DIABETES TECHNOLOGY & THERAPEUTICS

Volume 20, Number 12, 2018

ª Mary Ann Liebert, Inc.
DOI: 10.1089/dia.2018.0232

REVIEW

A Review of Blood Glucose Monitor Accuracy

Fraya King,1 David Ahn, MD,2 Victoria Hsiao, MD, PhD,3
Travis Porco, PhD, MPH,4 and David C. Klonoff, MD, FACP, FRCPE, Fellow AIMBE1

Abstract
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The aim of this study was to assess the accuracy of blood glucose monitors (BGMs) from studies reported in the
medical literature. A literature review was performed of publications between 2010 and 2017 that presented data
about the accuracy of BGMs using ISO 15197 2003 and/or ISO 15197 2013 as target standards. We found 58
publications describing the performance of 143 unique BGM systems, 59 of which were Food and Drug Admin-
istration (FDA) cleared. When compared with non-FDA-cleared BGMs, FDA-cleared BGMs were significantly
more likely to pass both ISO 15197 2003 (OR = 2.39, CI 1.45–3.92, P < 0.01) and ISO 15197 2013 standards
(OR = 2.20, CI 1.51–3.27, P < 0.01). Newer meters were more likely to pass both ISO 15197 2003 and ISO 15197
2013 standards. Many of the studies were supported by BGM manufacturers, and when compared with independent
studies, an FDA-cleared BGM was significantly more likely to pass in a manufacturer-supported study for both ISO
15197 2003 (OR = 22.4, CI 8.73–21.57, P < 0.001) and ISO 15197 2013 (OR = 23.08, CI 10.16–60.03, P < 0.001).
BGM accuracy should be assessed independently following regulatory clearance to ensure accurate performance.
Failure to meet performance levels mandated by standards can result in deleterious clinical and economic effects.

Keywords: Accuracy, FDA, Blood glucose, ISO, Monitor.

Introduction Some BGMs that have previously been cleared by the FDA
have been tested by independent investigators with protocols

S elf-monitoring of blood glucose (SMBG) with blood

glucose monitor (BGM) systems plays a central role in the
optimal management of diabetes mellitus. Many BGMs on the
similar to (but not necessarily exactly the same as) those used
by the manufacturer in pivotal trials, and have been found to
not meet the latest standards (ISO 15197 2013 and/or FDA
international market today, however, do not perform according 2016 for personal BGMs). Furthermore, some do not even
to the current international standard1 set by the International meet the older ISO 15197 2003 standard under which they
Organization for Standardization (ISO), known as ISO 15197 were initially cleared.6
2013,2 or even to its less rigorous predecessor, ISO 15197 If BGMs do not meet accuracy standards, then they pose
2003.3 Since 2003 in the United States, ISO 15197 2003 had a risk to the patients that rely on this information for: (1)
been used for all BGMs intended to perform SMBG until the making treatment decisions about insulin dosing and taking
Food and Drug Administration (FDA) released a draft guid- other actions based on the blood glucose level7; (2) cali-
ance in 2014 for personal over-the-counter BGMs,4 which was brating continuous glucose monitors which can inform
replaced by a final guidance in 2016.5 treatment decisions8; and (3) controlling closed-loop insulin
The analytical accuracy requirements for compliance with delivery systems that depend on accurate calibration of con-
ISO 15197 2003 (previously recognized both internationally tinuous glucose monitors.9
and by FDA), ISO 15197 2013 (recognized internationally To analyze the accuracy of BGMs, we reviewed current
but not by FDA) and FDA 2016 Over-The-Counter (recog- research from 2010 through July 2017 addressing the accu-
nized by FDA but not internationally) are found in Table 1. racy of personal BGMs according to the ISO 15197 2003,
Additionally, for ISO 15197 2013, there is a clinical ac- ISO 15197 2013, and FDA 2016 standards. The results were
curacy requirement that ‡99% of results must fall within analyzed according to the following five factors: (1) was
zones A and B of the Parkes Error Grid. the BGM cleared by the FDA; (2) if cleared, then what was
1
Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, California.
2
Department of Endocrinology, University of California, Los Angeles, Valencia, California.
3
Department of Medicine, University of California, San Francisco, San Francisco, California.
4
FI Proctor Foundation for Research in Ophthalmology and Department of Ophthalmology, University of California, San Francisco,
San Francisco, California.

843
 844
Table 1. International and Food and Drug
Administration Analytical Accuracy Requirements
for Blood Glucose Monitors for Self-Monitoring
Accuracy standard Minimum accuracy requirements
ISO 15197 2003 95% of glucose values must be
within –15 mg/dL of reference
for values <75 mg/dL or
within 20% of reference for
values ‡75 mg/dL
ISO 15197 2013 95% of glucose values must be
within –15 mg/dL of reference
for values <100 mg/dL or
within 15% of reference for
values ‡100 mg/dL
FDA 2016 for 95% of glucose values must be
over-the-counter within 15% of reference, and
BGMs (FDA 2016) 99% of glucose values must be
within 20% of reference
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BGMs, blood glucose monitors; FDA, Food and Drug Admin-
istration.
the year of clearance; (3) what was the BGM test strip
chemistry; (4) was the article either: (a) a manufacturer’s
study, which we defined as a BGM’s manufacturer either
performing the testing or not being declared to have been
excluded from significant participation in the design of the
study protocol for an independent investigator (defined as not
employed by the manufacturer) to test its product; or (b) not a
manufacturer’s study, which we called an independent study;
and (5) if a product was tested in a manufacturer’s study, then
was the product tested by its own manufacturer.
Methods
In 2015, Klonoff and Prahalad identified 11 studies pub-
lished between 2010 and 2014 that addressed the accuracy of
BGMs relative to ISO 15197 2003,2 ISO 15197 2013,1 or the
then-current FDA 2014 draft guidance for over-the-counter
BGM accuracy4 (that was later replaced by a final version in
20165). To update the information presented in that review,
we performed a new literature search.
We determined that to be included in our review, articles must
be: (1) written in English; (2) published between 2010 and July
31, 2017; (3) include the name of the BGM product tested; (4) be
accessible in the PubMed database; and (5) address the analyt-
ical accuracy of a BGM against ISO 15197 2003, ISO 15197
2013, and/or FDA over-the-counter 2016 by comparing the
values obtained by each system with a reference method. Ac-
cessibility in PubMed was defined as including a link to pur-
chase the article or open access. Articles were included only if
they addressed BGM accuracy in humans (as opposed to ani-
mals). We also excluded articles with limited study populations
(including those addressing only professional BGMs for hos-
pital use or testing the performance of BGMs only on pregnant
women), articles focusing on the performance of continuous
glucose monitors, and articles that only used mean absolute
relative difference (MARD) as a metric of BGM analytical ac-
curacy instead of the criteria defined by ISO and FDA.
For articles that addressed BGMs designed for personal
self-monitoring use and other BGMs intended for profes-
sional use, data were extracted for only the self-monitoring
KING ET AL.
(personal use) portion. Articles were also excluded if they
only used venous blood as the substrate to test BGM systems,
although articles using venous blood for the comparator
method were included. In studies where data from laboratory
accuracy studies (healthcare professionals assessed BGMs)
and user performance accuracy studies (lay users and health-
care professionals assessed BGMs) was reported, they were
treated as separate studies. For the user performance accuracy
studies, data from lay users and healthcare professionals were
combined. A BGM needed to pass ISO requirements in both
studies to receive a ‘‘pass’’ for that article. It should also be
noted that we did not exclude articles in which the total number
of data points and/or the distribution of data points did not
conform to ISO recommendations.2,3 In some articles the
reference method used differs from the one recommended by
the manufacturer.10–24 If a BGM was compared against two
different reference methods, then the BGM was assessed with
respect to the reference method specified by the manufacturer.
To begin our search, we used PubMed and Google Scholar
to review the initial 11 articles which were in the previous
review article on this topic by Klonoff and Prahalad. We also
reviewed all the references from each of these 11 articles. We
then used Google Scholar to find any newer articles that cited
any of the original 11. From these searches, we identified 19
new articles that met our inclusion criteria. Next, we re-
viewed the references from these 19 articles and performed a
Google Scholar search to find even newer articles that cited
any of these 19. This step yielded another 23 new articles for
inclusion. We then repeated the review of references and
Google Scholar search on these 23 articles and identified 5
more articles for inclusion. We repeated the review of the
references and Google Scholar search on these 5 articles and
found no new articles for inclusion.
In addition, a PubMed search was performed on July 12,
2017 for ‘‘blood glucose monitor analytical accuracy’’ with a
publication date between January 1, 2010 and July 12, 2017.
Forty-one articles were returned, but 36 did not meet the
inclusion criteria. Three articles had already been discovered
in the literature review based off of Klonoff and Prahalad, so
only two new articles were found whose eligibility for in-
clusion was confirmed by two reviewers (F.K. and V.H.). We
repeated our searches on August 7, 2017 (with publication
date set from January 1, 2010 to August 7, 2017) and no new
articles were returned. 58 articles in total met our inclusion
criteria (see Table 7).
BGMs were determined to be FDA cleared if they were
accessible in the FDA 510(k) searchable database25 or the
CLIA database.26 We searched each BGM name and extracted
the clearance year and 510(k) number from each entry. BGMs
were marked ‘‘pass’’ if they were within the minimum accu-
racy limits in every trial of the studies in which they were
tested. For example, if three lots were tested against ISO 15197
2013 in one study, then all three lots had to individually satisfy
the 95% accuracy criteria for the BGM to receive a ‘‘pass’’ for
that study. A BGM received either a pass or fail for each study
in which it was assessed. This approach was used to determine
the pass rate (N studies passed/N studies reported) for each of
the subgroups of BGMs analyzed in this review (FDA-cleared,
clearance date, etc.). For each study, we determined the number
of tests per study (N tested) and the number passing ISO 15197
2003 and/or ISO 15197 2013 (N compliant). From these two
numbers we were able to generate the compliance proportion
 A REVIEW OF BLOOD GLUCOSE MONITOR ACCURACY
(N compliant/N tested). Finally, we determined whether each
study was manufacturer supported, and if so, whether the
product was tested by its own manufacturer.
BGMs passing ISO 15197 2013 are assumed to pass ISO
15197 2003 because ISO 15197 2013 is stricter than ISO
15197 2003; however, those that fail ISO 15197 2013 are not
assumed to pass or fail ISO 15197 2003. Similarly, in studies
that only address ISO 15197 2003, BGMs that fail are as-
sumed to also fail ISO 15197 2013; however, for BGMs that
passed ISO 15197 2003, no assumption is made about ISO
15197 2013. Similarly, a product failing to meet ISO 15197
2013 would fail the FDA 2016 guidance; however, a product
passing ISO 15197 2013 will not necessarily pass the FDA
2016 guidance. Of note, we only found a single study in the
current literature that addressed the analytical accuracy of
BGM systems with respect to the recently published FDA
2016 guidance, and this study showed identical results when
using the ISO 15197 2013 and FDA 2016 standards.10 Eva-
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luation against the two ISO standards remains most practical
at this current point in time for assessing compliance with
current and past BGM analytical accuracy levels.
We conducted bias-reduced logistic regression (Firth27) to
analyze the relationships between predictors of passing each
standard, using pigeonhole bootstrap (Owen28) to adjust for
clustering of meters and studies. Statistical significance is
defined as a P-value of 0.05 or less. We used a Spearman
correlation to measure monotone relationships with respect to
manufacturer bias.
Results
One hundred forty-three different BGMs were reviewed in
a total of 58 studies.10–24,29–71 The minimum number of
BGMs analyzed per study was 1, and the maximum was 43.
The mean was 4.86 BGMs per study.
Around 93/137 (67.9%) of evaluated BGMs passed ISO
15197 2003, and 55/136 (40.4%) evaluated BGMs passed
ISO 15197 2013. Out of the 143 total BGMs that we re-
viewed, 59 BGMs had received FDA clearance. Around 43/
57 (75.4%) of FDA-cleared BGMs passed ISO 15197 2003,
whereas only 26/56 (46.4%) of FDA-cleared BGMs passed
the stricter ISO 15197 2013 standard. Among non-FDA-
cleared BGMs, 50/80 (62.5%) passed ISO 15197 2003 and
29/80 (36.3%) passed ISO 15197 2013. FDA-cleared BGMs
were found to be significantly more likely to meet both the
ISO 15197 2003 (OR = 2.39, CI 1.45–3.92, P < 0.01) and ISO
15197 2013 standards (OR = 2.20, CI 1.51–3.27, P < 0.01).
We also analyzed the 59 FDA-cleared BGMs with respect
to their year of clearance. The range of clearance years
spanned from 2001 to 2017. We divided these BGMs into
four groupings of 4-year increments, with the exception of
the oldest category, which was a 5-year increment. The re-
sults are presented in Table 2 and Figure 1. For BGMs cleared
from 2001 to 2005, 4/7 (57.1%) passed ISO 15197 2003,
whereas 3/8 (37.5%) passed ISO 15197 2013. For BGMs
cleared between 2006 and 2009, 13/23 (56.5%) passed ISO
15197 2003, whereas 7/23 (30.4%) passed ISO 15197 2013.
For BGMs cleared between 2010 and 2013, 11/12 (91.7%)
passed ISO 15197 2003, and 6/12 (50%) passed ISO 15197
2013. For BGMs cleared between 2014 and 2017, 15/15
(100%) passed ISO 15197 2003, and 10/13 (76.9%) passed
ISO 15197 2013. BGMs approved more recently performed
845
significantly better for both ISO 15197 2003 (OR 1.06, CI
1.06–1.07, P < 0.001, odds ratio reported for a 1-year period)
and ISO 15197 2013 standards (OR = 1.06, CI 1.03–1.06,
P < 0.01, odds ratio reported for a 1-year period).
In addition, FDA-cleared meters and the total sample were
analyzed and sorted by their test strip enzyme: either glucose
dehydrogenase (GDH) or glucose oxidase (GOX). We found
that among our entire cohort of tested BGMs, those that used
a GDH test strip chemistry outperformed those that used
GOX test strip chemistry for both ISO 15197 2003 and ISO
15197 2013. Around 46/57 (80.7%) and 32/55 (58.2%) of
GDH systems passed ISO 15197 2003 and ISO 15197 2013,
respectively (Table 3), whereas only 47/80 (58.8%) and 23/
81 (28.4%) of GOX systems passed ISO 15197 2003 and
2013, respectively (Table 4). GDH’s improved performance
over GOX was statistically significant for both the ISO 15197
2003 (OR = 0.23, CI 0.13–0.38, P < 0.001) as well as the ISO
15197 2013 standard (OR = 0.24, CI 0.15–0.35, P < 0.001).
This same statistically significant trend occurred when only
considering FDA-cleared meters, with 25/28 (89.3%) of
FDA-cleared BGMs using any type of GDH chemistry
passing ISO 15197 2003, and 16/25 (64%) passing ISO
15197 2013. For BGMs using GOX chemistry, 18/29
(62.1%) passed ISO 15197 2003, whereas 10/31 (32.3%)
passed ISO 15197 2013. FDA-cleared BGMs using GDH
significantly outperformed FDA-cleared BGMs using GOX
in both ISO 15197 2003 (OR = 0.17, CI 0.06–0.38, P < 0.001)
and ISO 15197 2013 (OR = 0.24, CI 0.13–0.45, P < 0.001).
The effect of test strip enzyme on accuracy as it relates to
clearance year is presented in Figure 2.
We also looked at the association of the recently popular
GDH enzymatic cofactors flavin adenine dinucleotide (FAD)
and nicotinamide adenine dinucleotide (NAD) compared
with GDH without these new cofactors and containing the
earlier used cofactor, pyrroloquinoline quinone (PQQ), on
performance (Tables 5 and 6). With respect to all analyzed
BGMs using GDH-FAD or GDH-NAD chemistry irrespec-
tive of FDA clearance status, 25/31 (80.6%) passed ISO
15197 2003, and 18/28 (64.3%) passed ISO 15197 2013.
Among all analyzed BGMs using GDH but not specifying
FAD or NAD as the enzymatic cofactor irrespective of FDA
status, 21/26 (80.8%) passed ISO 15197 2003 and 13/27
(48.1%) passed ISO 15197 2013. We do not find evidence
that FAD/NAD is more likely to be associated with passing
the ISO 2003 standard (OR = 0.66, CI 0.24–1.50, P = 0.29) or
ISO 2013 standard (OR = 0.91, CI 0.50–1.65, P = 0.76).
Among FDA-cleared BGMs using GDH-FAD or GDH-
NAD, 15/17 (88.2%) passed ISO 15197 2003, and 9/14
(64.3%) passed ISO 15197 2013. Among FDA-cleared
BGMs using GDH but not specifying FAD or NAD as the
cofactor, 10/11 (90.1%) passed ISO 15197 2003 and 7/11
(63.6%) passed ISO 15197 2013. These differences between
BGMs with GDH enzymes containing FAD or NAD com-
pared with those containing PQQ for noncleared BGMs were
also not statistically significant for the ISO 2003 standard
(OR = 0.51, CI 0.15–3.24, P = 0.38) or the ISO 2013 standard
(OR = 0.62, CI 0.23–1.48, P = 0.29).
Among FDA-cleared products tested in manufacturer-
supported studies,11,14–21,23,29–65,67–71 95/107 (88.8%) passed
in tests as per ISO 15197 2003 and in 59/88 (67%) passed in
tests as per ISO 15197 2013. FDA-cleared products tested in
independent studies10,12,13,21,24,66 passed in 19/23 (82.6%) of
 846 KING ET AL.

tests as per ISO 15197 2003 and in 16/27 (59.3%) of tests
as per ISO 15197 2013. The likelihood of an FDA-cleared
product passing in a manufacturer-supported test compared
with an independent test was significantly greater according
to both ISO 15197 2003 (OR = 22.4, CI 8.73–21.6, P < 0.001)
and ISO 15197 2013 (OR = 23.08, CI 10.2–60.0, P < 0.001).
For non-FDA-cleared products tested in manufacturer-
supported studies, 78/106 (73.6%) passed in tests as per ISO
15197 2003, and 48/95 (50.5%) passed in tests as per ISO
15197 2013. The likelihood of a noncleared product passing
in a manufacturer-supported test compared with an inde-
pendent test was significantly greater according to both ISO

Table 2. Performance of Blood Glucose Monitor Systems Stratified by Clearance Year Intervals

Approval Clearance
year range BGM Manufacturer year ISO 2003 ISO 2013
2001–2005 Accu-Chek Active Roche Diagnostics 2001 Pass Pass
Accu-Chek Compact Roche Diagnostics 2002 Pass Pass
Ascensia BREEZE Bayer Healthcare LLC 2003 n/a Fail
Accu-Chek Go Roche Diagnostics 2004 Faila Faila
EZ Smart Tyson Bioresearch, Inc. 2004 Fail Fail
Accu-Chek Aviva Roche Diagnostics 2005 Pass Faila
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OneTouch Ultra LifeScan, Inc. 2005 Pass Pass

Biocheck TD-4225 TaiDoc Technology Corp 2005 Fail Fail
Total fraction passing 4/7 3/8
Total percentage passing 57.10% 37.50%
2006–2009 OneTouch Ultra 2 LifeScan, Inc. 2006 Fail a Faila
Contour Bayer Healthcare LLC 2006 Faila Faila
Ascensia BREEZE2 Bayer Healthcare LLC 2006 Pass Pass
DANA DiabeCare IISG SOOIL Development Co 2007 Pass Pass
Accu-Chek Performa (maltose Roche Diagnostics 2007 Pass Pass
dependent)
Nova Max Nova Diabetes Care 2007 Fail Fail
microdot+ Cambridge Sensors Limited 2007 Pass Pass
GlucoCard-X-Meter Arkray, Inc. 2007 Pass n/a
WaveSense Jazz AgaMatrix 2007 Pass Pass
Advocate Redi-Code TaiDoc Technology Corp 2007 Fail Fail
OneTouch Select LifeScan, Inc. 2007 Fail Fail
Clever Check TD-4222 TaiDoc Technology Corp 2007 Fail Fail
Prodigy Voice Diagnostic Devices, Inc 2008 Fail Fail
WaveSense Presto AgaMatrix 2008 Pass Fail
TRUEresult Nipro Diagnostics 2008 Pass Fail
OneTouch VITA LifeScan, Inc. 2008 Pass Pass
CareSens II i-SENS, Inc 2008 Pass Fail
my glucohealth Mendor Oy/Entra Health 2009 n/a Fail
Systems LCC
CareSens N i-SENS, Inc. 2009 Pass Pass
TRUEbalance Nipro Diagnostics 2009 Fail Fail
On Call Plus ACON Biotech 2009 Pass Fail
Fora TD-4227 TaiDoc Technology 2009 Fail Fail
Contour USB Bayer Healthcare LLC 2009 Pass Faila
Embrace Apex Biotechnology Corp. 2009 Fail Fail
Total fraction passing 13/23 7/23
Total percentage passing 56.50% 30.40%
2010–2013 OKmeter Match Ok Biotech 2010 Pass Fail
Fora G31 TaiDoc Technology 2010 Pass Fail
Rightest GM 550 Bionime Corporation 2010 Pass Pass
Fora Comfort Pro GD40b TaiDoc Technology 2011 Pass Pass
GE 100 Bionime Corporation 2011 Pass Pass
OneTouch Verio IQ LifeScan, Inc. 2011 Faila Faila
CareSens N POP i-SENS, Inc. 2012 Pass Pass
Accu-Chek Compact Plus Roche Diagnostics 2013 Pass Pass
BGStar AgaMatrix, Inc. 2013 Pass Faila
iBGStar AgaMatrix, Inc. 2013 Pass Faila
GlucoCheck neo/GluNeo aktivmed GmbH/Infopia 2013 Pass Pass
OneTouch Verio LifeScan, Inc. 2013 Pass Faila
Total fraction passing 11/12 6/12
Total percentage passing 91.70% 50%

(continued)
 A REVIEW OF BLOOD GLUCOSE MONITOR ACCURACY 847

Table 2. (Continued)

Approval Clearance
year range BGM Manufacturer year ISO 2003 ISO 2013
2014–2017 Element Infopia Co. 2014 Pass Faila
EGV1 EPS Biotechnology Corp. 2014 Pass n/a
Accu-Chek Aviva Plus Roche Diagnostics 2014 Pass Pass
Accu-Chek Performa Roche Diagnostics 2014 Pass Faila
(dependence unspecified)
In Touch Livongo Health 2014 Pass Pass
FreeStyle Freedom Lite Abbott Diabetes Care 2015 Pass Pass
FreeStyle Lite Abbott Diabetes Care 2015 Pass Fail a
GE 200 Bionime Corp 2015 Pass Pass
Rightest GM700 Bionime Corporation 2015 Pass Pass
FreeStyle InsuLinx Abbott Diabetes Care 2015 Pass Pass
Contour Next USB Bayer Healthcare LLC 2015 Pass Pass
FreeStyle Freedom Abbott Diabetes Care 2015 Pass n/a
Accu-Chek Guide Roche Diagnostics 2016 Pass Pass
Contour Next ONE Ascensia Diabetes Care 2016 Pass Pass
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VivaChek Ino VivaChek Laboratories, Inc. 2017 Pass Pass

Total fraction passing 15/15 10/13
Total percentage passing 100% 76.90%
a
Always means a BGM passed in at least one study but also failed in at least one study.

15197 2003 (OR = 37.8, CI 15.7–35.8, P < 0.001) and ISO
15197 2013 (OR = 163, CI 68.4–158, P < 0.001).
To assess whether other products tested in a manufacturer-
supported study besides the manufacturer’s own products
were more or less likely to receive a passing score than
products tested by their own manufacturer, and we deter-
mined the passing percentage for products made by com-
peting manufacturers compared with products tested by their
own manufacturer. Seventeen manufacturer-supported stud-
ies also tested one or more products from other manufac-
turers.14,17,18,20,23,33,36,38,46–50,59,63,70,71 We also compared
this with independent tests to investigate the possibility of a
monotonic relationship between manufacturers testing their
own products, independent tests, and manufacturers testing
other products. We would expect there to be a relationship in
that order from most passing to least passing. The passing
percentages for these three classes of products (against ISO
15197 2003 and ISO 15197 2013 were 80/80 (100%) and 67/
68 (98.5%) for products’ own manufacturer, 32/39 (82.1%)
and 28/63 (44.4%) for independent tests, and 93/133 (69.9%)
FIG. 1. Percentage of BGMs passing ISO 2003 and ISO 2013
over four intervals of time. BGMs, blood glucose monitors.
(Color graphics available at www.liebertonline.com/dia)
and 40/115 (34.8%) for alternative manufacturers. We con-
cluded that the difference between independent tests and tests
by alternative manufacturers was statistically significant as
per ISO 15197 2003 (OR = 1.88, CI 1.02–4.08, P = 0.04), but
was not statistically significant as per ISO 15197 2013
(OR = 1.50, CI 0.93–2.41, P = 0.08). We also concluded that
there was a statistically significant difference between man-
ufacturers testing their own products versus a competitor’s
product according to both ISO 15197 2003 (OR = 37.2,
CI 4.62–299, P < 0.01) and ISO 15197 2013 (OR = 56.1,
CI 11.9–263, P < 0.01).
Discussion
The purpose of this review was to analyze factors con-
tributing to BGM compliance with ISO and FDA 2016
guidelines for analytical accuracy in hopes of promoting
development and use of BGMs with greater accuracy. The
factors analyzed were FDA clearance (yes or no), time period
of clearance (2001–2005, 2006–2009, 2010–2013, or 2014–
2017), the type of chemistry used by the BGM (GOX vs.
GDH and GDH-FAD and GDH-NAD vs. GDH not using
FAD or NAD), and manufacturer support of the study (which
could potentially introduce bias).
We would expect FDA-cleared BGMs to perform better than
non-FDA-cleared BGM’s in the medical literature, and FDA-
cleared BGMs did in fact perform significantly better than
noncleared BGMs. Even so, only 75.4% of FDA-cleared BGMs
managed to pass the older ISO 15197 2003 standard by which
they had initially been cleared. When evaluated according to
the newer ISO 15197 2013 standard, only 46.4% of FDA-
cleared BGMs passed the test. Furthermore, we can deduce that
even fewer would pass the more rigorous 2016 FDA Guidance.
One possible limitation to our approach is a slight bias
toward the fail mark. BGMs that are close to meeting the ISO
accuracy standards, and may be on average meeting them,
will be marked as ‘‘fail’’ in our review if one lot falls below
the requirement. Our review was designed as such because
 Table 3. Performance of Blood Glucose Monitor Systems Using Glucose Dehydrogenase
Test Strip Chemistry (With and Without Cofactors)
Test strip ISO FDA
BGM Manufacturer enzyme 2003 ISO 2013 cleared
Accu-Chek Mobile (dependence unspecified) Roche Diagnostics GDH Fail a Faila No
Accu-Chek Mobile (maltose dependent) Roche Diagnostics GDH Pass Pass No
Accu-Chek Mobile (maltose independent) Roche Diagnostics GDH Pass Pass No
Accu-Chek Performa Nano Roche Diagnostics GDH Pass Pass No
Contour Plasma Bayer Healthcare LLC GDH n/ a Fail No
Glucocard G+ Menarini Diagnostics GDH Pass Fail No
Glucocard G+Meter GT-1820 Arkray, Inc. GDH Pass Fail No
GlucoCheck XL (TD-4277) aktivmed GmbH GDH Faila Faila No
GlucoHexal II Med-WatchDoc GmbH GDH Fail Fail No
GlucoSmart Swing MSP Bodmann GmbH GDH Pass Fail No
GlucoSure ADVANCE Apex Biotechnology GDH Fail Fail No
GlucoTel BodyTel Europe GmbH GDH Pass Fail No
mylife Unio Bionime Corp GDH Pass Pass No
On Call Advanced ACON Biotech GDH Pass Fail No
Contour Next Link 2.4 Bayer Healthcare LLC GDH-FAD Pass Pass No
Contour Plus Bayer Healthcare LLC GDH-FAD Pass Pass No
Contour Plus ONE Ascencia Diabetes Care GDH-FAD Pass Pass No
Contour TS Bayer Healthcare LLC GDH-FAD Faila Faila No
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Contour XT Bayer Healthcare LLC GDH-FAD Pass Pass No

EXIMO Meril Diagnostics GDH-FAD Pass Pass No
GlucoHexal Allmedicus Co. GDH-FAD Fail Fail No
iDia IME-DC GDH-FAD Pass Fail No
Omni Pod LifeScan, Inc. GDH-FAD Pass Pass No
OneTouch Verio Pro LifeScan, Inc. GDH-FAD Faila Faila No
OneTouch Verio Vue LifeScan, Inc. GDH-FAD Pass Pass No
TRUEyou Nipro Diagnostics GDH-FAD Pass Pass No
TRUEyou mini Nipro Diagnostics GDH-FAD Pass Pass No
Optium Xceed Abbott Diabetes Care GDH-NAD Faila Faila No
Accu-Chek Performa (Maltose Independent) Roche Diagnostics GDH-PQQ Pass Pass No
Accu-Chek Aviva Nano Roche Diagnostics GDH-PQQ Pass Pass No
Total fraction passing 21/29 15/30
Total percentage passing 72.40% 50%
Accu-Chek Active Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Aviva Roche Diagnostics GDH Pass Faila Yes
Accu-Chek Aviva Plus Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Compact Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Compact Plus Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Go Roche Diagnostics GDH Faila Faila Yes
DANA DiabeCare IISG SOOIL Development Co GDH Pass Pass Yes
GE 200 Bionime Corp GDH Pass Pass Yes
Accu-Chek Guide Roche Diagnostics GDH-FAD Pass Pass Yes
Contour Bayer Healthcare LLC GDH-FAD Faila Faila Yes
Contour Next ONE Ascensia Diabetes Care GDH-FAD Pass Pass Yes
Contour Next USB Bayer Healthcare LLC GDH-FAD Pass Pass Yes
Contour USB Bayer Healthcare LLC GDH-FAD Pass Faila Yes
EGV1 EPS Biotechnology Corp. GDH-FAD Pass n/a Yes
Fora Comfort Pro GD40b TaiDoc Technology GDH-FAD Pass Pass Yes
FreeStyle Freedom Abbott Diabetes Care GDH-FAD Pass n/a Yes
FreeStyle Freedom Lite Abbott Diabetes Care GDH-FAD Pass Pass Yes
FreeStyle InsuLinx Abbott Diabetes Care GDH-FAD Pass Pass Yes
FreeStyle Lite Abbott Diabetes Care GDH-FAD Pass Faila Yes
GlucoCard-X-Meter Arkray, Inc. GDH-FAD Pass n/a Yes
GlucoCheck neo/GluNeo aktivmed GmbH/Infopia GDH-FAD Pass Pass Yes
OneTouch Verio LifeScan, Inc. GDH-FAD Pass Faila Yes
OneTouch Verio IQ LifeScan, Inc. GDH-FAD Faila Faila Yes
Rightest GM700 Bionime Corporation GDH-FAD Pass Pass Yes
microdot+ Cambridge Sensors Limited GDH-NAD Pass Pass Yes
Accu-Chek Performa (dependence unspecified) Roche Diagnostics GDH-PQQ Pass Faila Yes
Accu-Chek Performa (Maltose dependent) Roche Diagnostics GDH-PQQ Pass Pass Yes
TRUEresult Nipro Diagnostics GDH-PQQ Pass Fail Yes
Total fraction passing 25/28 16/25
Total percentage passing 89.30% 64%
a
Always means a BGM passed in at least one study but also failed in at least one study.
GDH, glucose dehydrogenase; FAD, flavin adenine dinucleotide; NAD, nicotinamide adenine dinucleotide; PQQ, pyrroloquinoline quinone.

848
 A REVIEW OF BLOOD GLUCOSE MONITOR ACCURACY 849

Table 4. Performance of Blood Glucose Monitor Systems Using Glucose Oxidase Test Strip Chemistry

FDA
BGM name Manufacturer Enzyme ISO 2003 ISO 2013 cleared
alphacheck professional i-SENS, Inc. GOX Pass Pass No
BeneCheck PLUS JET General Life Biotechnology GOX Fail Fail No
Beurer GL 30 Beurer GmbH GOX Fail Fail No
Beurer GL 32 Beurer GmbH GOX Pass Fail No
Beurer GL 40 Beurer GmbH GOX Pass Faila No
Beurer GL 50 Beurer GmbH GOX n/ a Fail No
Finetest Infopia Co. GOX Pass n/a No
Finetest Auto-coding Infopia Co. GOX Fail Fail No
FineTouch Terumo Corp GOX Fail Fail No
Futura Monometer TaiDoc Technology GOX Fail Fail No
Gluco-Test TD-4209 TaiDoc Technology Corp GOX Fail Fail No
Gluco-Test Plus+ TD-4230 TaiDoc Technology Corp GOX Pass Pass No
GlucoCheck Classic TaiDoc Technology Corp GOX Pass Fail No
GlucoCheck Comfort aktivmed GmbH GOX Pass Pass No
Glucofix Mio Menarini Diagnostics GOX Fail Fail No
Downloaded by Ghana Hinari Band 1 from www.liebertpub.com at 01/20/19. For personal use only.

GlucoMen Areo Menarini Diagnostics GOX Pass Pass No

Glucomen LX Menarini Diagnostics GOX Pass Fail No
GlucoMen LX Plus Menarini Diagnostics GOX Pass Fail No
GlucoRX (TD-4230) TaiDoc Technology Corp GOX Fail Fail No
GlucoSure Plus Apex Biotechnology GOX Pass Fail No
IME-DC BG Meter IME-DC GOX Fail Fail No
IME-DC Fidelity IME-DC GOX Fail Fail No
iXell Genexo Sp GOX Pass Fail No
Ixell OLED Genexo Sp GOX Pass Pass No
Medisafe Terumo Corp GOX Fail Fail No
Medisafe Mini Terumo Corp GOX Fail Fail No
Mendor Discreet Mendor Oy GOX Pass Pass No
mylife Pura Bionime Corp GOX Pass Pass No
MyStar Extra AgaMatrix, Inc GOX Pass Pass No
Omnitest 3 B. Braun Melsungen GOX Pass Fail No
Omron HEA-230 DELBio GOX Pass Fail No
OneTouch Select Plus LifeScan, Inc. GOX Pass Pass No
OneTouch Select Plus Simple LifeScan, Inc. GOX Pass Pass No
OneTouch Select Simple LifeScan, Inc. GOX Faila Fail No
OneTouch Ultra Easy LifeScan, Inc. GOX Faila Faila No
PixoTest iXensor Co Ltd GOX Pass Pass No
Pura Bionime Corp GOX Pass Pass No
Pura/mylife Pura Diagnostic Devices, Inc. GOX Fail Fail No
Rightest GM 101 Bionime Corporation GOX Pass n/a No
Rightest GM 300 Bionime Corporation GOX Pass Pass No
Saunno SXT Glucometer Sinocare GOX Fail Fail No
SeniorLine GM210 Bionime Corporation GOX Fail Fail No
SensoCardPlus 77 Elektronika Kft. GOX Pass n/a No
smartLAB Genie HMM Diagnostics GmbH GOX Pass Fail No
smartLAB Global HMM Diagnostics GmbH GOX Pass Fail No
smartLAB Mini HMM Diagnostics GmbH GOX n/a Fail No
SmartLAB Sprint HMM Diagnostics GmbH GOX Pass Fail No
Stada Glucocheck Home Diagnostics, Inc. GOX Fail Fail No
Super Glucocard II GT-1640 Arkray, Inc. GOX Fail Fail No
Wellion Calla MedTrust GOX n/a Fail No
Wellion Calla light MedTrust Handelsges.m.b.H GOX Fail Fail No
Wellion Linus AgaMatrix GOX Pass n/a No
Yicheng 5D-I Beijing Yicheng Bioelectronics Technology GOX Fail Fail No
Yuwell Accusure 710 Jiangsu Yuyue medical equipment and supply GOX Fail Fail No
Total fraction passing 29/51 13/50
Total percentage passing 56.90% 26%
Advocate Redi-Code TaiDoc Technology Corp GOX Fail Fail Yes
Ascensia BREEZE Bayer Healthcare LLC GOX n/a Fail Yes
Ascensia BREEZE2 Bayer Healthcare LLC GOX Pass Pass Yes
BG Star AgaMatrix, Inc. GOX Pass Faila Yes
Biocheck TD-4225 TaiDoc Technology Corp GOX Fail Fail Yes

(continued)
 850 KING ET AL.

Table 4. (Continued)

FDA
BGM name Manufacturer Enzyme ISO 2003 ISO 2013 cleared
CareSens II i-SENS, Inc. GOX Pass Fail Yes
CareSens N i-SENS, Inc. GOX Pass Pass Yes
CareSens N POP i-SENS, Inc. GOX Pass Pass Yes
Clever Check TD-4222 TaiDoc Technology Corp GOX Fail Fail Yes
Element Infopia Co. GOX Pass Faila Yes
Embrace Apex Biotechnology Corp GOX Fail Fail Yes
EZ Smart Tyson Bioresearch, Inc. GOX Fail Fail Yes
Fora G31 TaiDoc Technology GOX Pass Fail Yes
Fora TD-4227 TaiDoc Technology GOX Fail Fail Yes
GE 100 Bionime Corp GOX Pass Pass Yes
iBGStar AgaMatrix, Inc. GOX Pass Faila Yes
In Touch Livongo Health GOX Pass Pass Yes
my glucohealth Mendor Oy/Entra Health Systems LCC GOX n/a Fail Yes
Nova Max Nova Diabetes Care GOX Fail Fail Yes
OKmeter Match Ok Biotech GOX Pass Fail Yes
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On Call Plus ACON Biotech GOX Pass Fail Yes

OneTouch Select LifeScan, Inc. GOX Fail Fail Yes
OneTouch Ultra LifeScan, Inc. GOX Pass Pass Yes
OneTouch Ultra 2 LifeScan, Inc. GOX Faila Faila Yes
OneTouch VITA LifeScan, Inc. GOX Pass Pass Yes
Prodigy Voice Diagnostic Devices, Inc. GOX Fail Fail Yes
Rightest GM 550 Bionime Corporation GOX Pass Pass Yes
TRUEbalance Nipro Diagnostics GOX Fail Fail Yes
VivaChek Ino VivaChek Laboratories, Inc. GOX Pass Pass Yes
WaveSense Jazz AgaMatrix GOX Pass Pass Yes
WaveSense Presto AgaMatrix GOX Pass Fail Yes
Total fraction passing 18/29 10/31
Total percentage passing 62.10% 32.30%
a
Always means a BGM passed in at least one study but also failed in at least one study.
GOX, glucose oxidase.

patients depend on every lot fulfilling minimum accuracy
standards.
Some studies adhered strictly to ISO recommendations for
the distribution of data points, and BGMs in these studies
may also be at a disadvantage when compared with those who
used tighter distributions with fewer extreme blood glucose
(BG) values at which some BGMs may be less accurate.
More studies are needed to determine the accuracy of BGMs
at extreme hyperglycemic and hypoglycemic ranges.
Many stakeholders in the diabetes community expect or as-
sume that all cleared meters will perform to the standards under
which they were approved, as well as to current standards.
Parkin72 speculates that many FDA-cleared BGMs are failing to
meet the current standard because: (1) perhaps in some cases
quality standards in the manufacturing process have declined or
(2) perhaps in some cases companies are falsifying data to
present to the FDA (who might lack the resources to investigate,
especially when the companies are overseas). We recommend
that additional surveillance studies be conducted on BGMs that
have already been cleared by the FDA to ensure that BGMs
continue to adhere to accuracy standards following the initial
clearance. Failure to remain accurate over time can put some
patients who depend on this technology at risk of harm.
With respect to how long an existing blood glucose mon-
itoring system (BGMS) has been on the market and cleared
by the FDA, our analysis showed that newer BGMs per-
formed significantly better for both ISO 15197 2003 (OR
1.06, CI 1.06–1.07, P < 0.001, odds ratio reported for a 1-year
period) and ISO 15197 2013 standards (OR = 1.06, CI 1.03–
1.06, P < 0.01, odds ratio reported for a 1-year period). A
point of caution, however, is that while newer BGMs cer-
tainly outperformed older BGMs, 23.1% of BGMs cleared by
the FDA in the most recent 4 years still did not meet the ISO
15197 2013 standard, and even fewer would likely pass the
more rigorous 2016 FDA guidance.
Which technological advances are contributing most to the
improved performance of newer SMBGs? Pfützner73 identified
the following four factors: (1) changes in test strip chemistry;
(2) the elimination of hematocrit interference; (3) improved
electrode design; and (4) improved mathematical algorithms.
Our review demonstrated that approved BGMs utilizing GDH
as their test strip enzyme significantly outperformed those us-
ing GOX for ISO 15197 2003 (OR = 0.23, CI 0.13–0.38,
P < 0.001) and ISO 15197 2013 (OR = 0.24, CI 0.15–0.35,
P < 0.001), which could be why GDH is increasingly replacing
GOX over time as the test strip enzyme of choice. Unlike GOX
meters, BGMs utilizing GDH are not dependent on the partial
pressure of oxygen in the blood.74 Looking deeper, our analysis
of FAD/NAD as an enzymatic cofactor for GDH (as opposed to
the older PQQ cofactor) did not find a significant correlation
with compliance to either ISO standards (ISO 15197 2003
OR = 0.66, CI 0.24–1.50, P = 0.29; ISO 15197 2013 OR = 0.91,
CI 0.50–1.65, P = 0.76). It is also possible that BGMs using
GDH are on average newer than those using GOX and the
Downloaded by Ghana Hinari Band 1 from www.liebertpub.com at 01/20/19. For personal use only.

FIG. 2. Percentage of BGMs passing ISO 2003 and ISO 2013 based on clearance year and test strip enzyme. (Color
graphics available at www.liebertonline.com/dia)

Table 5. Performance of Blood Glucose Monitor Systems Using Glucose Dehydrogenase

Test Strip Chemistry Without Cofactors or Using Pyrroloquinoline Quinone Cofactor

Test strip FDA

BGM Manufacturer enzyme ISO 2003 ISO 2013 cleared
Accu-Chek Performa (Maltose Independent) Roche Diagnostics GDH, PQQ Pass Pass No
Accu-Chek Aviva Nano Roche Diagnostics GDH, PQQ Pass Pass No
Accu-Chek Mobile (dependence unspecified) Roche Diagnostics GDH Fail a Pass No
Accu-Chek Mobile (maltose dependent) Roche Diagnostics GDH Pass Pass No
Accu-Chek Mobile (maltose independent) Roche Diagnostics GDH Pass Pass No
Accu-Chek Performa Nano Roche Diagnostics GDH Pass Pass No
Contour Plasma Bayer Healthcare LLC GDH n/a Fail No
Glucocard G+ Arkray, Inc. GDH Pass Faila No
Glucocard G+Meter GT-1820 Arkray, Inc. GDH Pass Fail No
GlucoCheck XL (TD-4277) aktivmed GmbH GDH Faila Faila No
GlucoHexal II Med-WatchDoc GmbH GDH Fail Fail No
GlucoSmart Swing MSP Bodmann GmbH GDH Pass Fail No
GlucoSure ADVANCE Apex Biotechnology GDH Fail Fail No
GlucoTel BodyTel Europe GmbH GDH Pass Fail No
mylife Unio Bionime Corp GDH Pass Pass No
On Call Advanced ACON Biotech GDH Pass Fail No
Accu-Chek Performa (dependence unspecified) Roche Diagnostics GDH, PQQ Pass Faila Yes
Accu-Chek Performa (Maltose dependent) Roche Diagnostics GDH, PQQ Pass Pass Yes
TRUEresult Nipro Diagnostics GDH, PQQ Pass Fail Yes
Accu-Chek Active Roche Diagnostics GDH Pass Faila Yes
Accu-Chek Aviva Roche Diagnostics GDH Pass Faila Yes
Accu-Chek Aviva Plus Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Compact Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Compact Plus Roche Diagnostics GDH Pass Pass Yes
Accu-Chek Go Roche Diagnostics GDH Faila Faila Yes
DANA DiabeCare IISG SOOIL Development Co GDH Pass Fail Yes
GE 200 Bionime Corp GDH Pass Pass Yes
Total fraction passing 21/26 12/27
Total percentage passing 80.8% 44.4%
a
Always means a BGM passed in at least one study but also failed in at least one study.

851
 852 KING ET AL.

Table 6. Performance of Blood Glucose Monitor Systems Using Glucose Dehydrogenase Test Strip
Chemistry with Flavin Adenine Dinucleotide or Nicotinamide Adenine Dinucleotide Cofactor

BGM Manufacturer Test strip enzyme ISO 2003 ISO 2013 FDA cleared
Contour Next Link 2.4 Bayer Healthcare LLC GDH-FAD Pass Pass No
Contour Plus Bayer Healthcare LLC GDH-FAD Pass Pass No
Contour Plus ONE Ascencia Diabetes Care GDH-FAD Pass Pass No
Contour TS Bayer Healthcare LLC GDH-FAD Faila Faila No
Contour XT Bayer Healthcare LLC GDH-FAD Pass Pass No
EXIMO Meril Diagnostics GDH-FAD Pass Pass No
GlucoHexal Allmedicus Co. GDH-FAD Fail Fail No
iDia IME-DC GDH-FAD Pass Fail No
Omni Pod LifeScan, Inc. GDH-FAD Pass Pass No
OneTouch Verio Pro LifeScan, Inc. GDH-FAD Faila Faila No
OneTouch Verio Vue LifeScan, Inc. GDH-FAD Pass Pass No
TRUEyou Nipro Diagnostics GDH-FAD Pass Pass No
TRUEyou mini Nipro Diagnostics GDH-FAD Pass Pass No
Optium Xceed Abbott Diabetes Care GDH-NAD Faila Faila No
Total fraction passing 10/14 9/14
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Total percentage passing 71.40% 64.30%

a
Yes
Accu-Chek Guide Roche Diagnostics GDH-FAD Pass Pass Yes
Contour Bayer Healthcare LLC GDH-FAD Faila Faila Yes
Contour Next ONE Ascensia Diabetes Care GDH-FAD Pass Pass Yes
Contour Next USB Bayer Healthcare LLC GDH-FAD Pass Pass Yes
EGV1 EPS Biotechnology Corp. GDH-FAD Pass n/a Yes
Fora Comfort Pro GD40b TaiDoc Technology GDH-FAD Pass Pass Yes
FreeStyle Freedom Abbott Diabetes Care GDH-FAD Pass n/a Yes
FreeStyle Freedom Lite Abbott Diabetes Care GDH-FAD Pass Pass Yes
FreeStyle InsuLinx Abbott Diabetes Care GDH-FAD Pass Pass Yes
FreeStyle Lite Abbott Diabetes Care GDH-FAD Pass Faila Yes
GlucoCard-X-Meter Arkray, Inc. GDH-FAD Pass n/a Yes
GlucoCheck neo/GluNeo aktivmed GmbH/Infopia GDH-FAD Pass Pass Yes
OneTouch Verio LifeScan, Inc. GDH-FAD Pass Faila Yes
OneTouch Verio IQ LifeScan, Inc. GDH-FAD Faila Faila Yes
Rightest GM700 Bionime Corporation GDH-FAD Pass Pass Yes
microdot+ Cambridge Sensors Limited GDH-NAD Pass Pass Yes
Total fraction passing 15/17 9/14
Total percentage passing 88.20% 64.30%
a
Always means a BGM passed in at least one study but also failed in at least one study.

perceived improved accuracy of BGMs using GDH cannot be
entirely attributed to the enzyme itself.
Lastly, our analysis of manufacturer-supported studies
revealed that BGMs supported by the manufacturer signifi-
cantly outperformed BGMs from other manufacturers, both
according to ISO 15197 2003 (OR = 37.2, CI 4.62–299,
P < 0.01) and ISO 15197 2013 (OR = 56.1, CI 11.9–263,
P < 0.01). While some studies we reviewed were performed
by independent investigators, many were carried out or fun-
ded by a manufacturer with protocol input (to the extent that
the manufacturer was not declared to have been excluded
from significant participation in the design of the study
protocol for an independent investigator). We think it is pos-
sible that a manufacturer might be more likely to publish a
study with favorable results and less likely to publish such a
study with unfavorable results regarding the accuracy of their
BGM. Therefore, it is possible that even fewer BGMs would
pass ISO or FDA guidance if all studies were completed by
independent investigators and not subject to being selectively
reported by a manufacturer.
Additionally, even in independent studies, supplies (such
as the BGM system and test strips) are frequently supplied by
the manufacturer. We believe that BGM supplies for accu-
racy studies should ideally be obtained through the same
avenues that are used by patients, such as retail or mail-order
pharmacies. Doing so would best recreate a patient’s ‘‘real-
world’’ experience and prevent the possibility of nonrandom
selection of products.
The most accurate assessment of a blood glucose monitor-
ing system (BGMS)-measuring capillary blood is obtained by
also measuring capillary blood on a comparator method. In
some cases, comparison between capillary blood tested on a
BGM and venous blood tested on a comparator method could
have a negative impact on the perceived accuracy of a BGMS.
In other instances, the difference between the two matrices
could cause a BGM to appear to be more accurate than it
actually is. Whether the impact would be negative or positive
would depend on whether the BGM-measuring capillary blood
is biased away from or toward the direction where the refer-
ence method measuring venous blood is biased.75
BGM accuracy is of the utmost importance because patients
rely on the information obtained from their BGMs to make
treatment decisions. When results obtained are inaccurate,
clinical consequences can be potentially life threatening and
 Table 7. Studies Included with N Blood Glucose Monitors and N Lots Tested
Study name Publication year PubMed ID Manufacturer supported? N BGMs assessed LotN2003 LotN2013
Angelides et al. 2015 26002836 Yes 1 3505 3505
Bailey et al.a 2012 22853721 Yes 1 1152
Bailey et al.a 2015 26070512 Yes 1 1036
Bailey et al.a 2017 28617617 Yes 1 868
Baumstark et al. 2012 23063033 Yes 5 800 800
Baumstark et al. 2014 25107707 Yes 1 600
Baumstark et al. 2016 26428935 Yes 1 600
Baumstark et al.b 2017 28704063 Yes 6
Berti et al. 2015 26224761 Yes 6 200
Brazg et al. 2013 23439170 Yes 7 600b 600b
Brazg et al. 2016 27271844 Yes 1 600
Caswell et al.a 2015 25494048 Yes 1 1033 1033
Chandnani et al. 2017 28658800 Yes 1 1005
Charoensri et al. 2015 26591392 Yes 1 153 153
Chen et al. 2012 22266375 Yes 1
Christiansen et al.a 2017 28745099 Yes 1 1261
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Frank et al. 2011 21303645 Yes 1 838

Freckmann et al. 2010 20151773 Yes 25 200b
Freckmann et al. 2012 23063032 Yes 43 1
Freckmann et al. 2014 24205978 Yes 10 180–200 180–200
Freckmann et al. 2014 24681433 Yes 1 600 600
Freckmann et al. 2015 26110670 Yes 9 600 600
Freckmann et al.a 2017 28225633 Yes 4 300 300
Harrison et al. 2011 21880245 Yes 1 600 600
Hasslacher et al. 2013 24133899 No 19 238–303
Hasslacher et al. 2014 24876607 No 27 248–303
Hehmke et al. 2017 27707915 Yes 3 200
Huang et al. 2014 24613515 Yes 2 224/672
Jeanny and Hope 2016 26424240 Yes 2 600 600
Jendrike et al. 2015 25901021 Yes 2 600 600
Jendrike et al. 2017 28459160 Yes 1 600
Ji et al. 2016 26053011 Yes 1 362
Kamecke et al. 2017 28627219 Yes 1 600
Katz et al.a 2015 25702769 Yes 5 773–876
Katz et al.a 2017 28459033 Yes 1 600
Kuo et al. 2011 21406013 Yes 6 107
Link et al. 2014 24876597 Yes 3 600 600
Link et al. 2015 25872967 Yes 4 600 600
List et al.a 2011 22027308 Yes 1 296
Lock et al.a 2011 21142975 Yes 1 394
Pfützner et al. 2012 22435798 Yes 6 212
Pfützner et al. 2014 24156775 Yes 6 212b
Pfützner 2016 26553022 Yes 1 630
Philis-Tsimikas et al.a 2011 22226284 Yes 1 1188
Pleus et al. 2014 24876447 Yes 4 200b
Pleus et al. 2016 26809001 Yes 2 600 600
Robinson and Sharp 2012 22768885 Yes 5 214–216 214–216
Sachse et al.a 2012 22900743 No 1 260
Salzsieder and Berg 2016 26394775 Yes 1 600
Setford et al.a 2015 26488139 Yes 1 930
Setford et al. 2017 28406040 Yes 1 73600
Sølvik et al.a 2015 25737533 No 10 152–262 152–262
Sonmez et al. 2010 20615103 No 5 144b
Tack et al. 2012 22176154 Yes 5 480–510 480–510
Yon Hin et al. 2017 27578824 Yes 1 708
Yu-Fei et al. 2017 28480733 Yes 19 400 400
Zijlstra et al. 2016 27605592 Yes 5 330–342
Zueger et al. 2012 22791566 No 3 150
a
Data from lab and lay user accuracy was included.
b
One or more BGMs was tested with a different amount of lots.

853
 854
the economic repercussions can be costly. Modeling studies
have demonstrated the adverse outcomes of inaccurate BGMs,
such as hypoglycemia and overall poor glucose control76 and
insulin dosing errors.7
An empiric study has also been conducted to demonstrate
the real-world consequences of BGM inaccuracy.77 Retro-
spectively studied subjects were classified retrospectively
according to various levels of measurement error by BGMs
they were using. The investigators did not select the BGMs.
Consistently accurate BGMs had the best combination of
low mean glycemia and low incidence of hypoglycemia,
whereas BGMs providing falsely lower or higher readings
resulted in higher HbA1c values and/or increased hypo-
glycemia, respectively. Furthermore, BGMs with greater
accuracy have been shown in modeling studies to be eco-
nomically attractive.78,79
Finally, as technology continues to advance with the in-
creasing adoption of continuous glucose monitors (CGMs)
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and closed-loop systems approaching on the horizon, BGM
accuracy is more important than ever. BGMs are frequently
relied upon for calibrating CGMs that can be used either as a
standalone device or as part of a closed-loop system. The use
of an inaccurate BGM when calibrating a CGM can lead to
adverse changes in HbA1c levels as well as increase the
likelihood of an adverse event, such as hypoglycemia. CGMs
themselves must be accurate, and inaccurate CGM perfor-
mance can have adverse outcomes.8,9
Health risks and economic burdens accrue from inaccurate
BGMs. According to our review of more than 7 years of the
medical literature, many FDA-cleared BGMs used in the
United States and uncleared BGMS used internationally do
not deliver levels of accuracy called for by current standards.
The diabetes community expects and needs consistently ac-
curate systems for determining treatment. We believe that
independent testing and the addition of postmarket surveil-
lance testing will play a vital role in achieving that goal.
Author Disclosure Statement
D.A., V.H., F.K., and T.P. have nothing to disclose. D.K. is
a consultant to Ascensia, EOFlow, Intarcia, Lifecare, Novo
Nordisk, AstraZeneca, and Voluntis.
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Address correspondence to:
David C. Klonoff, MD, FACP, FRCPE, Fellow AIMBE
Medical Director, Diabetes Research Institute,
Mills-Peninsula Medical Center
100 South San Mateo Drive, Room 5147
San Mateo, CA 94401
E-mail: dklonoff@diabetestechnology.org