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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.
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:
After obtaining the informed consent, they will be randomized into one of two treatment groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) |
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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:
Patient must have signed the Patient Informed Consent Form.
Exclusion Criteria:
Any criteria that would disable surgical procedures involved
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41523586 | Derived | 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. |
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Data will be available upon reasonable request.
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
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| 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. |
|
Amount of 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 ) | Amount of 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 ) | Amount of 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 ) | Amount of 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 |
| Glycaemic variability assessed by standard deviation of 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 |
| Glycaemic variability assessed by coefficient of variation (%CV) | 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 | From admission until the discharge from postoperative ICU, approx. 5-7 days |
| Surgical complications | Surgical site infections, wound dehiscence, wound leakage | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days |
| Infectious complications | Pneumonia, abdominal sepsis, urosepsis | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days |
| Time until discharge from the inpatient care | From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days |