Critical IllnessGLAIVENCT02812927
Evaluation of Glycemic Variability (GLAIVE)
A study testing Edelvaiss Multiline-8 and Standard infusion line in people with Critical Illness and Anesthesia, run by University Hospital, Lille at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Anesthesia
- What is being tested?
- Edelvaiss Multiline-8 and Standard infusion line
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness, Anesthesia
- Being tested
- Edelvaiss Multiline-8, Standard infusion line
- Keywords
- Glycemic lability index, Continuous glucose monitoring system, intensive care, Insulin
- Medical subject headings
- Critical Illness, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edelvaiss Multiline-8Device
Optimised infusion line
Standard infusion lineDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard infusion line | Other | 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. Receives: Device: Standard infusion line |
| Optimised infusion line | Experimental | 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. Receives: Device: Edelvaiss Multiline-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
index GLI (Glycemic Lability Index)
This index is calculated from capillary blood glucose.
Measured: up to 48 hours
Secondary outcomes (8)
Number of hypoglycaemic events
Prevalence and incidence of hypoglycemia
Measured: 48 hours
Number of hyperglycaemic events
Prevalence and incidence of hyperglycemia
Measured: 48 hours
Sequential Organ Failure Assessment score (SOFA)
for measure morbidity and mortality
Measured: during the 4 days of hospitalization period
length of stay in Intensive Care Unit (ICU) or in hospital
for measure morbidity and mortality
Measured: during the 4 days of hospitalization period
Death rate
for measure morbidity and mortality
Measured: during the 4 days of hospitalization period
Mean Amplitude Glycemic Excusions score (MAGE)
Glycaemic variability
Measured: every 3 hours during 48 hours
standard deviation of blood glucose
Glycaemic variability
Measured: every 3 hours during 48 hours
average blood glucose
Glycaemic variability
Measured: every 3 hours during 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD, PhD, Principal investigator, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812927
- Sponsor's protocol ID
- 2011_17
- Other IDs
- 2012-A00188-35
- Acronym
- GLAIVE
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 28699150
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques
- ClinicalTrials.gov ID
- NCT02812927
- Acronym / sponsor ID
- GLAIVE / 2011_17
- Conditions
- Critical Illness, Anesthesia
- Keywords
- Glycemic lability index, Continuous glucose monitoring system, intensive care, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard infusion line | Other | Device: Standard infusion lineThe 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. |
| Optimised infusion line | Experimental | Device: Edelvaiss Multiline-8The 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edelvaiss Multiline-8Optimised infusion line | Device | Optimised infusion line |
| Standard infusion line | Device | Standard infusion line |
Primary outcome
index GLI (Glycemic Lability Index)
Time frame: up to 48 hours
This index is calculated from capillary blood glucose.
8 secondary outcomes
Number of hypoglycaemic events
Time frame: 48 hours
Number of hyperglycaemic events
Time frame: 48 hours
Sequential Organ Failure Assessment score (SOFA)
Time frame: during the 4 days of hospitalization period
length of stay in Intensive Care Unit (ICU) or in hospital
Time frame: during the 4 days of hospitalization period
Death rate
Time frame: during the 4 days of hospitalization period
Mean Amplitude Glycemic Excusions score (MAGE)
Time frame: every 3 hours during 48 hours
standard deviation of blood glucose
Time frame: every 3 hours during 48 hours
average blood glucose
Time frame: every 3 hours during 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 28699150Genay 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Lebuffe, MD, PhD principal investigator
University Hospital of Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edelvaiss Multiline-8 and Standard infusion line in people with Critical Illness and Anesthesia, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
index GLI (Glycemic Lability Index) (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.