CompletedNot Applicable

Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates

France48 participantsStarted 2008-12

Plain-language summary

Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.

Who can participate

Age range

1 Hour – 24 Hours

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: * Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours Exclusion Criteria: * a serious congenital abnormality, * a skin condition that contraindicated continuous glucose monitoring, * a transfer toward another hospital during the first days of life * an absence of parental agreement.

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

number of hypoglycemia episodes

Timeframe: at the end of the first 3 days of life

Trial details

NCT IDNCT01942239

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

View on ClinicalTrials.gov More Hypoglycemia trials