Page 43 - Glucose Monitoring Devices

List of authors 39

(GDH)-based test strips outperformed those using glucose oxidase (GOX) for ISO
15197 2003 (OR ¼ 0.23, CI 0.13e0.38, P <.001) and ISO 15197 2013
(OR ¼ 0.24, CI 0.15e0.35, P < .001). The GDH enzyme, different from GOX, al-
lows BGMs to not depend on the partial pressure of oxygen in the blood [18].
When the investigators looked deeper and compared different enzymatic cofactors
for GDH, the review did not find a significant difference in accuracy.

Conclusion
The recently published findings from the DTS-BGM Surveillance Program revealed
that only 6 of 18 (33%) FDA-cleared meters met the protocol-specified accuracy
standard similar to current ISO and FDA guidelines for analytical performance in
all three separate tests. As these 18 meters represented 90% of all commercially
used meters from 2013 to 2015, many patients are depending on BGM systems
that have been shown to fall short of current standards in what was the largest study
ever conducted of exclusively FDA-cleared BG monitors using a protocol that was
developed with input from the FDA. Contributing to the problem, the FDA lacks
resources to continuously monitor manufacturing processes, many of which take
place internationally. Furthermore, Medicare mail-order suppliers offer only a
limited selection of brands of BGM systems and supplies. The latest Office of the
Inspector General report [19] revealed that 78.8% of the SMBG systems sold to
Medicare beneficiaries via mail order in Q4 2016 were made by manufacturers of
systems that did not meet current standards.
Given the significant clinical role that BGMs play in the day-to-day management
of diabetes, inadequate performance and accuracy may increase the risk of both
hypoglycemia and hyperglycemia in patients, either of which can be costly on
both a financial and clinical scale. Therefore, diabetes stakeholders such as regula-
tors, patients, providers, and payers must seriously consider the implications of the
brands of BGMs that they authorize and recommend, in light of these devices’
analytical performance.

List of authors
David Ahn, MD is an endocrinologist and serves as Program Director of the Mary
and Dick Allen Diabetes Center for Hoag Memorial Hospital Presbyterian in New-
port Beach, California. At this institution, he is the recipient of the Dr. Kris V Iyer
Endowed Chair in Diabetes Care.
David Klonoff, MD is an endocrinologist specializing in the development and
use of diabetes technology. He is Medical Director of the Dorothy L. and James
E. Frank Diabetes Research Institute of Mills-Peninsula Medical Center in San
Mateo, California and a Clinical Professor of Medicine at UCSF.