Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06234787 |
| Other study ID # |
MCGUCI1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2023 |
| Est. completion date |
December 1, 2027 |
Study information
| Verified date |
February 2024 |
| Source |
Universidad Europea de Madrid |
| Contact |
Samuel G González, Doctor |
| Phone |
34692619904 |
| Email |
samuelgonlop[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
The disturbances in glycemic control, including type 1 and type 2 diabetes, are increasingly
prevalent in the general population, with estimates suggesting that this trend will continue
for at least the next 20 years. Critically ill patients are particularly predisposed to
glycemic alterations due, among other factors, to stress, fasting, infections, and
administered treatments.
Hyperglycemia is detrimental to critically ill patients. Sustainedly elevated blood glucose
levels lead to immunosuppression, hindering leukocyte function, reducing phagocytic capacity,
and altering complement function. Furthermore, hyperglycemia enhances proinflammatory
mechanisms and oxidative stress. Hemodynamic management is also affected, resulting in
endothelial dysfunction and osmotic diuresis, promoting dehydration, electrolyte imbalances,
and tissue hypoperfusion.
For this reason, most current recommendations for glycemic control in critically ill patients
advise insulin treatment when blood glucose levels exceed 180 mg/dL. However, the ideal
glucose range for maintaining patients is still a subject of debate because, despite knowing
that hyperglycemia is harmful, its treatment carries a high risk of hypoglycemia. Severe
hypoglycemia (glucose <40 mg/dL) increases the risk of death by more than three times in
critically ill patients.
The incidence of hypoglycemia in critically ill patients varies widely depending on the type
of patient and the protocol used for hyperglycemia control. Generally, it is estimated that
between 3% and 20% of critically ill patients may experience severe hypoglycemia during their
hospitalization. On the other hand, hypoglycemia can be easily prevented or treated in
hospitalized patients through the infusion of glucose solutions if identified correctly.
In recent years, the use of continuous subcutaneous glucose monitoring (CGM) sensors has
revolutionized clinical practice for non-hospitalized diabetic patients. Subcutaneous glucose
is directly related to capillary blood glucose and arterial blood glucose, so changes in
blood glucose concentration will be transmitted to subcutaneous tissue within the next 5 to
10 minutes. CGM in critically ill patients has been shown to significantly reduce the
incidence of hypoglycemia, mortality, and glycemic variability compared to standard practice.
Given the current evidence, the Intensive Care Unit (ICU) at HLA Moncloa University Hospital
has developed a guide for the use of CGM sensors in critically ill patients receiving insulin
treatment, with the primary goal of reducing episodes of severe hypoglycemia in these
patients. This guide has been in use since May 2023 (see ANNEX).
The main utility of these sensors in critically ill patients is to detect individuals at risk
of experiencing hypoglycemia, which the investigators may consider potential hypoglycemic
events. However, to the best of our knowledge, there is currently no unified clinical
practice regarding the use of these devices in critically ill patients, and it is not
possible to find clinical practice guidelines or recommendations for the detection thresholds
of potential hypoglycemic events or studies describing the characteristics of these events.
Design:
This is a single-center, observational, descriptive, longitudinal, and prospective study.
Scope and Study Population:
The study will be conducted on patients admitted to the ICU at HLA Moncloa Hospital over the
course of four years.
Procedures:
All patients admitted to the Intensive Care Unit (ICU) who are potential candidates for
inclusion in the study will be informed about it, and their informed consent will be
requested.
If patients agree to participate, the inclusion criteria will be ensured. Therefore, a
continuous glucose monitoring sensor will be placed according to the detailed instructions in
Annex 1.
Patients will receive treatments according to the center's usual clinical practice and
following the criteria of their responsible physician based on the patient's characteristics
in each case.
The device records glucose readings every 5 minutes. The information is automatically
recorded on the reading device.
If at any time the device detects a potential hypoglycemia, healthcare personnel will act
according to the device placement guide (ANNEX 1), which details the procedure to follow. If
confirmed, corrections will be made according to the criteria of the responsible physician.
At the time of patient discharge or death, the principal investigator will review the patient
medical history to create a pseudonymized database that includes the patient study variables,
treatments, and duration of ICU stay, as well as the glucose records made by the continuous
monitoring device. This information will be stored for 5 years on the hospital intranet
server, along with other confidential information from the ICU at HLA Moncloa Hospital.
Alarms:
Alarms will be set up with the Freestyle Libre 2 sensor reader similarly for all patients.
Low glucose alarm (subcutaneous glucose <80 mg/dL):
After the alarm, capillary, arterial, or venous blood glucose will be checked, and actions
will be taken according to the standard protocol of the ICU at HLA Moncloa Hospital.
Definitions of hypoglycemia:
Potential Hypoglycemia: Any continuous subcutaneous glucose measurement below 80 mg/dL
confirmed by checking capillary, arterial, or venous blood glucose values up to 90 mg/dL (a
margin of 10 mg/dL difference between subcutaneous glucose and blood glucose obtained will be
accepted for hypoglycemia confirmation).
Severe Hypoglycemia: Any glucose measurement below 40 mg/dL, whether in capillary, arterial,
or venous blood.
Moderate Hypoglycemia: Any glucose measurement between 40 and 54 mg/dL, whether in capillary,
arterial, or venous blood.
Mild Hypoglycemia: Any glucose measurement between 55 and 69 mg/dL, whether in capillary,
arterial, or venous blood.
False Hypoglycemia: Any continuous subcutaneous glucose measurement below 80 mg/dL is
discarded by checking capillary, arterial, or venous blood glucose values above 90 mg/dL.
Capillary, Arterial, and Venous Glucose:
Critically ill patients routinely undergo glucose determinations several times throughout the
day and in response to specific symptoms (dizziness, fatigue, weakness, headaches, confusion,
speech disturbances, blurred vision, seizures, and coma). This includes capillary glucose
measurements at the bedside, arterial blood gas analyses, or laboratory blood glucose tests
on arterial or venous blood.
The results of all glucose determinations performed on the patient will be systematically
recorded. This way, the incidence and incidence rate of mild, moderate, and severe
hypoglycemia occurring during hospitalization will be documented.
