Can a skin sensor replace finger pricks for kids with diabetes?
NCT ID NCT02821117
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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76 people
The number who actually took part.
- Started
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Jun 2016
- Finished
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Feb 2017
- Lead sponsor
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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
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4 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Altnagelvin Hospital
Londonderry, BT47 6SB, United Kingdom
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Antrim Area Hospital
Antrim, BT41 2RL, United Kingdom
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Kinder- und Jugendkrankenhaus
Hanover, 30173, Germany
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National Children's Hospital
Dublin, 24, Ireland
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Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
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Royal Belfast Hospital for Sick Children
Belfast, County Antrim, BT12 6BE, United Kingdom
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Southampton University Hospital NHS Trust
Southampton, SO16 6YD, United Kingdom
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St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
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Temple Street Children's University Hospital
Dublin, 7, Ireland
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Ulster Hospital
Belfast, BT16, United Kingdom
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Other studies related to the condition(s) this trial covers.
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