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Completed

NCT Number: NCT03120091

Assessment of the Accuracy,Feasibility,Safety of 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.

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Key information

Conditions

Continuous Glucose Monitoring System Accuracy Feasibility Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care unit of West China Hospital

Chengdu, Sichuan, 610000, China

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time continuous blood glucose monitoring system(CGMS)

Device

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

Primary outcomes

  1. The Spearman correlation analysis

    Time frame: 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

  2. Bland-altman analysis

    Time frame: CGMS will be used up to 5 days

    more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.

  3. The International Standardization Organization (ISO) criteria

    Time frame: 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

  4. Mean absolute relative difference(MARD) and possible confounding factors

    Time frame: 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.

  5. Clarke error grid analysis

    Time frame: 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)"

  6. Surveillance error grid

    Time frame: CGMS will be used up to 5 days

    There is no definite data field.The results will be analyzed comprehensively

Other outcomes

  1. Continuous data display/Total monitoring time

    Time frame: CGMS will be used up to 5 days

    CGM should continuously measure glucose and display in real time >95% of the time for the duration of total study period.

  2. device-related data gaps

    Time frame: CGMS will be used up to 5 days

    Skips in data acquisition should not exceed 30 minutes at a time

  3. Reasons for early disconnection of CGMS

    Time frame: CGMS will be used up to 5 days

    the number of each disconnection reason(3 categories:Accidentally,poor signal and early discharge)

  4. Number of Participants With Local complications, such as infection, bleeding, bruises and redness

    Time frame: CGMS will be used up to 5 days

    Number of Participants With Local complications, such as infection, bleeding, bruises and redness

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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