Continuous Glucose Monitoring in Intensive Care Unit

Status Recruiting

Clinical Trial Summary

Glucose control in ICU patients is challenging and exerts high burden on the nursing staff. Continuous glucose monitors (CGM) are now approved and widely available in the outpatient setting for patients with diabetes mellitus. However, only minimal evidence on CGM performance, reliability and benefit in achieving desired glucose control in the intensive care setting has been gathered so far. The objective of this study is to assess whether the use of CGM helps to maintain blood glucose levels within the time in range recommended for patients in the intensive care. In addition, accuracy of the sensor will be evaluated and compared to measurements of blood glucose by standardized biochemistry methods.

Clinical Trial Description

This will be a non-commercial, investigator-driven, active comparator-controlled, randomized, open-label and non-inferiority clinical study to be performed at the Institute for Clinical and Experimental Medicine in Prague. Patients that are being prepared for one of the surgical procedures mentioned below will be asked to participate: 1. pancreas surgery - total or partial pancreas resection 2. orthotopic liver transplantation 3. simultaneous pancreas and kidney transplantation 4. patients with diabetes mellitus undergoing major surgery After obtaining the informed consent, they will be randomized into one of two treatment groups: 1. Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment. 2. Control arm with blinded continuous glucose monitor that will be treated according to the standard of care, where the CGM data will be collected in a blind fashion and evaluated after completion of the follow-up. Each surgical group will be randomized and evaluated separately and independently. Continuous glucose monitoring will be initiated after completing the surgical procedure in order to avoid interferences during the procedure. Insulin therapy will be adjusted according to the standard in-house ICU protocol for insulin dose adjustment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05585801
Study type	Interventional
Source	Institute for Clinical and Experimental Medicine
Contact	Barbora Hagerf, MD
Phone	00420608301443
Email	barbora.voglova@gmail.com
Status	Recruiting
Phase	N/A
Start date	November 1, 2022
Completion date	December 2026

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.