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Active, Not Recruiting

NCT Number: NCT05585801

Continuous Glucose Monitoring in Intensive Care Unit

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Blood Glucose Critical Care

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical and Experimental Medicine

Prague, Czechia

About this study

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:

  • pancreas surgery - total or partial pancreas resection
  • orthotopic liver transplantation
  • simultaneous pancreas and kidney transplantation
  • patients with diabetes mellitus undergoing major surgery

After obtaining the informed consent, they will be randomized into one of two treatment groups:

  • Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Any criteria that would disable surgical procedures involved

Treatment and study plan

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.

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.

Primary outcomes

  1. Time in target range of 6-10 mmol/l

    Time frame: 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

  1. Mean blood glucose levels

    Time frame: 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

  2. Time spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )

    Time frame: 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 )

  3. Time spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )

    Time frame: 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 )

  4. Time spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )

    Time frame: 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 )

  5. Time spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )

    Time frame: 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 )

  6. Glycaemic variability assessed by standard deviation of blood glucose levels

    Time frame: 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

  7. Glycaemic variability assessed by coefficient of variation (%CV)

    Time frame: 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

  8. Daily dose of insulin

    Time frame: From admission until the discharge from postoperative ICU, approx. 5-7 days

    Daily dose of insulin and dosing speed throughout the day

  9. Surgical complications

    Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days

    Surgical site infections, wound dehiscence, wound leakage

  10. Infectious complications

    Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days

    Pneumonia, abdominal sepsis, urosepsis

  11. Time until discharge from the inpatient care

    Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2022
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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