Trial Outcomes & Findings for Continuous Glucose Monitoring in Critically Ill (NCT NCT00707434)

NCT ID: NCT00707434

Last Updated: 2020-03-23

Results Overview

Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient. Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.
• Results posted on: 2020-03-23

Participant Flow

Recruitment period: June 12, 2008 to May 19, 2011. All recruitment was done at The University of Texas (UT) and UT MD Anderson Cancer Center.

Participant milestones

Measure	Continuous Glucose Monitoring Device in ICU Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Continuous Glucose Monitoring Device in ICU Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
Overall Study Adverse Event	1

Baseline Characteristics

Continuous Glucose Monitoring in Critically Ill

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring in ICU n=6 Participants Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.

Population: Study was terminated due to insufficient funding and data were not collected.

Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient.

Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value.

Outcome measures

Outcome data not reported

Adverse Events

Continuous Glucose Monitoring in ICU

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Continuous Glucose Monitoring in ICU n=6 participants at risk Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
Injury, poisoning and procedural complications Bleeding at device insertion site	16.7% 1/6 • Number of events 1 • Participants monitored for up to 15 days or until leaving the ICU, whichever came first.

Additional Information

Clinical Research Operations, Office of VP Clinical Research

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place