In 124 patients with pregnancy complicated by type 1 diabetes, the use of hybrid closed-loop insulin therapy significantly improved maternal glycemic control, researchers report. The intervention “provided a clinical advantage beyond that achieved with continuous glucose monitoring and insulin-pump therapy,” writes the AiDAPT Collaborative Group. “These results support the recommendations, proposed in the guideline from the National Institute for Health Care Excellence, that hybrid closed-loop therapy should be offered to all pregnant persons with type 1 diabetes.”
Pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at 9 U.K. sites. While using continuous glucose monitoring, participants were randomized to standard insulin therapy or hybrid closed-loop therapy.
Based on a primary outcome of the percentage of time in the pregnancy-specific target glucose range of 63–140 mg/dL, the study showed the following: “A total of 124 participants with a mean (± SD) age of 31.1 ± 5.3 years and a mean baseline glycated hemoglobin level of 7.7 ± 1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 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). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, −10.2 percentage points; 95% CI, −13.8 to −6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, −0.31 percentage points; 95% CI, −0.50 to −0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy).”
Editorial: “Many recent global registries still report suboptimal glucose control in patients with type 1 diabetes,” editorialists write. “Higher cost, reduced access, and implementation challenges may contribute to this inability to achieve optimal glucose control. In addition, major barriers exist to implementing use of a closed-loop system or continuous glucose monitoring, including biases related to socioeconomic status, ethnicity, and implicit racial bias. Clearly, closed-loop systems have changed the landscape of diabetes care in nonpregnant populations. Although more studies are needed, the AiDAPT trial provides hope that this landscape may also be altered for the better for pregnant persons with type 1 diabetes.”