Metabolic Stress Hyperglycemia Clinical Trial
Official title:
A Study on the Effects of the Use of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients
After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion
Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate
treatment cohort will then be consecutively enrolled, followed by the tight glycemic control
cohort.
After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory
evaluations will be determined.
Subjects enrolled in the standard of care cohort will be treated according to the
institution's protocol for measuring glucose and managing insulin. These subjects will be
monitored on a GlucoClear System but they will not be managed based on the values or trends
of the GlucoClear system.
Subjects enrolled in the treatment cohorts will be monitored and managed with a special
version of the GlucoClear continuous monitoring system. This system contains the GlucoClear
Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to
manage patient glucose within pre-specified target levels. These recommendations are
presented on screen for a clinical professional to approve or override.
Subjects in the moderate treatment cohort will have their glucose managed in the range of
120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in
the range of 80 - 120 mg/dl.
After discharge from the ICU, subjects will followed for adverse events and mortality at 30
days, either by telephone contact or office visit.
Hyperglycemia, hypoglycemia and glycemic variability, the three components of dysglycemia
are independently associated with morbidity and mortality of critically ill patients. Blood
glucose (BG) control with insulin has the potential to decrease morbidity and mortality of
intensive care unit (ICU) patients. Blood glucose control with insulin, however, is
associated with an increased risk of hypoglycemia and its effect on glycemic variability is
uncertain. BG control with insulin utilizing manual systems for glucose measurement is
blood-consuming and time-consuming, since frequent blood draws for glucose measurements are
necessary in order to achieve blood glucose control.
Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood
glucose control with insulin. Undoubtedly, with implementation of blood glucose with insulin
the incidence of hypoglycemia increases. Reported incidences of severe hypoglycemia rise by
5 to 10-fold as compared to conventional glucose control strategies in randomized controlled
trials. Several reports showed a significant association between hypoglycemia and patient
outcomes. Recently, an association has even been suggested between moderate and mild
hypoglycemia (blood glucose level between 40-69 mg/dL) and patient outcomes. Incidences of
moderate hypoglycemia are more prevalent than severe hypoglycemia. The risk of developing
(severe or moderate) hypoglycemia hampers, at least in part, broad implementation of blood
glucose control with insulin, in particular when aiming at normal blood glucose levels
[17,18].
Recent studies showed also significant associations between glycemic variability and patient
outcomes. BG control algorithms, if properly applied, could decrease glycemic variability.
Experimentally, rodent experiment showed that brain damage was not associated with the
duration of severe hypoglycemia, but instead with its correction (mainly overcorrection)
with intravenous dextrose causing formation of radicals. Hence, a close glucose monitoring
to prevent overcorrection is mandatory.
These different arguments strongly support the need for reliable and accurate CGM. The
GlucoClearTM Continuous Glucose Monitoring system from Edwards Lifesciences measures blood
sugar by Glucose Oxidase Sensing Technology through in-blood measurement. Blood is
automatically drawn and analyzed every 5 minutes from a peripheral venous catheter, with
real time graphical display. Blood is then returned to the patient and the system
automatically self-calibrates. The GlucoClear CGM is designed to be highly accurate. In a
recent study performed in critically ill patients, it was shown to comply with the required
standards of quality.
The main research question addressed by the present study is: "To which extent a CGM-guided
strategy improve the quality of BG control performance"?
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04396964 -
A Natural History of Perioperative Metabolism
|