Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control

Not Applicable

Completed

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.

Recruitment & Eligibility

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 Outcome Measures

Name	Time	Method
Change in HbA1C From Baseline to 6 Months	Baseline and 6 months	HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%	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	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	2 weeks following baseline & 3 months	Proportion of time (hours per day) in hypoglycaemia (\<3.9mmol/L) for the unmasked phase

Locations (5): St. John's Hospital
🇬🇧
Livingston, Edinburgh, United Kingdom
Ayr Hospital
🇬🇧
Ayr, Ayrshire, United Kingdom
The Royal Liverpool University Hospital
🇬🇧
Liverpool, Cheshire, United Kingdom
University Hospital Aintree
🇬🇧
Liverpool, Cheshire, United Kingdom
Glan Clywd Hospital
🇬🇧
Rhyl, Denbighshire, United Kingdom