Research ajog.

org

OBSTETRICS
Candy twists as an alternative to the
glucola beverage in gestational diabetes
mellitus screening
Diana A. Racusin, MD; Kathleen Antony, MD; Lori Showalter, MSc; Susan Sharma, PhD;
Morey Haymond, MD; Kjersti M. Aagaard, MD, PhD

OBJECTIVE: Screening for gestational diabetes mellitus commonly
uses an oral glucose challenge test with a 50-g glucola beverage and
subsequent venous puncture. However, up to 30% of pregnant women
report significant side-effects, and the beverage is costly. We hy-
pothesized that equivalent glucose loads could be achieved from a
popular candy twist (Twizzlers; The Hershey Company, Hershey, PA)
and tested it as cost-effective, tolerable alternative with a test of
equivalency.
STUDY DESIGN: The glucose equivalent of the 50-g glucola was
calculated as 10 candy twists. We initially used a triple crossover
design in nonpregnant patients whereby each subject served as her
own control; this ensured the safety and equivalency of this load before
using it among pregnant subjects. We then recruited pregnant women
with an abnormal screening at 1 hour (glucose challenge test) in a
double crossover design study. Subjects consumed 10 candy twists
with a 1-hour venous blood glucose assessment. All subjects subse-
quently completed the confirmatory 3-hour glucose tolerance test.
Sensitivity, specificity, positive predictive values, negative predictive
values, false-referral rates, and detection rates were calculated.
RESULTS: At
130 mg/dL, the sensitivity (100%) was the same
for candy twists and glucola. However, the false-referral rate (82%
vs 90%), positive predictive value (18% vs 10%), and detection rate
(18% vs 10%) were improved for candy twists when compared with
the 50-g glucola beverage.
CONCLUSION: Our results indicate that strawberry-flavored candy
twists are potentially an equally effective screening test, compared
with the gold standard glucola beverage but lead to fewer false-
positive screens and therefore could be a cost-effective alternative.
Key words: diabetes mellitus, gestational diabetes mellitus, screening

Cite this article as: Racusin DA, Antony K, Showalter L, et al. Candy twists as an alternative to the glucola beverage in gestational diabetes mellitus screening. Am J
Obstet Gynecol 2014;212:.

T o meet the metabolic demands of

a developing fetus, pregnancy oc-
curs in a state of relative insulin resis-
recognized during pregnancy.”1 Al-
though the prevalence of GDM varies
accordingly with population risk fa-
population-wide level, it is reasonable
to anticipate ongoing increased preva-
lence of GDM in the coming years.5-7
tance. A nondiabetic pregnant woman ctors and prevalence of type II diabetes The current commonly used sequence
experiences mild fasting hypoglycemia, mellitus in most populations, the com- of screening for GDM uses a 50-g oral
postprandial hyperglycemia, and mild monly accepted point prevalence varies glucose challenge test (GCT) performed
hyperinsulinemia. In contrast, according from 2-5% but can be as high as 14%.2 between 24 and 28 weeks’ gestation. A
to the American College of Obstetricians Of note, almost 40% of all women positive screen is defined as a venous
and Gynecologists, gestational diabetes with GDM will continue to have ele- blood glucose level of either 130 or 140
mellitus (GDM) is defined as “carbohy- vated glucose values after pregnancy.3,4 mg/dL at 60 minutes.1,2 The 140 mg/dL
drate intolerance that begins or is first Given the epidemic of obesity at a cutoff is 10% less sensitive than the 130
mg/dL cutoff but is also less likely to
produce a false-positive result.1 When
From the Division of Maternal-Fetal Medicine (Dr Aagaard), Department of Obstetrics and
Gynecology (Drs Racusin, Antony, and Aagaard and Ms Showalter), and Divisions of Endocrinology 130 mg/dL is used as the screening
and Nutrition, Department of Pediatrics (Drs Sharma and Haymond), Baylor College of Medicine and threshold, roughly 25% of all pregnant
Texas Children’s Hospital, Houston, TX. women will ‘screen positive’ for GDM.1
Received April 18, 2014; revised July 24, 2014; accepted July 24, 2014. Once a positive screen has been estab-
Supported in part by National Institutes of Health grant number DP20D001500 (K.M.A.). lished, the patient then undergoes a
The authors report no conflict of interest. fasting 100-g 3-hour glucose tolerance
Presented in poster format at the 34th annual meeting of the Society for Maternal-Fetal Medicine, test (GTT) with a 100-g glucose
New Orleans, LA, Feb. 3-8, 2014. beverage. Venous blood glucose is
Corresponding author: Kjersti M. Aagaard, MD, PhD. aagaardt@bcm.tmc.edu measured fasting and then at 1-, 2-, and
0002-9378/$36.00  ª 2015 Elsevier Inc. All rights reserved.  http://dx.doi.org/10.1016/j.ajog.2014.11.010 3-hour intervals after the 100-g glucose
drink. Two sets of criteria exist for then

MONTH 2014 American Journal of Obstetrics & Gynecology 1.e1

Research Obstetrics
definitively diagnosing GDM: the Na-
tional Diabetes Data Group Criteria and
the Coustan Criteria. Although the cut-
off values differ in these criteria sets,
both require at least 2 of the 4 values to
be elevated to diagnose the patient with
GDM.1
Notably, up to 30% of pregnant women
cannot tolerate the traditional 50-g glu-
cola screening test.8,9 Reported side-
effects include nausea, emesis, bloating,
abdominal pain, diarrhea, sweating, and
headache. Given this side-effect profile,
pregnant women may be unwilling or
unable to complete screening for GDM
with the glucola beverage.8-10 There are
limited reports (PubMed, 1990-present)
that provide viable alternatives to
the glucola beverage.8-11 For example,
studies that have investigated jelly beans
demonstrated lower sensitivity than the
glucola (80% sensitivity when the ‘screen
positive’ cutoff is a blood glucose value of
140 mg/dL, 90% sensitivity when the
‘screen positive’ cutoff is a blood glucose
value of 130 mg/dL). However, subjects
documented that jelly beans were better
tolerated by the study participants than
the glucola drink.8,9,11
The effects of hyperglycemia/GDM
are well-known in obstetric populations.
Infants of mothers with diabetes mellitus
are at higher risk of macrosomia, fetal
malformations, shoulder dystocia, hy-
poglycemia, hypocalcemia, respiratory
distress syndrome, and thus neonatal
intensive care unit admissions. As adults,
children of mothers with diabetes mel-
litus are at higher risk of obesity and
the development of type II diabetes
mellitus.5,12-16 This is thought to be
secondary to “metabolic memory” from
an intrauterine diabetic milieu.15,17 The
mothers, themselves, are at higher risk
for hypertension, preeclampsia, future
type II diabetes mellitus, shoulder
dystocia, and operative/cesarean de-
livery. Furthermore, maternal obesity is
associated independently with adverse
pregnancy outcomes and greater sever-
ity of outcomes,15-19 and treatment of
even mild GDM results in improved
maternal and fetal morbidity.4,20,21 Ergo,
it is imperative that the cost-effective
and well-tolerated means of screening
are used.
1.e2 American Journal of Obstetrics & Gynecology MONTH 2014
ajog.org
In this study, we sought to identify an
alternative, possibly better tolerated, TABLE 1
screening method for GDM. We chose Demographics of study cohort
to substitute an equivocal 50-g glucose Subjects
load with the use of strawberry-flavored Demographic (n [ 20), n
twist candy (Twizzlers; The Hershey Age, y
Company, Hershey, PA) as an alternative 17-30 9
to the glucola beverage. To establish
31-40 9
safety, we initially tested and confirmed
equipoise in a nonpregnant cohort.22 In 41-50 2
this study, we hypothesized that straw- Body mass index, kg/m 2
berry twists would demonstrate equi-
<25 3
poise in screening for GDM when
compared with the glucola beverage in 25-29.9 3
pregnant women but at a fraction of the
30 14
cost.
Parity
M ATERIALS AND M ETHODS Nulliparous 3
Study cohort Parous 17
After institutional review board approval Race/ethnicity
(Institutional Review Board Project# H-
26324, renewal approved on June 24, White 1
2013), recruitment for the study was Black 2
open to all pregnant women seen at the Asian 1
high-risk obstetrics clinic at Ben Taub
Hispanic 16
General Hospital between July and
October of 2013 who underwent either Most of our cohort was Hispanic and multiparous. The
mean age of our population was 30.3, and the mean
universal or risk-based screening with body mass index was 33.83 kg/m2. The median interval
the 50-g 1-hour GCT and screened pos- between the glucose challenge test and the candy twists
challenge was 2 weeks. The median gestational age at
itive, thus requiring a confirmatory 3- glucola testing was 24.6 weeks and at candy twists
hour GTT. Written informed consent testing was 28.2 weeks.
was obtained, and subjects were reim- Racusin. Candy twists as an alternative to glucola.
Am J Obstet Gynecol 2014.
bursed for their participation. Mean
gestational age at the time of testing was
24.6 weeks n for glucola and 28.2 weeks html). Ten strawberry-flavored candy
for candy twists. In our institution, a twists yielded 47.408 g of sugars, mostly
positive screen is defined as 140 mg/dL. comprised of sucrose. Other major sugars
Demographics of our study cohort are in the composition were fructose, maltose,
presented in Table 1. We did not exclude and glucose; 91.968% of the calories were
women with a history of GDM. derived from carbohydrates; 4.527% of
the calories were derived from fat,
Choice and amount of candy and 3.515% of the calories were derived
To calculate the oral intake necessary from protein.23 In the pilot study popu-
to achieve a 50-g load, nutritionists lation, there was no significant difference
who specialized in diabetes mellitus in the mean serum glucose after con-
consulted product information re- sumption. Initially, a nonpregnant cohort
garding calories, total and saturated fat, was assembled to investigate this hypoth-
carbohydrates, sugars (including sugar esis. We found that candy twists provide
alcohols), and protein in candy twists an equivalent screening alternative to
in a per piece calculation. This yielded the glucola beverage in nonpregnant
50-g calculated consumption of 10 women.22 In this study, we set out to test
strawberry-flavored candy twists in 5 these findings in a pregnant population.
minutes. Nutritional calculations were
confirmed with the University of Minne- Study protocol
sota Nutrition Data System for Research Subject recruitment was limited to those
(http://www.ncc.umn.edu/products/ndsr. who had already ‘screened positive’ for
ajog.org
GDM based up a 50-g 1-hour GCT (Azer
Scientific, Morgantown, PA22) and who
were already scheduled to undergo a
confirmatory 3-hour 100-g GTT. This
way subjects served as their own con-
trols. At our institution, we use a cutoff
of 140 mg/dL as a positive screen. Sub-
jects consumed 10 strawberry-flavored
candy twists within 5 minutes. One
hour later, 5 mL of venous blood was
drawn for testing of blood glucose and
insulin concentrations. Screen-positive
values for blood glucose values after
candy twists consumption were set as

130 mg/dL to ensure that any and all
subjects with GDM were captured in our
cohort. After candy twists, blood glucose
values were blinded to providers; sub-
jects proceeded with the 3-hour GTT
as scheduled. Results of the 3-hour
confirmatory GTT were interpreted ac-
cording to Coustan2 and National Dia-
betes Data Group diagnostic criterion.24
By limiting our cohort to those who
already required a 3-hour GTT, we
minimized cost and discomfort for the
patient.
Sample size calculation and
statistical analysis
The decision regarding sample size of
this double crossover study was made
with the goal of achieving at least 80%
power to detect equivalence between
50-g glucola and candy twists with the
use of a paired t test where each subject
is compared with her own ‘control.’
Previous data have shown the available
estimates of mean (90 mg/dL) and
standard deviation (10 mg/dL) for
serum glucose values with the glucola
beverage.10,12,25,26 We estimated that a
sample size of 20 pairs will achieve 87%
power to detect equivalence when the
margin of equivalence is 8 (hence be-
tween 82 and 98 mg/dL). The actual
difference is 0; correlation between 50-g
glucola and candy twists test for serum
glucose is 0.4 (our pilot data), with a
significance of .05. This estimate was
based on 2000 Monte Carlo simulations.
All statistical analyses were performed in
SPSS statistical software (SPSS Inc, Chi-
cago, IL). Sensitivity, specificity, positive
predictive values, negative predictive
values, false-referral rate, and detection
rate were calculated with venous blood
glucose cutoffs of 130 mg/dL to ensure
maximum detection of GDM. We de-
fined false-referral rate as the proportion
of test subjects who test positive but do
not have the disease and the detection rate
as the proportion of participants who
test positive and have the disease.27
R ESULTS
Subject demographics
Most study participants were Hispanic.
The mean body mass index in our cohort
was 33.8 kg/m2; the mean age was 30.3
years. Overall, the demographic break-
down in the study was reflective of our
clinic population. The remainder of
the demographic data can be found in
Table 1.
Glucose challenge test
Each participant served as her own
control in our double crossover study
design, whereby all subjects were
screened by the standard glucola GCT
and the 50-g load of candy twists
(calculated at 10 individual twists), fol-
lowed with a confirmatory diagnostic
100-g GTT. The comparison of venous
glucose values after the candy twists
and glucola consumption can be seen in
Table 2. Two participants were diagnosed
with GDM by both the Coustan diag-
nostic criteria and the National Diabetes
Data Group; these subjects screened
positive by both candy twists and glu-
cola. The median difference in gesta-
tional age between the glucola GCT and
the candy twists challenge was 2 weeks.
No adverse side-effects were reported
in women after completion of the
candy twists challenge. In addition to
TABLE 2
Comparison of venous glucose values after candy twists and glucola
Mean glucose,
Variable mg/dL ± standard deviation
Candy twists 130.6  31.7
Glucola 154.4  14.6
Overall, there is no statistical difference in mean, minimum, or maximum venous glucose values after 10 candy twists and 50-g
glucola beverage consumption (P > .05).
a
One subject had a glucola glucose challenge test of 139 mg/dL but was recruited because a confirmatory 3-hr glucose
tolerance test had been ordered already.
Racusin. Candy twists as an alternative to glucola. Am J Obstet Gynecol 2014.
MONTH 2014 American Journal of Obstetrics & Gynecology
Obstetrics Research
calculating the serum glucose after con-
sumption of the glucola and the candy
twists, we also calculated the insulin
concentration after candy twists con-
sumption. There is no discernible cor-
relation between venous blood glucose
values after candy twists consumption
and insulin levels measured on the same
samples (R2 ¼ 0.131).
Performance of screening modalities
Sensitivity, specificity, positive predictive
value, and negative predictive value
were calculated for candy twists and the
glucola beverage (Table 3). In our
cohort, we found the sensitivity of the
candy twists and glucola beverage to be
equivalent (100%). Notably, we found
the positive predictive value of the candy
twists to be superior to that of the glucola
beverage (18% vs 10%, respectively).
The negative predictive value of the
candy twists was calculated to be 100%,
and the specificity was 50%. The receiver
operating curve value for the candy
twists was determined to be 0.75. The
prevalence of GTT-diagnosed GDM
was 10% in this sample cohort.
To broaden our applicability, we
calculated the detection rate and the
false-referral rate for both candy twists
and the glucola beverage. The detection
rate and false-referral rate were
improved in the candy twists when
compared with the glucola beverage
(18% vs 10% and 81.8% vs 90%,
respectively). Importantly, it should be
noted that only 11 of the 20 study par-
ticipants screened positive with the
candy twists. As per our protocol and
study design, all 20 participants screened
Minimum Maximum
glucose, mg/dL glucose, mg/dL
69.5 212.9
139 a
188
1.e3
Research Obstetrics
TABLE 3
Screening values after diagnostic 3-hour glucose tolerance test
Variable
Sensitivity
Specificity
Positive predictive value
Negative predictive value
Receiver operating curve values
False-referral rate
Detection rate
At
130 mg/dL, the sensitivity was the same for candy twists and the 50-g glucola beverage. However, the false-referral rate,
positive predictive value, and detection rate were improved for candy twists when compared with the 50-g glucola beverage.
Racusin. Candy twists as an alternative to glucola. Am J Obstet Gynecol 2014.
positive with the glucola beverage.
Although both candy twists and glucola
detected the 2 study participants who,
ultimately, would be diagnosed with
GDM, the candy twists screening
method would have avoided confirma-
tory 3-hour GTTs in 9 subjects (45%).
C OMMENT
This study was powered and designed
to demonstrate equipoise between the
standard 50-g glucola beverage and a
viable candy alternative in screening
for GDM. With each subject serving
as her own control, we used a double
cross-over design and observed that the
50-g glucola beverage and 10 strawberry
twists demonstrate equipoise for dia-
betic screening with the GCT in our
study cohort. Use of strawberry candy
twists was accompanied by a higher
detection rate, with the added advantage
that fewer women would have required
a confirmatory 3-hour GTT.
By using highly sensitive serum chem-
istry assays, we were also able to calculate
serum insulin concentrations in the sub-
jects during the course of the study. We
failed to observe a relationship between
venous blood glucose values after candy
twists consumption, whereby insulin levels
measured on the same subjects samples
were noncorrelative (R2 ¼ 0.131). Because
there exists an interesting trend among
some practitioners to attempt to diagnose
insulin resistance by virtue of fasting
and oral glucose screening measures, we
1.e4 American Journal of Obstetrics & Gynecology MONTH 2014
Screening values at ‡130 mg/dL, n/N (%)
Candy twists Glucola glucose challenge test
2/2 (100) 2/2 (100)
9/18 (50) — There are several limitations to our
2/11 (18) 2/20 (10)
9/9 (100) — with a known positive glucola screen,
0.75 —
9/11 (82) 18/20 (90)
2/11 (18) 2/20 (10)
elected to compare these formulations on
serum insulin levels.28-30 The ‘gold stan-
dard’ for diagnosing insulin resistance is by
hyperinsulinemic euglycemic insulin
clamp, although both fasting insulin and
insulin-glucose ratios are argued to be of
little clinical usefulness.29,30 Our data
would support this view. Because our
values are not fasting, we did not calculate
either homeostasis model assessment or
quantitative insulin sensitivity check in-
dices. Our findings would underscore the
point that, until further data emerges from
well-designed clinical studies, practi-
tioners ought to be exceedingly cautious in
using measured insulin levels in GCTs as
reliable surrogates for insulin resistance.29
There are several notable strengths
in our study. Our double cross-over
design allowed for each subject to serve
as her own control and therefore allowed
for a small sample size. Also, although
our primary aim was to investigate a
screening test, we were able to confirm
our findings to derive sensitivity, speci-
ficity, positive predictive value, and
negative predictive value by using a
confirmatory diagnostic 3-hour GTT.
Finally, our screening strategies were
used in a clinically relevant county-based
hospital setting with a substantial GDM
prevalence. Using PeriBank, our insti-
tutional database, we noted that the
prevalence of GDM at the time of de-
livery in our largely Hispanic clinical
population was 17.64%, with a 4.3%
prevalence of type II diabetes mellitus
ajog.org
and a 0.5% prevalence of type I diabetes
mellitus. Thirty-four percent of the
pregnant women in our institutional
population manifest a body mass index

30 kg/m2. This study setting makes our
results potentially generalizable to high
prevalence populations.
study. Given that we recruited women
the specificity, negative predictive value,
and receiver operating curve value are
limited by study design. Additionally, by
design, our study was conducted in an
obstetrics population with a baseline
positive screening GCT. Although in our
cohort we did not find any women with
GDM who screened positive with the
glucola GCT but negative with the candy
twists, this is a formal possibility that
would be best addressed in a population-
based cohort study and therefore would
be considered to be a factor that would
limit immediate clinical implementa-
tion. Further studies in a low-risk, at-
large population are warranted before
generalizing our findings for clinical
implementation.
The implications to our study are both
practical and clinically applicable. In
an attempt to simplify these diagnostic
criteria and improve outcomes, the
American Diabetic Association and the
World Health Organization have adop-
ted the alternative screening algorithm
(fasting 2-hour 75-g GTT be used in
lieu of the current 2-step process) after
publication of the hyperglycemia and
adverse pregnancy outcomes trial.31
Although opponents of 75-g single-step
GTT note that such an approach will
increase the GDM prevalence in the
United States to 18%,32,33 it is important
to note that currently 29% of the popu-
lation in the United States has either
prediabetes or diabetes mellitus.34 It is
unclear currently whether this is cost-
effective or results in better patient out-
comes; therefore, such a test has not
yet been accepted by the American Col-
lege of Obstetricians and Gynecolo-
gists.33 However, other studies have
demonstrated that most women who
are diagnosed by the new criteria are
projected to manifest GDM class A1
and thus not necessitate therapy.4,20
ajog.org
Although these new screening methods
have not been accepted universally for
the reasons discussed earlier, it is clear
that there is a desire for a more stream-
lined and cost-effective screening mo-
dality for GDM.
Regarding costs, standard cost infor-
mation estimates place 10 individually
wrapped candy twists at $0.97 (amazon.
com; 2012 costs). The 50-g glucola
beverage costs range from $3.41 (pur-
chase price) to much higher billed-to-
patient costs (dependent on the clinical
setting and cost plan). Although this
minimal 4-fold difference in cost is
small in actual dollars, further savings
may be realized in the reduced require-
ment for confirmatory 3-hour GTT
diagnostic tests. The cost of a 3-hour
GTT (including blood draws) at our
institution is $100. When combined with
the lower false-referral rate noted with
the candy twists, significant savings
could be demonstrated in the cost of
subsequent confirmatory 3-hour GTTs.
In our study population of 20 subjects,
we would have spared a minimum of
$948.80 by alternately using candy
twists. Taken together with our previous
findings in nonpregnant subjects, our
data suggest that strawberry twists are
potentially an equally effective screening
test, as compared with the gold standard
glucola beverage, but lead to fewer false-
positive screens and therefore could be
a more cost-effective alternative.
It is imperative that women with
GDM be diagnosed in a simple and
timely manner with the use of tolerable
means, such as the candy twists alter-
native that we have described herein. In
summary, we have found that candy
twists are potentially an equally effective
screening method for GDM when
compared with the standard 50-g glucola
drink but result in fewer false-positive
screens. - Med 2009;14:94-100.
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