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Abstract 


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.

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