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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia
• Intervention / Treatment: Other: Different methods of blood glucose monitoring between groups

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 Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Kang, MD; Phone Number: 86-028-85422508; Email: kang_yan_123@163.com
• Study Contact Backup: Name: Yan-yan Zuo, MM; Phone Number: 86-028-85422506; Email: zyyan21@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Intensive care unit of West China Hospital
      • Contact: Yan Kang, MD; Phone Number: 028-85422508; Email: kang_yan_123@163.com
      • Principal Investigator: Yan Kang, MD
      • Sub-Investigator: Yan-yan Zuo, MD
      • Sub-Investigator: Mei-zhu Lu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring Group; 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; Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
Active Comparator: Conventional Group; 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; Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kang Yan
• Investigators: Study Director: Yan Kang, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: continuous glucose monitoring；; critically ill
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperglycemia; Critical Illness
• Other Study ID Numbers: CGM-ky0521