Can a skin sensor replace finger pricks for kids with diabetes?

NCT ID NCT02821117

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 22, 2026 · Last updated Sep 22, 2026

Summary

Researchers are testing whether the FreeStyle Libre flash glucose monitoring system helps children and teenagers with type 1 diabetes control their blood sugar better than standard finger-prick testing. The study includes 76 young people aged 4 to 17 who use insulin and have a caregiver. Participants wear the sensor for 14 days while it records glucose in the background, then use it for 8 weeks to guide daily diabetes management, and researchers compare their time in a healthy glucose range.

What this could mean

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

Active substance
FreeStyle Libre flash glucose monitoring system
What this could lead to
If it works, children and teens with type 1 diabetes could manage their blood sugar with fewer finger pricks and steadier glucose levels.
What could go wrong
The trial is small and short, so results may not hold up in everyday life. Some participants may find the sensor uncomfortable or unreliable, and glucose control depends on many factors beyond the device.

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

76 people

The number who actually took part.

Started

Jun 2016

Finished

Feb 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

4 to 17 years

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: * Aged ≥4 years and ≤17 years. * Has an identified Caregiver of ≥18 years. * Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year. * Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen. * Currently testing BG, on average at least 2 times per day. Exclusion Criteria: * Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition. * Currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study). * Currently receiving dialysis treatment or planning to receive dialysis during the study. * Female participant known to be pregnant. * Participating in another device or drug study that could affect glucose measurements or glucose management. * Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study. * Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months. * Known (or suspected) allergy to medical grade adhesives. * In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Altnagelvin Hospital

    Londonderry, BT47 6SB, United Kingdom

  • Antrim Area Hospital

    Antrim, BT41 2RL, United Kingdom

  • Kinder- und Jugendkrankenhaus

    Hanover, 30173, Germany

  • National Children's Hospital

    Dublin, 24, Ireland

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Royal Belfast Hospital for Sick Children

    Belfast, County Antrim, BT12 6BE, United Kingdom

  • Southampton University Hospital NHS Trust

    Southampton, SO16 6YD, United Kingdom

  • St. James University Hospital, Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Temple Street Children's University Hospital

    Dublin, 7, Ireland

  • Ulster Hospital

    Belfast, BT16, United Kingdom

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