Abstract
Aim: Although insulin glargine is frequently being used in pregnancy, it is not approved by the FDA as the data on its safety is limited. The aim of this study was to determine the effects of insulin glargine use in pregnancy on maternal and fetal outcomes. Methods: From the perinatal center at Sparrow Hospital, Lansing, Michigan the charts of 92 women with diabetes (gestational diabetes, type 1 diabetes and type 2 diabetes) who were treated with insulin glargine during pregnancy were reviewed. Maternal and fetal outcomes were recorded. Results: Eighteen women had continued pre-pregnancy insulin glargine use through pregnancy and 74 were started on insulin glargine during pregnancy. The average HbA1c was 7.7%, 7.1% and 6.3% respectively in 1st, 2nd, and 3rd trimester. 31% of the woman had hypoglycemic episodes. No maternal deaths were reported. One pregnancy resulted in intrauterine fetal death. The rate of cesarean sections was 45% and the average age of gestation at delivery was 36 weeks. 12% of the newborns had macrosomia (defined as birth weight >4000 pounds), 2% had shoulder dystocia, and 7% had neonatal hypoglycemia. The data were compared to the outcome from prior studies of pregnant patients in NPH and insulin glargine. Conclusion: We present data on maternal and perinatal outcomes with use of insulin glargine during pregnancy at our institution. Our data compares favorably with the outcome from other studies of pregnant patients using NPH insulin.
Highlights
In order to improve the control of diabetes, insulin analogs with duration of action longer or shorter than traditional insulins, have been developed and have shown to provide better glucose control and decrease the rate of hypoglycemia in patients with diabetes [1,2,3]
This research demonstrated increased mitogenic potency of insulin glargine compared with native insulin in human sarcoma cells [6], it is uncertain if similar effects occur in vivo
The medical records of each woman and neonate were reviewed and data was collected for age, type of diabetes, trimester of pregnancy when insulin was started, episodes of maternal hypoglycemia, hemoglobin A1c levels achieved and units of insulin glargine used during each trimester
Summary
In order to improve the control of diabetes, insulin analogs with duration of action longer or shorter than traditional insulins, (regular and neutral protamine Hagedorn) have been developed and have shown to provide better glucose control and decrease the rate of hypoglycemia in patients with diabetes [1,2,3]. Insulin detemir was recently relabeled as a category “B” for the use in pregnancy on the basis of a trial involving 310 pregnant women with type 1 diabetes, with approximately half taking insulin detemir and the other half taking NPH insulin. Both groups achieved similar reductions in hemoglobin A1c. Insulin glargine is being used in pregnancy “off label”, it is still categorized as category “C” This classification implies that: (a) either study in animals has revealed adverse effects on the fetus (teratogenic or embryocidal effects or other); (b) studies in women and animals are not available, and/or (c) there are no controlled studies in humans. This research demonstrated increased mitogenic potency of insulin glargine compared with native insulin in human sarcoma cells [6], it is uncertain if similar effects occur in vivo
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