BogdanCauff Critical Assessment and Research Methods Worksheet

672237research-article2016
DSTXXX10.1177/1932296816672237Journal of Diabetes Science and TechnologyEkhlaspour et al
Original Article
Comparative Accuracy of 17 Point-ofCare Glucose Meters
Journal of Diabetes Science and Technology
2017, Vol. 11(3) 558­–566
© 2016 Diabetes Technology Society
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DOI: 10.1177/1932296816672237
journals.sagepub.com/home/dst
Laya Ekhlaspour, MD1, Debbie Mondesir, BS1,
Norman Lautsch, BS, MS1, Courtney Balliro, RN1,
Mallory Hillard, BS1, Kendra Magyar, NP1,
Laura Goergen Radocchia, MSN PMHNP-BC1,
Aryan Esmaeili, MD1, Manasi Sinha, MD, MPH1,
and Steven J. Russell, MD, PhD1
Abstract
Background: The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia,
calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare
the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of
reference BG and hemoglobin values.
Methods: Fresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked
with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels
from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl. We measured the BG of each sample with 17 different
commercially available glucose meters and the reference method (YSI 2300) at the same time. We determined the mean
absolute relative difference (MARD) for each glucose meter, overall and stratified by reference BG and by hemoglobin level.
Results: The accuracy of different meters widely, exhibiting a range of MARDs from 5.6% to 20.8%. Accuracy was lower in
the hypoglycemic range, but was not consistently lower in samples with anemic blood hemoglobin levels.
Conclusions: The accuracy of commercially available glucose meters varies widely. Although the sample mix in this study
was much more challenging than those that would be collected under most use conditions, some meters were robust to
these challenges and exhibited high accuracy in this setting. These data on relative accuracy and robustness to challenging
samples may be useful in informing the choice of a glucose meter.
Keywords
diabetes, blood glucose, plasma glucose, glucose meter, accuracy, MARD, hemoglobin
Tight glycemic control with intensive insulin therapy reduces
the risk of diabetic complications.1,2 Self monitoring of blood
glucose plays an important role in the safety and efficacy of
current therapy for diabetes mellitus because most dosing
decisions are based on blood glucose value obtained by measuring a fingerstick capillary blood specimen on a home glucose meter.3-5 The safety and effectiveness of continuous
glucose monitors, and automated glucose management systems that utilize them as component parts, are also critically
dependent on accurate BG measurements for calibrations. In
this setting, the impact of 1 inaccurate measurement can be
magnified.
The increase in the global prevalence of diabetes,6 the
importance of the accuracy of self monitoring glucose systems, and price pressures, have led the medical device
manufacturers to develop more brands and types of glucose
meters.7 The accuracy of results, the ease of technique and
maintenance, and the price of both the meter and the strips
are factors that are considered when choosing a glucose
meter.
The purpose of this study was to evaluate the comparative accuracy of 17 commercially available glucose meters
across a wide range of reference plasma glucose (PG) values
1
Massachusetts General Hospital Diabetes Research Center, Boston, MA,
USA
Corresponding Author:
Steven J. Russell, MD, PhD, Massachusetts General Hospital Diabetes
Research Center, 50 Staniford St, Ste 301, Boston, MA 02114, USA.
Email: sjrussell@mgh.harvard.edu
559
Ekhlaspour et al
and hemoglobins (Hb). We specifically aimed to choose a
meter for calibration of the continuous glucose monitor
component of a bionic pancreas system for automated glucose management.
Methods
The study was performed September 2014 through December
2014 at Massachusetts General Hospital’s Diabetes Research
Center, Boston, MA. Fresh discarded whole blood samples
collected in blood gas syringes and anticoagulated with heparin were obtained from the STAT lab. The protocol was
reviewed by the Partners Human Research Committee and
determined to be non–human subjects research.
Hemoglobin Estimation
The hemoglobin content of the samples was tested with the
HemoCue® B-Hemoglobin system (HemoCue AB,
Ängelholm, Sweden). If the hemoglobin level in the sample
was between 7 and 16.5 g/dl, the sample was transferred to a
coded tube for glucose testing. A total of 137 samples were
collected for glucose testing.
Laboratory PG Estimations
Reference glucose measurements on whole blood were performed with the YSI 2300 STAT PLUS Glucose & L-Lactate
Analyzer (Yellow Springs Instruments, OH). We chose this
instrument because the US Food and Drug Administration
(FDA) accepts it as the reference method, and most glucose
meters are factory calibrated using this device as the standard. Daily quality assurance tests were performed on the
YSI as suggested by the manufacture guidelines using glucose standards traceable to the NIST (National Institute of
Standards and Technology). We used a conversion based on
hemoglobin to convert YSI measurements on whole blood to
plasma equivalents: Hemoglobin corrected glucose = YSI
measurement × (0.84 / (0.93-0.22 × Hemoglobin %)).8
Preparation of Samples
Samples could be used with or without modification. To
obtain additional hyperglycemic samples, blood was spiked
with a solution of 3.5 M glucose in 150 mM NaCl. To obtain
additional hypoglycemic samples, blood was incubated in a
37°C warm water bath. After incubating or spiking procedures, samples were retested using the YSI. Within each 1 g/
dl hemoglobin bin in the 7-15 g/dl range, samples with an
even distribution across reference PG levels from 20 – 440
mg/ were generated. A total of 346 reference measurements
were available from 351 samples after samples with reference PG measurements less than 20 mg/dl or greater than
440 mg/dl were removed.
Glucose Meter Measurements
Once a value in the desired reference PG range was obtained,
the samples were immediately tested on 17 different commercially available blood glucose meters systems, consisting
of a meter and test strips (Table 1). Using a pipette, a drop of
blood from the sample was placed on a sheet of Parafilm
(Bemis Company, Inc, Neenah, WI). All 17 meters were used
to test this sample within 30 seconds and the values were
recorded. At least 3 lots of each strip type were used during
the study.9
Data Analysis
We calculated the mean absolute relative difference (MARD
= mean (|reference value – meter value|) / (reference value) ×
100) versus the PG measurement derived from the YSI as the
primary outcome measure. For the purposes of converting
YSI whole blood glucose measurements to PG measurements we used the hemoglobin value equal to the midpoint
of each hemoglobin bin. Some measurements with the pointof-care glucose meters did not produce a numerical reading;
rather, they displayed a “low” or “high” message. To include
these results in the numerical analyses, the results were censored by setting them to 1 mg/dl lower than the lowest value
in the meter’s reported glucose concentration range (eg, 19
mg/dl for a meter with a lower limit of 20 mg/dl) or 1 mg/dl
higher than the upper limit (eg, 445 for a meter with an upper
limit of 444 mg/dl), respectively.
Although our testing method was not the one specified by
the standard, we determined whether each meter met numerical
criteria for accuracy described in International Organization for
Standardization (ISO) 15197: 2003 (>95% within 15 mg/dl of
reference 95% within 15 mg/dl of reference

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