Clinical performance of the TRUE2go blood glucose system--a novel integrated system for meter and strips.

BACKGROUND

The complications of diabetes may be minimized by adequate glycemic control, which is aided by self-monitoring of blood glucose (SMBG) levels. A new SMBG system, TRUE2go (Home Diagnostics, Inc., Fort Lauderdale, FL), does not require calibration of test strips, thereby eliminating the potential source of error in blood glucose determination associated with mis-calibration. This study tested the performance of the TRUE2go system. The very small size and attachment of the meter to a vial of test strips make the TRUE2go system unique.

METHODS

The studies were carried out with adult patients with type 1 or 2 diabetes, using procedures for testing accuracy as specified in International Organization for Standardization (ISO) 15197:2003. The evaluation included patients' compliance with the TRUE2go system's written instructions, ease of understanding the supplied instructions, and ease of use of the system.

RESULTS

The study demonstrated the accuracy and precision of the TRUE2go system, with 100% of glucose test results falling within ISO-recommended limits for glucose concentrations ranging from 24 mg/dL to 549 mg/dL. There was agreement between data obtained with TRUE2go when used by healthcare professionals and by lay users on capillary blood from both fingertip and a forearm sticks. Lay users' understanding of and compliance with TRUE2go system instructions were excellent, as was their satisfaction with the system.

CONCLUSIONS

The TRUE2go system is accurate and convenient to use, and its instructions are easily understood by lay users. TRUE2go features that contribute to convenience, and therefore could improve compliance with monitoring regimens, include its small size, attachment to the vial of strips, easy-to-read display, automatic calibration for test strips, and suitability for fingertip as well as forearm testing.