Continuous Subcutaneous Glucose Monitoring in Critical Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad Europea de Madrid
About this trial
This is a single-center, observational, descriptive, longitudinal, and prospective study This study aims to determine the cumulative incidence during admission and the incidence rate of potential hypoglycemic events (defined as subcutaneous glucose \<80 mg/dL detected by CGM) in patients admitted to the Intensive Care Unit (ICU) of HLA Moncloa Hospital over four years of follow-up. The study also aims to document the occurrences of hypoglycemic events, describe the characteristics of patients receiving CGM sensors, and outline the actions taken as a result of detecting potential hypoglycemic events
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The study will be conducted in patients admitted to the ICU of HLA Moncloa Hospital over four years. Patients admitted to the ICU, undergoing insulin treatment, and having a CGM sensor.
Patients who sign the voluntary consent to participate in the study (Annex 2). If the participant is not in full physical or intellectual capacity to provide their signature on the informed consent, the responsible investigator will request such consent from their direct family member or the person legally designated to make decisions on their behalf regarding health matters. This measure is taken to ensure that the participant's rights are respected, and the integrity of the consent process is maintained, even in situations where their decision-making capacity may be compromised.
Disqualifiers
Patients from whom information on CGM cannot be obtained for technical reasons.
Trial population
Patients admitted to the ICU, undergoing insulin treatment, and having a CGM sensor
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
245 Participants
are grouped into 1 trial groupGroup A: ICU Patients
Trial outcomes
Primary outcomes
1
To determine the cumulative incidence or risk of potential hypoglycemia during ICU admission
To determine the cumulative incidence or risk of potential hypoglycemia during ICU admission (cases of potential hypoglycemia/number of patients x 100) and the incidence rate (cases of potential hypoglycemia/1000 x patient x hour) in critically ill patients undergoing insulin treatment using CGM sensors. The investigators will consider potential hypoglycemia any instance where the CGM sensor indicates low glucose (glucose \<80 mg/dL)
Time frame
4 yearsSecondary outcomes
1
To determine the incidence of severe hypoglycemia
To determine the incidence of severe hypoglycemia (glucose \<40 mg/dL), moderate (glucose between 40 and 55 mg/dL), or mild (glucose between 56 and 70 mg/dL) (cases of hypoglycemia/number of patients x 100) during the ICU stay and the incidence rates (cases of hypoglycemia/1000 patients x hour) in critically ill patients undergoing insulin treatment using CGM sensors.
Time frame
4 years2
To determine the percentage of false potential hypoglycemia
To determine the percentage of false potential hypoglycemia, understood as warnings for potential hypoglycemia that do not correspond to low capillary glucose values (glucose \<90 mg/dL)
Time frame
4 years3
To describe the type of patients admitted to the ICU who are equipped with a CGM sensor
To describe the type of patients admitted to the ICU who are equipped with a CGM sensor in our unit.
Time frame
4 years4
To describe the glycemic profile of critically ill patients
To describe the glycemic profile of critically ill patients undergoing insulin treatment (Maximum glucose, minimum glucose, average glucose, glycemic variability, time in range, Hb A1c, diet used, insulin requirement, insulin protocol employed).
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov