Diabetes MellitusNCT02434315
FreeStyle Libre Pro Use in Primary & Secondary Care
A study testing FreeStyle Libre Pro 4 sensor wears, 2 with reviews, FreeStyle Libre Pro 6 sensor wears, 4 with reviews and FreeStyle Libre Pro 3 sensor wears in people with Diabetes Mellitus, run by Abbott Diabetes Care at 23 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Libre Pro 4 sensor wears, 2 with reviews, FreeStyle Libre Pro 6 sensor wears, 4 with reviews and FreeStyle Libre Pro 3 sensor wears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 23 sitesUnited Kingdom
- Study dates
- Apr 2015to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years.
- Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
Who cannot join
- Age at least 18 years.
- Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
- Participant is currently prescribed animal insulin.
- Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study.
- Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
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- Has a pacemaker or any other neurostimulators.
- Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
- Currently receiving dialysis treatment or planning to receive dialysis during the study.
- Women who are pregnant, plan to become pregnant or become pregnant during the study.
- Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
- Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months.
- Currently using Continuous Subcutaneous Insulin Infusion (CSII).
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United Kingdom23 sites
Atherstone Surgery
Atherstone
Westongrove Partnership
Aylesbury
Pebsham Surgery
Bexhill-on-Sea
Omnia Practice
Birmingham
Hathaway Surgery
Chippenham
Rowden Surgery
Chippenham
Pound Hill Medical Group
Crawley
Claremont Medical Practice
Exmouth
White Horse Medical Practice
Faringdon
Parkwood Surgery
Hemel Hempstead
St James Hospital,
Leeds, LS9 7TF
Kings College Hospital
London
James Cook Hospital
Middlesbrough
Milton Keynes Hospital
Milton Keynes
Greenwood and Sneinton Centre
Nottingham
Mortimer Surgery
Reading
Clifton Medical Centre
Rotherham
Salford Royal Hospital
Salford
Ashfields Primary Care Centre
Sandbach
The Kiltearn Medical Centre
Sandbach
Albany House Surgery
Wellingborough
Rothwell Surgery
Wellingborough
Friarsgate Practice
Winchester
About this study
Official title: Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre Pro 4 sensor wears, 2 with reviews, FreeStyle Libre Pro 6 sensor wears, 4 with reviews, FreeStyle Libre Pro 3 sensor wears
- Keywords
- Diabetes Mellitus, 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 Pro 4 sensor wears, 2 with reviewsDevice
Subjects will wear the FreeStyle Libre Pro System for 14 days. 2 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.
FreeStyle Libre Pro 6 sensor wears, 4 with reviewsDevice
Subjects will wear the FreeStyle Libre Pro System for 14 days. 4 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.
FreeStyle Libre Pro 3 sensor wearsDevice
Subjects will wear the FreeStyle Libre Pro System for 14 days. 3 periods of Sensor wear for time in range measurement over a period of approximately 8 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Control | Active comparator | FreeStyle Libre Pro 3 sensor wears Receives: Device: FreeStyle Libre Pro 3 sensor wears |
| Group B - Intervention | Experimental | FreeStyle Libre Pro 4 sensor wears, 2 with reviews Receives: Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews |
| Group C - Intervention | Experimental | FreeStyle Libre Pro 6 sensor wears, 4 with reviews Receives: Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline - time in glucose range - for penultimate sensor wear
Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase
Measured: 14 day baseline phase compared to day 172 to 187
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionSep 2016
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 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
- NCT02434315
- Sponsor's protocol ID
- ADC-UK-PMS-14024
- Status last verified
- Sep 2016
- First submitted
- 27 Apr 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ajjan RA, Jackson N, Thomson SA. Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. Diab Vasc Dis Res. 2019 Jul;16(4):385-395. doi: 10.1177/1479164119827456.
PubMed 31271312
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
- ClinicalTrials.gov ID
- NCT02434315
- Acronym / sponsor ID
- ADC-UK-PMS-14024
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Sensing Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 May 2015 (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 purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Control | Active comparator | Device: FreeStyle Libre Pro 3 sensor wearsFreeStyle Libre Pro 3 sensor wears |
| Group B - Intervention | Experimental | Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviewsFreeStyle Libre Pro 4 sensor wears, 2 with reviews |
| Group C - Intervention | Experimental | Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviewsFreeStyle Libre Pro 6 sensor wears, 4 with reviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 18 years.
- Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
Key exclusion criteria (15 listed)
- Age at least 18 years.
- Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
- Participant is currently prescribed animal insulin.
- Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study.
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 Pro 4 sensor wears, 2 with reviewsSubjects will wear the FreeStyle Libre Pro System for 14 days. 2 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears. | Device | Group B - Intervention |
| FreeStyle Libre Pro 6 sensor wears, 4 with reviewsSubjects will wear the FreeStyle Libre Pro System for 14 days. 4 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears. | Device | Group C - Intervention |
| FreeStyle Libre Pro 3 sensor wearsSubjects will wear the FreeStyle Libre Pro System for 14 days. 3 periods of Sensor wear for time in range measurement over a period of approximately 8 months. | Device | Group A - Control |
Primary outcome
Change from Baseline - time in glucose range - for penultimate sensor wear
Time frame: 14 day baseline phase compared to day 172 to 187
Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase
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 29 Sep 2016.
- Derived from this study: PubMed 31271312Ajjan RA, Jackson N, Thomson SA. Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. Diab Vasc Dis Res. 2019 Jul;16(4):385-395. doi: 10.1177/1479164119827456.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre Pro 4 sensor wears, 2 with reviews, FreeStyle Libre Pro 6 sensor wears, 4 with reviews and FreeStyle Libre Pro 3 sensor wears in people with Diabetes Mellitus, run by Abbott Diabetes Care at 23 sites in United Kingdom.
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 3 inclusion and 15 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom. 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 from Baseline - time in glucose range - for penultimate sensor wear (time frame: 14 day baseline phase compared to day 172 to 187). 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 NCT02434315, 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 29 Sep 2016.