Other Clinical Trial - Effect of Continuous Glucose Monitoring System

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT05941286
Study type	Interventional
Source	Shanghai 6th People's Hospital
Contact	Jian Zhou, Dr.
Phone	+86 18930172033
Email	zhoujian@sjtu.edu.cn
Status	Recruiting
Phase	N/A
Start date	April 18, 2024
Completion date	September 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms