Actively Recruiting
Continuous Subcutaneous Glucose Monitoring: A Descriptive Study of Its Use in Critical Patients
Led by Universidad Europea de Madrid · Updated on 2024-02-05
245
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, observational, descriptive, longitudinal, and prospective study to assess the occurrence of potential hypoglycemic events in patients admitted to the Intensive Care Unit (ICU) at HLA Moncloa Hospital. This study focuses on critically ill patients who often experience disturbances in blood sugar control due to stress, infections, fasting, and treatments. The study aims to document the incidence and rate of hypoglycemic events detected by continuous glucose monitoring (CGM) sensors during a four-year follow-up period. Patients admitted to the ICU who receive insulin treatment and have CGM sensors placed will be observed. These sensors record glucose levels every 5 minutes, helping detect potential hypoglycemia defined as glucose levels below 80 mg/dL. When the device signals a potential low glucose event, healthcare staff will confirm this by blood glucose testing and take appropriate actions following standard ICU protocols. The study collects detailed data, including treatments, glucose readings, and patient characteristics, to better understand hypoglycemia in critical care. Participants will have CGM sensors placed and will receive usual clinical care by their physicians. Data from the sensors and patient records will be reviewed at discharge or death to create a pseudonymized database stored securely for research. The study monitors glucose continuously, records alarms, and tracks responses to potential hypoglycemic events. The main outcome is measuring the cumulative incidence of potential hypoglycemia during ICU admission over four years, alongside secondary measures describing patient profiles, glycemic patterns, and treatment responses.
CONDITIONS
Brief Title
Continuous Subcutaneous Glucose Monitoring in Critical Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the ICU of HLA Moncloa Hospital over four years
- Patients undergoing insulin treatment and having a continuous glucose monitoring (CGM) sensor
- Patients who voluntarily sign consent to participate or have a legal representative provide consent if unable to consent themselves
You will not qualify if you...
- Patients from whom continuous glucose monitoring (CGM) data cannot be obtained due to technical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to provide informed consent and confirm eligibility
Duration - Duration of ICU admission, up to 4 years for the study period
Participants admitted to the ICU will have a continuous glucose monitoring (CGM) sensor placed to record glucose levels every 5 minutes during their ICU stay. Healthcare personnel monitor glucose readings and respond to potential hypoglycemia alarms according to clinical protocols.
Continuous monitoring during ICU stay with glucose measurements every 5 minutes
Duration - Up to 5 years of data storage and review following participant discharge or death
After ICU discharge or death, glucose data and patient information are reviewed and stored securely for analysis and follow-up.
No participant visits; data review and storage only
Trial Site Locations
Total: 1 location
1
Hospital Universitario HLA Moncloa
Madrid, Spain, 28035
Actively Recruiting
Research Team
S
Samuel G González, Doctor
S
Samuel G González, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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