RecruitingNot ApplicableNCT05585801

Continuous Glucose Monitoring in Intensive Care Unit

Sponsor

Institute for Clinical and Experimental Medicine

Enrollment

500 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Blood Glucose Critical Care

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria1

Any criteria that would disable surgical procedures involved

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Interventions

DEVICEDexcom 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.

DIAGNOSTIC_TESTBlood 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.