Bayer BREEZE No Coding Study

Miscoding Study Summary Page

The Ascensia® BREEZE® Blood Glucose Monitoring System is designed to help make managing your diabetes simple and testing effortless!

  • No coding required
  • No strip handling with convenient Ascensia® AUTODISC® 10-Test Strip Disc
  • Load meter once for 10 accurate results
  • Single function buttons are easy to use
  • Fits perfectly in hand
  • Finger tip and alternative site testing

One of the features that helps make Ascensia® BREEZE® effortless is that NO CODING by the user is required.

The purpose of the attached study was to determine the extent of errors (in blood glucose test results) which may result when a meter that requires manual coding is coded incorrectly. Improper coding causes the meter and test strip codes to be mismatched.

When improperly coded, the OneTouch® Ultra® meter and FreeStyle™ meter gave blood glucose results that differed from the laboratory YSI blood glucose analyzer by median ranges of from -37.4% to 50.1%. 

The full study is available for your review.

A summary of results is provided below:

Meters Studied:

OneTouch® Ultra® meter (requires manual coding)
FreeStyle™ meter (requires manual coding)
Ascensia® BREEZE® System (automatically coded)

Study Intent:

  • To determine the extent of errors which may result when meter systems that require manual coding [OneTouch Ultra (Lifescan) and FreeStyle (TheraSense)] are coded incorrectly.
  • To assess the accuracy of readings obtained with the Ascensia® BREEZE® System when used with different reagent lots (since coding is automatic) of the Ascensia® AUTODISC® 10-Test Disc.

Results:

Precision (meaning the repeatability of the same result) of all systems was comparable when meters were correctly coded.

Certain miscoded meters produced median percent deviations in blood glucose readings that ranged from -31.3% to +45.9% when compared with correctly coded meters and -37.4% to 50.1% when compared to a glucose analyzer (Lab). The Ascensia® BREEZE® System did not exhibit such inaccuracies when used with 3 different reagent lots.

Considerations:

  • The calibration and electronic check of the Ascensia® BREEZE® System are performed automatically when the Ascensia® AUTODISC® test strip disc is inserted and the meter is closed.
  • Other single strip systems, including OneTouch Ultra (Lifescan) and FreeStyle (TheraSense), must be manually coded to match the codes of the test strips.

Methods:

  • The evaluation was performed by a Certified Diabetes Educator (CDE) in the Diabetes Care Unit of a large hospital.
  • The CDE followed a protocol provided by Bayer HealthCare but worked independently.
  • The Certified Diabetes Educator (CDE) performed finger sticks, a hematocrit determination, and a sample collection for a laboratory blood glucose deter-mination, on 52 subjects. Each subject received 4 finger sticks.
  • The order of testing among the three blood glucose monitoring systems and their respective code or test strip combinations was randomized. The study subjects had not eaten, used insulin or had any vigorous exercise for at least 2 hours prior to the testing.
  • Four meters of each brand of monitoring system were used.
  • Two OneTouch meters and two FreeStyle meters were coded with the correct code, and two of each were purposely coded incorrectly. The incorrectly coded meters were set with a code at or near the extreme limits of the available code numbers for each system. [Study meters were set to 1 and 49 (OneTouch) and 8 and 41(FreeStyle)].
  • The Ascensia® BREEZE® system cannot be miscoded, so three different reagent lots were used as an accuracy challenge.

Comparative Evaluation of Accuracy - Results/Conclusions:

  • The median percent differences in results from a miscoded OneTouch Ultra meter when compared to a correctly coded meter ranged from -31.3% to +7.6%.
  • The median percent differences in results from a miscoded Freestyle meter when compared to a correctly coded meter ranged from -15.2% to +45.9%.
  • The median percent differences in readings using different reagent lots of Ascensia® AUTODISC® Test Strips ranged from -1.5% to 4.3%.
  • No large errors, comparable to those seen in a miscoded meter, were ever observed with the BREEZE system.