Abbott FreeStyle Optium
Device Name:
FreeStyle Optium
Manufacturer:
Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Click here to download the Device Manual
Description:
The Abbott FreeStyle Optium is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Abbott FreeStyle Optium to measure blood glucose.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval Not recommended This device has not been clinically validated.
Relevant Publications:

Ceriotti F, Kaczmarek E, Guerra E, Mastrantonio F, Lucarelli F, Valgimigli F, Mosca A. Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside. J Diabetes Sci Technol. 2015 Mar;9(2):268-77. Epub: 2014 Dec 17. doi: 10.1177/1932296814563351. PMID: 25519295. Available from: PMC4604596.

The publication evaluates the performance of the Abbott FreeStyle Optium, though not in a formal validation.

The interferences assessed included acetoacetate, acetaminophen, ascorbic acid, galactose, maltose, uric acid, and sodium. The accuracies of both Optium ketone and glucose measurements were influenced significantly by varying levels of haematocrit and ascorbic acid.

Pariente Rodrigo E, Deib-Morgan K, García de Diego O, García-Velasco P, Sgaramella GA García González I. Exactitud y concordancia entre glucómetros: un estudio en condiciones habituales de práctica clínica. [Accuracy and reliability between glucose meters: A study under normal clinical practice conditions.] Semergen. 2017 Jan-Feb;43(1):20-27. Epub: 2016 Mar 8. doi: 10.1016/j.semerg.2016.01.011. PMID: 26968861. In Spanish.

The publication evaluates the performance of the Abbott FreeStyle Optium, though not in a formal validation.

Acceptable mean difference compared to plasma glucose. Nevertheless did not meeet American Diabetes Association standards.

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