CompletedNot Applicable

Evaluation of Glycemic Variability (GLAIVE)

France172 participantsStarted 2012-09

Plain-language 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 the "standard" installation in terms of control of glycaemic variability.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

index GLI (Glycemic Lability Index)

Timeframe: up to 48 hours

Trial details

NCT IDNCT02812927

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

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