Risk Factors for Hyperglycaemia in Pregnancy in Tamil Nadu, India.

INTRODUCTION: Hyperglycaemia in pregnancy (HIP), i.e. gestational diabetes mellitus (GDM) and diabetes in pregnancy (DIP), increases the risk of various short- and long-term adverse outcomes. However, much remains to be understood about the role of different risk factors in development of HIP. OBJECTIVE: The aims of this observational study were to examine the role of potential risk factors for HIP, and to investigate whether any single or accumulated risk factor(s) could be used to predict HIP among women attending GDM screening at three centres in urban, semi-urban and rural Tamil Nadu, India. METHODOLOGY: Pregnant women underwent a 75 g oral glucose tolerance test. Data on potential risk factors was collected and analysed using logistical regression analysis. Receiver operating characteristic (ROC) curves, sensitivity, specificity and predictive values were calculated for significant risk factors and a risk factor scoring variable was constructed. RESULTS: HIP was prevalent in 18.9% of the study population (16.3% GDM; 2.6% DIP). Increasing age and BMI as well as having a mother only or both parents with diabetes were significant independent risk factors for HIP. Among women attending the rural health centre a doubling of income corresponded to an 80% increased risk of HIP (OR 1.80, 95%CI 1.10-2.93; p = 0.019), whereas it was not significantly associated with HIP among women attending the other health centres. The performance of the individual risk factors and the constructed scoring variable differed substantially between the three health centres, but none of them were good enough to discriminate between those with and without HIP. CONCLUSIONS: The findings highlight the importance of socio-economic circumstances and intergenerational risk transmission in the occurrence of HIP as well as the need for universal screening.

Maternal serum biomarkers for risk assessment in gestational diabetes. A potential universal screening test to predict GDM status.

The prevalence of gestational diabetes mellitus (GDM) is increasing because of the worldwide obesity/diabetes epidemic. The complications of untreated GDM affect both the mother and baby and include complications during pregnancy as well as increased risk of subsequent type-2 diabetes in mothers and offspring. Standard tests for hyperglycemia in diabetes, such as fasting glucose and hemoglobin (HbA1c), are currently not recommended for GDM screening. Instead, an oral glucose tolerance test is specified, which is invasive, time-consuming, and not easily accessible to many at-risk populations. In this study, we describe a multi-analyte maternal serum profile test that incorporates novel glycoprotein biomarkers and previously described GDM-associated markers. In screening for GDM by multi-analyte panel, the detection rate was 87% at a false-positive rate of 1%.

A cohort study of gestational diabetes mellitus and complimentary qualitative research: background, aims and design.

BACKGROUND: Women with gestational diabetes mellitus (GDM) and their offsprings are at increased risk of future type 2 diabetes and metabolic abnormalities. Early diagnosis and proper management of GDM, as well as, postpartum follow-up and preventive care is expected to reduce this risk. However, no large scale prospective studies have been done particularly from the developing world on this aspect. The objective of this study is to identify and follow a cohort of pregnant women with and without GDM and their offspring to identify determinants and risk factors for GDM, for various pregnancy outcomes, as well as, for the development of future diabetes and metabolic abnormalities. METHODS: This is a prospective cohort study involving pregnant women attending prenatal clinics from urban, semi-urban and rural areas in the greater Chennai region in South India. Around 9850 pregnant women will be screened for GDM. Socio-economic status, demographic data, obstetric history, delivery and birth outcomes, perinatal and postnatal complications, neonatal morbidity, maternal postpartum and offsprings follow-up data will be collected. Those diagnosed with GDM will initially be advised routine care. Those unable to reach glycaemic control with diet alone will be advised to take insulin. Postpartum screening for glucose abnormalities will be performed at months 3 and 6 and then every year for 10 years. The offsprings will be followed up every year for anthropometric measurements and growth velocity, as well as, plasma glucose, insulin and lipid profile. In addition, qualitative research will be carried out to identify barriers and facilitators for early GDM screening, treatment compliance and postpartum follow-up and testing, as well as, for continued adherence to lifestyle modifications. DISCUSSION: The study will demonstrate whether measures to improve diagnosis and care of GDM mothers followed by preventive postpartum care are possible in the routine care setting. It will also map out the barriers and facilitators for such initiatives and provide new evidence on the determinants and risk factors for both GDM development and occurrence of adverse pregnancy outcomes and development of future diabetes and metabolic abnormalities in the GDM mother and her offspring.

Premixed insulin aspart 30 (BIAsp 30) versus premixed human insulin 30 (BHI 30) in gestational diabetes mellitus: a randomized open-label controlled study.

A randomized, open-label, parallel study was conducted to assess the efficacy and safety of premixed insulin aspart 30 (biphasic insulin aspart [BIAsp] 30) in managing gestational diabetes mellitus (GDM). A total of 323 women with GDM registered at a single center in India were randomly assigned to receive 6 U of either BIAsp 30 (Group A) or premixed human insulin (biphasic human insulin [BHI] 30; Group B) in a 1:1 ratio. Subjects performed home glucose monitoring and visited their care provider twice a month. The primary outcome was the degree of neonatal macrosomia (neonatal birth weight >90th percentile). Groups A and B were demographically comparable at study entry. Before labor onset, Groups A and B achieved similar degrees of fasting plasma glucose and postprandial plasma glucose control (92.97 ± 14.44 vs. 95.43 ± 18.96 and 127.59 ± 28.99 vs. 126.98 ± 29.89, respectively; both p = NS). Neonatal macrosomia frequency was 6.3% in Group A and 6.9% in Group B; however, this difference was not statistically significant. By last visit, the required insulin dose was significantly lower for Group A than Group B (19.83 ± 15.75 IU vs. 26.34 ± 23.15 IU, respectively; p = 0.006). BIAsp 30 was noninferior to BHI 30, producing comparable fetal outcomes when administered during pregnancy. Based on final doses, BIAsp 30 may offer greater treat-to-target potential for pregnant women.

Point of care for gestational diabetes mellitus--a community-based study.

Universal screening for gestational diabetes mellitus (GDM) is advocated in Indian women as they have the highest frequency of GDM, among South Asian population. For this the diagnostic procedure has to be simple, economical and evidence based. Hence, this study was undertaken to compare the point-of-care measuring capillary blood glucose (CBG) by glucometer and venous plasma glucose (VPG) estimated in the laboratory and to suggest the feasible diagnostic tool. Consecutive pregnant women in the third trimester were included in this study with the approval of the institutional ethical committee. They were given 75 g oral glucose in the fasting state. After 2 hours, CBG was measured by finger-prick using one touch select simple glucometer and venous blood was drawn to estimate VPG in the laboratory by GOD- POD method. The diagnosis of GDM was based on 2 hours plasma glucose > or = 7.8 mmol/l. Among a cohort of 500 pregnant women, 32 (6.4%) were diagnosed as GDM in their first visit. The CBG value at 2 hours plasma glucose > or = 7.8 mmol/l had a sensitivity of 93.8% and specificity of 97.4% with a false positive and false negative of 2.6% and 6.2%, respectively. The area under the receiver operating characteristic curve of CBG was 0.993. CBG value at 2 hours plasma glucose > or = 7.8 mmol/l may be recommended for the diagnosis of GDM in healthcare centres where laboratory technology is not available.

Diagnosis of gestational diabetes mellitus in the community.

BACKGROUND AND OBJECTIVE: Diabetes in Pregnancy Study Group India (DIPSI) recommends 2-h Plasma glucose (PG) > or = 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) > or = 92 mg/ dL, 1-h PG > or = 180 mg/dL or 2-h PG > or = 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 McNemar'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.

Diagnosis of gestational diabetes mellitus in Asian-Indian women.

OBJECTIVE: To assess the validity of Diabetes in Pregnancy Study Group India (DIPSI) guidelines, a modified version of the WHO criterion to diagnose gestational diabetes mellitus (GDM). MATERIALS AND METHODS: A total of 1 463 consecutive pregnant women in the second and third trimester of pregnancy underwent 75 g oral glucose tolerance test (OGTT) and 2-h plasma glucose (PG) was measured by the glucose oxidase-peroxidase (GOD-POD) method. GDM was diagnosed with 2-h PG ≥ 7.8 mmol/L (WHO criteria) and the rest were classified as normal glucose tolerant (NGT) women. GDM women were advised medical nutrition therapy (MNT) for two weeks. Those who failed to reach the target glycemic level of FPG < 5.0 mmol/L and 2-h PG < 6.67 mmol/L with MNT were advised insulin. All of them were followed throughout pregnancy until delivery. Birth weight of 90th percentile (> 3.45 kg) in the neonates was considered as macrosomia (primary outcome). RESULTS: The mean maternal age and body mass index were 23.60±3.32 years and 21.5±4.06 kg/m(2) respectively. The mean gestational age was 27.9±5.56 weeks. DIPSI criterion identified 196 women (13.4%) as GDM and the rest as NGT. Insulin was required in 19 (9.7%) women with GDM. Macrosomia was observed in 9.9% GDM women with intervention and 9.8% in NGT (P = 1.000). CONCLUSION: DIPSI criterion is a one step-cost effective and evidence-based procedure to diagnose GDM in any socio-economic setting.

Inadequacy of fasting plasma glucose to diagnose gestational diabetes mellitus in Asian Indian women.

The prevalence of Gestational Diabetes Mellitus (GDM) diagnosed by WHO criterion (2-hPG ≥ 7.8 mmol/L) was 13.4%. By International Association of Diabetes and Pregnancy Study Groups criteria of FPG ≥ 5.1 mmol/L, prevalence of GDM was 3.2%. FPG may not be suitable for diagnosis of GDM in Asian Indians due to high insulin resistance in addition to pregnancy hormonal effect.

Premixed insulin aspart 30 (Biasp 30) vs. premixed human insulin 30 (BHI 30) in gestational diabetes mellitus--a pilot study.

OBJECTIVE: The objective of the study was to compare premixed insulin aspart 30 (BIAsp 30) vs premixed human insulin 30 (BHI 30) on efficacy, safety, fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [GDM]. This was the first randomized study to use pre mixed insulin analogue [BIAsp] in GDM. METHODS: The study population consisted of 76 GDM women assigned to BIAsp 30 (group A) and an equal number to BHI 30 (group B). RESULTS: There was no statistically significant difference between the age, BMI, gestational weeks and glycemic level at entry between the group A and group B women (p > 0.05). There was no statistical difference between the two groups in glycemic control or insulin dose (p > 0.05) before confinement. The frequency of birth weight of new born above 90 percentile was 6.8% in Group 1 and 9.2% in Group 2. The proportion of macrosomia was higher in Group 2 when compared to Group 1, however the difference was not statistically significant (P = 0.819). CONCLUSION: BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing. Fetal outcome using BIAsp was also comparable with BHI 30.

Pregnancy and diabetes scenario around the world: India.

Women with gestational diabetes mellitus (GDM) are at an increased risk of developing diabetes in the future, as are their offspring. GDM is not only of clinical relevance, but is also an important public health issue. A community-based prospective study showed that the prevalence of GDM was 13.9%. We also observed that the frequency of GDM varied across urban, semi-urban, and rural areas. Based on multiple logistic regression analysis and taking the 3 areas into consideration, family history of diabetes, age greater than or equal to 25 years, and body mass index greater than or equal to 25 were found to have a significant independent association with GDM (P<0.001).

A single test procedure to diagnose gestational diabetes mellitus.

Universal screening for gestational diabetes mellitus (GDM), detects more cases and improves maternal and offspring prognosis. Of all the screening tests, World Health Organization (WHO) procedure is simple and cost effective; the only disadvantage is that the pregnant woman has to come in the fasting state to undergo oral glucose tolerance test (OGTT). Hence, we undertook a study to elucidate a test that is casual and reliable to diagnose GDM. A total of 800 pregnant women underwent 75-g glucose challenge test (GCT) irrespective of the time of the last meal and their 2-h plasma glucose (PG) was estimated. They also underwent a 2-h 75-g OGTT recommended by WHO after 72 h. There was no statistically significant difference in the glycemic profile between GCT and WHO OGTT in the diagnosis of GDM. In conclusion, GCT performed irrespective of the last meal timing is a patient-friendly approach and causes least disturbance in the pregnant woman's routine activities.

Prevalence of gestational diabetes mellitus in South India (Tamil Nadu)--a community based study.

AIM: Women diagnosed to have Gestational Diabetes Mellitus (GDM) are at increased risk of developing diabetes in future. Thus, diagnosis of GDM is an important public health issue. In a random survey 16.2% of pregnant women were found to have GDM in the Chennai urban population. Hence we undertook a planned community based study to ascertain the prevalence of GDM. MATERIALS AND METHODS: We conducted a prospective screening for GDM in the urban, semi urban and rural areas. All pregnant women irrespective of gestational weeks underwent a 75 g glucose challenge test in the fasting state. Diagnosis of GDM was made if the 2 hr plasma glucose was > or = 140 mg/dl (WHO criteria). RESULTS: A total of 4151, 3960 and 3945 pregnant women were screened in urban, semi urban and rural areas, respectively. GDM was detected in 739 (17.8%) women in urban, 548 (13.8%) in semi urban and 392 (9.9%) in rural areas. Out of 1679 GDM women, 1204 (72%) were detected in first visit and the remaining 28% in subsequent visits. A significant increase (P < 0.0001) in the prevalence of GDM was observed with family history of diabetes, increased maternal age and BMI. A trend for increased prevalence of GDM was observed in women with less physical activity, however, not statistically significant. CONCLUSION: In this community based study, the prevalence of GDM varied in the urban, semi urban and rural areas. Age > or = 25 years, BMI > or = 25 and family history of diabetes were found to be risk factors for GDM.

Scope for prevention of diabetes--'focus intrauterine milieu interieur'.

The prevalence of diabetes is increasing globally and India is no exception. The lifestyle modification and drug intervention are likely to delay or postpone the development of overt diabetes in persons diagnosed to have impaired glucose tolerance. This is a post primary prevention strategy. The primary prevention is more important as this effort is likely to reverse or halt the epidemic of disease. Women with Gestational Diabetes Mellitus (GDM) are an ideal group for the primary prevention of diabetes as they are at increased risk of future diabetes, predominantly type 2 diabetes, as are their children. Pima Indians have the highest prevalence of diabetes. This is attributed to the children exposed in utero to maternal diabetes. Hence as a policy to identify GDM and its consequences on the infant, a 75 gm Oral Glucose Tolerance Test has been recommended to all Pima Indian women during the 3rd trimester of pregnancy. Ethnically Asian Indian women also have high prevalence of diabetes and the relative risk of developing Gestational Diabetes Mellitus in them is 11.3 times compared to White women. This necessitates universal screening for gestational diabetes during pregnancy in India. Probably the undiagnosed gestational diabetes that has been occurring in the past has resulted in the increased prevalence of diabetes in India. The timely action taken now in screening all pregnant women for glucose intolerance, achieving euglycemia in them and ensuring adequate nutrition may prevent in all possibility, India becoming the diabetes capital of the world.

Detection and care of women with gestational diabetes mellitus from early weeks of pregnancy results in birth weight of newborn babies appropriate for gestational age.

The policy of screening for gestational diabetes mellitus (GDM) between 24 and 28 weeks of gestation and care has resulted in a few women delivering big babies despite good glycemic control. Hence we undertook a study to assess the merits of care given to women in whom GDM was diagnosed in different weeks of gestation and to find out the ideal period of screening in women with history of high-risk pregnancies. A total of 207 consecutive pregnant women irrespective of trimester referred to our referral clinic for diabetes in pregnancy, underwent a 75g oral glucose tolerance test (OGTT) and GDM was diagnosed if 2h plasma glucose (PG) >/=140mg/dl. A1c was estimated in all of them. Women who failed to respond to medical nutrition therapy were advised insulin and the dose titrated to maintain fasting PG (FPG) <90mg/dl and 2h PG <120mg/dl. The mean age of the population screened was 28.38+/-4.31 years and the mean gestational age of screening was 20.05+/-10.71 weeks. Among them, 87 were diagnosed as GDM. The gestational week at diagnosis was

Glycemic level at the first visit and prediction of GDM.

OBJECTIVE: To evaluate the glycemic level at the first visit that is likely to predict gestational diabetes mellitus (GDM). METHODS: Consecutive pregnant women underwent a 75g oral glucose tolerance Test (OGTT) recommended by WHO and diagnosed GDM if 2hr post plasma glucose (PG) value > or = 140 mg/dl. Women with normal OGTT results at the first visit were screened again with an OGTT at the subsequent visits. RESULTS: A total of 4151 pregnant women from different trimesters underwent OGTT. Of them 739 women (17.8%) had GDM. Among the GDM women, 528 (71.4%) were detected at the first visit. On screening during subsequent visits, GDM was diagnosed in the remaining 211(28.6%) women who had normal OGTT in the first visit. We performed the analysis taking the glycemic level in the first visit of 211 pregnant women who manifested GDM in the subsequent visit. During normal pregnancy, 2hr PG level is < 120 mg/dl. Taking this value into consideration among the 211 women who turned to have GDM in the subsequent visits 119 women (56.4%) had 2hrPG > or = 120 mg/dl and the remaining 92(43.6%) had 2hrPG < 120 mg/dl. CONCLUSION: Pregnant women irrespective of 2 hr PG > or = or < 120 mg/dl at initial visit progressed to GDM in the subsequent visit. No glycemic level in the early weeks of pregnancy predicts GDM and at the same time at no statistically significant glycemic cut-off level could we say that a woman will not develop GDM. Hence rescreening in the subsequent trimester or visits is essential.

Gestational diabetes mellitus manifests in all trimesters of pregnancy.

Screening for GDM is usually performed around 24-28 weeks of gestational age. We undertook a study to estimate the prevalence of glucose intolerance during different trimesters, as data in this aspect is sparse. A total of 4151 consecutive pregnant women irrespective of gestational weeks attending antenatal health posts across Chennai city underwent a 75 g OGTT recommended by WHO and diagnosed GDM if 2 hr PG value > or =140 mg/dl. Women who had normal OGTT at the first visit were screened with a repeat OGTT at the subsequent visits. Among the screened, 741 women (17.9%) had 2 hr PG> or =140 mg/dl and were identified to have gestational diabetes. Analysis based on gestational weeks revealed that out of the 741 GDM women, 121 (16.3%) were within 16 weeks, 166 (22.4%) were between 17 and 23 weeks and 454 (61.3%) were more than 24 weeks of gestation. Observation in this study was that 38.7% developed gestational diabetes even prior to 24th week of gestation. Out of the total 741 GDM women, 214 (28.9%) were diagnosed on repeat testing at subsequent visits. Glucose intolerance occurs in the early weeks of gestation. Women who had normal glucose tolerance in the first visit require repeat OGTT in the subsequent visits.

Gestational diabetes mellitus in India.

BACKGROUND: Glucose intolerance during pregnancy predisposes the offspring for increased risk of developing glucose intolerance in the future. This vicious cycle is likely to influence and perpetuate the incidence and prevalence of glucose intolerance in any population. AIM: No data is available about the prevalence of glucose intolerance during pregnancy in our country and hence a study was undertaken on this aspect. METHODS: This study was performed in the antenatal clinic of Government Maternity Hospital, Chennai, India. As a pregnant woman in second or third trimester checks into the antenatal clinic, she was given 50 gm oral glucose load and blood sample was collected after one hour. This test was performed on 1251 pregnant women. They were requested to come after 72 hours for the 75 gm OGTT recommended by WHO. Among the 1251 women, 891 responded. The blood sample was taken in the fasting state and at 2 hours after 75 gm of oral glucose. Diagnosis was based on the WHO criteria for gestational diabetes mellitus (GDM). RESULTS: The mean age of these pregnant women was 23+/-4 years. There was a significant increase in the prevalence of GDM in relation to gravida. The effect of BMI did not quite reach statistical significance (chi2 (df=1) = 3.659, P = 0.055), but a model of linear trend was significant. Of the 1251 women who underwent the 50 gm oral glucose challenge test, 670 (53.55%) had one hour plasma glucose > or = 130 mg/dl. Among the 891 pregnant women who had 75 gms OGTT, 168 (18.9%) were diagnosed as GDM, taking both FPG > or = 126 mg/dl and/or 2 hr PPG > or = 140 mg/dl as cut-off values. Taking only 2 hr plasma glucose for analysis, 144 (16.2%) had a value > or = 140 mg/dl. A similar study was conducted in different parts of the country taking only the 2 hr 75 gm post-glucose value of > or = 140 mg/dl as diagnostic criteria for GDM. Of the total number of pregnant women (n = 3674) screened, 16.55% of them found to have GDM. CONCLUSION: Our study has documented the increased prevalence of GDM in our population necessitating universal screening for glucose intolerance in pregnancy. Using 2 hr plasma glucose > or = 140 mg/dl as a one step procedure is simple and economical, particularly for the countries ethnically more prone to high prevalence of diabetes.