Heart FailureNCT07045298
CGM Use in Heart Failure
A study testing Libre 2 rt-CGM and POC BG + Blinded CGM in people with Heart Failure and Diabetes Mellitus, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Diabetes Mellitus
- What is being tested?
- Libre 2 rt-CGM and POC BG + Blinded CGM
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-Time Continuous Glucose Monitoring for the Management of Patients With Type 2 Diabetes and Acutely Decompensated 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.
Read the 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.
- Conditions
- Heart Failure, Diabetes Mellitus
- Being tested
- Libre 2 rt-CGM, POC BG + Blinded CGM
- Keywords
- Continuous Glucose Monitoring (CGM) system, Acute Decompensated Heart failure, Glycemic control, Inpatient, Bedside point-of-care capillary glucose monitoring
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libre 2 rt-CGMDevice
Also called FreeStyle Libre Pro Glucose Monitoring System, Continuous Glucose Monitoring (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.
POC BG + Blinded CGMDiagnostic test
Also called Standard of care capillary glucose test and 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Libre 2 rt-CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily BG concentration after discharge (DC)
Glucose levels measured by RT-CGM compared to traditional glucose monitoring testing (POCT-BG)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: After hospital discharge up to 12 weeks
Secondary outcomes (4)
Composite number of HF re-hospitalization, emergency department/urgent clinic visits for HF management
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.
Measured: After hospital discharge up to 12 weeks
Participants with symptoms of HF using the Chronic Heart Failure Questionnaire (CHQ-SAS)
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.
Measured: Baseline, 6 and 12 weeks
Quality of life measures using Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: Baseline, 6 and 12 weeks
Six-minute walk distance (6MWD)
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
Measured: Baseline, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Abbott Diabetes Care
- Responsible party
- Principal investigator, Kasra Moazzami, Emory University
- Investigators
- Kasra Moazzami, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045298
- Sponsor's protocol ID
- STUDY00007814
- Other IDs
- 2025P009798
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Continuous Glucose Monitoring for the Management of Patients With Type 2 Diabetes and Acutely Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07045298
- Acronym / sponsor ID
- STUDY00007814
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Abbott Diabetes Care
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POC glucose meter with Blinded CGM (Control/standard of care) | Active comparator | Diagnostic Test: POC BG + Blinded CGMParticipants 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. |
| Real Time CGM (RT-CGM) | Experimental | Device: Libre 2 rt-CGMParticipants 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Libre 2 rt-CGMAlso: FreeStyle Libre Pro Glucose Monitoring System, Continuous Glucose Monitoring (CGM) deviceFreestyle 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. | Device | Real Time CGM (RT-CGM) |
| POC BG + Blinded CGMAlso: Standard of care capillary glucose test and blinded CGMStandard 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. | Diagnostic test | POC glucose meter with Blinded CGM (Control/standard of care) |
Primary outcome
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)
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).
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).
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.
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
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.
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)
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
4 secondary outcomes
Composite number of HF re-hospitalization, emergency department/urgent clinic visits for HF management
Time frame: After hospital discharge up to 12 weeks
Participants with symptoms of HF using the Chronic Heart Failure Questionnaire (CHQ-SAS)
Time frame: Baseline, 6 and 12 weeks
Quality of life measures using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, 6 and 12 weeks
Six-minute walk distance (6MWD)
Time frame: Baseline, 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kasra Moazzami, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libre 2 rt-CGM and POC BG + Blinded CGM in people with Heart Failure and Diabetes Mellitus, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kasra Moazzami, MD, MPH (404- 616-1000, kasra.moazzami@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily BG concentration after discharge (DC) (time frame: After hospital discharge up to 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.