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Clinical Trials/NCT01992965
NCT01992965UnknownNot Applicable

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

Kang Yan1 site in 1 country144 target enrollmentStarted: April 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
144
Locations
1
Primary Endpoint
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

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: Glycemic control measures will be assessed up to five days.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Kang Yan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Kang Yan

Director of Intensive Care Unit

West China Hospital

Study Sites (1)

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