Effect of Sliding Scale regimen versus Buffered Insulin on the glycemic control in diabetic women receiving antenatal corticosteroids for fetal lung maturity a randomized controlled trial

This study will be done in the Department of Obstetrics and Gynecology JIPMER Pondicherry from women admitted to the labor wards, antenatal wards, ICU and HDU. Women will be enrolled in the study if they fulfill the inclusion and exclusion criteria. All diabetic antenatal women beyond 26 weeks of gestation receiving corticosteroids for fetal lung maturity will be included in the study. This will include women with known preexisting T2DM, Diabetes in Pregnancy (DIP) or GDM treated with diet alone (GDM-diet) or diet and insulin therapy (GDM-insulin). GDM and DIP were defined by the revised International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria. Written informed consent will be taken from all participants enrolled in the study in both English and local language known to the study subjects on admission to the labor room or the antenatal ward. Detailed history will be obtained from all participants and entered in the proforma. Randomization will be done in 1:1 ratio into two groups using the computerized random number generator. They will be randomly allocated to 2 groups - Group A and Group B. An independent person will be allocating the sequence. Both drugs will be coded and packed before recruitment and kept in the labor room. Allocation will be concealed using sequentially numbered opaque sealed envelopes (SNOSE) containing the drug codes. Each woman will be administered the drug in the envelope assigned corresponding to her allocation code. Participants in group A will receive the sliding scale insulin regimen and participants in Group B will receive buffered dextrose insulin regimen for the management of hyperglycemia developing after steroid administration. Both the group we will continue whatever they are receiving for sugar control-oral hypoglycemics/insulin.

All participants will undergo capillary blood glucose monitoring every 4 hours and the insulin dose will be adjusted as per the regimen they are allotted to. Urine ketones will be tested if the blood glucose levels exceeds 200 mg/ dl. Participants having ketonuria will be managed as per the diabetic ketoacidosis protocol followed routinely in the department. Similarly hypoglycemic episode will be managed as per the department protocol. All the maternal baseline characteristics, blood sugar values will be noted along with episodes of hypoglycemia or ketoacidosis if any. Following 48 hours patients will be restarted on the previous treatment for diabetes mellitus and blood sugars will be monitored according to standard departmental protocol and all the blood glucose values will be noted and entered in the proforma. Poor glycemic control will be fasting >95 mg/dl, 1 hour postprandial >140 mg/dl, 2 hour postprandial >120 mg/dl Any adverse maternal events during the study will be reported to the DSMB (Data and Safety Monitoring Board) for their review, and the report will be submitted to the institute ethics committee.

All the study participants will be kept under close observation in the hospital until discharge.