Clinical trial NCT05585801: Continuous Glucose Monitoring in Intensive Care Unit
Official title: Continuous Glucose Monitoring in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Glucose
Critical Care
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2022-10-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients, of 18 to 80 years of age, undergoing one of the following surgical procedures and post-operative care at ICU:

   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
2. Patient must have signed the Patient Informed Consent Form.

Exclusion Criteria:

Any criteria that would disable surgical procedures involved

Primary outcomes:
measure: Time in target range of 6-10 mmol/l
timeFrame: 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 outcomes:
measure: Mean blood glucose levels
timeFrame: 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
measure: Time spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )
timeFrame: 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
measure: Time spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )
timeFrame: 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
measure: Time spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )
timeFrame: 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
measure: Time spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )
timeFrame: 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
measure: Glycaemic variability assessed by standard deviation of blood glucose levels
timeFrame: 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
measure: Glycaemic variability assessed by coefficient of variation (%CV)
timeFrame: 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
measure: Daily dose of insulin
timeFrame: From admission until the discharge from postoperative ICU, approx. 5-7 days
measure: Surgical complications
timeFrame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
measure: Infectious complications
timeFrame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
measure: Time until discharge from the inpatient care
timeFrame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
References: