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Abbott FreeStyle Navigator

Device Name:FreeStyle Navigator
Manufacturer:Sole: Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm or Abdomen
Measurement Occurrence:Single and continuous measurements
Availability:Available Currently
Description: The Abbott FreeStyle Navigator is a clinically validated blood glucose meter. Measurements are taken from the upper arm or abdomen and it is intended for self-measurement and home use.
Assessment:

The technology used in the Abbott FreeStyle Navigator, to measure blood glucose, has failed in clinical validation studies, in general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications. It has also been assessed, in general and specific populations, according to non-standard protocols.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

Wilson DM, Beck RW, Tamborlane WV, Dontchev MJ, Kollman C, Chase P, Fox LA, Ruedy KJ, Tsalikian E, Weinzimer SA; DirecNet Study Group. The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes Care. 2007 Jan;30(1):59-64. PMID: 17192334.

Ad Hoc protocol Children and adolescents

Kovatchev B, Anderson S, Heinemann L, Clarke W. Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Diabetes Care. 2008 Jun;31(6):1160-4. Epub: 2008 Mar 13. doi: 10.2337/dc07-2401. PMID: 18339974. Available from: PMC4607511.

Ad Hoc protocol General population

Leelarathna L, Nodale M, Allen JM, Elleri D, Kumareswaran K, Haidar A, Caldwell K, Wilinska ME, Acerini CL, Evans ML, Murphy HR, Dunger DB, Hovorka R. Evaluating the accuracy and large inaccuracy of two continuous glucose monitoring systems. Diabetes Technol Ther. 2013 Feb;15(2):143-9. Epub: 2012 Dec 20. doi: 10.1089/dia.2012.0245. PMID: 23256605. Available from: PMC3558677.

15197:2003 - Fail Type 1 DM

Rijkenberg S, van Steen SC, DeVries JH, van der Voort PHJ. Accuracy and reliability of a subcutaneous continuous glucose monitoring device in critically ill patients. J Clin Monit Comput. 2018 Oct;32(5):953-964. Epub: 2017 Dec 7. doi: 10.1007/s10877-017-0086-z. PMID: 29218549.

15197:2013 - Fail Critically Ill

The authors conclude that the analytical accuracy of the FreeStyle Navigator I in critically ill patients was suboptimal and that clinical accuracy did not meet the required standards and was considerably lower in hyperglycaemic and hypoglycaemic ranges.

Relevant Publications

Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. Epub: 2014 Jan 1. doi: 10.1177/1932296813511747. PMID: 24876543. Available from: PMC4454101.

Measurements from the Abbott FreeStyle Navigator are compared to those from the Abbott FreeStyle Lite, though not in a formal validation.

Fingerstick and wired-enzyme technologies are compared.