CGM Use in Heart Failure

NCT07045298 | Not Yet Recruiting FDA Device

• 2 other identifiers: STUDY000078142025P009798
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diabetes Mellitus

Keywords

Continuous Glucose Monitoring (CGM) system; Acute Decompensated Heart failure; Glycemic control; Inpatient; Bedside point-of-care capillary glucose monitoring

Outcome Measures

Primary Outcomes (8)

• Mean Daily BG concentration after discharge (DC)

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

  After hospital discharge up to 12 weeks

• Frequency of clinically significant hypoglycemia after discharge

  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).

  After hospital discharge up to 12 weeks

• Frequency of overall and nocturnal hypoglycemia events after discharge

  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).

  After hospital discharge up to 12 weeks

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

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

  After hospital discharge up to 12 weeks

• Percentage of time within target of 70 - 180 mg/dl

  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

  After hospital discharge up to 12 weeks

• Frequency of hyperglycemia > 180 mg/dl and >250 mg/dl

  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.

  After hospital discharge up to 12 weeks

• Percent of time with hyperglycemia

  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)

  After hospital discharge up to 12 weeks

• Glycemic variability

  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

  After hospital discharge up to 12 weeks

Secondary Outcomes (4)

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

  After hospital discharge up to 12 weeks

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

  Baseline, 6 and 12 weeks

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

  Baseline, 6 and 12 weeks

• Six-minute walk distance (6MWD)

  Baseline, 6 and 12 weeks

Study Arms (2)

POC glucose meter with Blinded CGM (Control/standard of care)

ACTIVE COMPARATOR

Participants in the standard-of-care study arm will be provided with a Bluetooth-enabled blood glucose (BG) meter and testing supplies. A blood glucose monitoring account will be established and linked to the research site. Participants will be asked to perform glucose testing from 1- 3x daily. Testing would involve a minimum of once-daily tests that should include random fasting and post-prandial measurements. All participants will also be wearing blinded CGM devices. Providers will adjust oral agents or insulin doses based on POC results.

Diagnostic Test: POC BG + Blinded CGM

Real Time CGM (RT-CGM)

EXPERIMENTAL

Participants in the CGM group will wear a Libre 2 rt-CGM with hypoglycemia and hyperglycemia alarms, and providers will adjust insulin therapy based on CGM profile information. All participants will be instructed on CGM placement and care. Diabetes educators will provide training sessions in the CGM system. The diabetes educator will educate subjects on how the CGM system differs from the traditional blood glucose (BG) meter

Device: Libre 2 rt-CGM

Interventions

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.

Also known as: FreeStyle Libre Pro Glucose Monitoring System, Continuous Glucose Monitoring (CGM) device

Real Time CGM (RT-CGM)

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.

Also known as: Standard of care capillary glucose test and blinded CGM

POC glucose meter with Blinded CGM (Control/standard of care)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator
• Abbott Diabetes Care: collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Kasra Moazzami, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasra Moazzami, MD, MPH

CONTACT

404- 616-1000; kasra.moazzami@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 1, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)