Back to resultsEffect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Primary Purpose
Hyperglycemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Different methods of blood glucose monitoring between groups
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring continuous glucose monitoring；, critically ill;
Eligibility Criteria
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.
Sites / Locations
- Intensive care unit of West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous Glucose Monitoring Group
Conventional Group
Arm Description
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, 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate
Cost
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01992965
Brief Title
Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Official Title
Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kang Yan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
continuous glucose monitoring；, critically ill;
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous Glucose Monitoring Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Different methods of blood glucose monitoring between groups
Intervention Description
Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate
Time Frame
All the participants will be followed for the duration of hospital stay or 28 days.
Title
Cost
Time Frame
Cost associated with glucose monitoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Kang, MD
Phone
86-028-85422508
Email
kang_yan_123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan-yan Zuo, MM
Phone
86-028-85422506
Email
zyyan21@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Kang, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Intensive care unit of West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Kang, MD
Phone
028-85422508
Email
kang_yan_123@163.com
First Name & Middle Initial & Last Name & Degree
Yan Kang, MD
First Name & Middle Initial & Last Name & Degree
Yan-yan Zuo, MD
First Name & Middle Initial & Last Name & Degree
Mei-zhu Lu, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
We'll reach out to this number within 24 hrs