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NCT Number: NCT07045298

CGM Use in Heart Failure

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30303, United States

About this study

HF is one of the leading causes of hospitalization among older adults. Nearly 1 in 4 HF patients are readmitted within 30 days of discharge and despite various strategies, the re-hospitalization rates remain high. HF hospitalization has an impact on morbidity, mortality, and healthcare costs. Therefore, it is crucial to identify and implement effective strategies to reduce the health and economic burden of HF re-hospitalization. Diabetes mellitus (DM) is one of the most common comorbidities in HF, impacting approximately a third of all patients. Several studies have reported that HF patients with DM have higher rates of recurrent HF hospitalizations, longer durations of hospital stay, and significantly higher mortality compared to HF patients without DM. Given the high prevalence and impact of DM on HF prognosis, it is important to understand how optimizing DM control can affect and improve the prognosis in this population. Glucose monitoring is central to safe and effective management for individuals with DM, particularly those using insulin. Recent studies have shown that real-time (rt) continuous glucose monitoring (CGM), by providing glucose measurements as often as every 5 minutes, low and high glucose alerts, and glucose trend information, with the potential to better inform diabetes management decisions compared with episodic self-monitoring with a blood glucose meter.

This pilot study will examine the potential benefits of remote glucose monitoring by rt-CGM-driven decisions for the hospital and post-discharge management patients with comorbid HF and DM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Libre 2 rt-CGM

Device

Freestyle Libre 2 consists of a sensor applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin's surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor continuously reads interstitial glucose readings every minute and syncs with the Freestyle View app. The hypoglycemia alarm will be set to < 80 mg/dl (for prevention of low blood glucose levels). Participants will be instructed to provide 15 grams of carbohydrates in response to a hypoglycemia alarm. The hyperglycemia alarm will be set at 300 mg/dl. Participants will call the research team if they experience repeated episodes > 300 mg/dl (more than 2 episodes in a single day or 2 or more episodes in consecutive days). The research team will instruct the participant to check with their physician for a possible new insulin regimen, but they will be allowed to remain in the study.

Other names: FreeStyle Libre Pro Glucose Monitoring System, Continuous Glucose Monitoring (CGM) device

POC BG + Blinded CGM

Diagnostic Test

Standard of care point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the study participation for up to 3 months.

Other names: Standard of care capillary glucose test and blinded CGM

Primary outcomes

  1. Mean Daily BG concentration after discharge (DC)

    Time frame: After hospital discharge up to 12 weeks

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

  2. Frequency of clinically significant hypoglycemia after discharge

    Time frame: After 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).

  3. Frequency of overall and nocturnal hypoglycemia events after discharge

    Time frame: After 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).

  4. Percentage of glucose readings and time within target of 70 - 180 mg/dl

    Time frame: After 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.

  5. Percentage of time within target of 70 - 180 mg/dl

    Time frame: After 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

  6. Frequency of hyperglycemia > 180 mg/dl and >250 mg/dl

    Time frame: After 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.

  7. Percent of time with hyperglycemia

    Time frame: After 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)

  8. Glycemic variability

    Time frame: After 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

Secondary outcomes

  1. Composite number of HF re-hospitalization, emergency department/urgent clinic visits for HF management

    Time frame: After hospital discharge up to 12 weeks

    A composite number of hospital admissions and emergency department/urgent clinic visits for HF management after admission with ADHF will be documented from electronic medical records (EMR) or as reported by participants.

  2. Participants with symptoms of HF using the Chronic Heart Failure Questionnaire (CHQ-SAS)

    Time frame: Baseline, 6 and 12 weeks

    Participants will complete the CHQ-SAS, a validated questionnaire that assesses patients' perception of their HF and measures the impact of HF symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue, and emotional function. Items are rated on a 7- 7-point Likert scale ranging from 1 to 7.

  3. Quality of life measures using Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: Baseline, 6 and 12 weeks

    KCCQ is a disease-specific health status instrument composed of 23 items that quantify physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100, with higher scores reflecting better health status. For the KCCQ overall summary score, a small but clinically meaningful change is ≥ 5 points.

  4. Six-minute walk distance (6MWD)

    Time frame: Baseline, 6 and 12 weeks

    Six-minute walk distance measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The six-minute walk test serves as a standardized test for functional capacity quantification of HF patients and is predictive of adverse cardiovascular outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Kasra Moazzami, MD, MPH

CONTACT

[email protected]

404- 616-1000

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Abbott Diabetes Care
  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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