Blood GlucoseNCT05585801
Continuous Glucose Monitoring in Intensive Care Unit
A study testing Dexcom G6 continuous glucose monitor and Blood glucose measurements according to standards of care in people with Blood Glucose and Critical Care, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Glucose, Critical Care
- What is being tested?
- Dexcom G6 continuous glucose monitor and Blood glucose measurements according to standards of care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any criteria that would disable surgical procedures involved
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Blood Glucose, Critical Care
- Being tested
- Dexcom G6 continuous glucose monitor, Blood glucose measurements according to standards of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 continuous glucose monitorDevice
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 careDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Device: Dexcom G6 continuous glucose monitor |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: Blood glucose measurements according to standards of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target range of 6-10 mmol/l
Measured: 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
Measured: 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 )
Amount of time (%) spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )
Measured: 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 )
Amount of time (%) spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )
Measured: 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 )
Amount of time (%) spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )
Measured: 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 )
Amount of time (%) spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )
Measured: 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 standard deviation of blood glucose levels
Measured: 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)
Measured: 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
Daily dose of insulin
Daily dose of insulin and dosing speed throughout the day
Measured: From admission until the discharge from postoperative ICU, approx. 5-7 days
Surgical complications
Surgical site infections, wound dehiscence, wound leakage
Measured: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Infectious complications
Pneumonia, abdominal sepsis, urosepsis
Measured: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Time until discharge from the inpatient care
Measured: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barbora Hagerf, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585801
- Sponsor's protocol ID
- CGM 001
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request.
Publications
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.
PubMed 41523586
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05585801
- Acronym / sponsor ID
- CGM 001
- Conditions
- Blood Glucose, Critical Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Dexcom G6 continuous glucose monitor |
| Control Group | Active comparator | Diagnostic Test: Blood glucose measurements according to standards of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients, of 18 to 80 years of age, undergoing one of the following surgical procedures and post-operative care at ICU:
- Patient must have signed the Patient Informed Consent Form.
Key exclusion criteria (1 listed)
- Any criteria that would disable surgical procedures involved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G6 continuous glucose monitorContinuous 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. | Device | Intervention Group |
| Blood glucose measurements according to standards of careBlood 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. | Diagnostic test | Control Group |
Primary outcome
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
11 secondary outcomes
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
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
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
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
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
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
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
Daily dose of insulin
Time frame: From admission until the discharge from postoperative ICU, approx. 5-7 days
Surgical complications
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Infectious complications
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Time until discharge from the inpatient care
Time frame: From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 41523586Protus 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.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 continuous glucose monitor and Blood glucose measurements according to standards of care in people with Blood Glucose and Critical Care, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.