Abstract Aims: This study performed a systematic review and meta-analysis on glycemic control and pregnancy outcomes in women with type 1 diabetes mellitus (T1DM) treated with lispro (LP) versus regular insulin (RI) since before pregnancy. Methods: We performed a MEDLINE and EMBASE search. Abstracts (and full articles when appropriate) were reviewed by two independent researchers. Inclusion criteria were patients with T1DM, data on women treated with RI and LP since before pregnancy until delivery in the same article, at least five pregnancies in each group, and information on at least one pregnancy outcome. Quality assessment was performed using the Newcastle-Ottawa Quality Assessment Scale for cohort studies. Results: Outcome data were summarized with Revman version 5.0 (ims.cochrane.org/revman/download [The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark]), applying a random effects model. Two hundred sixty-seven abstracts were identified, and four full articles fulfilled inclusion criteria, all of them corresponding to observational studies. Baseline characteristics were similar in women treated with LP or RI. Regarding outcome data, no differences between LP and RI groups were observed in hemoglobin A1c, gestational age at birth, birth weight, and rate of diabetic ketoacidosis, pregnancy-induced hypertension, pre-eclampsia, spontaneous miscarriages, interruptions, total abortions, cesarean section, preterm birth, macrosomia, small-for gestational-age newborns, stillbirth, neonatal and perinatal mortality, neonatal hypoglycemia, and major malformations. The rate of large-for-gestational age newborns was higher in the LP group (relative risk 1.38; 95% confidence interval 1.14-1.68). Conclusions: In relation to women with T1DM treated with RI, those treated with LP display similar baseline characteristics and no differences in metabolic control or perinatal outcome with the exception of a higher rate of large-for-gestational-age newborns.