Ann. N.Y. Acad. Sci.

ISSN 0077-8923

A N N A L S O F T H E N E W Y O R K A C A D E M Y O F SC I E N C E S
Issue: Women’s Health and Disease

Establishing consensus criteria for the diagnosis

of diabetes in pregnancy following the HAPO study
Eran Hadar and Moshe Hod
Perinatal Division, Helen Schneider’s Hospital for Women, Rabin Medical Center, Petah-Tiqva, Sackler Faculty of Medicine,
Tel Aviv University, Tel Aviv, Israel

Address for correspondence: Moshe Hod, M.D., Director, Perinatal Division, Helen Schneider’s Hospital for Women, Rabin
Medical Center, Petah-Tiqva 49100, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. mhod@clalit.org.il

The current diagnostic criteria for gestational diabetes mellitus are controversial because they lack correlation to
maternal and perinatal outcome. The results of the hyperglycemia and adverse pregnancy outcome (HAPO) study
demonstrate a linear association between increasing levels of fasting, 1- and 2-h plasma glucose post a 75 g oral
glucose tolerance test to several significant outcome endpoints, such as birth weight above the 90th percentile, cord
blood serum C-peptide level above the 90th percentile, primary cesarean delivery, clinical neonatal hypoglycemia,
premature delivery, shoulder dystocia or birth injury, intensive neonatal care admission, hyperbilirubinemia, and
preeclampsia. A consensus report by the IADPSG, based on a vigorous assessment of the HAPO results and other
studies, recommended an endorsement of risk-based, internationally accepted criteria for the diagnosis and classifi-
cation of diabetes in pregnancy. This review follows the steps from defining the problem to the endpoint of achieving
a worldwide policy change.

Keywords: diagnosis; gestational; diabetes mellitus; HAPO

Gestational diabetes mellitus (GDM) is defined as
any carbohydrate intolerance, with onset or first
recognition during pregnancy.1 The occurrence of
GDM is associated with an increased incidence of
maternal morbidity—cesarean deliveries, postpar-
tum type-2 diabetes; and also perinatal/neonatal
morbidity—macrosomia, birth injury, shoulder
dystocia, hypoglycemia, polycythemia, and biliru-
binemia. Long-term sequelae of in utero exposure
to hyperglycemia may include a higher risk for obe-
sity and diabetes later in life.2
The diagnostic criteria for GDM were first pub-
lished more than 40 years ago, in a pivotal trial
conducted by O’Sullivan and Mahan.3 These cri-
teria were established based upon nonpregnancy
values, and were designed to predict the future oc-
currence of maternal type-2 diabetes.4,5 Another
widely used set of criteria, are those published by
the world health organization. These criteria are
those used to classify impaired glucose tolerance,
again, established for a nonpregnant population.6
Therefore, the current and commonly used criteria
are controversial mainly because they lack correla-
tion to outcome, be it maternal or perinatal. One
of the major features for screening and diagnosing
GDM is determining the diabetic threshold—that
is, the level at which maternal blood glucose con-
veys a significant risk to the fetus. This threshold
remains an elusive endpoint due to lack of uni-
form, risk-based standards and due to the unknown
implications of possible confounders on pregnancy
outcome—such as maternal age, weight, hyperten-
sion, history of previous GDM and macrosomia,
caregiver bias, and other nonglucose-related medi-
cal complications.7–10 Previous studies have shown
that the current accepted criteria may lead to un-
der diagnosis of diabetes.11–15 Also, several inter-
ventional studies have demonstrated that treatment,
aiming for lower glucose levels, may lead to better
perinatal outcome.16,17
Not only the glucose threshold is controversial,
but other fundamental aspects of GDM, still remain
unanswered: whether to screen or not to screen,18 if
screening or diagnosing is undertaken; what is the

doi: 10.1111/j.1749-6632.2010.05671.x
88 Ann. N.Y. Acad. Sci. 1205 (2010) 88–93 
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Hadar & Hod
optimal timing and what are the best modalities to
do so;19–21 what are the optimal treatment modal-
ities, in terms of risk and benefits, to the baby and
the mother?16,17 To answer some of the abovemen-
tioned controversies, the hyperglycemia and adverse
pregnancy outcome (HAPO) study was planned and
executed.
The HAPO study was an investigator initi-
ated trial, prospective, observational, multicenter,
blinded study. Special care was implemented in
planning the study, with standardization applied
for participant enrollment, data collection, labo-
ratory analyses, and interpretation of results.22–25
The study was held in a multinational, multicul-
tural, ethnically diverse population, from various
countries. The preliminary hypothesis of the study
was that gestational hyperglycemia, even below the
threshold for diabetes, will be associated with in-
creased maternal, fetal, and neonatal morbidities.22
The participating teams in the study included 15
medical centers, in nine different countries. Eligible,
consenting women were recruited from July 2000 to
April 2006. Each pregnant woman at a gestational
age closely as possible to 28 weeks (range was 24–32
weeks) was evaluated for weight, height, and blood
pressure. Each woman filled a standard question-
naire to collect demographic data and medical his-
tory. A blood sample was drawn, for fasting plasma
glucose (FPG), followed by a 75 g oral glucose tol-
erance test (OGTT). Additional blood samples were
collected 1 and 2 h postglucose intake. Also, a sam-
ple for random plasma glucose (RPG) was collected
at 34–37 weeks of gestation, to identify late onset di-
abetes. The caregivers and the participating women
were blinded to the results unless: FPG exceeded 105
mg/dL (5.8 mmol/L), 2-h OGTT plasma glucose ex-
ceeded 200 mg/dL (11.1 mmol/L), RPG was equal
or greater than 160 mg/dL (8.9 mmol/L) or if any
glucose value was below 45 mg/dL (2.5 mmol/L).
Only women whose results remained blinded and
who had no additional glucose testing outside the
study protocol were included in the final data anal-
ysis. Cord blood was collected at delivery for mea-
surement of glucose and C-peptide (as a surrogate
marker for plasma insulin levels). Prenatal care, tim-
ing, and mode of delivery and postnatal follow up
were practiced according to standard care guide-
lines, for each of participating center. Data regard-
ing prenatal course, labor, delivery, postpartum fol-
low up, and the newborn’s status were extracted
Ann. N.Y. Acad. Sci. 1205 (2010) 88–93 
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Consensus criteria following the HAPO study
from medical records. At 4–6 weeks following de-
livery, a questionnaire was administered to col-
lect follow-up information for the mother and her
baby.23
A total of 23,316 women completed the course of
the study, not being lost to follow up, and remaining
with blinded data. The results of the HAPO study
demonstrate a linear association between increasing
levels of fasting, 1- and 2-h plasma glucose post a 75
g OGTT, to the four primary endpoints of the study:
birth weight above the 90th percentile, cord blood
serum C-peptide level above the 90th percentile,
primary cesarean delivery, and clinical neonatal hy-
poglycemia. Positive correlations were also found
between increasing plasma glucose levels to the five
secondary outcomes: premature delivery, shoulder
dystocia or birth injury, intensive neonatal care
admission, hyperbilirubinemia, and preeclampsia.
Adjustments were made for field center, maternal
BMI, blood pressure, height, parity, baby’s gender,
and ethnic group—these reduced the observed as-
sociations, but they generally remained valid. This
validates the results for all age groups, countries,
and ethnic origin—thus, eliminating the proposed
impacts of some speculated confounders.23
Additional analyses examined the issue of neona-
tal adiposity. Out of the total HAPO participants,
cord serum C-peptide results were available for
19,885 newborns and skin-fold measurements for
19,389. These measurements were used to deter-
mine the relationship between neonatal adiposity
(defined as the sum of skin folds higher than 90th
percentile or body fat percentage over 90th per-
centile) to maternal glucose levels. There is a sta-
tistically significant correlation between increasing
values of maternal glycemia, on all glucose values,
and cord serum C-peptide to neonatal adiposity.
The pattern is similar to the correlation between
maternal glucose values and birth weight above the
90th percentile, and was held true also for fat free
mass (derived by subtracting fat mass from total
body weight).24 The results of these anthropomet-
ric measurements suggest a link between maternal
glycemia to neonatal adiposity, which may be medi-
ated by fetal insulin. This validates the 50-year-old
Pedersen hypothesis that maternal glucose trans-
ported to the fetus, across the placenta, causes fetal
hyperglycemia, which in turn stimulates fetal in-
sulin release that acts as the secondary messenger
that leads to the fetal overgrowth.26
89
Consensus criteria following the HAPO study Hadar & Hod

Figure 1. Frequency of primary outcomes across the glucose categories. Glucose categories are defined as follows: fasting plasma
glucose level—category 1, less than 75 mg/dL (4.2 mmol/L); category 2, 75–79 mg/dL (4.2–4.4 mmol/L); category 3, 80–84 mg/dL
(4.5–4.7 mmol/L); category 4, 85–89 mg/dL (4.8–4.9 mmol/L); category 5, 90–94 mg/dL (5.0–5.2 mmol/L); category 6, 95–99 mg/dL
(5.3–5.5 mmol/L); and category 7, 100 mg/dL (5.6 mmol/L) or more. 1-h plasma glucose level—category 1, 105 mg/dL (5.8 mmol/L)
or less; category 2, 106–132 mg/dL (5.9–7.3 mmol/L); category 3, 133–155 mg/dL (7.4–8.6 mmol/L); category 4, 156–171 mg/dL
(8.7–9.5 mmol/L); category 5, 172–193 mg/dL (9.6–10.7 mmol/L); category 6, 194–211 mg/dL (10.8–11.7 mmol/L); and category 7,
212 mg/dL (11.8 mmol/L) or more. 2-h plasma glucose level—category 1, 90 mg/dL (5.0 mmol/L) or less; category 2, 91–108 mg/dL
(5.1–6.0 mmol/L); category 3, 109–125 mg/dL (6.1–6.9 mmol/L); category 4, 126–139 mg/dL (7.0–7.7 mmol/L); category 5, 140–57
mg/dL (7.8–8.7 mmol/L); category 6, 158–177 mg/dL (8.8–9.8 mmol/L); and category 7, 178 mg/dL (9.9 mmol/L) or more.

The HAPO study therefore demonstrated that
fasting glucose levels and post 75 g OGTT glucose
measurements are correlated to maternal, perinatal,
and neonatal outcomes. The correlation exists in a
linear manner, without a clear cut threshold. Glu-
cose has an impact on pregnancy outcome, even at
levels below the current, commonly accepted range.
These results provide the evidence for developing
outcome-based standards to diagnose and classify
GDM, that are valid and applicable worldwide. The
process to determine such a worldwide consensus
is not simple to achieve, and it demands the co-
operation of multiple diabetic interest groups, in
multiple countries, with a multitude of medical and
economical aspects to be considered, to transform
the HAPO results into clinical practice guidelines.
The International Association of Diabetes and Preg-
nancy Study Groups (IADPSG) was formed in 1998
to collaborate between international groups inter-
ested in pregnancy and diabetes. At June 2008, the
IADPSG held an international workshop on GDM
diagnosis and classification, publishing a consensus
report that represents the opinion of the IADPSG
members on the diagnosis of GDM.27 The results
of the HAPO study were vigorously assessed, and
served as the fundamental basis for the IADPSG
report, along with other studies consistent with the
HAPO results.28–30 The IADPSG panel members

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c 2010 New York Academy of Sciences.
Hadar & Hod
Table 1. Threshold values for diagnosis of GDM
Glucose
concentration
threshold
Glucose measure mg/dL mmol/L
Fasting plasma glucose (FPG) 92 5.1
1-h plasma glucose 180 10.0
2-h plasma glucose 153 8.5
Note: One or more of these values from a 75 g OGTT
must be equaled or exceeded for diagnosis of GDM.
state that they expect for their report to serve as
the basis to endorse a risk-based, international ac-
cepted criteria for the diagnosis and classification of
diabetes in pregnancy.
The HAPO study, compared the prevalence of the
abovementioned endpoints across the entire distri-
bution of glucose concentrations, with the lowest
glucose concentration ranges, used as the reference
for establishing odds ratios (Fig. 1). The IADPSG
panel decided that for selection of diagnostic thresh-
olds, mean values for FPG, 1-h, and 2-h OGTT
plasma glucose values are to be used as reference.
The predefined value for the OR, at the threshold,
relative to the mean was selected to be 1.75. The
recommended glucose values for FPG, 1-h, and 2-h
plasma OGTT, are listed in Table 1. These thresh-
olds are the average glucose values at which odds
for birth weight >90th percentile, cord C-peptide
>90th percentile, and percent body fat >90th per-
centile reached 1.75 times the estimated odds of
these outcomes at mean glucose values, based on
fully adjusted logistic regression models. At least
one out of these three thresholds must be equaled or
exceeded to make a diagnosis of GDM. Among the
HAPO cohort, 11.1% had only one elevated value,
3.9% had two elevated results, and 1.1% had ele-
vation of all three results. In addition, 1.7% of the
cohort was unblinded due to an FPG or 2-h plasma
glucose value, at enrollment, over the abovemen-
tioned predefined values. Thus, by these new crite-
ria, the total incidence of GDM in the HAPO study
was 17.8%.
The issue of classification of women with likely
prepregnancy diabetes (overt diabetes), only first
diagnosed during pregnancy, was also addressed
Ann. N.Y. Acad. Sci. 1205 (2010) 88–93 
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Consensus criteria following the HAPO study
in the IADPSG report. Prepregnancy diabetes is
important to identify, while pregnant, for several
reasons: an increased risk of congenital anomalies;
higher prevalence of end organ diabetic complica-
tions; need for rapid and early treatment and follow-
up during pregnancy to ensure prompt restoration
of normal glycemia and to ensure confirmation and
appropriate treatment of diabetes postpartum.31–33
The assessment for overt diabetes should be made
during the initial visit for prenatal care, although
there is still debate whether it should be done as uni-
versal or risk-based testing. Hemoglobin A1C value
above 6.5% (measured in a laboratory standardized
with the Diabetes Control and Complications Trial
[DCCT]/UK Prospective Diabetes Study [UKPDS]
assay) is used for diagnosis of diabetes outside preg-
nancy.34,35 Other than the use of A1C, consensus
thresholds are recommended for the other individ-
ual glycemia measures—FPG or RPG (Table 2). A
tentative diagnosis of overt diabetes, based on mea-
surement of random plasma glucose, must be con-
firmed with either an FPG or A1C.
The overall strategy recommended by the
IADPSG panel for detection and diagnosis of hyper-
glycemic disorders in pregnancy is summarized in
Table 3. The first step of evaluation is the detection of
overt diabetes, in women not previously diagnosed
outside of pregnancy. Universal early testing in pop-
ulations with a high prevalence of type 2 diabetes
is recommended, especially if metabolic testing in
this age-group is not commonly performed outside
of pregnancy. The second step is a 75 g OGTT pre-
formed at 24–28 weeks of gestation, in all women
Table 2. Threshold values for diagnosis of overt diabetes
in pregnancy
Measure of glycemia Concensus thresholds
Fasting plasma glucose ≥126 mg/dL (7 mmol/L)
Hemoglobin A1C ≥6.5%a
Random plasma glucose ≥200 mg/dL (11.1mmol/L)
+ confirmationb
Note: One of these must be met to identify the patient as
having overt diabetes in pregnancy.
a
Using a DCCT/UKPDS-standardized assay.
b
If RPG is initially measured, the tentative diagnosis of
overt diabetes in pregnancy should be confirmed by FPG
or A1C.
91
Consensus criteria following the HAPO study Hadar & Hod

Table 3. Strategy for the detection and diagnosis of hyperglycemic disorders in pregnancy

First prenatal visit

Measure FPG, A1C, or RPG on all or only high-risk womena
If results indicate overt diabetes, treatment and follow-up as for preexisting diabetes
If results not diagnostic of overt diabetes and FPG are 92–126 mg/dL (5.1–7.0 mmol/L), diagnose as GDM
If results not diagnostic of overt diabetes and FPG are <92 mg/dL (5.1 mmol/L), test for GDM from 24–28 weeks
with a 75 g OGTTb
24–28 weeks’ gestation
2–h 75 g OGTT, performed after an overnight fast, on all women not previously found to have overt diabetes or GDM
during testing earlier in this pregnancy:
Overt diabetes if FPG ≥126 mg/dL (7.0 mmol/L)
GDM if one or more values equals or exceeds thresholds indicated in Table 1
Normal if all values on OGTT less than thresholds indicated in Table 1
Postpartum glucose testing
Should be performed for all women diagnosed with overt diabetes during pregnancy or GDM

Note: To be applied to women without known diabetes antedating pregnancy.

a
Decision to perform blood testing for evaluation of glycemia on all pregnant women or only on women with
characteristics indicating a high risk for diabetes is to be made on the basis of the background frequency of abnormal
glucose metabolism in the population and on local circumstances.
b
There have been insufficient studies performed to know whether there is a benefit of generalized testing to diagnose
and treat GDM before the usual window of 24–28 weeks’ gestation.

not previously found to have overt diabetes or
GDM.
The HAPO study was an observational trial. How-
ever, two randomized controlled trials of treatment
of mild GDM have been carried out successfully in
the period of the HAPO study.24,25 In both trials,
treatment, achieved primarily by diet/lifestyle mod-
ification, resulted in reduced birth weight, macroso-
mia, and preeclampsia. Recruitment and glycemic
values of participants were not identical to the
HAPO study, however, there was substantial overlap
between glucose values used for inclusion in the ran-
domized controlled trials (RCTs) and those recom-
mended in the IADPSG report, as the new threshold
values. Hence, although not directly comparable,
these RCTs are in concordance, and complementary
to the new recommended criteria.
It is important to mention that simpler and more
cost-effective strategies that do not require perform-
ing an OGTT on most pregnant women may be de-
veloped. The HAPO study showed that the risks of
some of the endpoints are low when FPG falls be-
neath 4.4 mmol/L (80 mg/dL). However, using FPG
to potentially identify pregnancies at very low risk
for GDM and for adverse outcomes still requires
further evaluation, before it can be routinely rec-
ommended.
In conclusion, glucose testing early in pregnancy
to detect overt diabetes and again with a 75 g OGTT
at 24–28 weeks of gestation, in all pregnancies not
already diagnosed with overt diabetes or GDM by
early testing, represents a fundamental change in
the detection of hyperglycemia in pregnancy. Also,
applying these criteria will substantially increase the
frequency of hyperglycemic disorders in pregnancy.
This is consistent with the high prevalence of obesity
and disorders of glucose metabolism in the general
population.
Conflicts of interest
The authors declare no conflicts of interest.
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