Diabetes Mellitus
Conditions
Keywords
Continuous glucose monitoring, Accuracy, Continuous glucose-error grid analysis
Brief summary
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
Interventions
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.
Sponsors
Abbott Diabetes Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Countries
United States
Outcome results
None listed