Hybrid closed-loop insulin therapy has shown to proffer beneficial effects in managing type 1 diabetes during pregnancy. However, the extent of efficacy the hybrid closed-loop systems offers remains unclear. In a multicenter, controlled trial, 124 pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% were randomly assigned to receive either standard insulin therapy or hybrid closed-loop therapy at nine sites in the United Kingdom. Both groups utilized continuous glucose monitoring throughout the study.
The primary outcome of the trial was the percentage of time that glucose levels remained within the pregnancy-specific target glucose range (63 to 140 mg/dl as measured by continuous glucose monitoring) from 16 weeks’ gestation until delivery. Major secondary outcomes included the percentage of time spent in a hyperglycemic state (glucose level >140 mg/dl), overnight time within the target range, the glycated hemoglobin level, and safety events.
The results revealed that the mean percentage of time the glucose level remained within the target range 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P<0.001). The secondary outcome findings were consistent with those of primary outcomes. Participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group. There were notably no unexpected safety issues observed with the use of closed-loop therapy during pregnancy. The findings from study were published in ‘The New England Journal of Medicine’, emphasizing the potential of hybrid closed-loop insulin therapy as a valuable tool for managing type 1 diabetes during pregnancy.