Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes
New England Journal of Medicine Oct 24, 2019
Brown SA, Kovatchev BP, Raghinaru D, et al. - In this 6-month randomized, multicenter trial, 168 individuals with T1DM were randomized in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group; n = 112) or a sensor-augmented pump (control group; n = 56) in order to ascertain whether closed-loop systems that automate insulin delivery enhanced glycemic outcomes in individuals with T1DM. The results relative to the main secondary outcomes, all met the prespecified hierarchical criterion for importance, supporting the closed-loop system. In the closed-loop group, the median percentage of time was 90% over 6 months, that the system was in closed-loop mode. In either group, no severe hypoglycemic events transpired, nonetheless, one episode of diabetic ketoacidosis happened in the closed-loop group. The use of a closed-loop system was related to a higher percentage of time spent in a target glycemic range vs the use of a sensor-augmented insulin pump. Thus, in this 6-month trial including individuals with T1DM, the use of a closed-loop system was related to a higher percentage of time given in a target glycemic range compared with the use of a sensor-augmented insulin pump.
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