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

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ClinicalTrials.gov Identifier: NCT01992965
Recruitment Status : Unknown
Verified May 2014 by Kang Yan, West China Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Kang Yan, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Other: Different methods of blood glucose monitoring between groups Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Study Start Date : April 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. Cost [ Time Frame: Cost associated with glucose monitoring ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992965


Contacts
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Contact: Yan Kang, MD 86-028-85422508 kang_yan_123@163.com
Contact: Yan-yan Zuo, MM 86-028-85422506 zyyan21@163.com

Locations
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China, Sichuan
Intensive care unit of West China Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Yan Kang, MD    028-85422508    kang_yan_123@163.com   
Principal Investigator: Yan Kang, MD         
Sub-Investigator: Yan-yan Zuo, MD         
Sub-Investigator: Mei-zhu Lu, MD         
Sponsors and Collaborators
Kang Yan
Investigators
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Study Director: Yan Kang, MD West China Hospital
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Responsible Party: Kang Yan, Director of Intensive Care Unit, West China Hospital
ClinicalTrials.gov Identifier: NCT01992965    
Other Study ID Numbers: CGM-ky0521
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Keywords provided by Kang Yan, West China Hospital:
continuous glucose monitoring;
critically ill;
Additional relevant MeSH terms:
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Hyperglycemia
Critical Illness
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases