Is insulin lispro associated with the development or progression of diabetic retinopathy during pregnancy?

OBJECTIVE: This study was designed to determine whether there is an associa tion between the use of insulin lispro during pregnancy and the development or progression of diabetic retinopathy. STUDY DESIGN: This observational cohort study included women with type 1 di abetes mellitus (n = 12) who were enrolled in our diabetes mellitus in preg nancy program and were treated with insulin lispro during pregnancy. We com pared these women with a historical cohort (n = 42) who were treated with r egular insulin during pregnancy All patients underwent ophthalmologic exami nations before 24 weeks' gestation and post partum, and retinopathy was gra ded according to a previously defined scale. RESULTS: Whereas none of the patients in the insulin lispro group showed an y change in retinopathy status, 6 patients in the regular insulin group (14 %) demonstrated changes in retinopathy status. Mild background retinopathy (change from grade 0 to 1) developed in 3 of these patients, and extensive proliferative retinopathy developed in 1 patient after normal results of th e baseline examination (change from grade 6 to 6). Two patients had progres sion of retinopathy-1 had progression from background retinopathy to mild p roliferative retinopathy (change from grade 2 to 4) and 1 had progression f rom mild proliferative retinopathy to extensive proliferative retinopathy ( change from grade 4 to 6). CONCLUSIONS: These preliminary findings provide no evidence that insulin li spro treatment during pregnancy is associated with the development or progr ession of diabetic retinopathy.