Objective: This study was designed to determine whether there is an association 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 diabetes mellitus (n = 12) who were enrolled in our diabetes mellitus in pregnancy program and were treated with insulin lispro during pregnancy. We compared these women with a historical cohort (n = 42) who were treated with regular insulin during pregnancy. All patients underwent ophthalmologic examinations before 24 weeks' gestation and post partum, and retinopathy was graded according to a previously defined scale.
Results: Whereas none of the patients in the insulin lispro group showed any 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 the baseline examination (change from grade 0 to 6). Two patients had progression of retinopathy--1 had progression from background retinopathy to mild proliferative retinopathy (change from grade 2 to 4) and 1 had progression from mild proliferative retinopathy to extensive proliferative retinopathy (change from grade 4 to 6).
Conclusions: These preliminary findings provide no evidence that insulin lispro treatment during pregnancy is associated with the development or progression of diabetic retinopathy.