Diabetes MellitusNCT00920881
Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 3 sites in United States.
Trial summary
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard. 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
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2005to Dec 2005
- 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: Subjects recruited from clinical research centers which specialize in diabetes-related therapies.
Who may be able to join
- History consistent with type 1 diabetes
- 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
- Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
- Seizure disorder
- Myocardial ischemia
Show all 9Show fewer
- History of stroke
- Severe hypoglycemia unawareness
- Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ranier Clinical Research
Renton, Washington, 98055
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Navigator Continuous Glucose Monitoring System
- 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 SystemDevice
Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Not described Receives: Device: FreeStyle Navigator Continuous Glucose Monitoring System |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joe Bugler, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920881
- Sponsor's protocol ID
- TS05-066
- Status last verified
- Jun 2009
- First submitted
- 11 Jun 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2.
PubMed 17337488McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50. doi: 10.1089/dia.2008.0047.
PubMed 19216686
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT00920881
- Acronym / sponsor ID
- TS05-066
- Conditions
- Diabetes Mellitus
- Keywords
- Continuous glucose monitoring, Accuracy, Continuous glucose-error grid analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 Jun 2009 (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.
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Device: FreeStyle Navigator 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
- Subjects recruited from clinical research centers which specialize in diabetes-related therapies.
Key inclusion criteria (4 listed)
- History consistent with type 1 diabetes
- 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 (9 listed)
- Pregnancy
- Type 2, gestational, or secondary diabetes
- Known allergy to medical grade adhesives
- Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
- Seizure disorder
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 SystemSubjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study. | 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 15 Jun 2009.
- Results publication: PubMed 17337488Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2.
- Results publication: PubMed 19216686McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50. doi: 10.1089/dia.2008.0047.
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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.
Joe Bugler study director
Abbott Diabetes Care
3 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 3 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 4 inclusion and 9 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 15 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
On the ClinicalTrials.gov record for NCT00920881, which also lists 2 linked publications.
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 15 Jun 2009.