Continuous Subcutaneous Glucose Monitoring in Critical Patients

NCT06234787 | Recruiting

• 1 other identifier: MCGUCI1
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperglycemia; Hypoglycemia; Diabetes; Critical Care; Critically Ill Patients

Keywords

continuous subcutaneous glucose monitoring; critical care; intensive care; hypoglycemia

Outcome Measures

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)

  4 years

Secondary Outcomes (6)

• To determine the incidence of severe hypoglycemia

  4 years

• To determine the percentage of false potential hypoglycemia

  4 years

• To describe the type of patients admitted to the ICU who are equipped with a CGM sensor

  4 years

• To describe the glycemic profile of critically ill patients

  4 years

• To describe the actions taken by healthcare personnel after a potential hypoglycemia alarm

  4 years

Study Arms (1)

ICU Patients

Patients admitted to the Intensive Care Unit (ICU) at HLA Moncloa Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU, undergoing insulin treatment, and having a CGM sensor

You may qualify if:

• 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\&#39;s rights are respected, and the integrity of the consent process is maintained, even in situations where their decision-making capacity may be compromised.

You may not qualify if:

• Patients from whom information on CGM cannot be obtained for technical reasons.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital Universitario HLA Moncloa

Madrid, 28035, Spain

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Samuel G González, Doctor

CONTACT

34692619904; samuelgonlop@gmail.com

Samuel G González, Doctor

CONTACT

samuelgonlop@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 31, 2024
• Study Start: November 30, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

ES (1)