CGM Use in Heart Failure

Conditions

• Diabetes Mellitus
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Nov 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: POC glucose meter with Blinded CGM (Control/standard of care)
  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.
• Experimental: Real Time CGM (RT-CGM)
  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

Primary Outcome Measure

Mean Daily BG concentration after discharge (DC) [ Time Frame: After hospital discharge up to 12 weeks ]

Central Contacts

• Kasra Moazzami, MD, MPH
  404- 616-1000
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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