Clinical trial NCT01214824: Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
Official title: Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Continuous Glucose Monitoring
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
name: National Heatlh Service Ayrshire and Arran
name: NHS Lothian
name: National Health Service, United Kingdom
name: Cardiff and Vale University Health Board
First posted: 2010-10-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 start of the study, after which their Healthcare Professionals (HCPs) may recommend changes to their glucose management based on the continuous glucose monitoring(CGM) data. Subjects will then return to self-managing their diabetes with a blood glucose meter. After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review their results and glucose management with their HCPs. Subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic variability are recorded.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in HbA1C From Baseline to 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%
timeFrame: Baseline and 6 months
measure: Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked
timeFrame: Baseline & 6 months
measure: Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked
timeFrame: 2 weeks following baseline & 3 months
Other outcomes:
Locations:
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Ayrshire
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
state: Cheshire
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
state: Cheshire
city: Rhyl
country: United Kingdom
facility: Glan Clywd Hospital
state: Denbighshire
city: Livingston
country: United Kingdom
facility: St. John's Hospital
state: Edinburgh
Study officials:
affiliation: The Royal Liverpool and Broadgreen University Hospitals NHS Trust
name: Jiten Vora, MRCP
role: PRINCIPAL_INVESTIGATOR
References: