Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

Detailed Description
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Real-time continuous glucose monitoring system has shown great accuracy and feasibility in critically ill patients. However, its impact on glucose control and outcomes has nearly unknown. Thus, Investigators designed this study to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

Official Title
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Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients

Conditions
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Hyperglycemia

Intervention / Treatment
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* Other: Different methods of blood glucose monitoring between groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years old male or female; Expected ICU stays longer than 72 hours; Glucose level more than 8 mmol/L when enrolls in the ICU; Patients or their legal surrogates have signed the informed consent. Exclusion Criteria: Pregnant or lactating women; ICU stays less than 72 hours; Usage of real-time continuous glucose monitoring system is considered as a contraindication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring Group<br>Continuous Glucose Monitoring Group: Different methods of blood glucose monitoring between groups, and this group will use real-time continuous glucose monitoring system with alarm limits（high and low limit is 10 mmol/L and 8 mmil/L , respectively ) up to five days for glucose control, the target mean glucose level is between 8 and 10 mmol/L. | Other: Different methods of blood glucose monitoring between groups<br>* Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group<br>|
| Active Comparator: Conventional Group<br>Conventional Group： Different methods of blood glucose monitoring between groups, and this group will use finger prick blood glucose measurements for glucose control with the same target mean glucose level of 8 -10 mmol/L. Patients also wear real-time continuous glucose monitoring system to collect glucose measurements. The values of real-time continuous glucose monitoring system are blinded to investigator and patients. | Other: Different methods of blood glucose monitoring between groups<br>* Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control Measures including: Percentage of target blood glucose levels (defined as between 8mmol/L and 10mmol/L); Time of hyperglycemia (defined as >10mmol/L); Hypoglycemia rate (defined as < 2.2mmol/L); Glucose lability index |  | Glycemic control measures will be assessed up to five days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate |  | All the participants will be followed for the duration of hospital stay or 28 days. | 
| Cost |  | Cost associated with glucose monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous glucose monitoring；, critically ill;