Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sep… (NCT07686939) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients
China60 participantsStarted 2023-01-01
Plain-language summary
Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Continuous glucose monitoring (CGM) offers real-time interstitial glucose readings and has the potential to improve detection of dysglycemic events, enhance adherence to glycemic protocols, and reduce nursing workload. This prospective, randomized controlled trial was designed to evaluate the accuracy, clinical effectiveness, and operational utility of a factory-calibrated CGM system (FreeStyle Libre II) compared with standard blood glucose monitoring (fingerstick, arterial, and venous measurements) in septic ICU patients. The primary outcomes include CGM accuracy against reference methods, protocol adherence rates, time efficiency, and the incidence of hypoglycemic and hyperglycemic events. The findings of this trial will help determine whether CGM can provide a reliable, clinically feasible, and time-saving alternative for glycemic management in this high-risk population, thereby supporting its integration into routine ICU practice and informing future larger-scale studies on long-term outcomes and cost-effectiveness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Confirmed infection accompanied by an increase in Sequential Organ Failure Assessment (SOFA) score of ≥ 2 points.
* Written informed consent provided by the patient or legally authorized representative.
Exclusion Criteria:
* Discharge against medical advice or transfer to another facility before study completion, leading to incomplete data.
* Non-cooperation with study procedures.
* Contraindications to the application of the flash glucose monitoring sensor (e.g., severe skin disease at insertion site, known allergy to sensor components).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — can you tell me if the results showed that continuous glucose monitors were accurate enough (meeting that less-than-15% error threshold) to be safely used in sepsis patients in the ICU, and does that change how my glucose might be monitored if I'm critically ill?
2Since this study was specifically looking at CGM accuracy in sepsis patients with hyperglycemia, does it mean that CGMs work differently or less reliably in someone who is critically ill compared to a typical diabetes patient, and is that something my care team already accounts for?
3The trial measured whether CGM readings fell within safe error zones — what does it mean for my care if the device readings were slightly off, and how does my medical team double-check glucose levels when I'm in the ICU?
4Given that this was a validation study focused on measurement accuracy rather than testing a new treatment, would the findings from this trial actually affect the equipment or monitoring approach used in my care right now, or is this more about future ICU practices?
5If continuous glucose monitoring in sepsis is still being studied for accuracy, what method is currently considered the gold standard for tracking my blood sugar if I develop hyperglycemia during a critical illness, and what are the tradeoffs between that and CGM?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B)