Continuous Glucose Monitoring in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: pancreas surgery - total or partial pancreas resection orthotopic liver transplantation simultaneous pancreas and kidney transplantation patients with diabetes mellitus undergoing major surgery After obtaining the informed consent, they will be randomized into one of two treatment groups: Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment. 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.

Official Title
-----------------
Continuous Glucose Monitoring in Intensive Care Unit

Conditions
-----------------
Blood Glucose, Critical Care

Intervention / Treatment
-----------------
* Device: Dexcom G6 continuous glucose monitor
* Diagnostic Test: Blood glucose measurements according to standards of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, of 18 to 80 years of age, undergoing one of the following surgical procedures and post-operative care at ICU: pancreas surgery - total or partial pancreas resection orthotopic liver transplantation simultaneous pancreas and kidney transplantation patients with diabetes mellitus undergoing major surgery Patient must have signed the Patient Informed Consent Form. Exclusion Criteria: Any criteria that would disable surgical procedures involved

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Device: Dexcom G6 continuous glucose monitor<br>* 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.<br>|
| Active Comparator: Control Group<br> | Diagnostic Test: Blood glucose measurements according to standards of care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in target range of 6-10 mmol/l |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood glucose levels |  | 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 ) | 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 ) | 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 ) | 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 ) | 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 |  | 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) |  | 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 | From admission until the discharge from postoperative ICU, approx. 5-7 days | 
| Surgical complications | Surgical site infections, wound dehiscence, wound leakage | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days | 
| Infectious complications | Pneumonia, abdominal sepsis, urosepsis | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days | 
| Time until discharge from the inpatient care |  | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days |