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Completed

NCT Number: NCT02812927

Evaluation of Glycemic Variability (GLAIVE)

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.

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Key information

Conditions

Critical Illness Anesthesia Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edelvaiss Multiline-8

Device

Optimised infusion line

Standard infusion line

Device

Primary outcomes

  1. index GLI (Glycemic Lability Index)

    Time frame: up to 48 hours

    This index is calculated from capillary blood glucose.

Secondary outcomes

  1. Number of hypoglycaemic events

    Time frame: 48 hours

    Prevalence and incidence of hypoglycemia

  2. Number of hyperglycaemic events

    Time frame: 48 hours

    Prevalence and incidence of hyperglycemia

  3. Sequential Organ Failure Assessment score (SOFA)

    Time frame: during the 4 days of hospitalization period

    for measure morbidity and mortality

  4. length of stay in Intensive Care Unit (ICU) or in hospital

    Time frame: during the 4 days of hospitalization period

    for measure morbidity and mortality

  5. Death rate

    Time frame: during the 4 days of hospitalization period

    for measure morbidity and mortality

  6. Mean Amplitude Glycemic Excusions score (MAGE)

    Time frame: every 3 hours during 48 hours

    Glycaemic variability

  7. standard deviation of blood glucose

    Time frame: every 3 hours during 48 hours

    Glycaemic variability

  8. average blood glucose

    Time frame: every 3 hours during 48 hours

    Glycaemic variability

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: GLAIVE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2016
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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