Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
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ClinicalTrials.gov Identifier: NCT01214824
Recruitment Status :
First Posted : October 5, 2010
Results First Posted : June 6, 2013
Last Update Posted : July 2, 2013
Abbott Diabetes Care
Royal Liverpool and Broadgreen University Hospitals NHS Trust
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.
Condition or disease
Device: FreeStyle Navigator Continuous Glucose Monitoring System
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.
Change in HbA1C From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)
Secondary Outcome Measures :
Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% [ Time Frame: Baseline and 6 months ]
Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).
Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked [ Time Frame: Baseline & 6 months ]
Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.
Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked [ Time Frame: 2 weeks following baseline & 3 months ]
Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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