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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

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.

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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).

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No