Comparison of efficacy of PREMIXED SPLIT INSULIN REGIME with MULTIPLE SPLIT INSULIN REGIME on diabetes complicating pregnancy – A Randomized Controlled Trial

Gestational diabetes mellitus is a global health problem, affecting up to 5 million women in India annually. The estimated prevalence of GDM varies from <1 to 28% in different countries. As of 2010, there were an estimated 22 million women with diabetes between the ages of 20 and 39 & an additional 54 million women in this age group with impaired glucose tolerance (IGT) or pre-diabetes with the potential to develop GDM if they become pregnant. A recent study summarizing 69 studies involving 1,778,706 Indian adults showed that between 1972 and 2019, the prevalence of T2DM increased in rural and urban India from 2.4% to 15% and from 3.3% to 19.0%, respectively. GDM is associated with the prevalence of T2DM, so as the prevalence of diabetes increases, the number of women affected by GDM also increases.

If the blood sugars are not controlled, various complications can occur. MATERNAL COMPLICATIONS such as Abortion, Polyhydramnios, Pre-eclampsia, Prolonged labor, Obstructed labor, Cesarean section, Uterine atony, Postpartum hemorrhage, and Infection may occur. The fetal risks are Spontaneous abortion, Intra-uterine death, Stillbirth, Macrosomia, Congenital malformation, Shoulder dystocia, Birth injuries, Neonatal hypoglycemia, and Infant respiratory distress syndrome. Neonatal complications in GDM are Hypoglycemia, Hyperbilirubinemia, Respiratory distress syndrome, Hypocalcemia, Polycythemia, Hypomagnesaemia, and Neurodevelopmental abnormalities. In the long term, the patient may develop Obesity and Type 2 diabetes mellitus. Therefore, we need strict sugar control during pregnancy to prevent the maternal, fetal, neonatal, and long-term complications of diabetes complicating pregnancy.

In addition to medical nutrition therapy and Oral hypoglycemic drugs, insulin may be given to control blood sugar levels. According to FOGSI guidelines, Insulin is the drug of first choice and Metformin can be considered for the treatment of GDM after 20 weeks of gestation.

It is recommended to use either Injection Actrapid or Mixtard insulin during pregnancy. However, FOGSI recommends only injection human premix insulin 30/70. Pregnancy can cause fasting hypoglycemia(due to insulin-independent glucose uptake by the placenta), and postprandial hyperglycemia (as a result of diabetogenic placental hormones). A fixed ratio of insulin in the form of premixed insulin can’t be adjusted as per the requirements of pregnant women as compared to multiple split dose. As the pharmacokinetics of insulin (difference in peak insulin action and duration of action) varies within different ratios of insulin, glycemic control without hypoglycemia might vary with these two insulin regimens. Hence, we aimed  to compare the efficacy of different insulin regimes in pregnancy to achieve tight glycemic control and its outcome on pregnancy. We are excluding insulin analogs from our study due to their high cost, which makes it unaffordable for most people with low socioeconomic status.