Glucose control in ICU patients is challenging and exerts high burden on the nursing staff. Continuous glucose monitors (CGM) are now approved and widely available in the outpatient setting for patients with diabetes mellitus. However, only minimal evidence on CGM performance, reliability and benefit in achieving desired glucose control in the intensive care setting has been gathered so far. The objective of this study is to assess whether the use of CGM helps to maintain blood glucose levels within the time in range recommended for patients in the intensive care. In addition, accuracy of the sensor will be evaluated and compared to measurements of blood glucose by standardized biochemistry methods.
This will be a non-commercial, investigator-driven, active comparator-controlled, randomized, open-label and non-inferiority clinical study to be performed at the Institute for Clinical and Experimental Medicine in Prague. Patients that are being prepared for one of the surgical procedures mentioned below will be asked to participate: 1. pancreas surgery - total or partial pancreas resection 2. orthotopic liver transplantation 3. simultaneous pancreas and kidney transplantation 4. patients with diabetes mellitus undergoing major surgery After obtaining the informed consent, they will be randomized into one of two treatment groups: 1. Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment. 2. Control arm with blinded continuous glucose monitor that will be treated according to the standard of care, where the CGM data will be collected in a blind fashion and evaluated after completion of the follow-up. Each surgical group will be randomized and evaluated separately and independently. Continuous glucose monitoring will be initiated after completing the surgical procedure in order to avoid interferences during the procedure. Insulin therapy will be adjusted according to the standard in-house ICU protocol for insulin dose adjustment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Continuous glucose monitor will be used to measure interstitial glucose and aid in guiding the insulin therapy to achieve target blood glucose range of 6-10 mmol/l. In the control group, blood glucose will be measured according to standards of care and a blinded continuous monitor will be used to compare the time i range between the arms.
Blood glucose will be measured using point of care glucose meter and standard biochemistry methods. Blinded CGM will be applied to obtain continuous glucose values for post-hoc comparison.
Institute for Clinical and Experimental Medicine
Prague, Czechia
RECRUITINGTime in target range of 6-10 mmol/l
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Mean blood glucose levels
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Time spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )
Amount of time (%) spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Time spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )
Amount of time (%) spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Time spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )
Amount of time (%) spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Time spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )
Amount of time (%) spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Glycaemic variability assessed by standard deviation of blood glucose levels
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Glycaemic variability assessed by coefficient of variation (%CV)
Time frame: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
Daily dose of insulin
Daily dose of insulin and dosing speed throughout the day
Time frame: From admission until the discharge from postoperative ICU, approx. 5-7 days
Surgical complications
Surgical site infections, wound dehiscence, wound leakage
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Infectious complications
Pneumonia, abdominal sepsis, urosepsis
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Time until discharge from the inpatient care
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
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