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CompletedNCT02434315Updated Sep 29, 2016

FreeStyle Libre Pro Use in Primary & Secondary Care

An interventional study of FreeStyle Libre Pro 4 sensor wears, 2 with reviews and FreeStyle Libre Pro 6 sensor wears, 4 with reviews in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 23 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes Mellitus
  • Sensing Technology
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 175 is above the median of 80 across 8,491 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.

Browse Abbott Diabetes Care studies →All Abbott studies →

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

04

Who can participate

Ages eligible
18 Years and older
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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
175 participants (actual)

Study arms

  • Active comparator
    Group A - Control

    FreeStyle Libre Pro 3 sensor wears

    Device: FreeStyle Libre Pro 3 sensor wears

  • Experimental
    Group B - Intervention

    FreeStyle Libre Pro 4 sensor wears, 2 with reviews

    Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews

  • Experimental
    Group C - Intervention

    FreeStyle Libre Pro 6 sensor wears, 4 with reviews

    Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews

Interventions

  • DeviceFreeStyle Libre Pro 4 sensor wears, 2 with reviews

    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.

  • DeviceFreeStyle Libre Pro 6 sensor wears, 4 with reviews

    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.

  • DeviceFreeStyle Libre Pro 3 sensor wears

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 14 day baseline phase compared to day 172 to 187

07

Study locations

23 sites
  • Atherstone Surgery
    Atherstone, United Kingdom
  • Westongrove Partnership
    Aylesbury, United Kingdom
  • Pebsham Surgery
    Bexhill-on-Sea, United Kingdom
  • Omnia Practice
    Birmingham, United Kingdom
  • Hathaway Surgery
    Chippenham, United Kingdom
  • Rowden Surgery
    Chippenham, United Kingdom
  • Pound Hill Medical Group
    Crawley, United Kingdom
  • Claremont Medical Practice
    Exmouth, United Kingdom
  • White Horse Medical Practice
    Faringdon, United Kingdom
  • Parkwood Surgery
    Hemel Hempstead, United Kingdom
  • St James Hospital,
    Leeds, LS9 7TF, United Kingdom
  • Kings College Hospital
    London, United Kingdom
  • James Cook Hospital
    Middlesbrough, United Kingdom
  • Milton Keynes Hospital
    Milton Keynes, United Kingdom
  • Greenwood and Sneinton Centre
    Nottingham, United Kingdom
  • Mortimer Surgery
    Reading, United Kingdom
  • Clifton Medical Centre
    Rotherham, United Kingdom
  • Salford Royal Hospital
    Salford, United Kingdom
  • Ashfields Primary Care Centre
    Sandbach, United Kingdom
  • The Kiltearn Medical Centre
    Sandbach, United Kingdom
  • Albany House Surgery
    Wellingborough, United Kingdom
  • Rothwell Surgery
    Wellingborough, United Kingdom
  • Friarsgate Practice
    Winchester, United Kingdom
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2015, a primary completion of Jun 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

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

Registered
Apr 27, 2015
First posted
May 5, 2015
Start
Apr 2015
Primary completionActual
Jun 2016
CompletionActual
Sep 2016
Last update
Sep 29, 2016
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 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02434315
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
May 5, 2015
Start date
Apr 2015
Primary completion
Jun 2016
Completion
Sep 2016
Last update
Sep 29, 2016

Oversight

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

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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