Diabetes in Pregnancy Study Group in India (DIPSI) – A Novel Criterion to Diagnose GDM

Abstract

Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance recognised
first only during pregnancy. Women with GDM are more prone to future diabetes and other
maternal and fetal complications. Most of the people in India reside in rural areas and an Universal
screening is required in such settings which is simple, convenient and economical. Diabetes in
Pregnancy Study Group India (DIPSI) has recommended a modified 75 g oral glucose tolerance
test (OGTT) to diagnose GDM. Very few studies are available to show the effectiveness of DIPSI.
Aim: Our aim is to compare and correlate WHO and DIPSI CRITERIA in diagnosing GDM.
Materials and Methods: 149 healthy pregnant women attending antenatal clinic of Santhiram
General Hospital underwent 75 g OGTT between 24-28 weeks of pregnancy recommended by
WHO. Two venous blood samples and urine samples, one fasting and other 2 hr sample after 75 g
glucose load were obtained and analysed. Three days later all of them were made to undergo 75 g
OGTT recommended by DIPSI. A single 2 hr blood sample was collected after the load and
analysed. Both criteria values are subjected to statistical analysis.
Statistical Analysis: The mean and S.D of age and parity, BMI, 2 hr plasma glucose were
calculated. Comparision and correlation of diagnostic criteria of GDM by WHO and DIPSI were
analyzed by Fischer exact test (chi- square test) and significance done using Statistical analysis
using SPSS software (version 20) and MedCalc (version 12.7.0).
Results: Out of 149 pregnant women who underwent screening for GDM, 63 were diagnosed to
have GDM. The mean age and S.D of nonGDM and GDM pregnant women were 22.7±3.5 vs
24.35±4.77 year. The mean 2nd hr glucose values and S.D of nonGDM and GDM cases were
98±14 vs154.32±8.7mg/dl. WHO identified 63 GDM cases and DIPSI identified 58 GDM cases i.e.
92% of GDM cases identified by WHO were found to be identified by DIPSI. Out of them 52
women were diagnosed as GDM by both WHO and DIPSI. We compared the correlation of DIPSI
with WHO 2ndhr sample for diagnosing GDM by Fischer exact t-test. P-value and its significance is
calculated. Chi squared test equals to 75.181(P<0.0001) which is extremely significant.
Conclusion: DIPSI has all those qualities of a screening test. It is simple, single, convenient,
economical, can be used as both diagnostic as well as screening test and with good perinatal
outcome. So can be used in routine laboratory to diagnose GDM.

Full text

_____________________________________________________________________________________________________
*Corresponding author: E-mail: havilah.polur@gmail.com;
International Journal of Biochemistry Research
& Review
10(1): 1-6, 2016, Article no.IJBcRR.22624
ISSN: 2231-086X, NLM ID: 101654445
SCIENCEDOMAIN international
www.sciencedomain.org
Diabetes in Pregnancy Study Group in India (DIPSI)
– A Novel Criterion to Diagnose GDM
Havilah Polur
1*
, K. Durga Prasad
1
,
Pandit Vinodh Bandela
2
, Hindumathi
3
and Shaik Hussain Saheb
4
1
Department of Biochemistry, Santhiram Medical College, Nandyal, Andhra Pradesh, India.
2
Department of Biochemistry, Konaseema Institute of Medical Sciences and Research Foundation,
Amalapuram, India.
3
Department of OBG, Santhiram Medical College, Nandyal, Andhra Pradesh, India.
4
Department of Anatomy, JJM Medical College, Davangere, Karnataka, India.
Authors’ contributions
This work was carried out in collaboration between all authors. Author HP designed the study, wrote
the protocol and wrote the first draft of the manuscript.
Authors PVB, Hindumathi and SHS managed
the literature searches and analysis of the study performed. All authors read and approved the final
manuscript.
Article Information
DOI: 10.9734/IJBCRR/2016/22624
Editor(s):
(1)
Chan-Min Liu, School of Life Science, Xuzhou Normal University, Xuzhou City, China.
(2)
Dileep G. Nair, Ministry of Higher Education, Sultanate of Oman.
Reviewers:
(1) Jerzy Beltowski, Medical University, Lublin, Poland.
(2)
Shigeki Taga, Kagawa Prefectural Central Hospital, Japan.
(3)
Jahan Ara Ainuddin, Dow University of Health Sciences, Karachi, Pakistan.
(4)
Marco Matteo Ciccone, University of Bari, Italy.
Complete Peer review History:
http://sciencedomain.org/review-history/12940
Received 15
th
October 2015
Accepted 9
th
December 2015
Published 11
th
January 2016
ABSTRACT
Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance recognised
first only during pregnancy. Women with GDM are more prone to future diabetes and other
maternal and fetal complications. Most of the people in India reside in rural areas and an Universal
screening is required in such settings which is simple, convenient and economical. Diabetes in
Pregnancy Study Group India (DIPSI) has recommended a modified 75 g oral glucose tolerance
test (OGTT) to diagnose GDM. Very few studies are available to show the effectiveness of DIPSI.
Aim: Our aim is to compare and correlate WHO and DIPSI CRITERIA in diagnosing GDM.
Original Research Article

Polur et al.; IJBcRR, 10(1): 1-6, 2016; Article no.IJBcRR.22624
2
Materials and
Methods
:
149 healthy pregnant women attending antenatal clinic of Santhiram
General Hospital underwent 75 g OGTT between 24-28 weeks of pregnancy recommended by
WHO. Two venous blood samples and urine samples, one fasting and other 2 hr sample after 75 g
glucose load were obtained and analysed. Three days later all of them were made to undergo 75 g
OGTT recommended by DIPSI. A single 2 hr blood sample was collected after the load and
analysed. Both criteria values are subjected to statistical analysis.
Statistical Analysis: The mean and S.D of age and parity, BMI, 2 hr plasma glucose were
calculated. Comparision and correlation of diagnostic criteria of GDM by WHO and DIPSI were
analyzed by Fischer exact test (chi- square test) and significance done using Statistical analysis
using SPSS software (version 20) and MedCalc (version 12.7.0).
Results: Out of 149 pregnant women who underwent screening for GDM, 63 were diagnosed to
have GDM. The mean age and S.D of nonGDM and GDM pregnant women were 22.7±3.5 vs
24.35±4.77 year. The mean 2
nd
hr glucose values and S.D of nonGDM and GDM cases were
98±14 vs154.32±8.7mg/dl. WHO identified 63 GDM cases and DIPSI identified 58 GDM cases i.e.
92% of GDM cases identified by WHO were found to be identified by DIPSI. Out of them 52
women were diagnosed as GDM by both WHO and DIPSI. We compared the correlation of DIPSI
with WHO 2
nd
hr sample for diagnosing GDM by Fischer exact t-test. P-value and its significance is
calculated. Chi squared test equals to 75.181(P<0.0001) which is extremely significant.
Conclusion: DIPSI has all those qualities of a screening test. It is simple, single, convenient,
economical, can be used as both diagnostic as well as screening test and with good perinatal
outcome. So can be used in routine laboratory to diagnose GDM.
Keywords: Gestational Diabetes Mellitus (GDM); World Health Organization (WHO); Diabetes in
Pregnancy Study Group in India (DIPSI); Impaired Glucose Tolerance (IGT).
1. INTRODUCTION
Gestational Diabetes Mellitus (GDM) is defined
as any degree of glucose intolerance with onset
or first recognition during pregnancy. The recent
data on the prevalence of GDM in our country
was 16.55% by WHO criteria of 2 hr PG≥140
mg/dl [1]. The maternal and fetal outcomes
depend on proper screening of high risk patients.
The conventional methods so far used to
diagnose GDM are confusing, contradictory and
country specific guidelines. DIPSI- a modified
WHO criteria was designed as per Indian
standards. It is simple, convenient and can be
used as a universal screening test [1-3]. Our aim
of the study is to compare WHO 2
nd
hr sample
and DIPSI CRITERIA in diagnosing GDM.
2. MATERIALS AND METHODS
The study was initiated after informed consent
was taken from the participants and with the
approval of the institutional ethical committee of
Santhiram Medical College, Nandyal, Kurnool.
The present study was a preliminary cross
sectional study done during June 2015- Sep
2015. 149 pregnant women aged between 19-35
yrs attending antenatal o.p in the department of
gynaecology and obstetrics, Santhiram general
hospital were selected and followed till delivery.
Details of their pregnancy, anthropometric
measurements, family history of DM, prior history
of GDM and other relevant history were recorded
at their first visit. Inclusion criteria: Primi aged
>25 yrs, women with gestation age of 24-28
weeks. past history of GDM, BMI>25 [4],
first
degree relative with diabetes, PCOS, precious
pregnancy, Women with excessive weight gain
during pregnancy, previous macrosomic baby
(more than 4 kg) or a pasthistory of recurrent
miscarriages, congenitalanomalies [4].
Women known to have pre-existing diabetes,
previously undiagnosed diabetes if the woman is
at low risk for diabetes, thin and no personal or
family history of diabetes were excluded from the
study. All the participants were screened during
gestational period of 24 weeks - 28 weeks. Body
mass index (BMI) was calculated using the
formula weight (in kg) divided by height in meters
(squared) in the first antenatal visit itself.
Participant women were prepared for the day of
GTT by instructing not to take food after 8 PM
the previous night. Should not take any
breakfast. This is to ensure 12 hours fasting. The
patients are advised to remain in the hospital
during the waiting period of two hours without
any active exercise. On the day of the test fasting
venous blood sample and urine samples are
collected.

Polur et al.; IJBcRR, 10(1): 1-6, 2016; Article no.IJBcRR.22624
3
Oral Glucose Tolerance Test (OGTT) is
performed based on WHO critera. 75 grams of
glucose dissolved in 300 ml of water and
instructed to take within 5 min and time is noted.
After 2 hrs of giving glucose load another venous
blood sample and urine samples are collected.
Two blood samples collected in sodium fluoride
vacutainers are subjected to centrifugation.
Plasma is analysed for glucose levels by GOD-
POD method using commercial kits supplied by
Agappe diagnostics on a semi automated erba-
chem -7 within an hour. Urine samples are
analysed for glucose by urine dipstick method.
Two days later they were asked to visit the lab to
undergo GTT according to DIPSI in a nonfasting
state. As soon as they arrive, irrespective of time
of last meal 75 g of glucose dissolved in 300 ml
of water is administered and time noted. Venous
blood samples are collected after 2 hrs and
subjected to centrifugation and analysed in a
semiautomated analyser. Women diagnosed as
GDM were managed appropriately. Follow up is
not done as these women did not complete their
fullterm gestational age by the end of the study.
Routine Ultra sonographic findings and anamoly
scan details were assessed during the study for
monitoring the morphology, growth and weight of
the fetus.
2.1 Definitions of GDM (5)
1. According to WHO 1999 criteria, diagnosis
was based on 1hr >126 mg/dl, 2-h VPG
value of ≥140 mg/dl (7.8 mmol/l) done in
the fasting state.
2. According to the DIPSI criteria, diagnosis
of GDM was based on a 2-h VPG ≥140
mg/dl (7.8 mmol/l) in the non-fasting
OGTT.
2.2 Statistical Analysis
WHO criteria and DIPSI were compared to
diagnose GDM. According to WHO guidelines,
any one criterion can be used to diagnose GDM
fasting ≥ 126 mg/dl (7.0 mmol/l) or 2-hr value
≥140 mg/dl (7.8 mmol/l) [3,4]. According to DIPSI
criteria irrespective of meals and time 2-hours
value ≥ 140 mg/dl a single step, nonfasting
procedure.
Descriptive statistics was used to calculate the
mean and standard deviation. Z test was used on
the results obtained and a ‘p’ value <0.05 was
considered statistically significant The mean and
S.D of age and parity were calculated.
Comparision of WHO and DIPSI were analyzed
by Fischer exact test (chi- square test) by using
SPSS software (version 20) and MedCalc
(version 12.7.0).
3. RESULTS
A total of 149 pregnant women underwent the
initial fasting OGTT. Women vomited after
consuming the glucose were not excluded from
analysis. All participant women were requested
to come back 2–3 days later, for the nonfasting
OGTT. The mean age of the 149 women was
23±5.1 years, mean BMI 22.6±4 kg/m
2
and mean
gestational age, 23.7±4.2 weeks. Of them 126
were primi and 23 were multipara. Of the 149
pregnant women 63 (42.28%) were diagnosed to
have GDM using the WHO 1999 criteria whereas
58 (34.89 %) women were diagnosed to have
GDM using the DIPSI criteria.
In Table 1 the mean age and S.D of pregnant
GDM women were 24.35±4.77 years. The mean
glucose values and S.D of GDM cases is
154.32±8.7. The mean BMI values and S.D of
GDM cases is 23.5±4.6 kg/m
2
.
Table 2 shows the number of cases diagnosed
by WHO and DIPSI criteria. 63 cases were
screened by WHO out of which 6 cases were
diagnosed by 1
st
hr sample and rest of 57 cases
by 2
nd
hr sample. By applying DIPSI to the same
63 GDM cases, 58 cases were diagnosed to
have GDM. This shows that DIPSI was found to
identify 58/63 (92.06%) of GDM cases identified
by WHO. If we consider the 2
nd
hr samples out of
57 cases of WHO, 58 cases of DIPSI identified
GDM (57/58) almost 98.27% cases could be
screened by DIPSI. If we carefully observe the 1
st
hr sample normal range (126 mg/dl) it is diabetes
range outside the pregnancy but not IGT or
GDM. The reason for those 6 cases diagnosed
by 1
st
hr seems to be over diagnosed by WHO
criteria.
However, as shown in the (Fig. 1) Venn diagram
Of the 63 women identified to have GDM by the
WHO 1999 criteria, only 58 (92.06%) women
were diagnosed by the DIPSI non-fasting criteria
Only 52 women of the total 63 women with GDM
(82.5%) were identified by both DIPSI and WHO
criteria. Thus, 11/63 (17.4%) of the GDM women
would have been missed if DIPSI criteria alone
were used. Conversely, 6/63 (9.5%) of the GDM
women would have been missed if WHO criteria
alone was used.

Polur et al.; IJBcRR, 10(1): 1-6, 2016; Article no.IJBcRR.22624
4
Table 1. Antepartum charactersics of the study women
Antepartum characteristics
Non GDM
GDM
p
-
value
Number of cases 86 63 Total 149
Age 22.7±3.5 24.35±4.77 years <0.001
BMI 22.8±5 kg/m
2
23.5±4.6 kg/m
2
<0.001
Mean glucose values of 2
nd
hr mg/dl 98±14 154.32±8.7 <0.0001
Table 2. Distribution of cases in WHO and
DIPSI criteria
Diagnostic criteriae 1
st
hr 2
nd
hr
WHO n=63 6 cases 57 cases
DIPSI n=58 - 58 cases
Fig. 1. Venn diagram
Table 3 shows the comparision of two diagnostic
tests. When both criteriae were applied 52 cases
were diagnosed, 11 cases were diagnosed only
by WHO criteria, 6 cases were identified only by
DIPSI criteria, and 80 cases were GDM negative
by both. Fischer exact test (chi square) is applied
to analyze the significance of both tests. P-value
is extremely statistically significant. 92% of cases
identified by WHO were also found by DIPSI. Chi
square equals to 75.181 with 1 degrees of
freedom. The two tailed p-value is < 0.0001.
The association between rows and columns is
considered to be extremely statistically
significant. This shows DIPSI can be used not
only as a screening test but also as a diagnostic
procedure.
Table 3. Fischer’s exact test
WHO
DIPSI
positive
DIPSI
negative
Total
Positive 52 11 63
Negative 6 80 86
4. DISCUSSION
Normal pregnancy is characterized by “facilitated
insulin action” during 1
st
half of pregnancy and
“diabetogenic stress” in the 2
nd
half of pregnancy.
These changes are a result of high hormone
levels (elevation of progesterone, oestriol,
oestradiol, oestrone and human chorionic
somatomammotropin (HCS) or human placental
lactogen (HPL), decreased glucose disposal rate,
increased fasting serum insulin levels, and
decreased insulin secretion after meals.
(6)
A
pregnant woman who is not capable of
increasing her insulin levels against the
developed insulin resistance land up in
GDM.GDM is considered as IGT (impaired
glucose tolerant)outside pregnancy. Diabetes
setsin 3 phases. 1. Plasma glucose with
demonstable insulin resistance (IR) normal
insulin levels raised 2. IR worsens so that
postprandial hyperglycemia develops despite
increased insulin conc 3. IR doesnt change
but declining secretion caused fasting
hyperglycemia. Postprandial blood glucose (2 hr
sample) is elevated prior to fasting glucose.
GDM is associated with increased rate of
neonatal hypoglycaemia, preterm birth,
hyperbilirubinemia, hypocalcemia, polycythemia,
childhood obesity, neuropsychological
disturbance. Women with GDM demonstrated
high rate of caesarean section and future risk of
diabetes [4]. With the alarming rising tide of GDM
it is necessary to set standards that meet high
risk Indian population [6,7,8]. Conventional
diagnostic criteriae like American Diabetes
Association (ADA) guidelines, American College
of Obstetricians and Gynecologists (ACOG)
guidelines and National Institute of Health and
Clinical Excellence (NICE) guidelines and
IADPSG guidelines (1) are controversial and
country specific do not give any information
about perinatal outcome. To standardize the
diagnosis of GDM, the World Health
Organization (WHO) recommends using a 2-hour
75 g oral glucose tolerance test (OGTT) with a
threshold plasma glucose concentration of
greater than 140 mg/dL at 2 hours, similar to that

Polur et al.; IJBcRR, 10(1): 1-6, 2016; Article no.IJBcRR.22624
5
of IGT (> 140 mg/dL and < 199 mg/dL), outside
pregnancy.
“DIPSI- A modified version of WHO criteria is a
one step procedure with a single glycemic value”
In the antenatal clinic, a pregnant woman after
undergoing preliminary clinical examination is
given a 75 g oral glucose load, irrespective of
whether she is in the fasting or non fasting state,
without regard to the time of the last meal. A
venous blood sample is collected at 2 hours for
estimating plasma glucose by the GOD- POD
method. GDM is diagnosed if 2- hour plasma
glucose is ≥ 140 mg/ dl. [9,10] 2 hr plasma
glucose values of both criteriae is same
(>140 mg/dl). Both criteriae looks similar in every
aspect except the fact that WHO requires fasting
and DIPSI doesn’t which is rational. After a meal,
a normal glucose tolerant woman would be able
to maintain euglycemia despite glucose
challenge due to brisk and adequate insulin
response. Whereas a woman with GDM who has
impaired insulin secretion her glycemic excursion
exaggerates further. Advantages of DIPSI are
Pregnant women need not be fasting will not
experience morning sickness, no nausea or
vomiting after load, no waiting period, Causes
least disturbance in a pregnant woman’s routine
activities, can diagnose pre GDM, Serves as
both screening and diagnostic procedure and in
management.
By following the usual recommendation universal
screening is done between 24 - 28 weeks of
gestation, early screening in the first trimester
is suggested if the 2 hr PG > 200 mg/dl. The
recent concept is to screen for glucose
intolerance in the first trimester itself as the fetal
beta cell recognizes and responds to maternal
glycemic level as early as 16
th
week of gestation.
If found negative at this time, the screening test
is to be performed again around 24
th
-28
th
week
and finally around 32
nd
–34
th
week. Gestational
prediabetes worsens the cardivacular risk profile.
So they are emphasized to undergo screening in
early weeks during next pregnancy. If 2
nd
hr
plasma glucose is >200 mg/dl and HbA1c is
>6.5% it is confirmatory of pre GDM [10,11].
Our study shows 92% of cases identified by
WHO has also been screened by DIPSI. This is
in accordance with the study done by
Sivagnanam Nallaperumal et al. where 98% of
cases were picked up by DIPSI [12] when 2
nd
hr
samples are considered out of 63 cases, 57
GDM cases were picked up by WHO criteria and
58 GDM cases by DIPSI. 98.27% (57/58) cases
could be screened by DIPSI. The difference seen
may be because of the inherent contradiction
that exists in the normal range of 1
st
hr sample in
WHO >126 mg/dl which is used to diagnose
diabetes outside pregnancy, where as GDM is
IGT outside pregnancy. Wahi et al. observed in
their randomized controlled study, the advantage
of adhering to a cut-off level of 2-hour PG ≥ 7.8
mmol/L in diagnosis and management of GDM
for a significantly positive effect on pregnancy
outcomes both in relation to mother as well the
child [13]. Perucchini et al. also suggest one-step
diagnostic procedure (2-hour PG ≥ 7.8 mmol/L)
to diagnose GDM. Franks et al. documented that
when maternal 2-hour PG was ≥ 7.8 mmol/L, the
cumulative risk of offspring developing type 2 DM
was 30% at the age 24 years [14,15,16]. In a
study done by Viswanathan Mohan et al. DIPSI
has poor sensitivity compared to both the WHO
1999 criteria (27.7 %) and the IADPSG criteria
(22.6 %). It was found to miss 72.3 % of women
with GDM diagnosed by the WHO 1999 criteria
and 77.4% of women with GDM diagnosed by
the IADPSG criteria. One interesting feature
observed in our study is one of the riskfactor BMI
was found to be in normal range in 70% of
cases. Out of them 42% were found to have
PCOS (polycystic ovarian syndrome). One of the
limitations of this study is that maternal and foetal
outcomes based on these recommendations are
not available as it is done in a span of 4 months
where women did not complete their
term pregnancy. Instead we assessed
ultrasonographic findings and TIFA scans for the
morphological anamolies, growth and weight of
the fetus. No significant changes were observed.
5. CONCLUSION
Traditional WHO requires fasting and is
inconvenient to the patient whereas DIPSI, a
nonfasting single step procedure has the same
sensitivity and specificity in diagnosing and
screening GDM. Perinata l outcome cannot be
commented as the study is done in a short period
of time. Further advanced studies among larger
population are required to generate more reliable
data to prevent false positives and increase the
specificity of the test.
COMPETING INTERESTS
Authors have declared that no competing
interests exist.
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Peer-review history:
The peer review history for this paper can be accessed here:
http://sciencedomain.org/review-history/12940