Closed-loop system improves glycemic control but not hypoglycemia for young children with type 1 diabetes mellitus

Reference

Ware J, Allen JM, Boughton CK, et al, for the KidsAP Consortium. Randomized trial of closed-loop control in very young children with type 1 diabetes. N Engl J Med 2022;386(3):209-219.

Synopsis

Sensor-augmented pump therapy (SAPT) uses continuous monitoring of blood glucose combined with an insulin pump. A closed-loop system (sometimes called an "artificial pancreas") takes the human out of the loop and uses an algorithm to adjust insulin delivery. These authors identified 74 children, aged 1 year to 7 years, who had type 1 diabetes mellitus for at least 6 months and a glycated hemoglobin level of 11.0% or lower. Those 74 children were randomized into 2 groups. The mean age of the children was 5.6 years, the 2 groups were balanced at the beginning of the study, and the analysis was by intention to treat. Group A began with the closed-loop system; Group B began with the SAPT. After 16 weeks, they had a 1- to 4-week washout period before they crossed over to receive the other therapy for 16 weeks. During the closed-loop period, children were more likely to be in the target glucose range of 70 to 180 mg/dL (71.6% vs 62.9%; P < .001; number needed to treat = 11) and their mean glycated hemoglobin level was a bit lower (6.4% vs 7.0%; P < .001). There was no difference in the time spent with low blood sugar (defined as < 54 mg/dL, < 63 mg/dL, or < 70 mg/dL), no difference in insulin use, and only a very small reduction in the percentage of time spent with a glucose level higher than 300 mg/dL (2.0% vs 3.1%; 95% CI for the difference –1.6% to –0.6%). Overall adverse events were similar, but there was one severe episode of hypoglycemia in the closed-loop group compared with zero in the SAPT group.