A prospective cohort study comparing IADPSG and DIPSI criteria for diagnosing gestational diabetes and evaluating impact on maternal and neonatal health outcomes (DECIDE study protocol)

BACKGROUND: Accurate diagnosis of gestational diabetes mellitus (GDM) is important for improving the short and long-term outcomes of mothers and babies. There are different criteria to diagnose GDM. ​ Around the world, many use the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. ​ However, in India, a different method called the Diabetes in Pregnancy Study Group of India (DIPSI) criteria is more commonly used. ​ However, there is limited evidence comparing how well these two criteria work in improving pregnancy outcomes for Indian women. ​ This study aims to fill that gap by looking at the pregnancy outcomes of women who are diagnosed with GDM using the IADPSG method but are considered normal by the DIPSI method. ​ METHODOLOGY: The DECIDE (Diagnostic Evaluation and Comparison of IADPSG and DIPSI criteria for expectant mothers) study is a prospective, multicenter observational cohort study being conducted across seven sites in India, enrolling pregnant women 18 years or older and between 24 to 28 weeks of pregnancy. Two glucose tests are conducted as part of this study. ​ The first test follows the DIPSI method, which does not require fasting beforehand. ​ The second test follows the IADPSG method, which requires fasting overnight and measures blood glucose levels three times, before drinking a glucose solution, one hour after, and two hours after. ​ The results of the IADPSG test are kept blinded from the treating physician and the participant, unless the woman is found to have very high blood glucose levels (overt diabetes). ​Postdelivery, pregnancy outcomes of both the mothers and their newborns are collected using medical records and lab reports. ​ DISCUSSION: This study aims to address the ongoing debate about the effectiveness of two diagnostic criteria for gestational diabetes: DIPSI and IADPSG. ​The goal is to determine whether the higher costs and complexity of adopting the IADPSG criteria are justified by better maternal and neonatal outcomes.​ The findings are expected to provide valuable insights that could help shape national guidelines on appropriate diagnostic criteria for GDM that can help in improving the health of mothers and newborns in India.