Maternal-Fetal Outcomes in 34 Pregnant Women with Type 1 Diabetes in Sensor-Augmented Insulin Pump Therapy.

BACKGROUND: Pregnancy in women with type 1 diabetes (T1D) is associated with increased risk of maternal complications and neonatal morbidity and mortality. Optimizing glycemic control improves these outcomes. OBJECTIVE: To describe the experience of using sensor-augmented insulin pump therapy (SAPT) and SAPT + low-glucose suspension (LGS) on pregnant women with T1D, including neonatal and maternal outcomes. METHODS: A prospective observational study was conducted in women with T1D who started SAPT and SAPT + LGS before or during pregnancy at the San Ignacio University Hospital Diabetes Center in Bogotá, Colombia. The main indication was severe hypoglycemia (SH) and poor glycemic control. Glycated hemoglobin (A1c), hypoglycemia, and maternal and fetal outcomes were assessed. RESULTS: Thirty-four pregnant women with T1D on SAPT and SAPT + LGS were included. Sixteen patients started therapy during pregnancy at a mean gestational age of 17.6 ± 8.3 weeks. Mean preconceptional A1c was 8.24% ± 2.02%. Absolute reduction of A1c level from prepregnancy to third trimester was -1.63% (P < 0.0001), with a significant clinical and statistical reduction in both groups, women who initiated SAPT before or during pregnancy. 52.9% of patients in second trimester and 66.6% in third trimester achieved A1c <6.5%, respectively. 91.1% underwent cesarean section. The main reasons were iterative cesarean (30%), fetal distress (20%), and preeclampsia (16%). The median gestational age at delivery was 37 weeks and 15 pregnancies resulted in preterm delivery. There was neither maternal-fetal mortality nor severe hypoglycemic episodes. Two patients had diabetic ketoacidosis. CONCLUSIONS: In pregnant patients with T1D and high risk of hypoglycemia, SAPT and SAPT + LGS should be considered as a therapeutic alternative for A1c reduction with a low risk of SH. However, additional studies are required to evaluate the efficacy and safety of this therapy during pregnancy.

Long-Term Efficacy and Safety of Sensor Augmented Insulin Pump Therapy with Low-Glucose Suspend Feature in Patients with Type 1 Diabetes.

BACKGROUND: Literature supports short-term efficacy and safety of Sensor Augmented Insulin Pump (SAP) therapy in patients with type 1 diabetes (T1D). However, no data are available showing long-term outcomes. Our study describes the long-term outcomes of SAP therapy with low-glucose suspend feature (SAP+LGS) in hypoglycemia in a Colombian population with T1D and hypoglycemia. METHODS: A cohort study was conducted with T1D patients receiving SAP+LGS therapy who initiated this therapy because of hypoglycemia at San Ignacio University Hospital diabetes center in Bogotá, Colombia. Glycated hemoglobin (A1c) was assessed at least every 6 months, severe hypoglycemia (SH) and hypoglycemia unawareness (HU) incidence yearly. Adherence to therapy was also evaluated. RESULTS: One hundred eleven patients were included in the analysis. Total daily insulin dose was reduced during follow-up (mean difference -0.22 U/kg; 95% confidence interval [CI] -0.18 to -0.26; P < 0.001). A1c levels were reduced from a baseline value of 8.8% ± 1.9% to 7.5% ± 1.0% at 5 months (mean difference -1.3%; 95% CI -1.09 to -1.50; P < 0.001) and 7.1% ± 0.8% (mean difference -1.7%; 95% CI -1.59 to -1.90; P < 0.001) at the end of follow-up (47 months on average). The incidence of SH and HU episodes decreased significantly since the first year, and this effect was maintained over time (P < 0.001). CONCLUSIONS: SAP+LGS therapy in T1D patients with hypoglycemia led to a significant and sustained decrease in A1c during long periods of follow-up, as well as a significant reduction in SH and HU. Future randomized clinical trials are desired.