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Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes
Ahmad Haidar1, Rémi Rabasa-Lhoret1, Laurent Legault1
1Institut de Recherches Cliniques de Montréal (A.H., R.R.-L., R.R., V.M., M.D.), Montréal, Québec, Canada H2W 1R7; Division of Experimental Medicine (A.H., R.R.-L.), McGill University, Montréal, Québec, Canada H9X 3V9; Department of Nutrition (R.R.-L.), Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada H3T 1A8; Montréal Diabetes Research Centre (R.R.-L.), Montréal, Québec, Canada H2X 0A9; Montréal Children's Hospital (L.L.), McGill University Health Centre. Montréal, Québec, Canada H4A 3J1; Lunenfeld-Tanenbaum Research Institute (L.E.L., C.M.F., T.J., A.O., H.T., B.A.P.), Mt Sinai Hospital, Toronto, Ontario, Canada M5T 3L9; Hôpital Maisonneuve-Rosemont (É.D.), Montréal, Québec, Canada H1T 3W5; Centre de Recherche (M.L.), Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada H2W 1T8; Division of Endocrinology and Metabolism (B.A.P.), Department of Medicine, University of Toronto, Toronto, Ontario, Canada M5G 2C4.
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 (4-8 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%-71%) for conventional therapy, higher on both single-hormone (76% [65%-91%], P < .001) and dual-hormone artificial pancreas (81 [68%-93%], P < .001). The median (interquartile range) time spent below 4 mmol/L was 14% (4%-28%) for conventional therapy, lower on both single-hormone (5% [0%-13%], P = .004) and dual-hormone artificial pancreas (1% [0%-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 dual-hormone 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.
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