NCT06329297

Continuous Glucose Monitoring in Inpatients

Continuous Glucose Monitoring in Medical and Open-Heart Surgical Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Parkview Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.

Detailed description

The use of continuous glucose monitors (CGM) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. Federal Drug Administration (FDA) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. As the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. With the announcement of the FDA granting enforcement discretion regarding the use of CGM technology in the hospital setting during the COVID-19 pandemic, the result was an abundance of research evaluating the potential of CGM longevity in the hospital setting. The Standards of Care in Diabetes: 2023 reported that "preliminary data suggests that CGM can significantly improve glycemic management and other hospital outcomes." Additionally, a systematic review of 32 studies evaluated the accuracy of CGM in the intensive care unit, with a consensus of moderate to good accuracy. CGM in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. Other potential benefits of CGM include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. The Diabetes Technology Society organized the Hospital Consensus Guideline Panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of CGM use in the inpatient setting.

Conditions

• Hyperglycemia

Interventions

Type	Name	Description
DEVICE	CGM monitor	blood glucose sensor used to monitor interstitial glucose

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2024-03-25
• Last updated: 2025-03-06

Regulatory

• FDA-regulated device study