulin. The study will measure your daily blood sugar levels and how often you experience low blood sugar (hypoglycemia) after you leave the hospital for up to 12 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 140 participants. It compares using the Freestyle Libre 2 rt-CGM device with standard point-of-care blood glucose monitoring and a blinded CGM.
What's involved
You would use a Freestyle Libre 2 sensor on your arm and have point-of-care blood glucose monitoring before meals and bedtime daily for up to 3 months.
Compensation
Not stated in the trial record.
Follow-up
Your blood glucose levels and hypoglycemia events will be monitored for up to 12 weeks after hospital discharge.

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NCT07045298

CGM Use in Heart Failure

Not Yet Recruiting
NAAges 18–90InterventionalDiagnostic
Emory University
~140 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Libre 2 rt-CGMPOC BG + Blinded CGM

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Daily BG concentration after discharge (DC)
Measured over After hospital discharge up to 12 weeks
+7 more outcomes measured
Heart Failure
Diabetes Mellitus
1 sites across 1 states
Georgia1
  • Kasra Moazzami, MD, MPH · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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.
  • Mean Daily BG concentration after discharge (DC)After hospital discharge up to 12 weeks

    Glucose levels measured by RT-CGM compared to traditional glucose monitoring testing (POCT-BG)

  • Frequency of clinically significant hypoglycemia after dischargeAfter hospital discharge up to 12 weeks

    The mean number of clinically significant hypoglycemia (BG \< 54 mg/dL (\<3.0 mmol/L)) events. Measurements by the POCT glucose monitoring testing (control) and real-time CGM (rt-CGM).

  • Frequency of overall and nocturnal hypoglycemia events after dischargeAfter hospital discharge up to 12 weeks

    The mean number of events of nocturnal hypoglycemia per participant by control (blinded CGM) and real time CGM group. Nocturnal hypoglycemia occurs between 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and clinically significant hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).

  • Percentage of glucose readings and time within target of 70 - 180 mg/dlAfter hospital discharge up to 12 weeks

    Glycemic control will be measured by the percent of BG readings: 70-180 mg/dL measured by the control (blinded CGM) and rt-CGM.

  • Percentage of time within target of 70 - 180 mg/dlAfter hospital discharge up to 12 weeks

    Glycemic control will be measured by the percentage of time with BG: 70-180 mg/dL measured by the control (blinded CGM) and real-time CGM

  • Frequency of hyperglycemia > 180 mg/dl and >250 mg/dlAfter hospital discharge up to 12 weeks

    Number of events with hyperglycemia, defined as BG between 181 mg/dl and 249 mg/dl by traditional glucose monitoring testing (control) and real-time CGM group.

  • Percent of time with hyperglycemiaAfter hospital discharge up to 12 weeks

    Glycemic control will be measured by the percentage of the time with hyperglycemia \> 180 mg/dl and \> 250 mg/dl by traditional glucose monitoring testing (control) and by CGM (real-time)

  • Glycemic variabilityAfter hospital discharge up to 12 weeks

    Glycemic variability will be calculated by glucose values obtained from the control (blinded CGM) and rt-CGM devices using standard deviation and coefficient of variation. It is designed to assess major glucose swings and exclude minor ones