FreeStyle Libre Pro Use in Primary & Secondary Care
- Conditions
- Diabetes Mellitus
- Interventions
- Device: FreeStyle Libre Pro 3 sensor wearsDevice: FreeStyle Libre Pro 4 sensor wears, 2 with reviewsDevice: FreeStyle Libre Pro 6 sensor wears, 4 with reviews
- Registration Number
- NCT02434315
- Lead Sponsor
- Abbott Diabetes Care
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - Control FreeStyle Libre Pro 3 sensor wears FreeStyle Libre Pro 3 sensor wears Group B - Intervention FreeStyle Libre Pro 4 sensor wears, 2 with reviews FreeStyle Libre Pro 4 sensor wears, 2 with reviews Group C - Intervention FreeStyle Libre Pro 6 sensor wears, 4 with reviews FreeStyle Libre Pro 6 sensor wears, 4 with reviews
- Primary Outcome Measures
Name Time Method Change from Baseline - time in glucose range - for penultimate sensor wear 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Westongrove Partnership
🇬🇧Aylesbury, United Kingdom
Omnia Practice
🇬🇧Birmingham, United Kingdom
Atherstone Surgery
🇬🇧Atherstone, United Kingdom
Pebsham Surgery
🇬🇧Bexhill, 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
James Cook Hospital
🇬🇧Middlesborough, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Parkwood Surgery
🇬🇧Hemel Hempstead, United Kingdom
St James Hospital,
🇬🇧Leeds, 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
Ashfields Primary Care Centre
🇬🇧Sandbach, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom
The Kiltearn Medical Centre
🇬🇧Sandbach, United Kingdom
Friarsgate Practice
🇬🇧Winchester, United Kingdom
Albany House Surgery
🇬🇧Wellingborough, United Kingdom
Rothwell Surgery
🇬🇧Wellingborough, United Kingdom