Single- and dual-hormone artificial pancreas for overnight glucose control in type 1 diabetes

Abstract

Context: The added benefit of glucagon in artificial pancreas systems for overnight glucose control in type 1 diabetes has not been fully explored. Objective: The objective of the study was to compare the efficacy of dual-hormone (insulin and glucagon) artificial pancreas, single-hormone (insulin alone) artificial pancreas, and conventional insulin pump therapy. Design: This study was a three-center, three-arm, open-label, randomized, crossover controlled trial involving three interventions, each applied over a night after a high carbohydrate/high fat meal and a second after exercise to mimic real-life glycemic excursions. Setting: The study was conducted in a home setting. Patients: Twenty-eight type 1 diabetes participants (21 adults and seven adolescents) participated in the study. Interventions: Dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional pump therapy was activated from 9:00 PM to 7:00 AM. Main Outcome: The main outcome was a proportion of time in target (4â€"8 mmol/L) by continuous glucose monitoring from 11:00 PM to 7:00 AM. Analysis was by intention to treat. Results: The median (interquartile range) percentage of time-in-target glucose range was 47% (36%â€"71%) for conventional therapy, higher on both single-hormone (76% [65%â€"91%], P=.001) and dual-hormone artificial pancreas (81 [68%â€"93%], P = .001). The median (interquartile range) time spent below 4 mmol/L was 14% (4%â€"28%) for conventional therapy, lower on both singlehormone (5% [0%â€"13%], P=.004) and dual-hormone artificial pancreas (1% [0%â€"8%], P=.001). There were 14 hypoglycemic events on conventional therapy compared with six incidences on the single-hormone artificial pancreas (P = .059) and three incidences on the dual-hormone artificial pancreas (P = .017). None of these outcomes differed significantly between single- and dualhormone configurations. Conclusions: Single- and dual-hormone artificial pancreas systems both provided better glucose control than conventional therapy. Although the dual-hormone configuration did not increase overnight time-in-target glucose levels, an effect on lowering hypoglycemia risk cannot be ruled out.