CGM Use in Heart Failure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Libre 2 rt-CGM
  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 ins
• Диагностический тест POC BG + Blinded CGM
  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.

Первичные конечные точки

• Mean Daily BG concentration after discharge (DC) [Срок оценки: After hospital discharge up to 12 weeks]
• Frequency of clinically significant hypoglycemia after discharge [Срок оценки: After hospital discharge up to 12 weeks]
• Frequency of overall and nocturnal hypoglycemia events after discharge [Срок оценки: After hospital discharge up to 12 weeks]
• Percentage of glucose readings and time within target of 70 - 180 mg/dl [Срок оценки: After hospital discharge up to 12 weeks]
• Percentage of time within target of 70 - 180 mg/dl [Срок оценки: After hospital discharge up to 12 weeks]
• Frequency of hyperglycemia > 180 mg/dl and >250 mg/dl [Срок оценки: After hospital discharge up to 12 weeks]
• Percent of time with hyperglycemia [Срок оценки: After hospital discharge up to 12 weeks]
• Glycemic variability [Срок оценки: After hospital discharge up to 12 weeks]

Вторичные конечные точки (4)

• Composite number of HF re-hospitalization, emergency department/urgent clinic visits for HF management [Срок оценки: After hospital discharge up to 12 weeks]
• Participants with symptoms of HF using the Chronic Heart Failure Questionnaire (CHQ-SAS) [Срок оценки: Baseline, 6 and 12 weeks]
• Quality of life measures using Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: Baseline, 6 and 12 weeks]
• Six-minute walk distance (6MWD) [Срок оценки: Baseline, 6 and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Grady Health System — Atlanta

Идентификаторы

NCT: NCT07045298 · STUDY00007814 · 2025P009798

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗