Evaluation of Glycemic Variability (GLAIVE) (GLAIVE)

Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques

This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Anesthesia
• Intervention / Treatment: Device: Standard infusion line; Device: Edelvaiss Multiline-8

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients under postoperative intensive care
• Treatment with insulin on bi-lumen central venous catheter over than 48 hours
• Eligibility for interstitial glucose monitoring
• Blood glucose control every 3 hours

Exclusion Criteria:

• Pregnant or breastfeeding women
• Patient unwilling to participate in the study
• Patients participating in another study biomedical over the same period
• Patient can not understand the study and its objectives
• Patient under guardianship, curatorship
• Patient malnourished (BMI <18 kg / m²)
• Patient with morbid obesity (BMI> 40 kg / m²)
• Patient in shock (septic or hemodynamic)
• Patients refusing to sign the Medtronic consent on the storage of personal data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard infusion line; The standard insulin infusion system consisted in regular human insulin administration through a six-stopcock manifold connected to the distal line of a multilumen central venous catheter by 150 cm tubing. Insulin was systematically infused by syringe pump on the patient proximal port of the manifold. Carrier was infused via pump through the manifold. All others medicines were infused through the other five stopcocks.	Device: Standard infusion line
Experimental: Optimised infusion line; The optimised insulin infusion system consisted in regular human insulin administration through a multilumen device (Edelvaiss Multiline-8, Doran International, Toussieu, France). This device had ports for eight infusions which run through separate channels within a 150 cm flexible plastic tube. Since fluids from the individual channels do not meet until they exit the distal tip. Carrier was infused through the high flow (HF) line and insulin was infused by syringe pump systematically next to the HF line port. All others medicines were administered via adjacent ports on the Multiline-8.	Device: Edelvaiss Multiline-8; Optimised infusion line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
index GLI (Glycemic Lability Index)	This index is calculated from capillary blood glucose.	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypoglycaemic events	Prevalence and incidence of hypoglycemia	48 hours
Number of hyperglycaemic events	Prevalence and incidence of hyperglycemia	48 hours
Sequential Organ Failure Assessment score (SOFA)	for measure morbidity and mortality	during the 4 days of hospitalization period
length of stay in Intensive Care Unit (ICU) or in hospital	for measure morbidity and mortality	during the 4 days of hospitalization period
Death rate	for measure morbidity and mortality	during the 4 days of hospitalization period
Mean Amplitude Glycemic Excusions score (MAGE)	Glycaemic variability	every 3 hours during 48 hours
standard deviation of blood glucose	Glycaemic variability	every 3 hours during 48 hours
average blood glucose	Glycaemic variability	every 3 hours during 48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Gilles Lebuffe, MD, PhD, University Hospital of Lille

Publications and helpful links

General Publications

• Genay S, Decaudin B, Ethgen S, Alluin A, Babol E, Labreuche J, Behal H, Vantyghem MC, Odou P, Lebuffe G. Effect of insulin infusion line on glycaemic variability in a perioperative high dependency unit (HDU): a prospective randomised controlled trial. Ann Intensive Care. 2017 Dec;7(1):74. doi: 10.1186/s13613-017-0298-x. Epub 2017 Jul 11.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimated): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Insulin; intensive care; Glycemic lability index; Continuous glucose monitoring system
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Critical Illness; Insulin Resistance
• Other Study ID Numbers: 2011_17; 2012-A00188-35 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED