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

This study has been completed.
Sponsor:
Collaborators:
Royal Liverpool and Broadgreen University Hospitals NHS Trust
National Heatlh Service Ayrshire and Arran
NHS Lothian
National Health Service, United Kingdom
Cardiff and Vale University Health Board
Aintree University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01214824
First received: October 4, 2010
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Device: FreeStyle Navigator Continuous Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Change in HbA1C From Baseline to 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)


Secondary Outcome Measures:
  • Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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).

  • Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked [ Time Frame: Baseline & 6 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked [ Time Frame: 2 weeks following baseline & 3 months ] [ Designated as safety issue: No ]
    Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase


Enrollment: 32
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214824

Locations
United Kingdom
Ayr Hospital
Ayr, Ayrshire, United Kingdom, KA6 6DX
The Royal Liverpool University Hospital
Liverpool, Cheshire, United Kingdom, L7 8XP
University Hospital Aintree
Liverpool, Cheshire, United Kingdom, L9 7AL
Glan Clywd Hospital
Rhyl, Denbighshire, United Kingdom, LL18 5UJ
St. John's Hospital
Livingston, Edinburgh, United Kingdom, EH54 6PP
Sponsors and Collaborators
Abbott Diabetes Care
Royal Liverpool and Broadgreen University Hospitals NHS Trust
National Heatlh Service Ayrshire and Arran
NHS Lothian
National Health Service, United Kingdom
Cardiff and Vale University Health Board
Aintree University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Jiten Vora, MRCP The Royal Liverpool and Broadgreen University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01214824     History of Changes
Other Study ID Numbers: ADC-PMR-NAV-09005
Study First Received: October 4, 2010
Results First Received: March 1, 2013
Last Updated: June 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Abbott Diabetes Care:
Diabetes
Continuous Glucose Monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014