Continuous Glucose Monitoring in Intensive Care Unit

Not Applicable

Recruiting

• Conditions: Blood Glucose; Critical Care
• Interventions: Device: Dexcom G6 continuous glucose monitor; Diagnostic Test: Blood glucose measurements according to standards of care

• Registration Number: NCT05585801
• Lead Sponsor: Institute for Clinical and Experimental Medicine

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.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2022-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Dexcom G6 continuous glucose monitor	-
Control Group	Blood glucose measurements according to standards of care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Infectious complications	From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days	Pneumonia, abdominal sepsis, urosepsis
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	Amount of time (%) spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )
Daily dose of insulin	From admission until the discharge from postoperative ICU, approx. 5-7 days	Daily dose of insulin and dosing speed throughout the day
Surgical complications	From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days	Surgical site infections, wound dehiscence, wound leakage
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
Time until discharge from the inpatient care	From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
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	Amount of time (%) spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )
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	Amount of time (%) spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )
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	Amount of time (%) spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia