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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Navigator Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FreeStyle Navigator Continuous Glucose Monitoring System|Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C From Baseline to 6 Months | HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline) | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% | 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). | Baseline and 6 months | 
| Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked | 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. | Baseline & 6 months | 
| Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked | Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase | 2 weeks following baseline & 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Continuous Glucose Monitoring