CGM Use in Heart Failure
- Conditions
- Heart FailureDiabetes Mellitus
- Registration Number
- NCT07045298
- Lead Sponsor
- Emory University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 discharge 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).
Frequency of overall and nocturnal hypoglycemia events after discharge 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).
Percentage of glucose readings and time within target of 70 - 180 mg/dl 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.
Percentage of time within target of 70 - 180 mg/dl 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
Frequency of hyperglycemia > 180 mg/dl and >250 mg/dl 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.
Percent of time with hyperglycemia 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)
Glycemic variability 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 Outcome Measures
Name Time Method Composite number of HF re-hospitalization, emergency department/urgent clinic visits for HF management 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.
Participants with symptoms of HF using the Chronic Heart Failure Questionnaire (CHQ-SAS) 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.
Quality of life measures using Kansas City Cardiomyopathy Questionnaire (KCCQ) 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.
Six-minute walk distance (6MWD) 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
Trial Locations
- Locations (1)
Grady Health System
🇺🇸Atlanta, Georgia, United States
Grady Health System🇺🇸Atlanta, Georgia, United States