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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992965
• Other study ID #: CGM-ky0521
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: May 6, 2014
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2014
• Source: West China Hospital
• Contact: Yan Kang, MD
• Phone: 86-028-85422508
• Email: kang_yan_123[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia

Intervention

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

Locations

Country	Name	City	State
China	Intensive care unit of West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Kang Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Cost		Cost associated with glucose monitoring	No