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

Not Applicable

• Conditions: Hyperglycemia
• Interventions: Other: Different methods of blood glucose monitoring between groups

• Registration Number: NCT01992965
• Lead Sponsor: Kang Yan

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 Timeline

• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring Group	Different methods of blood glucose monitoring between groups	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.
Conventional Group	Different methods of blood glucose monitoring between groups	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Intensive care unit of West China Hospital; 🇨🇳 Chengdu, Sichuan, China