Diabetes MellitusNCT01214824

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

A study testing FreeStyle Navigator Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: FreeStyle Navigator Continuous Glucose Monitoring System
Type of treatment: Medical device
How many people: 32 participants
Where: 5 sitesUnited Kingdom
Study dates: Nov 2010to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United Kingdom5 sites

Ayr Hospital
Ayr, Ayrshire, KA6 6DX
The Royal Liverpool University Hospital
Liverpool, Cheshire, L7 8XP
University Hospital Aintree
Liverpool, Cheshire, L9 7AL
St. John's Hospital
Livingston, Edinburgh, EH54 6PP
Glan Clywd Hospital
Rhyl, Denbighshire, LL18 5UJ

Other trials in United Kingdom

About this study

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.

Read the 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.

Conditions: Diabetes Mellitus
Being tested: FreeStyle Navigator Continuous Glucose Monitoring System
Keywords: Diabetes, Continuous Glucose Monitoring
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1C From Baseline to 6 Months
HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)
Measured: Baseline and 6 months

Secondary outcomes (3)

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).
Measured: 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.
Measured: 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
Measured: 2 weeks following baseline & 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jun 2012

First posted5 Oct 2010 (estimated)
Study startNov 2010
Primary completionFeb 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214824
Sponsor's protocol ID: ADC-PMR-NAV-09005
Status last verified: Jun 2013
First submitted: 4 Oct 2010
Last updated: 2 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
ClinicalTrials.gov ID: NCT01214824
Acronym / sponsor ID: ADC-PMR-NAV-09005
Conditions: Diabetes Mellitus
Keywords: Diabetes, Continuous Glucose Monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Abbott Diabetes CareIndustry (pharma, biotech, devices)
Collaborators: Liverpool University Hospitals NHS Foundation Trust, National Heatlh Service Ayrshire and Arran, NHS Lothian, National Health Service, United Kingdom, Cardiff and Vale University Health Board
Study start: Nov 2010
Primary completion: Feb 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 5 Oct 2010 (estimated)
Results: Posted 6 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FreeStyle Navigator Continuous Glucose Monitoring SystemSix 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).	Device	–

Primary outcome

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)

3 secondary outcomes

Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%
Time frame: Baseline and 6 months
Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked
Time frame: Baseline & 6 months
Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked
Time frame: 2 weeks following baseline & 3 months

Results and safety

Results posted to the registry on 6 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	32	29

Primary outcome: Change in HbA1C From Baseline to 6 Months

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: HbA1c %

Measure	Intervention Group n = 32
Baseline	9.3 (1.3)
6 months	9.1 (1.3)

Intervention Group: Median Difference (Final Values): -0.3, p = 0.014, Wilcoxon signed rank test

Population analysed: Intention to treat analysis

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	3 of 32 (9.4%)	3 of 32 (9.4%)	Not reported

Limitations and caveats (from the sponsor): After an enrolment review recruitment was ceased on 02 Sep 11 with only 32/50 enrolled subjects. The screening/recruitment phase had been 12 weeks but was significantly extended. Only 7/32 subjects had completed 6 month HbA1c when recruitment ceased.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Type 2 Diabetes
Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jiten Vora, MRCP principal investigator

The Royal Liverpool and Broadgreen University Hospitals NHS Trust

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FreeStyle Navigator Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1C From Baseline to 6 Months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01214824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.