Bioartificial pancreas use in diabetic pregnancy

The purpose of this study was to evaluate the feasibility and effectiveness of Bioartificial Pancreas (BAP) technology use during diabetic pregnancy. In particular, the study asked 1) can microencapsulated islet cells effecti vely correct carbohydrate metabolism during diabetic pregnancy and 2) will such therapy, if initiated before conception, eliminate diabetes-induced co ngenital malformations in the fetus? Streptozotocin-induced diabetic female mice (ICR) received transplants of rat islets encapsulated within alginate microbeads. Animals were placed with male mice and bred. Random, nonfastin g blood glucose (BG) determinations were made posttransplantation and throu ghout pregnancy. Pups were delivered by cesarean section on day 19 of gesta tion. Outcome parameters from transplanted animals (Tx) were compared to no ndiabetic control animals and to untreated diabetic (DM) animals. Transplan ted animals had significantly lower BG levels throughout pregnancy, compare d with DM animals, but also had levels that were often lower than those see n in control nondiabetic animals, and had increased episodes of documented hypoglycemia. The malformation and fetal loss rate in the Tx group was sign ificantly lower than the untreated group (ICR: 5.4% vs. 40%). Only 3 of 84 pups from the Tx group had major malformations, but all had anencephaly, a malformation not seen in any other study group. Both maternal BG levels and fetal malformation rates are significantly reduced using BAP technology in our animal models. However, the possible role these encapsulated islets ma y play in producing increased episodes of hypoglycemia or specific congenit al malformations in pregnancy must be thoroughly investigated before any cl inical studies.