Continuous Glucose Monitoring in Intensive Care Unit

NCT05585801 | Recruiting

• 1 other identifier: CGM 001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 )

  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 )

  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 )

  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 )

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Device: Dexcom G6 continuous glucose monitor

Control Group

ACTIVE COMPARATOR

Diagnostic Test: Blood glucose measurements according to standards of care

Interventions

Dexcom G6 continuous glucose monitor 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.

Intervention Group

Blood glucose measurements according to standards of care 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any criteria that would disable surgical procedures involved

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czechia

RECRUITING

Related Publications (1)

• Protus M, Voglova Hagerf B, Jabor A, Franekova J, Nemetova L, Uchytilova E, Indrova V, Beckova J, Macek A, Doleckova M, Svirlochova V, Mraz M, Haluzik M, Girman P, Viravova M, Kohn MA, Klonoff DC, Kieslichova E. Accuracy and feasibility of real-time continuous glucose monitoring in early postoperative intensive care after liver transplantation. Ther Adv Endocrinol Metab. 2026 Jan 9;17:20420188251405372. doi: 10.1177/20420188251405372. eCollection 2026.

  PMID: 41523586 DERIVED

Central Study Contacts

Barbora Hagerf, MD

CONTACT

00420608301443; barbora.voglova@gmail.com

Marek Protuš, MD

CONTACT

prtm@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol will be available upon request throughout the study duration. Source data will be available upon request after completion of the study and publication of the results

Locations

CZ (1)