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

Abbott Diabetes Care32 enrolled

Overview

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 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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

FreeStyle Navigator Continuous Glucose Monitoring SystemDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Ayr Hospital

Ayr, Ayrshire, United Kingdom

The Royal Liverpool University Hospital

Liverpool, Cheshire, United Kingdom

University Hospital Aintree

Liverpool, Cheshire, United Kingdom

Glan Clywd Hospital

Rhyl, Denbighshire, United Kingdom

Outcomes

Primary Outcomes

Change in HbA1C From Baseline to 6 Months

HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)

Time frame: Baseline and 6 months

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: 2 weeks following baseline & 3 months

Data from ClinicalTrials.gov

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