Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
This study has been completed.
Sponsor:
Abbott Diabetes Care
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: January 16, 2013
Last verified: January 2013
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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:
- Reduction in HbA1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]Reduction in HbA1C as an average over 50 subjects
Secondary Outcome Measures:
- Average glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Time spent in euglycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of hypoglycaemic episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adjustments to insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient Reported Outcome Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of Life/Patient Reported Outcome Measures using the Audit of Diabetes-Dependant Quality of Life (ADDQoL) and Hypoglycaemia Fear Survey questionnaire scores
- Proportion of subjects who had reduction in HbA1c of > or = 0.5% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Glucose variability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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:
Detailed Description:
-
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).
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 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
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 |
| Last Updated: | January 16, 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 May 19, 2013