NCT05941286

Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital

Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 533 (actual)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current continuous glucose monitoring (CGM) devices provide features that alert for current and impending adverse glycemic events.This trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

Detailed description

Glycemic management for patients with diabetes during hospitalization is highly challenging, especially for those requiring intensive insulin therapy. For those patients, hypoglycemia is a common adverse event, which is associated with adverse clinical outcomes. Bedside capillary point-of-care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital. However, POC glucose testing only provides glucose measurements at specific time points, leading to missed information important for glycemic control. Continuous glucose monitoring (CGM) measures interstitial glucose every 5 min, thus providing a more complete glycemic profile during a 24 h period compared with standard POC glucose testing. The cloud-based real-time continuous glucose monitoring (RT-CGM) and management system was previously observed to be safe and effective in guiding intensive insulin therapy. Therefore, this CGM intergraded system holds promise for improving glucose control in patients with diabetes during hospitalization. However, it is currently unclear if alerts are the main reason for the better outcome in the RT-CGM groups, or rather the fact that sensor values are available in real-time. Moreover, the current system provided the feature of predictive threshold alerts that could alert before the onset of clinical hypoglycemia or hyperglycemia. Thus, this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	CGM system with both glucose predictive alerts and threshold alerts on	the cloud-based real-time continuous glucose monitoring and management system with both glucose predictive alerts and threshold alerts on
DEVICE	CGM system with only glucose threshold alerts on	the cloud-based real-time continuous glucose monitoring and management system with only glucose threshold alerts on
DEVICE	CGM system with glucose alerts off	the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off

Timeline

• Start date: 2024-04-18
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2023-07-12
• Last updated: 2025-12-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study