Ahmad Haidar1, Rémi Rabasa-Lhoret1, Laurent Legault1, Leif E Lovblom1, Rohan Rakheja1, Virginie Messier1, Émilie D'Aoust1, C Marcelo Falappa1, Tara Justice1, Andrej Orszag1, Holly Tschirhart1, Maryse Dallaire1, Martin Ladouceur1, Bruce A Perkins1. 1. Institut 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.
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 (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.
RCT Entities:
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 diabetesparticipants (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.
Authors: Firas H El-Khatib; Courtney Balliro; Mallory A Hillard; Kendra L Magyar; Laya Ekhlaspour; Manasi Sinha; Debbie Mondesir; Aryan Esmaeili; Celia Hartigan; Michael J Thompson; Samir Malkani; J Paul Lock; David M Harlan; Paula Clinton; Eliana Frank; Darrell M Wilson; Daniel DeSalvo; Lisa Norlander; Trang Ly; Bruce A Buckingham; Jamie Diner; Milana Dezube; Laura A Young; April Goley; M Sue Kirkman; John B Buse; Hui Zheng; Rajendranath R Selagamsetty; Edward R Damiano; Steven J Russell Journal: Lancet Date: 2016-12-20 Impact factor: 79.321
Authors: Laya Ekhlaspour; Laura M Nally; Firas H El-Khatib; Trang T Ly; Paula Clinton; Eliana Frank; Molly L Tanenbaum; Sarah J Hanes; Rajendranath R Selagamsetty; Korey Hood; Edward R Damiano; Bruce A Buckingham Journal: J Diabetes Sci Technol Date: 2019-08-30