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

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

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

Study Overview

• Status: Completed
• Conditions: Feasibility; Safety; Continuous Glucose Monitoring System; Accuracy
• Intervention / Treatment: Device: Real-time continuous blood glucose monitoring system(CGMS)

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Intensive care unit of West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients were screened in a 52-bed general ICU of West China Hospitaland enrolled if they were at least 18 years old and had an anticipated stay in ICU for more than 48 hours.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Enrolled Patients; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Surveillance error grid	There is no definite data field.The results will be analyzed comprehensively	CGMS will be used up to 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
device-related data gaps	Skips in data acquisition should not exceed 30 minutes at a time	CGMS will be used up to 5 days
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Yan Kang, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): January 31, 2015
• Study Completion (Actual): January 31, 2015

Study Registration Dates

• First Submitted: April 8, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: accuracy-ky65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No