Diagnosis of Gestational Diabetes Mellitus in the Community

© JAPI • august 2012 • VOL. 60 15
Original Article
Diagnosis of Gestational Diabetes Mellitus in the
Community
V Seshiaha, V Balajib, Siddharth N Shahc, Shashank Joshid, AK Dase, BKSahayf,
Samar Banerjeeg, AH Zargarh, Madhuri Balajii
Abstract
Background and Objective: Diabetes in Pregnancy Study Group India (DIPSI) recommends 2-h Plasma glucose (PG)
≥ 140 mg/dL with 75g oral glucose load to diagnose GDM, akin to WHO criteria. Recently, International Association of
Diabetes in Pregnancy Study Group (IADPSG) recommends any one value of Fasting plasma glucose (FPG) ≥ 92 mg/
dL, 1-h PG ≥ 180 mg/dL or 2-h PG ≥ 153 mg/dL to diagnose GDM. The objective of this study was to find out whether
DIPSI guidelines could still be continued to diagnose GDM in our country, as this requires one blood test compared to
three tests of IADPSG, which is expensive.
Method: Consecutive pregnant women (N = 1463) underwent 75g oral glucose tolerance test (OGTT). The proportion of
GDM was computed based on IADPSG and DIPSI criteria and the discordant pair of diagnosing GDM was examined
by McNemar test. Analysis was two tailed and P-value <0.05 was considered for statistical significance.
Result: The prevalence of GDM was 14.6% (N=214) by IADPSG criteria and 13.4% (n=196) by DIPSI criteria. The discordant
pair between the two criteria examined by Mc Nemar’s test indicated that there was no statistical significance (P = 0.21)
and thereby implying a close agreement between these two procedures.
Conclusion: DIPSI procedure is cost-effective, without compromising the clinical equipoise and can be continued to
diagnose GDM in our country, as well as other less resource countries.
G
Introduction
estational Diabetes Mellitus (GDM) is characterized by
carbohydrate intolerance of varying severity with onset or
first recognition during pregnancy.1 Women with a history of
GDM are at increased risk of future diabetes, predominantly type
2 diabetes, as are their children2. The extent of this risk depends on
the diagnostic criteria used to identify GDM.2 Studies conducted
in different populations and with different methodologies,
consistently reported an increase in GDM in all race/ethnicity
groups, suggesting that there is an increase in GDM prevalence.3
A true increase in the prevalence of GDM aside from its adverse
consequences for the infant in the newborn period might reflect
or contribute to the ongoing pattern of increasing diabetes
and obesity.3 This implies that Universal screening and care of
women with GDM is of paramount public health priority4 in high
risk population for GDM and diabetes like Asian Indians,5 rather
than risk factor screening.6 In this aspect, except the existing
diagnostic criterion of World Health Organization (WHO) 2-h
plasma glucose (PG) ≥ 140 mg/dL with 75g oral glucose load,7
other diagnostic criteria are country specific or recommended by
Chairman, bDirector and Senior Consultant Diabetologist, Dr.
V. Seshiah Diabetes Research Institute, Chennai; cProfessor of
Diabetology, S.L. Raheja Hospital, Mumbai; dEndocrinologist,
Lilavati and Bhatia Hospital, Mumbai; eSenior Professor of Medicine
and Medical Superintendent, Jawaharlal Institute of Postgraduate
Medical Education and Research, Puducherry; fConsultant Physician
and Diabetologist, Sahay’s Diabetic Clinic and Research Centre,
Hyderabad; gProfessor of Medicine, Vivekananda Institute of Medical
Sciences, Kolkata; hProf. and Head, Department of Endocrinology,
Sheri-Kashmir Institute of Medical Sciences, Srinagar; iSenior
Consultant Diabetologist, Dr. V. Seshiah Diabetes Research Institute,
Chennai
Received: 28.02.2011; Revised: 29.06.2011; Accepted: 02.07.2011
a
various associations. Recently, based on the Hyperglycemia and
Adverse Pregnancy Outcome (HAPO) study, the International
Association of Diabetes and Pregnancy Study Groups (IADPSG)
consensus panel recommended that GDM can be diagnosed, if
any one value of fasting plasma glucose (FPG), 1-h and 2-h PG
concentrations meet or exceed 92 mg/dL, 180 mg/dL and 153 mg/
dL respectively, with 75g oral glucose tolerance test (OGTT).8,9
India one of the most populous countries in the world was not
a part of the HAPO study. Hence this prospective, collaborative
study was undertaken to ascertain whether the present practice
of diagnosing GDM by the guidelines recommended by Diabetes
In Pregnancy Study Group India (DIPSI)10 based on WHO
criterion of 2-h PG ≥ 140 mg/dL can still be followed in our
country or adopt IADPSG recommendation.
Methods
The study was initiated with the approval of the Institutional
Ethics Committee. The sample size was determined based on
the overall prevalence of GDM in our population (13.9%)11
and with 90% statistical power. A total of 1,463 consecutive
pregnant women registered at a community health centre at
Chennai between April 2009 and February 2010 were recruited
into the study. Key exclusion criteria included pregnant women
in the first trimester of pregnancy, previous history of GDM or
pre- GDM. A standardized questionnaire was used and details
pertaining to their anthropometrics, family history, medical
and obstetric history were collected. Their Body Mass Index
(BMI) and blood pressure were recorded. All of them gave
their informed consent to undergo 75g OGTT. After drawing
the venous blood sample in the fasting state, they were given
75g oral glucose and their 1-h and 2-h venous blood samples
were drawn. The plasma glucose was estimated in the central
laboratory by glucose oxidase peroxidase (GOD-POD) method.
16
© JAPI • august 2012 • VOL. 60
Table 1 : Performance of fasting plasma glucose test for the
prediction of gestational diabetes
FPG (mg/dL)
60
70
80
90
92
100
110
120
2- h PG 140
Test
positive
13.3
11.9
8.1
3.9
3.2
1.8
0.9
0.6
13.4
2- h PG value
Sensitivity
Specificity
(95% CI)
(95% CI)
99.0(96.0-99.8)
1.3(0.8-2.2)
88.8(83.3-92.7)
11.2(9.5-13.1)
60.2(53.0-67.0)
56.5(53.7-59.3)
29.1(22.9-36.1)
89.4(87.6-91.0)
24.0(18.3-30.7)
93.0(91.4-94.3)
13.8(9.4-19.6)
97.4(96.3-98.2)
7.1(4.1-11.9)
99.2(98.5-99.6)
4.6(2.3-8.8)
99.8(99.4-100.0)
Diagnosis and the prevalence of GDM were assessed by applying
both DIPSI and IADPSG criteria.
Statistical Analysis: The mean and proportion were computed
for the basic characteristics of the study subjects. The proportion
of GDM was computed based on IADPSG and DIPSI criteria and
the discordant pair of diagnosing the GDM was examined by
McNemar test. Analysis was two tailed and P-value <0.05 was
considered for statistical significance. All analysis was performed
by using SPSS 10 version package.
Results
The mean maternal age of the 1,463 pregnant women was
23.60 ± 3.32 years and BMI was 21.5 ± 4.06 kg/m2. The mean
gestational age was 27.9 ± 5.56 weeks. The pregnant women who
had family history of diabetes were 18.3%. The percentage of
pregnant women who came to the prenatal clinic in the second
trimester was 52% and in the third trimester was 48%. Using the
DIPSI criterion of 2-h PG ≥ 140mg/dL, 196 (13.4%) women were
diagnosed as GDM. By applying IADPSG recommendation of
any one value of FPG ≥ 92 mg/dL, 1-h PG ≥ 180mg/dL or 2-h PG ≥
153 mg/dL, the prevalence of GDM observed was 14.6% (N=214).
Measuring FPG alone identified 136 cohorts (9.3%) as having
GDM. Adding measurement of 1-h PG identified an additional
36 (2.46%) and adding 2-h PG measurement identified another
42 (2.87%) of the cohorts. We found that there was no significant
difference (P>0.05) in the discordant pair of diagnosing GDM by
the two criteria which in turn implies, that the disagreement in
diagnosing GDM by both criteria was not significant (P = 0.21).
We also assessed the FPG cut-off point 92 mg/dL recommended
by IADPSG in relation to the diagnostic criterion of DIPSI. This
cut-off point had a specificity of 93% and sensitivity of 24%.
Thus, the ability of testing positive was 3.2% and the missing
proportion of cases was 76% (Table 1).
Discussion
DIPSI follows 2-h PG to diagnose GDM, as in all GDM, the
FPG values does not reflect the postprandial hyperglycemia12.
In this study, we also found that by applying this criterion of
FPG ≥ 92 mg/dL, only 24% (3.2% of the total population) of
those diagnosed as GDM using DIPSI criterion 2-h PG ≥ 140
mg/dL would have been identified as GDM. This is due to the
ethnicity of Asian Indians who have high insulin resistance
(IR) and as a consequence, their postprandial plasma glucose
is higher compared to Caucasians.13,14 Asian and South Asian
ethnicity are both independently associated with increased IR in
late pregnancy.15 Siddhartha Das et al documented an increased
IR during pregnancy in Asian Indian Women and IR escalates
further in GDM.16 These studies provide evidence that FPG may
not be an appropriate option to diagnose GDM in Asian Indian
women.12 Further, the soundness of diagnosing GDM by 2- h
PG ≥ 140 mg/dL has been established by both short-term17 and
long-term18 outcome studies in the off-springs.
IADPSG recommends the diagnosis of GDM if any one or
more value meet or exceed the cut off values: FPG 92mg/dL, 1-h
PG 180mg/dL and 2-h PG 153 mg/dL.8 In this study population,
we utilized both DIPSI and IADPSG criteria to ascertain the
prevalence of GDM, which were 13.4% and 14.6% respectively.
IADPSG recommendation necessarily requires estimation of
PG in three blood samples after administrating 75g oral glucose
load. Pregnant women resent this procedure, as they are pricked
three times and feel too much of blood is drawn. Whereas, DIPSI
criterion requires one blood sample drawn at 2-h for estimating
the plasma glucose. Interestingly, the difference in the diagnostic
capability between IADPSG and DIPSI was 1.2% which was not
significant (P>0.02). Further, the cost involved for performing
IADPSG recommended procedure is high, as this procedure
requires three blood tests compared to one blood test of DIPSI.
In our earlier study, we also found that glucose tolerance test
can be performed irrespective of last meal timing to diagnose
GDM19 and DIPSI follows this one step diagnostic procedure.10
This procedure requires little preparation, without requiring the
prior interposition of the screening test and it could be applied
to the entire obstetric population. Thus, DIPSI procedure would
still serve the purpose of implementing public health program
to diagnose GDM in the community.
Conclusion
In less resource countries to diagnose GDM, DIPSI procedure
based on WHO criterion of 2- h PG ≥ 140 mg/dL would be costeffective without compromising the clinical equipoise.
Disclosure of Interest
There are no conflicts of interest with any of the authors and
the contents of this report.
Acknowledgement
We acknowledge the support given by Prof. Cynthia
Alexander, Former Director, Institute of Obstetrics and
Gynecology and Government Maternity Hospital, Egmore,
Chennai. We also would like to thank Prof. Anjalakshi, Professor
and Head, Department of Obstetrics and Gynecology, SRM
Medical College and Hospital, Chennai.
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