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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214824
• Other study ID #: ADC-PMR-NAV-09005
• Status: Completed
• Phase: N/A
• First received: October 4, 2010
• Last updated: June 21, 2013
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Ayr Hospital	Ayr	Ayrshire
United Kingdom	The Royal Liverpool University Hospital	Liverpool	Cheshire
United Kingdom	University Hospital Aintree	Liverpool	Cheshire
United Kingdom	St. John's Hospital	Livingston	Edinburgh
United Kingdom	Glan Clywd Hospital	Rhyl	Denbighshire

Sponsors (7)

Lead Sponsor	Collaborator
Abbott Diabetes Care	Aintree University Hospitals NHS Foundation Trust, Cardiff and Vale University Health Board, National Health Service, United Kingdom, National Heatlh Service Ayrshire and Arran, NHS Lothian, Royal Liverpool and Broadgreen University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No