FreeStyle Libre Pro Use in Primary & Secondary Care
Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
1 other identifier
interventional
175
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Apr 2015
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 29, 2016
September 1, 2016
1.2 years
April 27, 2015
September 28, 2016
Conditions
Keywords
Outcome Measures
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
14 day baseline phase compared to day 172 to 187
Study Arms (3)
Group A - Control
ACTIVE COMPARATORFreeStyle Libre Pro 3 sensor wears
Group B - Intervention
EXPERIMENTALFreeStyle Libre Pro 4 sensor wears, 2 with reviews
Group C - Intervention
EXPERIMENTALFreeStyle Libre Pro 6 sensor wears, 4 with reviews
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
Related Publications (1)
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.
PMID: 31271312DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
May 5, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
September 29, 2016
Record last verified: 2016-09