Trial Outcomes & Findings for LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (NCT NCT01420302)

NCT ID: NCT01420302

Last Updated: 2024-08-26

Results Overview

The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.
• Results posted on: 2024-08-26

Participant Flow

Patients were recruited from 22 August 2011 to 16 December 2011 in a 56-bed ICU of a tertiary referral university hospital

Participant milestones

Measure	LOGIC-Insulin Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm	Nurse-directed Nurse-directed blood glucose control (80-110 mg/dL)
Overall Study STARTED	149	151
Overall Study COMPLETED	149	151
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness

Baseline characteristics by cohort

Measure	LOGIC-Insulin n=149 Participants Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm	Nurse-directed n=151 Participants Nurse-directed blood glucose control (80-110 mg/dL)	Total n=300 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 15 • n=5 Participants	62 years STANDARD_DEVIATION 14 • n=7 Participants	63 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	93 Participants n=7 Participants	181 Participants n=5 Participants
Region of Enrollment Belgium	149 participants n=5 Participants	151 participants n=7 Participants	300 participants n=5 Participants
BMI (kg/m²)	26.5 kg/m² STANDARD_DEVIATION 5.5 • n=5 Participants	25.9 kg/m² STANDARD_DEVIATION 4.8 • n=7 Participants	26.2 kg/m² STANDARD_DEVIATION 5.2 • n=5 Participants
Apache II score (mean SD)	23 units on a scale STANDARD_DEVIATION 10 • n=5 Participants	24 units on a scale STANDARD_DEVIATION 10 • n=7 Participants	23 units on a scale STANDARD_DEVIATION 11 • n=5 Participants
Admission type After cardiac surgery	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Admission type Transplantation	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Admission type Medical	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Admission type Other surgery	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Diabetes	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.

The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control.

Outcome measures

Measure	LOGIC-Insulin n=149 Participants Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm LOGIC-Insulin: Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm	Nurse-directed n=151 Participants Nurse-directed blood glucose control (80-110 mg/dL) Nurse directed: Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
Glycemic Penalty Index (GPI) During the Intervention	9.8 units on a scale Interval 6.0 to 14.5	12.4 units on a scale Interval 8.2 to 18.5

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Adequacy of reaching and maintaining the target range for blood glucose during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Marker of blood glucose variability

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Marker of workload

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Adequacy of reaching and maintaining the target range for blood glucose during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 days post-randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 days post-randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 days post-randomization

Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 days post-randomization

Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention

Outcome measures

Outcome data not reported

Adverse Events

LOGIC-Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 19 deaths

Nurse-directed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Greet Van den Berghe

Department and Laboratory of Intensive Care Medicine KULeuven/UZLeuven

Phone: 003216344017

Email: greet.vandenberghe@kuleuven.be

Results disclosure agreements

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