CLINICAL CHEMISTRY

Original Article

Accuracy of Portable Blood

Glucose Monitoring
Effect of Glucose Level and Prandial State
DINO A. VALLERA, M.D., MICHAEL G. BISSELL, M.D., PH.D., M.P.H.,
AND WILLIAM BARRON, M.D.

Glucose was determined on capillary and venous blood samples
from 274 adult diabetics by three different methodologies: the
Glucoscan 2000® and Accu-Check II® portable glucose meters
(capillary) and the Kodak Ektachem 700® analyzer (venous).
Both glucose meters correlated significantly with the Ektachem
results. A significant positive bias was found for the Glucoscan
compared with Ektachem, not found with the Accu-Check II.
The Accu-Check performed better than the Glucoscan at venous
plasma glucose levels < 1 g/L. The mean error of Glucoscan
determinations was significantly greater and biased positive when
the measurement was performed within 4 hours of eating,
whereas no such effect was seen with Accu-Check error. Multiple
regression analysis revealed that the Glucoscan measurement
was independently influenced by both venous plasma glucose
and prandial state, whereas the Accu-Check II measurement
was not dependent on either variable. The within-run precision
for both glucose meters were comparable. (Key Words: Portable
glucose monitoring; Accuracy.) Am J Clin Pathol 1991;95:247-
252

Portable capillary blood glucose meters have been used termined by a laboratory reference methodology.12 Con-
extensively in both inpatient and outpatient settings for sideration of this factor is important because there may
many reasons, including patient and physician conve- be significant peripheral tissue glucose extraction in the
nience and cost.1,2 Although the accuracy and precision postprandial state,13 resulting in venous plasma levels that
of this technology have been addressed by a number of are considerably lower than capillary values.
previous investigators,3,4 many of these studies have had The present investigation was designed to address a
considerable limitations. For example, sample sizes are number of these issues by performing a large number of
often small,5"7 meter accuracy frequently is addressed only capillary blood glucose determinations on two currently
through determination of the correlation coefficient be- popular instruments, analyzing differences between por-
tween meter and reference laboratory methods,5,8"12 and table meter and standard laboratory measurements as a
the impact of ambient plasma glucose levels on accuracy function of both ambient plasma glucose level and the
often is neglected. Furthermore, we are aware of only one time since the patient's last meal.
study that has addressed the impact of prior feeding on
the concordance between capillary blood glucose mea- METHODS
sured by a portable meter and venous plasma glucose de-
Study subjects included 274 adult diabetics on whom
a blood glucose level had been requested by their primary
From the Departments of Pathology, Medicine, and Obstetrics and
care physician in the University of Chicago Health Service,
Gynecology, University of Chicago Hospitals, Chicago, Illinois. a large internal medicine clinic with more than 50,000
Received September 18, 1989; accepted for publication July 24, 1990. outpatient visits per year. Participants included patients
Dr. Vallera is currently with the Department of Pathology, Hinsdale on dietary therapy only, on oral hypoglycemic agents and
Hospital, Hinsdale, Illinois; Dr. Bissell is currently with the Department on insulin. Each subject was asked when he had last eaten,
of Clinical Pathology, City of Hope National Medical Center, Duarte,
California. and the time was recorded to the nearest 30 minutes.
Supported by Boehringer Mannheim Diagnostics, Indianapolis, In- Blood was obtained from an antecubital vein and placed
diana. immediately into a tube containing potassium oxalate
Address reprint requests to Dr. Bissell: Department of Clinical Pa-
thology, City of Hope National Medical Center, 1500 East Duarte Road, (14.0 mg) and sodium fluoride (17.5 mg) (Becton Dick-
Duarte, California 91010-0269. inson Vacutainer Systems, Rutherford, NJ). Plasma ob-

247
248 CLINICAL CHEMISTRY
Original Article
tained from the specimen was analyzed for glucose in the
General Clinical Chemistry Laboratory of the University
of Chicago Hospitals on the Ektachem 700® analyzer
(Eastman Kodak Co., Rochester, NY), which uses a glu-
cose oxidase-based reflection densitometric method.
Within 4 minutes after venipuncture, the patient's finger
was punctured with a spring-loaded lancet to obtain a
drop of capillary whole blood. This was analyzed for glu-
cose with either the Glucoscan 2000® with Glucoscan test
strips (Lifescan, Inc., Mountain View, CA) or the Accu-
Check II® with Chemstrip bG test strips (Boehringer
Mannheim Diagnostics, Indianapolis, IN). All determi-
nations were performed by a single nurse who was trained
in the operation and quality control of both instruments
as directed by the manufacturers. One instrument of each
type was used for the entire study.
The precision of the Ektachem 700 was assessed by
performing 20 repeated glucose determinations on a single
sample over 20 consecutive minutes and by analyzing the
same sample once daily on 20 consecutive days. Precision
of each portable meter was evaluated by daily determi-
nations of the glucose concentration of a standard test
solution (provided by the manufacturer) for 20 days. In
addition, the precision of the entire portable glucose meter
methodology was assessed for each instrument by per-
forming 20 repeated capillary blood glucose determina-
tions on a single subject over a 30-60 minute period.
The statistical approach used to assess the agreement
between each meter and the laboratory reference method
is a modification of that suggested by Bland and Altman.14
First, least squares linear regression analysis was used to
assess correlations between meter and Ektachem deter-
minations. Next, two-tailed paired /-tests were performed
to evaluate the difference between meter and Ektachem
determinations (referred to here as "meter bias" or "er-
ror") and to compare the magnitude of these two differ-
ences for the two meters. In addition, 95% confidence
intervals (CI) were calculated for the mean bias for each
meter.
To determine whether meter bias was dependent on
plasma glucose level, we performed a linear regression of
the difference between meter and Ektachem measure-
ments on the Ektachem value. To further clarify this re-
lationship, data were stratified in 1 g/L increments ac-
cording to the Ektachem value, and an analysis of variance
was performed, followed by two-tailed two sample Mests
to assess differences between the meters at various levels
of venous plasma glucose.
To analyze the impact of prior meal ingestion on mon-
itor accuracy, meter and Ektachem values were grouped
by the length of time that had passed since the last meal.
Preliminary analysis separating data into four groups (0-
2.0 hours, 2.5-4.0 hours, 4.5-6.0 hours, and >6.0 hours)
A.J.C.P. • February 1991
indicated that results for groups 1 and 2 were similar, as
were those for groups 3 and 4; therefore, data were com-
bined into two groups, 0-4.0 hours and >4.0 hours since
the last meal, and two-tailed, paired and two-sample t-
tests were performed to assess group differences. Finally,
a multiple regression analysis was performed to assess the
independent contributions of (1) the Ektachem value, and
(2) the time since the last meal, on meter error. Data are
reported as mean ± 1 SD. A P value of <0.05 was con-
sidered significant, except where multiple testing was per-
formed, in which case the critical P value was adjusted
by the Bonferroni method (both uncorrected and Bon-
ferroni P values are presented). All calculations were per-
formed on a microcomputer using SYSTAT software.
Precision evaluation experiments were performed on
both the Accu-Check II and the Ektachem according to
the National Committee for Clinical Laboratory Stan-
dards (NCCLS) Guidelines EP5T. Briefly, manufacturers'
supplied glucose control material was analyzed in dupli-
cate, in two runs per day, for 20 days. Two analyte con-
centrations were tested for each method. This data was
analyzed to provide an estimate of within-run and total
imprecision. For the Accu-Check II, the determinations
were performed by the same trained nurse who performed
the patient determinations. The Ektachem study was per-
formed by trained medical technologists in the General
Clinical Chemistry Laboratory.
The Glucoscan 2000 could not be included in this phase
of the study because of the nature of its control materials.
These were packaged in small plastic vials and, according
to the manufacturer's instructions, are to be used within
24 hours of opening. This would necessitate the use of 20
different vials of control material for each analyte con-
centration to complete the study and would introduce
another source of variability into the data.
RESULTS
A total of 277 determinations were made with the Glu-
coscan 2000, and 232 were performed on the Accu-Check
II. There was a highly significant correlation between cap-
illary (meter) and venous (Ektachem) glucose values for
both instruments:
Glucoscan: meter value = 0.84 X (Ektachem value)
+ 37.1, r = 0.94
Accu-Check: meter value = 0.92 X (Ektachem value)
+ 14.9, r = 0.94
Despite these results, further evaluation disclosed sig-
nificant differences in performance of the two meters.
Capillary glucose values measured with the Glucoscan
averaged 1.91 ± 0.84 g/L (range = 0.29-4.50 g/L; n
= 277), whereas venous plasma glucose values on the same
 VALLERA, BISSELL, AND BARRON
Accuracy of Portable Blood Glucose Monitoring
subjects measured with the Ektachem averaged 1.85
± 0.96 g/L (range = 0.24-5.16 g/L), a highly significant
difference (P = 0.001). The average absolute difference
between the Glucoscan and Ektachem was 0.065 ± 0.326
g/L (95% confidence interval = 0.026-0.104), and the
average percentage difference was 8.8 ±21.6% (95% con-
fidence interval = 6.2-11.3). The observation that neither
of these 95% confidence intervals includes 0 supports the
given result (i.e., the mean Glucoscan 2000 and Ektachem
values are significantly different from one another).
Mean capillary glucose values determined with the
Accu-Check II were 1.95 ± 0.99 g/L (range = 0.22-5.00
g/L; n = 232), and paired venous samples measured on
the Ektachem averaged 1.94 ± 1.01 g/L (range = 0.24-
6.05 g/L), a difference that was not significant (P = 0.93).
The mean difference between the Accu-Check and Ek-
tachem was 0.002 ± 0.35 g/L (95% confidence interval
= -0.017-+0.39), data which confirm the lack of differ-
ence between Accu-Check and Ektachem determinations.
For the Glucoscan, 79.8% of determinations were
within 20% of the correct value, whereas 87.9% of the
Accu-Check measurements were in this range. Fourteen
Glucoscan (5.0%) and five Accu-Check (2.2%) values de-
viated more than 50% from that determined on the Ek-
tachem. Direct comparison of the average bias of the two
meters indicated a highly significant difference when
measured as a percentage of the Ektachem value. (Glu-
coscan: 8.8 ± 21.6%; Accu-Check: 1.1 ± 21.8%, P
< 0.001), and a trend in the same direction when the bias
was expressed in g/L (Glucoscan: 0.065 ± 0.326 g/L; Accu-
Check: 0.002 ± 0.351 g/L, P = 0.038, Bonferroni critical
value: P = 0.025).
Next, we analyzed the effect of the venous plasma glu-
cose level (Ektachem measurement) on the accuracy of
each meter. For the Glucoscan there was a significant lin-
ear correlation between the meter error expressed in either
absolute [(Glucoscan value) - (Ektachem value) = -0.17
X (Ektachem value) + 37.1, r = 0.486, P < 0.001] or
percentage terms [% difference between Glucoscan and
TABLE 1. METER BIAS IN ABSOLUTE (mg/dl) AND PERCENTAGE TERMS AS A FUNCTION
OF VENOUS PLASMA GLUCOSE LEVEL
Venous
Plasma Glucoscan 2000 Bias
Glucose
(q/L) 3'L % H
<1.0 0.18 ±0.13 23 ± 17
1.0-1.9 0.16 + 0.34* 12 ± 2 5 *
2.0-2.9 -0.05 ± 0.28 -2+11
3.0-3.9 -0.11 ±0.25 -3 ±8
^4.0 -0.52 ± 0.29 -11 ± 6
• When four outliers {% difference from Ektachem >90%) were excluded, differences were 0.11
± 0.20 g/L and 8 ± 13%.
Vol. 95 • No. 2
249
Ektachem = -0.11 X (Ektachem) + 28.6, r = 0.477, P
< 0.001]. This effect was much less evident for the Accu-
Check II, and was significant only for the error measured
in absolute terms [difference (g/L) = -0.08 X (Ektachem)
+ 15.6, r = 0.229, P< 0.001; % difference = -0.02 X (Ek-
tachem) + 4.8, r = 0.09, P = 0.18].
This effect is better appreciated when the data are
grouped in 1-g/L intervals of the Ektachem value (Table
1). The average bias of the Glucoscan is more than 20%
(95% confidence interval = 19-28) when the Ektachem
value is less than 1 g/L, becomes minimal in the range
2-3 g/L, and is more than - 1 0 % when the venous plasma
level is >4 g/L. In contrast, the error of the Accu-Check
at the lowest glucose values averaged - 6 ± 15% (95%
confidence interval = - 2 — 11; P < 0.005 vs. Glucoscan
error, Bonferroni critical P = 0.01) and varied from —6.3%
to +7.8% in other ranges of venous glucose (= not sig-
nificant vs. Glucoscan for each of these ranges). Thus, the
Accu-Check performed better (i.e., had less bias) than the
Glucoscan primarily when the venous plasma glucose was
<lg/L.
It also is of interest to note that all meter determinations
with a difference from the Ektachem value of greater than
90% occurred in the most commonly encountered venous
plasma glucose range (1-2 g/L) for both the Glucoscan
(n = 4) and Accu-Check (n = 3). These seven determi-
nations were made on four different subjects; on two of
these, other meter measurements were within 20% of Ek-
tachem values. When these seven outliers were excluded,
the mean measurement error in the 1-2 g/L range was 8
± 13% (95% confidence interval = 6-11) for the Glucoscan
and 3 ± 16% (95% confidence interval = -0.3-+7.0) for
the Accu-Check (P = 0.023, Bonferroni critical P = 0.01).
Assessment of the effect of prior meal ingestion on
measurement bias indicated further differences in meter
performance (Table 2). The mean error of Glucoscan de-
terminations was significantly greater and biased in a pos-
itive direction when the measurement was performed
within 4 hours of eating, whereas recent food intake did
Accu-Check II Bias
9IL % n
55 -0.05 ±0.12 - 6 ± 15 44
125 0.11 ±3.9| 8±30f 90
63 0.01 ± 0.26 1 ± 11 61
23 -0.23 ± 0.38 6+10 28
11 -0.12 ±0.67 1 ± 13 9
t When three outliers were excluded, differences were 0.05 ± 0.25 g/L and 3 ± 16%.
Results are expressed as mean ± SD; n = number of paired determinations.
250 CLINICAL CHEMISTRY
Original Article
TABLE 2. EFFECT OF PRIOR MEAL INGESTION GLUCOSCAN 2000
ON METER BIAS

Time Since Last Meal

Instrument Units 0-4 hours n >4 hours n

Glucoscan g/L 0.102 ± 0.34 171 0.005 ± 0.28* 106

% 11.4 ±23.6 171 4.5 ± 16.9f 106
Accu-Check g/L
%
0.016
2.1
± 0.38* 149 -0.024 ±
±23.4§ 149 -0.8 ±
0.28
18.6
83
83 I
* P < 0.02 for the comparison with the 0-4 hour time period.
t P < 0.001 for the comparison with the 0-4 hour time period.
X P = 0.038 for the comparison with Glucoscan.
§ P < 0.001 for the comparison with Glucoscan.
Bonferroni critical P = 0.0125.
Results are expressed as mean ± SD; n = number of paired determinations. -60 -50 -40 -30 -20 -10 10 20 30 40

DIFFERENCE (X)

not appear to have a significant effect on the Accu-Check ACCUCHECK II

meter error. Furthermore, the Accu-Check performed
significantly better (i.e., less bias) compared with the Glu-
coscan only for measurements made less than 4 hours
after the last meal.
Finally, multiple regression analysis was performed to
determine whether the level of venous plasma glucose
and the time since the last meal had independent effects
on meter bias. Regression coefficients (Table 3) demon-
strate that the bias of the Glucoscan, in both g/L and
percent, is independently influenced by both plasma glu-
cose and prandial state. In contrast, the bias of the Accu-
Check, as a percentage of the Ektachem value, was de-
pendent upon neither of these variables, although the bias -60 -50 -40 -30 -20 -10 10 20 30 40 50 60

in g/L was significantly influenced, albeit to a smaller de- B DIFFERENCE (%)

gree than for the Glucoscan, by the venous plasma glucose. FIG. 1. A (upper). Percent differences between EKTACHEM and
For the Accu-Check II meter, the overall mean of all GLUCOSCAN 2000 values grouped according to the level of venous
determinations using the high glucose control material glucose determined by the EKTACHEM. Note that the ambient level
of venous glucose has a significant effect on meter bias and that when
was 3.093 g/L. The within-run precision was 0.177 g/L, venous glucose is less than 1 g/L, bias is approximately +20%. B (lower).
whereas the between-run precision was 0.268 g/L (coef- Percent differences between EKTACHEM and ACCUCHECK II values
ficient of variation = 8.7%). With the low concentration grouped according to the level of venous glucose determined by the Ek-
tachem. There is no significant relationship between meter bias and ve-
glucose control, the overall mean was 0.409 g/L, with the nous plasma glucose levels.
within-run precision being 0.0185 g/L and the between-
run precision being 0.0236 g/L (coefficient of variation
= 6.4%). With the Ektachem, using the high concentration glu-
cose control, the overall mean was 4.28 g/L, with the
within-run precision being 0.0172 g/L, between-run pre-
TABLE 3. COEFFICIENT OF MULTIPLE REGRESSION cision being 4.08 g/L (coefficient of variation = 0.95%).
ANALYSIS EVALUATING THE DEPENDENCE OF
METER BIAS ON PLASMA VENOUS GLUCOSE For the low glucose control, the overall mean was 0.827
AND TIME SINCE LAST MEAL g/L, with within-run precision being 0.0052 g/L and be-
tween-run precision being 0.0121 g/L (coefficient of vari-
Glucose
Instrument Units Level Time Interval
ation = 5.5%).
In the whole method precision study, both the Accu-
Glucoscan g/L -0.17 ±0.02 <0.001 -8.94 ±3.50 0.011 Check II and Glucoscan 2000 were tested. Using the Glu-
% -0.11 ±0.01 <0.001 -6.47 ±2.32 0.006
Accu-Check g/L -0.08 ± 0.02 <0.001 -4.87 ± 4.69 0.30 coscan 2000, the first volunteer's mean blood glucose
% -0.02 + 0.01 0.16 -3.12 ±2.98 0.296 concentration was 0.94 g/L, with SD of 0.0615 g/L (coef-
ficient of variation = 6.5%). The second volunteer was
Results are expressed as mean ± SE. "Time period since last meal" is categorized into "0-4
hours" or ">4 hours." tested with the Accu-Check II, yielding a mean blood glu-

A.J.C.P. • February 1991

 VALLERA, BISSELL, AND BARRON
Accuracy of Portable Bh <d Glucose Monitoring
cose concentration of 0.735 g/L, with SD of 0.0405 g/L
and coefficient of variation of 5.5%. Repetitive sampling
(n = 20) of the Ektachem high glucose control resulted
in a mean concentration of 4.398 g/L, with SD of 0.0405
g/L and coefficient of variation of 0.53%. For the low
control, the mean concentration was 0.817 g/L, with SD
of 0.0047 g/L and coefficient of variation of 0.58%.
DISCUSSION
This study critically evaluated the performance of two
popular blood glucose meters in a busy clinical setting
and attempted to identify variables that might account
for any observed bias. As reported by others, 815 we found
that both meters' readings were highly correlated (r = 0.94)
with the laboratory reference method; however, additional
analysis disclosed that, on average, the Accu-Check II
provided more accurate determinations, with a mean bias
of only 1. i % compared with 8.8% for the Glucoscan 2000.
Yet more detailed evaluation disclosed that the greater
bias of the latter instrument occurred primarily at lower
levels of plasma glucose and when the patient had eaten
within several hours of capillary glucose measurement.
There have been numerous published reports that pur-
portedly have investigated the accuracy of portable blood
glucose monitors.5"8,10,11,15"20 However, as discussed in
detail by Bland and Altman,14 many investigators inap-
propriately report only the correlation coefficient between
measurements made by meter and some reference meth-
odology.5"12 Such a statistic fails to provide clinically rel-
evant information {i.e., how much does the meter deter-
mination deviate from the true [laboratory reference]
value, and does this deviation change at various levels of
venous plasma glucose).
Godine and colleagues15 evaluated the accuracy of the
Accu-Check meter when used by staff nurses and found
a mean error of 8 ± 7%, whereas Landon and colleagues,20
studying the same meter, observed a mean deviation of
approximately 15%. Brooks and co-workers'8 found a
mean bias of—0.06 ± 0.30 g/L for the Accu-Check II and
0.08 ± 0.27 g/L for the Glucoscan 2000 (percentage data
not available). Results of average bias for the two meters
in the present study were in the ranges cited, with a mean
error for the Accu-Check II of 1 ± 22% (0 ± 0.35 g/L)
and 9 ± 22% (0.06 ± 0.33 g/L) for the Glucoscan 2000.
Although the mean measurement error (as a % of the
venous glucose level) of both glucose meters was relatively
small (<10%; 95% confidence interval for mean bias:
Glucoscan: 6.2-11.3%; Accu-Check II: -1.7-4-3.9%), this
does not provide an estimate of a given capillary glucose
determination, a parameter of considerable clinical im-
portance. The latter is better estimated by the 95% limits
of agreement (i.e., mean error ± 2 SD), which in the pres-
Vol. 95 • No. 2
251
ent study allow one to be 95% certain that a given glu-
coscan measurement was between - 3 4 % and +52% of
the laboratory reference value and that an Accu-Check
determination was between —43% and +45% of this value.
When viewed in this light, the two meters do not appear,
on average, to differ as much as suggested by comparison
of the mean bias. Furthermore, the range of these limits
make it clear that portable blood glucose meter results
must be interpreted with caution, particularly in those
ranges where a change in therapy may have substantial
adverse effects.21
Overall estimates of glucose meter bias as described
may be misleading if this bias is significantly dependent
on the level of venous plasma glucose (e.g., the bias may
be large at one glucose level and minimal at another).
Indeed, we found a significant linear relationship between
Glucoscan 2000 meter error and venous plasma glucose,
with highest errors at the lowest levels of plasma glucose,
a phenomenon not observed for the Accu-Check II. Two
previous studies of earlier models of the Accu-Check meter
provided similar results.6,20 When we stratified venous
glucose levels (Table 1), it was discovered that the major
difference between the two meters occurred at concentra-
tions of <1 g/L, at which level the mean bias of the Glu-
coscan was +23% (95% limits of agreement: +6-+40%),
whereas the average error for the Accu-Check II was —6%
(95% limits of agreement: -21-+9%).
These observations may have important clinical im-
plications. For example, when rigid metabolic control is
being attempted, such as is standard during diabetic
pregnancy10,22 (for which desired fasting and postprandial
glucose levels are <1 and <1.2 g/L, respectively), Glu-
coscan 2000 results may lead to excessive insulin admin-
istration. On the other hand, use of Accu-Check II would
be somewhat more likely to lead to unacceptably high
blood glucose levels. Such conclusions highlight the need
to understand glucose meter performance at levels of
blood glucose that are likely to lead to changes in therapy.
Another factor that might affect meter accuracy is the
proximity of glucose measurement to the patient's last
meal because significant forearm glucose uptake occurs
in the postprandial state.13 This could lead to capillary
(meter) glucose levels that are significantly higher than
venous (Ektachem) if food had been consumed shortly
before measurement. 23 We are aware of only one study
that addressed the impact of this phenomenon on the
apparent bias of portable meter capillary glucose deter-
minations. 12 In the fasting state, capillary determinations
exceeded venous glucose levels by 14%; however, 1 and
2 hours after a 100-g glucose load, capillary measurements
were, respectively, 20% and 19% higher than venous de-
terminations. Surprisingly, we found a similar effect only
with the Glucoscan 2000 and not with the Accu-Check
252 CLINICAL CHEMISTRY
Original Article
II (Table 2). Furthermore, multiple regression analysis
indicated that this was not simply due to the positive bias
of the Glucoscan 2000 at certain levels of venous glucose.
Thus, we have no explanation for this observation, but
the data indicate that a greater allowance for error must
be taken into account if the Glucoscan 2000 is used to
measure capillary glucose in the postprandial state.
In considering all of these statistics, one must balance
factors such as availability, turnaround time, convenience,
and portability against the difference in accuracy and pre-
cision in various testing systems. These factors may be-
come more or less important in different clinical settings.
For example, accuracy and precision may be more im-
portant in measurements used to adjust insulin doses in
a "rigidly" controlled diabetic, whereas ease of operation
and availability may have increased importance in less
tightly controlled patients.
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