Clinical trial NCT03120091: Assessment of the Accuracy,Feasibility,Safety of Continuous Glucose Monitoring System
Official title: The Accuracy, Feasibility, Safety and Confounding Factors of Real-time Continuous Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Glucose Monitoring System
Accuracy
Feasibility
Safety
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The Spearman correlation analysis
timeFrame: CGMS will be used up to 5 days
measure: Bland-altman analysis
timeFrame: CGMS will be used up to 5 days
measure: The International Standardization Organization (ISO) criteria
timeFrame: CGMS will be used up to 5 days
measure: Mean absolute relative difference(MARD) and possible confounding factors
timeFrame: CGMS will be used up to 5 days
measure: Clarke error grid analysis
timeFrame: CGMS will be used up to 5 days
measure: Surveillance error grid
timeFrame: CGMS will be used up to 5 days
Secondary outcomes:
Other outcomes:
measure: Continuous data display/Total monitoring time
timeFrame: CGMS will be used up to 5 days
measure: device-related data gaps
timeFrame: CGMS will be used up to 5 days
measure: Reasons for early disconnection of CGMS
timeFrame: CGMS will be used up to 5 days
measure: Number of Participants With Local complications, such as infection, bleeding, bruises and redness
timeFrame: CGMS will be used up to 5 days
Locations:
city: Chengdu
country: China
facility: Intensive care unit of West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yan Kang, MD
role: STUDY_DIRECTOR
References: