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COMMENTARY

The One Step test:


The better diagnostic approach
for gestational diabetes mellitus
It is time for the United States to reconsider its guidelines
for screening for GDM

Vincenzo Berghella, MD Gabriele Saccone, MD


Professor and Director Resident
Division of Maternal-Fetal Medicine and Fellowship Program Department of Neuroscience
Department of Obstetrics and Gynecology Reproductive Sciencesand Dentistry School of Medicine
Sidney Kimmel Medical College of Thomas Jefferson University University of Naples Federico II
Philadelphia, Pennsylvania Naples, Italy

G
estational diabetes mellitus Diagnostic options Why we support
(GDM) generally is defined Different methods for screening and the One Step test
as any degree of glucose diagnosis of GDM have been pro- There are several reasons to prefer
intolerance with onset or first rec- posed by international societies; the One Step approach for the diag-
ognition during pregnancy.1-14 The there is controversy regarding the nosis of GDM, compared with the
best approach and exact criteria to diagnosis of GDM by either the One Two Step approach.
use for GDM screening and diag- Step or the Two Step approach.6 Women testing negative for
nosis are under worldwide debate. The One Step approach includes GDM with Two Step still experi-
In TABLE 1 we present just some of an oral glucose tolerance test with ence complications pregnancy.
the many differing suggestions by a 75-g glucose load with measure- Women who test positive for GDM
varying organizations.2,7-9,11,12,15-17 The ment of plasma glucose concentra- with the One Step test, but nega-
American College of Obstetricians tion at fasting state and 1 hour and tive with the Two Step test, despite
and Gynecologists, for instance, sug- 2 hours post–glucose administra- having therefore a milder degree
gests a Two Step approach to diag- tion. A positive result for the One of glucose intolerance, do have a
nosis.15 We will make the argument Step approach is defined as at least higher risk of experiencing several
in this article, however, that diag- 1 measurement higher than 92, 180, complications.23 For the mother,
nosis should be defined universally or 153 mg/dL at fasting, 1 hour, or these complications include gesta-
as an abnormal result with the One 2 hours, respectively. tional hypertension, preeclampsia,
Step 75-g glucose testing, as adopted The Two Step approach includes and cesarean delivery. The baby also
by the World Health Organization, a nonfasting oral 50-g glucose load, can experience problems at birth
International Federation of Gyne- with a glucose blood measurement (TABLE 2).23 Therefore, women who
cology and Obstetrics, and others. 1 hour later. A positive screening, test positive for GDM with the One
Approximately 8% of all pregnancies defined often as a blood glucose Step test deserve to be diagnosed
are complicated by GDM by the One value higher than 135 mg/dL (range, with and treated for the condition,
Step test in the United States.18-22 The 130 to 140 mg/dL), is followed by a as not only are they at risk for these
prevalence may range from 1% to diagnostic test with a 100-g glucose complications but also treatment of
14% of all pregnancies, depending on load with measurements at fasting the GDM decreases the incidence of
the population studied and the diag- and 1, 2, and 3 hours post–glucose these complications.18,19
nostic tests employed.1,19 administration. A positive diagnos- There is indeed an increased
The authors report no financial relationships
tic test is defined as 2 measurements GDM diagnosis rate with the One
relevant to this article. higher than the target value. Step (about 8%) compared with

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TABLE 1 Criteria for gestational diabetes mellitus screening by selected societies2,7-9,11,12,15-17
No. of
abnormal Fasting 1 hour 2 hours 3 hours
values required glucose after loading after loading after loading
Society Test for diagnosis (mg/dL) (mg/dL) (mg/dL) (mg/dL)
ACOG 2017 ; 15
Two Step 3-hr 100 g ≥2 95 180 155 140
C&C16
ACOG 201715; Two Step 3-hr 100 g ≥2 105 190 165 145
NDDG17
ADA 20177 One Step 2-hr 75 g ≥2 95 180 155 Not required
75 g
ADA 20177 Two Step 3-hr 100 g ≥2 95 180 155 140
100 g
CDA 20138 Two Step 2-hr 75 g ≥2 95 191 160 Not required
FIGO 201312 One Step 2-hr 75 g ≥1 92 180 153 Not required
IADPSG 2015 2,12
One Step 2-hr 75 g ≥1 92 180 153 Not required
NICE/RCOG 2015 9
One Step 2-hr 75 g ≥1 101 Not required 140 Not required
WHO 201311 One Step 2-hr 75 g ≥1 92 180 153 Not required
Abbreviations: ACOG, American College of Obstetricians and Gynecologists; ADA, American Diabetes Association; CDA, Canadian Diabetes Association; C&C, Carpenter and
Coustan; FIGO, International Federation of Gynecology and Obstetrics; IADPSG, International Association of Diabetes Pregnancy Study Group; NICE, National Institute for
Health and Care Excellence; RCOG, Royal College of Obstetricians and Gynecologists; NDDG, National Diabetes Data Group; WHO, World Health Organization.

the Two Step test (about 4%). important and convincing reason the the One Step approach is associated
Nonetheless, this increase is mild One Step test should be used is that with significant reductions in: large
and nonsignificant in the meta- meta-analysis of the 4 RCTs com- for gestational age (56%), admission
analysis of randomized controlled paring the approaches (including to neonatal intensive care unit (51%),
trials (RCTs),18,19 is less than the 18% 2 US trials) shows that diagnosing and neonatal hypoglycemia (48%).
difference in diagnosis rate previ- and treating mild GDM as per the Tests of heterogeneity in the meta-
ously hypothesized, is consistent One Step approach, compared with analysis and of quality all pointed
with the increased diabetes/predia- screening and treating using the to better outcomes in the One Step
betes rates in the general popula- Two Step approach, is associated test group.13,19
tion, and is linked to the increasing with increased incidence of GDM The need for a second step in
incidence of obesity and insulin (8% vs 4%) and with better maternal the Two Step approach delays
resistance. and perinatal outcomes.13,18,19 In fact, diagnosis and treatment. The One
Overall test adherence is bet-
ter. Five percent to 15% of patients,
depending on the study, are not TABLE 2 Complication risks in pregnancies that are positive
adherent with taking the second part for GDM at the One Step test but negative at the Two Step
of the Two Step test. Women indeed test compared with pregnancies that are negative at the
prefer the One Step approach; One Step test23
the second step in the Two Step Maternal Neonatal
approach may be a burden.
Gestational hypertension Preterm birth
Less costly. The One Step process is
cost-effective when postpregnancy Preeclampsia Macrosomia/LGA
diabetes mellitus prevention is Cesarean delivery Hypoglycemia
considered. Intensive care unit admission
Better maternal and perinatal Abbreviations: GDM, gestational diabetes mellitus; LGA, large for gestational age.
outcomes. Probably the most

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COMMENTARY

TABLE 3Benefits of the One Step approach, compared with Step approach is associated with an
the Two Step approach increase in GDM test adherence and
• The increased GDM rate (8% with One Step vs 4% with Two Step) is consistent
earlier diagnosis,13 which is another
with the increased diabetes/prediabetes rates in the general population reason for better outcomes with the
One Step approach. In the presence
• Better adherence, as patients may not be adherent with the second part of the
Two Step test of risk factors, such as prior GDM,
prior macrosomia, advanced mater-
• Milder GDM (positive One Step test, but negative Two Step) is associated with
several maternal and perinatal adverse outcomes, compared with euglycemic
nal age, multiple gestations, and oth-
women (see TABLE 2)23 ers, the One Step test should be done
at the first prenatal visit.
• The One Step process is cost-effective when postpregnancy DM prevention is
considered
• Meta-analysis of RCTs19 shows that diagnosing and treating mild GDM as per the
One Step approach, compared with screening and treating using the Two Step
US guidelines should
approach, is associated with several benefits, including less: be reconsidered
– Preeclampsiaa The One Step, 75-g, 2-hour oral glu-
– Large for gestational age cose tolerance test is universally
– Neonatal hypoglycemia used to diagnose diabetes mel-
– NICU admission litus outside of pregnancy. Given
– Neonatal deatha
our many noted reasons (TABLE 3),
• The need for a second step in the Two Step approach delays diagnosis and we recommend universal screen-
treatment of GDM
ing of GDM by using the One Step
• The One Step, 75-g, 2-hour OGTT is universally used outside of pregnancy approach. It is time, indeed, for
Abbreviations: GDM, gestational diabetes mellitus; DM, diabetes mellitus; NICU, neonatal intensive care unit; the United States to reconsider
OGTT, oral glucose tolerance test; RCT, randomized controlled trial.
its guidelines for screening for
a
Statistical trends.
GDM.

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