HealthDay News — For pregnant women with type 1 diabetes, a closed-loop system is associated with comparable glucose control and significantly less hypoglycemia than sensor-augmented pump (SAP) therapy, according to a study published online in Diabetes Care.
Zoe A. Stewart, from the University of Cambridge in the United Kingdom, and colleagues recruited 16 pregnant women to an open-label randomized trial.
Participants completed 28 days of closed-loop and SAP insulin delivery separated by a washout period; for up to 6 weeks postpartum, participants could continue to use the closed-loop system.
The researchers found that the proportion of time with glucose levels within target was comparable for the closed-loop and SAP insulin delivery periods (62.3% vs 60.1%). There was also no difference in the mean glucose (131.4 vs 131.4 mg/dL) and time spent hyperglycemic >140 mg/dL (36.6% vs 36.1%).
Significantly fewer hypoglycemic episodes (median, 8.0 vs 12.5), and less time at <63 mg/dL (1.6% vs 2.7%) occurred during closed-loop; the rates of hypoglycemia <50 mg/dL (0.24% vs 0.47%) and low blood glucose index (1.0 vs 1.4) were significantly lower.
During closed-loop therapy there was significantly less nocturnal hypoglycemia (1.1% vs 2.7%).
“Larger, longer duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes,” the authors write.
Several authors disclosed financial ties to the pharmaceutical and medical device industries; several authors reported related patents and patent applications.
Stewart ZA, Wilinska ME, Hartnell S, et al. Day-and-night closed-loop insulin delivery in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial [published online March 13, 2018]. Diabetes Care. doi: 10.2337/dc17-2534