Page 10 - Glucose Monitoring Devices

The evidence base for SMBG in type 1 diabetes 5

and support persons with diabetes and healthcare professionals to make appropriate
management strategies [23]. Data retrieval has further improved with wireless
connectivity to smartphone apps [24]. The analytical quality of personal blood
glucose meters used for at-home monitoring is important as appropriate therapeutic
decisions rely on accurate glucose readings. Standardized quality among manufac-
turers is required by the regulatory recommendations and analytical performance
criteria. In 2003, the International Organization for Standardization (ISO) criteria
for glucose meters were introduced. The ISO 15197: 2003 standard recommended
an allowable error of 15 mg/dL for blood glucose levels <75 mg/dL and 20%
for blood glucose levels 75 mg/dL [25]. These criteria were updated in ISO
15197:2013 standard, which required an allowable error of 15 mg/dL for BG
concentrations <100 mg/dL and 15% for BG concentrations 100 mg/dL [26].
In the United States, the Food and Drug Administration (FDA) standard finalized
in 2016 recommended that at least 95% of measurement results shall fall within
15% of the reference value at blood glucose concentrations <100 mg/dL and
15% at 100 mg/dL, thus requiring greater hypoglycemia accuracy than the
ISO 15197:2013 [27].

The evidence base for SMBG in type 1 diabetes
Richard Bernstein was the first reported person with type 1 diabetes (T1D) to adopt a
glucometer for personal use. With frequent glucose monitoring, he was able to refine
insulin doses and diet regimen to maintain essentially normal blood glucose levels
and prevent hypoglycemia. However, he failed to publish his personal experience
using SMBG until he earned a medical degree in the early 1980s [28]. In the mid-
1970s, people with diabetes for the first time started using reflectance glucometers
Eyetone and Reflomat at home for SMBG. In 1978, first experiences in teaching
people with insulin-dependent diabetes to measure their own blood glucose concen-
trations were published [29e34]. Direct measurement of blood glucose by people
with diabetes at home provided sufficiently accurate results for easier and more
predictable adjustment of insulin doses over the urine-glucose analysis [35].
Frequent SMBG as a guide to multiple injections of insulin has considerably
improved metabolic control and could guard against undue hypoglycemia [36];
it was well accepted by persons with diabetes and improved their understanding
of diabetes and motivation to become more involved in their own care [37]. Due
to the growing evidence in the late 1970s that chronic complications of diabetes
can be minimized with glycemic control, daily SMBG gained wider acceptance
[38]. In addition, improved glycemic control could objectively be assessed by the
measurement of glycated hemoglobin levels [39]. Over the next decade, SMBG
proved to be one of the major technological advances in addition to multiple daily
insulin injections and the newly developed insulin pumps that established intensive
insulin therapy, a therapeutic strategy that has become increasingly used in an
attempt to achieve near-normal glycemia [40,41]. In the 1980s, smaller, more