Alternate Site Testing for Hemoglobin A1C in Children With Diabetes

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Alternate Site Testing for

Hemoglobin A1C in Children
With Diabetes
Purpose
Alternate site testing is appropriate for blood glucose
monitoring in euglycemic states, but use of alternate sites
for collection of hemoglobin A1C has not been studied.
The purpose of this study was to determine whether A1C
results obtained from palm or forearm samples are
equivalent to A1C results obtained from fingertip sam-
ples in a pediatric population. The secondary purposes
were to determine whether there were differences in
the perceived level of site pain and if there was a site
preference.
Methods
Eighty-four children aged 5 to 20 years with type 1 or
Sarah L. Flores, MS, RN, BC
From the CHOC Children’s Hospital, Specialty Care Clinics, Orange,
California.
Correspondence to Sarah L. Flores, MS, RN, BC, CHOC Children’s
Hospital, Specialty Care Clinics, 455 S. Main Street, Orange, CA 92868
(sarflores@choc.org).
Acknowledgment: This research was supported by the Children’s
Hospital of Orange County Nursing Research Fellowship Program and
funding from the Walden and Jean Young Shaw Foundation. The author
gratefully acknowledges the assistance of Karen Sechrist, PhD, RN,
FAAN, for her guidance and support as research mentor and statistician.
Support for the CHOC Nursing Research Fellowship is sponsored by the
Walden and Jean Young Shaw Foundation.

type 2 diabetes were randomly assigned to either finger-

tip and palm (N = 41) or fingertip and forearm (N = 40) DOI: 10.1177/0145721710370719
groups. A1C samples were obtained in random order
with 1 sample immediately following the other. © 2010 The Author(s)

Results
Intraclass correlation coefficients were 0.99 for fingertip
and palm, and 0.98 for fingertip and forearm. Paired t
tests showed no differences between either set of values.
Bland-Altman bias was minimal: -0.01% (95% confi-
dence interval [CI], -0.07% to 0.05%) for the fingertip/
palm comparison and 0.0% (95% CI, -0.001 to 0.001) for
the fingertip/forearm comparison. The fingertip was pre-
ferred by 54.8%, the forearm by 25%, and the palm by
20.2% of the children. Pain ratings were lowest for the
forearm followed by the fingertip and palm.

Flores
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The Diabetes EDUCATOR

624

Conclusions although there is some debate on whether forearm sam-

Blood samples for measurement of A1C are clinically
equivalent from the fingertip and palm or fingertip and
forearm. Perceived pain was lowest when samples were
obtained from the forearm. Just over half (54.8%) of the
children preferred the fingertip.
ples produce accurate BG readings in a state of rapid
decrease of BG or hypoglycemic episodes.11-13 While the
literature supports use of AST for BG monitoring in eug-
lycemic states, no studies could be found related to the
use of AST for collection of A1C.
Purpose

T
The purpose of this study was to determine whether
he goal for diabetes management is eugly- A1C results obtained from palm or forearm samples are
cemia with blood glucose (BG) and hemo- equivalent to A1C data obtained from fingertip samples
globin A1C levels remaining as close to in a pediatric population with type 1 and type 2 diabetes.
normal for age as possible without severe The secondary purposes of the study were to determine
hypoglycemia.1 A1C is now well estab- if there were differences in the level of perceived pain
lished as the best index of medium-term control, reflect- between the fingertip and alternate sites and if there was
ing the integrated blood glucose level over the preceding a site preference for obtaining samples.
10 to 12 weeks.2 The American Diabetes Association
(ADA) recommends measurement of A1C levels 4 times
a year in addition to measuring BG several times during
Methods
the day.3 Setting and Participants
Measurement of A1C can be reliably accomplished
The study was conducted with approval of the
with either venous or capillary samples in individuals
Institutional Review Board at a free-standing children’s
without hemoglobin pathology.4 The A1C is performed at
hospital and its associated hospital-based specialty clin-
the hospital-based pediatric diabetes clinic where this
ics in Southern California. The hospital is the largest
study was conducted as a point-of-care test using the DCA
provider of care for children with diabetes in the region.
2000+ Analyzer (Bayer Corporation, Elkhart, Indiana) to
The endocrine clinic provides services for approximately
quantitatively measure the percent concentration of A1C
1300 children with diabetes across the socioeconomic
in blood for children with appropriate hemoglobin levels
spectrum. A convenience sample of 84 children between
(7 to 24 g/dL) and without hemoglobin abnormalities.5
the ages of 5 and 20 years with the diagnosis of type 1 or
Current hospital policy is to obtain the sample for the
type 2 diabetes was recruited using a convenience sam-
A1C from the fingertip, which is the traditional BG test-
pling method.
ing site. The fingertips are used for BG testing because
Inclusion criteria for the study were (1) children
of the ease of access, the high capillary density leading
between the ages of 5 and 20 years and (2) diagnosis of
to the ability to obtain an adequate sample, and the ease
type 1 or type 2 diabetes. Exclusion criteria included (1)
of transferring the sample to the BG monitor strip.6
hemoglobin A1C results less than 2.5% or greater than
Recently, home BG monitoring systems have been devel-
14.0%, which fall outside the range of linearity for the
oped that allow sample collection from thenar or hypo-
DCA 2000+ Analyzer; (2) diagnosis of diabetes made
thenar areas of the palm and from the forearm. These
less than 1 month ago, in which case collecting an A1C
sites have a lower density of pain receptors compared
was not routine care; (3) diagnosis of thalassemia or
with the fingertip and, therefore, offer benefits such as
sickle cell disease, which may lead to erroneous A1C
decreased perceived pain, decreased callous formation,
results; and (4) exclusively speaking a language other
and increased adherence to home BG monitoring.7
than English or Spanish.
Studies have demonstrated that BG readings obtained
from the palm have clinical agreement with those from
Recruitment
the fingertip through a range of glycemic conditions.6,8
Use of the forearm as a collection site has also been dem- Clinic staff members received education about the study
onstrated as an acceptable alternative to the fingertip,7,9,10 and were asked to assist with distributing recruitment

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 Alternate Site Testing for Hemoglobin A1C in Children With Diabetes
flyers to potentially eligible patients, which was accom-
plished while collecting vital sign data. Families had the
opportunity to discuss participation in the study with one
another during the wait period before being seen by a
member of the diabetes care team. If the families
expressed interest in participating, the investigator, who
is fluent in English and Spanish, determined eligibility
and obtained informed consent. Per hospital policy, pedi-
atric assent by subjects over the ages of 7 years also was
obtained. All forms were available in English and
Spanish. Demographic data collected included age, gen-
der, race/ethnicity, type of diabetes, length of diagnosis,
and home blood glucose testing site. All protected health
information was secured and was not reused or disclosed
to any third party except as required by law, for oversight
of the research, or for other research which the use or
disclosure would be permitted by the Privacy Rule in
accordance with hospital policy. Participants who com-
pleted the study received a gift card.
Data Collection
This study was conducted using a within-subjects
comparative design, comparing paired blood samples
from each subject. Data were collected from the finger-
tip, which is current hospital policy, and 1 of 2 alternate
sites, the palm or forearm. The alternate site (palm or
forearm) was randomly assigned to the study subject
before their involvement. The order in which samples
were collected (alternate site or finger-stick) was also
randomly assigned before recruitment. Data collection
commenced after eligibility was confirmed, informed
consent/assent was obtained, and demographic data were
collected.
The investigator collected blood samples at both fin-
gertip and alternate sites, 1 sample immediately follow-
ing the other, using the procedure outlined by the
manufacturer of the DCA 2000+ Analyzer (Bayer
Corporation). The subject’s perception of pain at each
site was assessed using the FACES Pain Rating Scale by
Wong-Baker, which has been demonstrated to be a valid
and reliable instrument for measuring pain intensity
among verbal children with procedural pain across the 3
developmental levels of cognitive development.14
Participants were then asked which site they would pre-
fer to use on a regular basis for A1C sample collection.
A1C samples from the alternate site and the finger were
randomized to 1 of 2 DCA analyzers for processing before
Flores
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625
obtaining the samples and were processed at the same time.
Normal and abnormal controls were run to ensure instru-
ment accuracy. DCA Analyzer instrument accuracy was
further established using proficiency samples run on both
instruments before beginning the study, which were all
within acceptable limits. Instrument linearity and calibra-
tion were verified and within acceptable allowable error.
Both machines were determined to perform accurately and
within a clinically acceptable range of difference. The
sample collected from the fingertip was used for clinical
documentation, as is the current standard of practice.
Data Analysis
Statistical analysis was performed using SPSS for
Windows 15.0 (SPSS Inc., Chicago, Illinois, 2001) and
Analyse-it v2.03 (Analyse-it Software, Leeds, UK,
2007). Agreement between results from the finger and
forearm or palm sites was examined using intraclass cor-
relation15 to look for bias and degree of agreement
between values, paired t tests to test for overall mean dif-
ferences between the 2 sites, and the Bland-Altman
analysis,16 which looks for highly disparate values and
demonstrates whether 2 methods of measurement agree
sufficiently closely.
Results
Descriptive characteristics of pediatric clinic patients
with the diagnosis of type 1 or type 2 diabetes are pre-
sented in Table 1. The 50 males represented 59.5% of the
sample and 34 females, 40.5%. Ages ranged from 5 to 20
years, with a mean of 12.96 years (standard deviation
[SD] = 4.14). The majority of the participants (81%) had
a diagnosis of type 1 diabetes, whereas 16 participants
(19%) were diagnosed with type 2 diabetes. The length
of time with the diagnosis of diabetes ranged from 2
months to 18 years; the average length of diagnosis was
4 years, 3 months (SD = 3 years, 8 months). When asked
to report their usual site for home testing blood glucose
levels, almost all of the participants (N = 77; 91.7%)
reported they used their fingertip, whereas only 7 par-
ticipants (8.3%) stated they used the forearm alternate
site. None of the participants reported using the palm as
an alternate site for home testing of blood glucose levels.
The A1C results from the alternate sites had a high
degree of agreement with A1C results from the finger-
tip. Results from 3 participants were lost because of
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Scatter Plot
Table 1 0.11

Characteristics of the Sample (N = 84)

0.1

Characteristics Range Mean (SD)

0.09
Age, y 5-20 12.96 (4.14)
Length of diagnosis, mos 2-216   51.01(44.37)

Palm
0.08
N % of Sample
Gender 0.07
  Male 50 59.5
  Female 34 40.5
Race/ethnicity 0.06
Identity
  Caucasian 44 52.4
  Hispanic 27 32.1 0.05
  Asian  4   4.8 0.05 0.06 0.07 0.08 0.09 0.1 0.11
  African American  2   2.4 Finger
  Other  7   8.1
Diabetes type Figure 1.  Bland-Altman scatter plot for agreement between fingertip and
  Type 1 68 81 palm A1C results. A1C reported as percentage for clinical use (eg, 0.11 = 11%).
  Type 2 16 19
Home blood glucose testing site
  Fingertip 77 91.7
Difference Plot
  Palm  0 0 0.004
  Forearm  7   8.3
0.003

0.002
Difference (Palm - Finger)

inadequate sample amounts, all from the forearm site. 0.001

Intraclass correlation coefficients (ICC) for the labora- 0

tory values were 0.99 (95% confidence interval [CI],
–0.001
0.98 to 0.99) for fingertip and palm, and 0.98 (95% CI,
0.96 to 0.99) for fingertip and forearm. The high ICC –0.002
value and very narrow CI support near-equivalence of –0.003
results gained from the palm and forearm alternate sites
when compared with the fingertip. Paired t tests showed –0.004

no differences between either set of laboratory values; –0.005

fingertip vs palm (t40 = -0.33, not significant) or finger- 0.05 0.06 0.07 0.08 0.09 0.1 0.11

tip vs forearm (t39 = 0.98, not significant). Mean of All

The level of agreement was further evaluated using Identity Bias (–0.0)
Bland-Altman analyses. Bias was -0.01% (95% CI, 95 % Limits of agreement (–0.0 to 0.0)
-0.07% to 0.05%) for the fingertip/palm comparison
(Figures 1 and 2) and the 95% limits of agreement were
Figure 2.  Bland-Altman difference plot for agreement between fingertip
lower, -0.004 (95% CI, -0.48 to -0.28), and upper, 0.004 and palm A1C results.
(95 CI, 0.26 to 0.46). Bias was 0.0% (95% CI, -0.001 to
0.001) for the fingertip/forearm comparison (Figures 3
and 4), and the 95% limits of agreement were lower, of A1C across the spectrum of linearity of the instru-
-0.006 (95% CI, -0.007 to -0.004), and upper, 0.006 ments; approximately 50% of A1C values fell above and
(95% CI, 0.005 to 0.008). There was a good distribution below a value of 8.0%.

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 Alternate Site Testing for Hemoglobin A1C in Children With Diabetes

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for each of the 2 sites where blood was collected. The

Scatter Plot
0.12 mean rating for pain at the fingertip was 0.65 (SD = .95);
at the palm the mean pain rating was 1.24 (SD = .1.113);
0.11 and at the forearm the mean pain rating was 0.60 (SD =
.98). Of the entire sample of 84 participants, 49 (58.3%)
0.1 rated the pain at “0” at the fingertip. When evaluating the
alternate site, pain ratings were lowest for the forearm
0.09
(rating = 0 for 62.8% of forearm-fingertip sample), fol-
Forearm

lowed by the palm (rating = 0 for 29.3% of palm-finger-

tip sample).
0.08
Site preference was also assessed. Among the entire
sample, 46 (54.8%) of the children preferred the fingertip
0.07
over the alternate site tested. However, the forearm was
preferred over the fingertip by 21 (49%) of the children
0.06
who had forearm and fingertip sites tested, and the palm
Identity
was preferred over the fingertip by 17 (41%) of the chil-
0.05 dren who had both fingertip and palm sites tested.
0.05 0.06 0.07 0.08 0.09 0.1 0.11 0.12
Finger
Discussion
Figure 3.  Bland-Altman scatter plot for agreement between fingertip and
forearm A1C results. A1C reported as percentage for clinical use (eg, 0.11 = 11%). Recruitment for this study occurred over a 2-month
period in the pediatric diabetes clinic. The sample popu-
lation was well distributed and reflective of the clinic
Difference Plot population with regard to gender, ethnicity, age, and
0.01
length of diagnosis. Approximately 85% of the diabetes
0.005
population at this clinic has type 1 diabetes and roughly
Difference (Forearm - Finger)

15% have type 2 diabetes, so the study sample adequately

0
represented the target population in this setting. Patients
were generally receptive to the study and eager to assist
with research related to diabetes.
–0.005
While alternate site testing for BG levels at home has
gained in popularity in recent years, only 7 (8.3%) of the
–0.01
participants in this study stated they used an alternate site
at home, and all reported using their forearm. Anecdotally,
–0.015
many participants stated they were open to exploring
alternate site testing at home for BG readings as a result
–0.02
0.05 0.06 0.07 0.08 0.09 0.1 0.11 0.12 of the study; the possibility of using an alternate site to
Mean of All decrease callous formation was attractive to these par-
ticipants. Forty-nine percent (21) of participants who had
Identity Bias (0.0)
both fingertip and forearm tested preferred the forearm.
95% Limits of agreement (–0.0 to 0.0)
This outcome is interesting in light of the fact that the
experience of the investigator was that generally the fore-
Figure 4.  Bland-Altman difference plot for agreement between fingertip arm did not yield as much blood as compared with the
and forearm A1C results. palm; 3 participant’s A1C results were lost because of
inadequate sample from the forearm. Forty-one percent
Pain levels were assessed using the FACES Pain (17) of the participants who had both fingertip and palm
Rating Scale by Wong-Baker. Pain assessments were tested preferred the palm, although fewer participants
obtained on a scale of 0 (no pain) to 5 (significant pain) reported no pain (rating = 0) with testing at the palm.

Flores
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628
The majority (91.7%) of participants test at the finger-
tip site at home for blood glucose testing. All participants
were allowed to choose which finger to poke for the
study. It is likely they chose their “favorite” most cal-
loused finger, which would then lead to lower pain scores
due to the decreased sensation at the calloused site. This
may have introduced bias into the pain scores. In future
studies, it may be a recommendation that which fingertip
site to be used for the study be predetermined or selected
by the investigator to decrease bias with regard to pain
levels.
Blood samples from the fingertip and palm or finger-
tip and forearm yielded clinically equivalent A1C results
without bias across a range of values in this study. Given
that there was no statistical or clinical significance
between alternate sites and fingertip, the patient and/or
family may select which site they prefer for the A1C dur-
ing their clinic visit without compromising clinical care.
Alternate sites were preferred by approximately 39
(45%) of the participants and received favorable reviews
(rating = 0–2) with regard to pain by 77 (92%) of the
study participants, despite the fact that this was the first
exposure to alternate site testing for the majority of par-
ticipants. The procedure at the author’s institution was
updated to allow for collection of A1C at the palm or
forearm, according to the child’s preference. The endo-
crine team endorsed the results of the study and instituted
a practice change to allow for alternate site collection for
A1C in the clinic.
Limitations
Few participants in this study used alternate sites for
BG testing at home. It would be beneficial to further
evaluate pain perception and site preferences in alternate
site testing for blood glucose and/or A1C in other pediat-
ric populations. Consideration should be given to assign-
ment of the fingertip site used for the study rather than
allowing the participant to choose, to decrease bias.
Findings from this study are limited to the pediatric set-
ting; further study in the adult population is warranted.
The adult population may have differing perceptions of
pain and, therefore, site preference as well. During the
course of the study, a new alternate site testing lancing
device was released. The manufacturer reported improve-
ments on current alternate site lancing devices and, there-
fore, increased ease of use and collection of blood
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samples, with less pain sensation. Use of the updated
lancing device may have prevented the loss of 3 samples
due to inadequate blood samples at the forearm site in 3
participants. It would be beneficial to use the updated
device in future studies.
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