ClinicalTrials.gg
CompletedNCT02821117SELFYUpdated Sep 22, 2026

FreeStyle Libre Glucose Monitoring System Paediatric Study

An interventional study of FreeStyle Libre Flash Glucose Monitoring System in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 10 sites in 3 countries. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Abbott Diabetes Care (part of Abbott) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
4 Years to 17 Years
Sex
All
01

Study summary

The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes Mellitus, Paediatric
  • Sensing Technology
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 76 is close to the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Intervention

    FreeStyle Libre Flash Glucose Monitoring System

    Device: FreeStyle Libre Flash Glucose Monitoring System

Interventions

  • DeviceFreeStyle Libre Flash Glucose Monitoring System

    Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear. During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase. Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.

06

What researchers measure

Primary outcomes

  1. Change in Time in Range

    Time in range (Sensor glucose 3.9-10.0 mmol/L \[70-180 mg/dL\]) in days 56-70 minus time in range at baseline (days 1-15).

    Time frame: Baseline and days 56 to 70

07

Study locations

10 sites
  • Kinder- und Jugendkrankenhaus
    Hanover, 30173, Germany
  • National Children's Hospital
    Dublin, 24, Ireland
  • Temple Street Children's University Hospital
    Dublin, 7, Ireland
  • Royal Belfast Hospital for Sick Children
    Belfast, County Antrim BT12 6BE, United Kingdom
  • Antrim Area Hospital
    Antrim, BT41 2RL, United Kingdom
  • Ulster Hospital
    Belfast, BT16, United Kingdom
  • St. James University Hospital, Leeds Teaching Hospitals NHS Trust
    Leeds, LS9 7TF, United Kingdom
  • Altnagelvin Hospital
    Londonderry, BT47 6SB, United Kingdom
  • Nottingham University Hospitals NHS Trust
    Nottingham, NG7 2UH, United Kingdom
  • Southampton University Hospital NHS Trust
    Southampton, SO16 6YD, United Kingdom
08

References and documents

Publications

  • Campbell FM, Murphy NP, Stewart C, Biester T, Kordonouri O. Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes. 2018 Nov;19(7):1294-1301. doi: 10.1111/pedi.12735. Epub 2018 Aug 29. PubMed 30054967 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Nov 2016, 5 months.

Of 160 industry-sponsored interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's 5 months is below that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2016
First posted
Jul 1, 2016
StartActual
Jun 30, 2016
Primary completionActual
Nov 30, 2016
CompletionActual
Feb 22, 2017
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02821117
Responsible party
Sponsor
First posted
Jul 1, 2016
Start date
Jun 30, 2016
Primary completion
Nov 30, 2016
Completion
Feb 22, 2017
Last update
Sep 22, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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