Comparative study between the use of long-acting insulin versus multiple dose regimen in control of Gestational Diabetes Mellitus: a randomized controlled trial

Abstract

Objective : The aim of our work is the comparison between long-acting insulin and multiple dose regimens in control of gestational diabetes. Patients and Methods : This prospective randomized controlled trial included 128 Pregnant women with gestational DM who required insulin treatment after failure of diet control in Ain Shams maternity hospital from September 2019 to December 2020. Patients were randomized into two groups; Group A: received long-acting insulin analogs as a single dose once daily at bedtime, while Group B received intermediate-acting insulin (NPH) besides short-acting insulin (lispro) in divided doses. Results: Group B showed a shorter statistically significant time to control blood sugar than Group A (10+1 vs 14+2 days, respectively). ▪ There was no statistically significant difference between groups regarding Maternal hypoglycemia (P<0.05). Group A had a non-significant higher rate of obstetric complications as PIH, Preterm delivery, Shoulder dystocia, and CS delivery rate and lower Polyhydramnios rate than group B. Group (A) had a non-significant higher rate of fetal/Neonatal complications such as fetal macrosomia, congenital anomalies, IUFD, NICU admission, and Neonatal death than group (B) by Per protocol (PP) analysis (P<0.05). Conclusion: We can conclude that there is no clinical difference between using a multiple-dose regimen and using long-acting insulin analogs to control gestational diabetes regarding maternal and fetal outcomes. However, a multiple-dose regimen needs a shorter time for blood glucose control than long-acting insulin. It is to be noted that long-acting insulin is more expensive.