Diabetes MellitusSELFYNCT02821117
FreeStyle Libre Glucose Monitoring System Paediatric Study
A study testing FreeStyle Libre Flash Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Libre Flash Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 30 Jun 2016to 22 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United Kingdom7 sites
Antrim Area Hospital
Antrim, BT41 2RL
Royal Belfast Hospital for Sick Children
Belfast, County Antrim, BT12 6BE
Ulster Hospital
Belfast, BT16
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Altnagelvin Hospital
Londonderry, BT47 6SB
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Southampton University Hospital NHS Trust
Southampton, SO16 6YD
Ireland2 sites
National Children's Hospital
Dublin, 24
Temple Street Children's University Hospital
Dublin, 7
About this study
Official title: An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
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.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre Flash Glucose Monitoring System
- Keywords
- Diabetes Mellitus, Paediatric, Sensing Technology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre Flash Glucose Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | FreeStyle Libre Flash Glucose Monitoring System Receives: Device: FreeStyle Libre Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and days 56 to 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start30 Jun 2016
- Primary completion30 Nov 2016
- Study completion22 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821117
- Sponsor's protocol ID
- ADC-UK-PMS-16028
- Acronym
- SELFY
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2016
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
- ClinicalTrials.gov ID
- NCT02821117
- Acronym / sponsor ID
- SELFY / ADC-UK-PMS-16028
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Paediatric, Sensing Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FreeStyle Libre Flash Glucose Monitoring SystemFreeStyle Libre Flash Glucose Monitoring System |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring SystemSubjects 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. | Device | Intervention |
Primary outcome
Change in Time in Range
Time frame: Baseline and days 56 to 70
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 30054967Campbell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre Flash Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Ireland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time in Range (time frame: Baseline and days 56 to 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.