Actively Recruiting

Age: 18Years +
All Genders
ID06234787

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patients from whom continuous glucose monitoring (CGM) data cannot be obtained due to technical reasons

AI-Screening

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Your Study Journey

Screening

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

Monitoring

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

Long-term Monitoring

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

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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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