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

Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

• NCT number: NCT01214824
• Study type: Interventional
• Source: Abbott Diabetes Care
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Completion date: June 2012