Assessment of the Accuracy,Feasibility,Safety of Continuous Glucose Monitoring System

Safety Clinical Trial

Official title:

The Accuracy, Feasibility, Safety and Confounding Factors of Real-time Continuous Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120091
• Other study ID #: accuracy-ky65
• Status: Completed
• Phase: N/A
• First received: April 8, 2017
• Last updated: April 18, 2017
• Start date: July 1, 2014
• Est. completion date: January 31, 2015

Study information

• Verified date: April 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.

Description:

Acute glucose metabolic disorder (hyperglycemia, hypoglycemia and high glucose variability) is common during critical illness and associated with poor prognosis.Continuous glucose monitoring system (CGMS), which providing continuous glucose values, is promising to overcome these problems mentioned above and finally optimize glucose control.But its feasibility, accuracy and confounding factors are controversial.The aims of this study is to assess the accuracy, feasibility and safety of CGMS in daily routine in a general ICU in comparison with simultaneous laboratory arterial blood glucose (ABG) values

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 31, 2015
• Est. primary completion date: January 31, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria: Critically ill patients who were older than 18 years old and expected length of ICU stay longer than 48 hours

Exclusion Criteria:

• 1) they were pregnant.2) had broken skin. 3) had a platelet count of less than 30 × 109/L 4) had participated in another trial.5) diabetic ketoacidosis or hyperosmotic coma.6) judged to be improper to complete this trial by the investigator

Related Conditions & MeSH terms

• Accuracy
• Continuous Glucose Monitoring System
• Feasibility
• Safety

Intervention

Device:
• Real-time continuous blood glucose monitoring system(CGMS)
A total of 20 patients were enrolled for the place of CGMS.CGMS were placed on the right chest wall of each patients and recorded the interstitial glucose. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous data display/Total monitoring time	CGM should continuously measure glucose and display in real time >95% of the time for the duration of total study period.	CGMS will be used up to 5 days
Other	device-related data gaps	Skips in data acquisition should not exceed 30 minutes at a time	CGMS will be used up to 5 days
Other	Reasons for early disconnection of CGMS	the number of each disconnection reason(3 categories:Accidentally,poor signal and early discharge)	CGMS will be used up to 5 days
Other	Number of Participants With Local complications, such as infection, bleeding, bruises and redness	Number of Participants With Local complications, such as infection, bleeding, bruises and redness	CGMS will be used up to 5 days
Primary	The Spearman correlation analysis	correlation coefficient (between 0.3 and 0.5):low correlation;(between 0.5 and 0.8);moderate correlation;(above 0.8):high correlation	CGMS will be used up to 5 days
Primary	Bland-altman analysis	more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.	CGMS will be used up to 5 days
Primary	The International Standardization Organization (ISO) criteria	more than 95% of CGMS readings should be within 0.83mmol/L( of the reference values when the reference value is =5.56mmol/L and within 15.0% of the reference values when the reference value is >5.56mmol/L	CGMS will be used up to 5 days
Primary	Mean absolute relative difference(MARD) and possible confounding factors	The MARD in critical ill patients should not be more than 14%.Stratified MARD according to 7 factors(history of diabetes, blood glucose variability (determined using standard deviation of blood glucose), glucose ranges(<4.4mmol/L,4.4-10mmol/L,>10mmol/L), vasoactive drugs,continuous renal replacement therapy(CRRT), glucocorticoids, enteral nutrition(EN) and parenteral nutrition(PN) will be calculated and made a comparison.	CGMS will be used up to 5 days
Primary	Clarke error grid analysis	More than 98% data pairs should locate in "accuracy zone(Zone A)" and "clinically acceptable zone(Zone B)"	CGMS will be used up to 5 days
Primary	Surveillance error grid	There is no definite data field.The results will be analyzed comprehensively	CGMS will be used up to 5 days