Performance and Ease of Use of the BREEZE®2 Blood Glucose Monitoring System

YEAR:  2007  AUTHORS:  JOY FRANK, THOMAS M. BLOK, JUDY A. CARTER, LUCY MULLEN, ANN M. TIDEMAN, JOAN LEE PARKES Institutions:  Fairfield, NJ, Kalamazoo, MI, Oak Park,IL, Tarrytown, NY

The purpose of these clinical trials was to evaluate the performance and ease-of-use of the BREEZE®2 Blood Glucose Monitoring System.

An in-clinic study was completed by 201 subjects and eight healthcare professionals (HCP) at two clinical research centers. The following were conducted:

  • Subject and HCP meter results for fingertip capillary blood were compared with YSI laboratory analyzer glucose results.

  • Precision (reproducibility) for testing capillary blood samples.

  • Subject precision study with three control solutions

  • Subjects evaluated the meter instructions for use.

  • Subjects completed a questionnaire about the new meter system.


A home use study of the BREEZE 2 Meter was conducted at one clinical center. In this study, 53 subjects used the BREEZE 2 Meter at home for one week to determine the acceptability of the system for self testing.

The results of the studies were as follows:

  • Both subject and HCP BREEZE 2 results exceeded ISO 15197 performance guidelines.

  • Subject and HCP results were clinically acceptable (Error Grid Analyses results were 98.2% in Zone A for subjects and 98.7% for HCPs; no results were in Zones C, D or E).

  • The average within-run CV was 4.3% for subjects and 3.8% for HCPs when testing capillary blood samples.

  • Subject total CV results ranged from 2.8 to 4.2% when testing control solutions

  • Subjects were able to learn to use the meter from the illustrated user guide and complete a series of tasks, with success rates ranging from 70.3 to 98.2% for individual tasks.

  • Subjects gave positive ratings to the meter features and ease of use.

In conclusion, the BREEZE 2 System was found to be accurate, precise and easy to use.
Read the entire study here.