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Completed

NCT Number: NCT01214824

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayr Hospital, Ayr, Ayrshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeStyle Navigator Continuous Glucose Monitoring System

Device

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).

Primary outcomes

  1. Change in HbA1C From Baseline to 6 Months

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%

    Time frame: Baseline and 6 months

    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).

  2. Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked

    Time frame: Baseline & 6 months

    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.

  3. Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked

    Time frame: 2 weeks following baseline & 3 months

    Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Collaborators

  • Cardiff and Vale University Health Board
  • Liverpool University Hospitals NHS Foundation Trust
  • NHS Lothian
  • National Health Service, United Kingdom
  • National Heatlh Service Ayrshire and Arran

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2010
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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