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Year : 2015  |  Volume : 19  |  Issue : 5  |  Page : 658-662

Insulin aspart in patients with gestational diabetes mellitus and pregestational diabetes mellitus

1 Consultant Diabetologist, Madhav Diabetes Centre, Chennai, Tamil Nadu, India
2 Department of Obstetrician and Gynaecology, Joseph Nursing Home, Chennai, Tamil Nadu, India
3 Nandita's Fertility Centre, Chennai, Tamil Nadu, India

Correspondence Address:
M C Deepaklal
Madhav Diabetes Centre, AA2, Avenue Round Tana, Anna Nagar, Chennai - 600 040, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2230-8210.163202

Clinical trial registration CTRI/2008/091/000070

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Aims: This study was undertaken to assess the effectiveness and safety of insulin aspart in patients with gestational and pregestational diabetes. Settings and Design: An open-label, prospective, nonrandomized, comparative, and observational study conducted at single center in India. Subjects and 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.

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