Page 37 - Glucose Monitoring Devices

P. 37

CHAPTER

Analytical performance of

SMBG systems 2

1
David Ahn, MD , David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE 2
1
Program Director, Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian,
2
Newport Beach, CA, United States; Medical Director, Diabetes Research Institute,
Mills-Peninsula Medical Center, San Mateo, CA, United States

Introduction
The foundation for the current optimal management of diabetes mellitus centers
heavily on self-monitoring of blood glucose (SMBG) using blood glucose meters
(BGMs) [1]. The overwhelming majority of people living with type 1 diabetes
and type 2 diabetes still utilize SMBG, and even alternative methods of glucose
monitoring such as continuous glucose monitoring still beneﬁt from calibration
with traditional BGMs. Therefore the analytical performance and accuracy of
SMBG systems are of the utmost importance because substandard performance
would pose a risk to patients that rely on this information for (1) making treatment
decisions about insulin dosing and taking other actions based on the blood glucose
level; (2) detecting critical events such as severe hypoglycemia and hyperglycemia;
(3) calibrating continuous glucose monitors that can inform treatment decisions; and
(4) controlling closed-loop insulin delivery systems that depend on accurate calibra-
tion of continuous glucose monitors [2].
Because of the important clinical role that SMBG plays, standards have been
created and utilized by governing bodies such as the United States’ Food and
Drug Administration (FDA) [3] and the International Organization for Standardiza-
tion (ISO) [4] to regulate and clear BGMs intended for over-the-counter commercial
release in their respective territories. Despite these performance standards being
consistently used to clear certain meters before market release, multiple studies
have demonstrated that many of these meters, after they have been cleared, perform
below the same international or FDA standards [5e7].
As a result of these concerning ﬁndings, a panel of experts in clinical chemistry,
clinical diabetes, and regulatory science created a consensus protocol for the
Diabetes Technology Society (DTS)-BGM Surveillance Program [8] to provide an
independent assessment of BGM accuracy after receiving clearance by the FDA.
The study was the largest accuracy study exclusively testing FDA-cleared BGM
systems ever reported. Their ﬁndings were published in August 2018 [9].

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