ABSTRACT
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.
ABSTRACT
AIM: To assess the safety and efficacy of insulin lispro in improving glycemic control in patients with gestational diabetes. MATERIALS AND METHODS: A retrospective observational study was conducted at a single center on 201 gestational women with diabetes. Subjects who received insulin lispro performed blood glucose self-monitoring and recorded the readings in the fasting state and 1 h after each meal. At each contact (in person or telephonic contact), the insulin dose was adjusted based on the readings measured. A total of 53 subjects also recorded glucose levels post-partum. Pregnancy and post-delivery glucose level and insulin requirements of these 53 patients were compared. RESULTS: Analysis of glucose levels both fasting and post-prandial glucose levels revealed that after using insulin lispro, the number of episodes of post-prandial hyperglycemia (1 h plasma glucose >120 mg/dL) was minimal and so was the incidence of hypoglycemia. Hypoglycemia was defined as a blood sugar value of. There was neither any congenital abnormality except for a poorly formed pinna in the right ear of one baby nor any post-partum complications of note. CONCLUSION: Insulin lispro is an effective and safe treatment option in gestational diabetes.
