Trial Outcomes & Findings for Computerized Glucose Control in Critically Ill Patients (NCT NCT01002482)

NCT ID: NCT01002482

Last Updated: 2013-12-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2684 participants
• Primary outcome timeframe: Day 90
• Results posted on: 2013-12-03

Participant Flow

Adult patients who were assumed to require at least 3 days in the ICU were eligible for inclusion. The study, carried out between October 2009 and June 2011, involved 34 ICUs (19 in academic tertiary care hospitals and 15 in community hospitals)

876 participants were eligible but were excluded: 844 Had objection of the treating physician, 32 declined to participate

Participant milestones

Measure	CGAO-based Glucose Control Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Study STARTED	1351	1333
Overall Study COMPLETED	1336	1312
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Measure	CGAO-based Glucose Control Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Study Withdrawal by Subject	14	21
Overall Study Included twice	1	0

Baseline Characteristics

Computerized Glucose Control in Critically Ill Patients

Baseline characteristics by cohort

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.	Total n=2648 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	720 Participants n=5 Participants	722 Participants n=7 Participants	1442 Participants n=5 Participants
Age, Categorical >=65 years	616 Participants n=5 Participants	590 Participants n=7 Participants	1206 Participants n=5 Participants
Age Continuous	61.5 years STANDARD_DEVIATION 16.2 • n=5 Participants	61.6 years STANDARD_DEVIATION 16.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	474 Participants n=5 Participants	468 Participants n=7 Participants	942 Participants n=5 Participants
Sex: Female, Male Male	862 Participants n=5 Participants	844 Participants n=7 Participants	1706 Participants n=5 Participants
Region of Enrollment France	1336 participants n=5 Participants	1312 participants n=7 Participants	2648 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 90

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
All-cause 90-day Mortality	431 participants	447 participants

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
All-cause 28-day Mortality	326 participants	328 participants

SECONDARY outcome

Timeframe: Date of discharge from the ICU

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
All-cause Intensive Care Unit Mortality	302 participants	310 participants

SECONDARY outcome

Timeframe: Day of discharge from the hospital

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
All-cause In-hospital Mortality	376 participants	393 participants

SECONDARY outcome

Timeframe: 28 days

Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Intensive Care Unit Free Days	14 days Interval 0.0 to 22.0	13 days Interval 0.0 to 23.0

SECONDARY outcome

Timeframe: Day of discharge from the ICU

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date of discharge from the ICU

Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs

Outcome measures

Measure	CGAO-based Glucose Control n=1314 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1289 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Severe Hypoglycemia	174 participants	79 participants

SECONDARY outcome

Timeframe: Date of discharge from the hospital

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Hospital Length of Stay	20 days Interval 10.0 to 37.0	20 days Interval 9.0 to 39.0

SECONDARY outcome

Timeframe: Date of discharge from the ICU

Outcome measures

Measure	CGAO-based Glucose Control n=1336 Participants Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 Participants Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Intensive Care Unit Length of Stay	9 days Interval 5.0 to 18.0	8 days Interval 4.0 to 17.0

SECONDARY outcome

Timeframe: Date of discharge from the ICU

Outcome measures

Outcome data not reported

Adverse Events

CGAO-based Glucose Control

Serious events: 20 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard-Care Glucose Gontrol

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CGAO-based Glucose Control n=1336 participants at risk Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.	Standard-Care Glucose Gontrol n=1312 participants at risk Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Metabolism and nutrition disorders BG of 40 mg per deciliter or less accompanied with observed or suspected neurological symptoms	1.5% 20/1336 • Number of events 23	0.46% 6/1312 • Number of events 9

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pierre Kalfon

CH Chartres

Phone: 003323730303073

Email: pkalfon@ch-chartres.fr

Results disclosure agreements

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