title: Insulin aspart in patients with gestational diabetes mellitus and pregestational diabetes mellitus.
abstract: OBJECTIVE
  This study was undertaken to assess the effectiveness and safety of insulin aspart in patients with gestational and pregestational diabetes.
  
  
  METHODS
  An open-label, prospective, nonrandomized, comparative, and observational study conducted at single center in India.
  
  
  METHODS
  A total of 276 patients were in gestational diabetes mellitus (GDM) group, 79 were in the pre-GDM group. Patients were started on insulin therapy (insulin aspart ± neutral protamine hagedorn) once medical nutrition therapy for 2 weeks failed to achieve control, that is., fasting plasma glucose ≥90 mg/dL and/or 1.0 h postprandial plasma glucose ≥130 mg/dL. Insulin dose was titrated to keep the blood glucose values between 90 and 130 mg/dL. Patients were followed once every 4 weeks until the 28(th) week, then once every 2 weeks until 32(nd) week, then once every week until delivery, and the final visit was on 60 ± 7 days. The final outcome was assessed in terms of incidence of macrosomia (>3.5 kg body weight) between the two groups and episodes of confirmed (blood glucose <56 mg/dL) minor or major maternal hypoglycemia.
  
  
  RESULTS
  There was no statistically significant difference among the two groups in terms of incidence of macrosomia that is., it was 5.1%, 8.9% in GDM, pre-GDM group, respectively.
  
  
  CONCLUSIONS
  Insulin aspart was found safe in pregnancy, however, more studies with double-blind, standard controlled studies are required to confirm the findings of this study.
authors.affiliation: Consultant Diabetologist, Madhav Diabetes Centre, Chennai, Tamil Nadu, India.
authors.forename: M C
authors.initials: MC
authors.lastname: Deepaklal
authors.affiliation: Department of Obstetrician and Gynaecology, Joseph Nursing Home, Chennai, Tamil Nadu, India.
authors.forename: Kurian
authors.initials: K
authors.lastname: Joseph
authors.affiliation: Department of Obstetrician and Gynaecology, Joseph Nursing Home, Chennai, Tamil Nadu, India.
authors.forename: Kurian
authors.initials: K
authors.lastname: Rekha
authors.affiliation: Nandita's Fertility Centre, Chennai, Tamil Nadu, India.
authors.forename: Thakkar
authors.initials: T
authors.lastname: Nandita
keywords: Gestational diabetes mellitus; insulin aspart; pregestational diabetes mellitus