NCT03120091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 8, 2017

Last Update Submit

April 18, 2017

Conditions

Continuous Glucose Monitoring SystemAccuracyFeasibilitySafety

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Continuous data display/Total monitoring time

    CGMS will be used up to 5 days

  • device-related data gaps

    CGMS will be used up to 5 days

  • Reasons for early disconnection of CGMS

    CGMS will be used up to 5 days

  • +1 more other outcomes

Study Arms (1)

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)

Interventions

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

Enrolled Patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit of West China Hospital

Chengdu, Sichuan, 610000, China

Location

Study Officials

  • Yan Kang, MD

    West China Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 8, 2017

First Posted

April 19, 2017

Study Start

July 1, 2014

Primary Completion

January 31, 2015

Study Completion

January 31, 2015

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)