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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle Navigator Continuous Glucose Monitoring System

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ayrshire
    • Ayr, Ayrshire, United Kingdom, KA6 6DX
      • Ayr Hospital
  • Cheshire
    • Liverpool, Cheshire, United Kingdom, L7 8XP
      • The Royal Liverpool University Hospital
    • Liverpool, Cheshire, United Kingdom, L9 7AL
      • University Hospital Aintree
  • Denbighshire
    • Rhyl, Denbighshire, United Kingdom, LL18 5UJ
      • Glan Clywd Hospital
  • Edinburgh
    • Livingston, Edinburgh, United Kingdom, EH54 6PP
      • St. John's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Collaborators: Liverpool University Hospitals NHS Foundation Trust; NHS Lothian; Cardiff and Vale University Health Board; National Health Service, United Kingdom; National Heatlh Service Ayrshire and Arran
• Investigators: Principal Investigator: Jiten Vora, MRCP, The Royal Liverpool and Broadgreen University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (ESTIMATE): October 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 2, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes; Continuous Glucose Monitoring
• Other Study ID Numbers: ADC-PMR-NAV-09005