Continuous Glucose Monitoring in Intensive Care Unit

NCT ID: NCT05585801

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Blood Glucose; Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Group Type: EXPERIMENTAL

Dexcom G6 continuous glucose monitor

Intervention Type: DEVICE

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.

Control Group

Group Type: ACTIVE_COMPARATOR

Blood glucose measurements according to standards of care

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Dexcom G6 continuous glucose monitor

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.

Intervention Type: DEVICE

Blood glucose measurements according to standards of care

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Barbora Hagerf

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Barbora Hagerf, MD

Role: CONTACT

barbora.voglova@gmail.com

00420608301443

Marek Protuš, MD

Role: CONTACT

prtm@ikem.cz

Facility Contacts

Barbora Hagerf, MD

Role: primary

vogb@ikem.cz

Other Identifiers

CGM 001

Identifier Type: -

Identifier Source: org_study_id