- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434315
FreeStyle Libre Pro Use in Primary & Secondary Care
September 28, 2016 updated by: Abbott Diabetes Care
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
175
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Atherstone, United Kingdom
- Atherstone Surgery
-
Aylesbury, United Kingdom
- Westongrove Partnership
-
Bexhill, United Kingdom
- Pebsham Surgery
-
Birmingham, United Kingdom
- Omnia Practice
-
Chippenham, United Kingdom
- Hathaway Surgery
-
Chippenham, United Kingdom
- Rowden Surgery
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Crawley, United Kingdom
- Pound Hill Medical Group
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Exmouth, United Kingdom
- Claremont Medical Practice
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Faringdon, United Kingdom
- White Horse Medical Practice
-
Hemel Hempstead, United Kingdom
- Parkwood Surgery
-
Leeds, United Kingdom, LS9 7TF
- St James Hospital,
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London, United Kingdom
- Kings College Hospital
-
Middlesborough, United Kingdom
- James Cook Hospital
-
Milton Keynes, United Kingdom
- Milton Keynes Hospital
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Nottingham, United Kingdom
- Greenwood and Sneinton Centre
-
Reading, United Kingdom
- Mortimer Surgery
-
Rotherham, United Kingdom
- Clifton Medical Centre
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Salford, United Kingdom
- Salford Royal Hospital
-
Sandbach, United Kingdom
- Ashfields Primary Care Centre
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Sandbach, United Kingdom
- The Kiltearn Medical Centre
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Wellingborough, United Kingdom
- Albany House Surgery
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Wellingborough, United Kingdom
- Rothwell Surgery
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Winchester, United Kingdom
- Friarsgate Practice
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A - Control
FreeStyle 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.
|
Experimental: Group B - Intervention
FreeStyle 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.
|
Experimental: Group C - Intervention
FreeStyle 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14 day baseline phase compared to day 172 to 187
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 27, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 5, 2015
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADC-UK-PMS-14024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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