Continuous Glucose Monitoring in Intensive Care Unit

Institute for Clinical and Experimental Medicine

Status: Enrolling

Conditions: Critical Care; Blood Glucose

Treatments: Device: Dexcom G6 continuous glucose monitor; Diagnostic Test: Blood glucose measurements according to standards of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05585801

CGM 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention Group

Experimental group

Treatment:

Device: Dexcom G6 continuous glucose monitor

Control Group

Active Comparator group

Treatment:

Diagnostic Test: Blood glucose measurements according to standards of care