Diabetes MellitusFSNQSNCT01076218
Navigator 1.5 Accuracy Study
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 2 sites in United States.
Trial summary
The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 diabetes requiring multiple daily insulin injections or using an insulin pump
Who may be able to join
- History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
- For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
- At least 18 years of age;
- Available and capable of following the protocol instructions provided by the healthcare professional;
- Signed and dated Informed Consent form.
Who cannot join
- Pregnancy;
- Type 2, gestational, or secondary diabetes;
- Known allergy to medical grade adhesives or skin disinfectant;
- Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
- Blood donation within 6 weeks prior to beginning study activities;
- Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
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- Active myocardial ischemia;
- Previous history of stroke;
- Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
- Current participation in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rainier Clinical Research
Renton, Washington, 98057
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5
The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5
- Keywords
- Continuous Glucose Monitoring, Accuracy, Continuous Glucose Error-Grid Analysis
- 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 System Version 1.5Device
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Patients with type 1 diabetes requiring multiple daily insulin injections or using insulin pumps Receives: Device: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara K Alva, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076218
- Sponsor's protocol ID
- ADC08-075
- Acronym
- FSNQS
- Status last verified
- Feb 2010
- First submitted
- 24 Feb 2010
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5
- ClinicalTrials.gov ID
- NCT01076218
- Acronym / sponsor ID
- FSNQS / ADC08-075
- Conditions
- Diabetes Mellitus
- Keywords
- Continuous Glucose Monitoring, Accuracy, Continuous Glucose Error-Grid Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Device: FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5Patients with type 1 diabetes requiring multiple daily insulin injections or using insulin pumps |
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 diabetes requiring multiple daily insulin injections or using an insulin pump
Key inclusion criteria (5 listed)
- History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
- For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
- At least 18 years of age;
- Available and capable of following the protocol instructions provided by the healthcare professional;
- Signed and dated Informed Consent form.
Key exclusion criteria (10 listed)
- Pregnancy;
- Type 2, gestational, or secondary diabetes;
- Known allergy to medical grade adhesives or skin disinfectant;
- Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
- Blood donation within 6 weeks prior to beginning study activities;
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 System Version 1.5This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration. | Device | Diabetes |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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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 K Alva 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 Mellitus, 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 5 inclusion and 10 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 17 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 17 Jun 2024.