DiabetesNCT01455064
Navigator II Continuous Glucose Monitor Home Use Study
An observational study of Diabetes, run by Abbott Diabetes Care at 2 sites in United States.
Trial summary
This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- FreeStyle Navigator II Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Jan 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump
Who may be able to join
- The subject must:
- Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
- Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
- Be at least 18 years of age.
- Be able to read and understand English.
- In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Be available for all study visits.
- Be willing to provide written signed and dated informed consent.
Who cannot join
- The subject must not:
- Be pregnant or likely to become pregnant during the study duration.
- Have skin abnormalities at the insertion sites.
- Have known allergy to medical grade adhesive or skin disinfectant.
- Be using a continuous glucose monitor currently or within the past 6 months
- Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
- Be participating in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Southwest Clinical Research Center
Santa Fe, New Mexico, 87505
About this study
Official title: FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)
This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.
- Conditions
- Diabetes
- Being tested
- FreeStyle Navigator II Continuous Glucose Monitoring System
- 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 II Continuous Glucose Monitoring SystemDevice
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration
| Study group | Role | What they receive |
|---|---|---|
| Type 1 or 2 diabetes, MDI or pump | Not described Receives: Device: FreeStyle Navigator II Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarke Error Grid Analysis
Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.
Measured: 15 days sensor wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionJan 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 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara A Karinka, Ph.D., Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455064
- Sponsor's protocol ID
- ADC11-106
- Status last verified
- May 2013
- First submitted
- 15 Oct 2011
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)
- ClinicalTrials.gov ID
- NCT01455064
- Acronym / sponsor ID
- ADC11-106
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 22 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 or 2 diabetes, MDI or pump | – | Device: FreeStyle Navigator II Continuous Glucose Monitoring System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump
Key inclusion criteria (8 listed)
- Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
- Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
- Be at least 18 years of age.
- Be able to read and understand English.
- In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
Key exclusion criteria (7 listed)
- Be pregnant or likely to become pregnant during the study duration.
- Have skin abnormalities at the insertion sites.
- Have known allergy to medical grade adhesive or skin disinfectant.
- Be using a continuous glucose monitor currently or within the past 6 months
- Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
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 II Continuous Glucose Monitoring SystemThis is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration | Device | Type 1 or 2 diabetes, MDI or pump |
Primary outcome
Clarke Error Grid Analysis
Time frame: 15 days sensor wear
Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shridhara A Karinka, Ph.D. study director
Abbott Diabetes Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Abbott Diabetes Care at 2 sites in United States.
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 8 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 22 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 2 sites in United States. 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 22 Jul 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?
Clarke Error Grid Analysis (time frame: 15 days sensor wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2013.