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New device could protect tiny babies from dangerous low blood sugar

NCT ID NCT01942239

Disease control Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a real-time continuous glucose monitor could help detect and manage low blood sugar (hypoglycemia) in very low birth weight newborns. 48 infants were randomly assigned to either the continuous monitor or standard finger-stick testing for their first three days of life. The goal was to see if the monitor reduced the number and duration of hypoglycemia episodes, which can harm brain development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
real-time continuous glucose monitoring device
What this could lead to
If successful, this could lead to better management of low blood sugar in fragile newborns, potentially reducing brain damage risk.
What could go wrong
This is a small, single-center study with only 48 infants. Results may not apply to all hospitals or babies, and the device may not catch all low sugar events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Start date

Dec 2008

Finished

Nov 2009

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 hour to 24 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypoglycemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoglycemia

Contacts and locations

Locations

  • UH Tours Clocheville hospital

    Tours, 37000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.