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

Completed

• Conditions: Accuracy; Continuous Glucose Monitoring System; Safety; Feasibility
• Interventions: Device: Real-time continuous blood glucose monitoring system(CGMS)

• Registration Number: NCT03120091
• Lead Sponsor: West China Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2015-01-31
• Study Completion: 2015-01-31
• Status Verified: 2017-04
• Study First Submitted: 2017-04-08
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled Patients	Real-time continuous blood glucose monitoring system(CGMS)	A total of 20 patients were enrolled for the place of CGMS. 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

Primary Outcome Measures

Name	Time	Method
The International Standardization Organization (ISO) criteria	CGMS will be used up to 5 days	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
Mean absolute relative difference(MARD) and possible confounding factors	CGMS will be used up to 5 days	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.
Clarke error grid analysis	CGMS will be used up to 5 days	More than 98% data pairs should locate in "accuracy zone(Zone A)" and "clinically acceptable zone(Zone B)"
Surveillance error grid	CGMS will be used up to 5 days	There is no definite data field.The results will be analyzed comprehensively
The Spearman correlation analysis	CGMS will be used up to 5 days	correlation coefficient (between 0.3 and 0.5):low correlation;(between 0.5 and 0.8);moderate correlation;(above 0.8):high correlation
Bland-altman analysis	CGMS will be used up to 5 days	more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.

Trial Locations

Locations (1)

Intensive care unit of West China Hospital; 🇨🇳 Chengdu, Sichuan, China