Status:
COMPLETED
Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
Lead Sponsor:
Abbott Diabetes Care
Collaborating Sponsors:
Liverpool University Hospitals NHS Foundation Trust
National Heatlh Service Ayrshire and Arran
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.
Detailed Description
Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period of 20 days at the st...
Eligibility Criteria
Inclusion
- Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for \>1yr)
- Age 18-65 years
- HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment
- Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment.
- Testing Blood Glucose ≥ 4 times a day for previous 12 months
Exclusion
- Subject is currently on an insulin pump.
- Subject has known allergy to medical grade adhesives
- Subject has concomitant disease that influences metabolic control
- Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring.
- Subject is receiving peritoneal dialysis solutions containing icodextrin
- Subject is pregnant / planning to become pregnant during study
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01214824
Start Date
November 1 2010
End Date
June 1 2012
Last Update
July 2 2013
Active Locations (5)
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1
Ayr Hospital
Ayr, Ayrshire, United Kingdom, KA6 6DX
2
The Royal Liverpool University Hospital
Liverpool, Cheshire, United Kingdom, L7 8XP
3
University Hospital Aintree
Liverpool, Cheshire, United Kingdom, L9 7AL
4
Glan Clywd Hospital
Rhyl, Denbighshire, United Kingdom, LL18 5UJ