title: Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial.
abstract: To assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared to the single-hormone (insulin alone) artificial pancreas in outpatient settings during the day and night.
  
  
  
  In a randomized, three-way, crossover trial we compared the dual-hormone artificial pancreas, the single-hormone artificial pancreas and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 8 AM Day 1 to 8 PM Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than .017 was regarded as significant.
  
  
  
  The median difference between the dual-hormone system and the single-hormone system was -2.3% (P = .072) for time spent below 4.0 mmol/L, -1.3% (P = .017) for time below 3.5 mmol/L, and -0.7% (P = .031) for time below 3.3 mmol/L. Both systems reduced (P < .017) hypoglycaemia below 4.0, 3.5 and 3.3 mmol/L compared to control therapy, but reductions were larger with the dual-hormone system than with the single-hormone system (medians -4.0% vs -3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and -2.2% vs -1.2% for 3.3 mmol/L). There were 34 hypoglycaemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system and 6 with the dual-hormone system. These differences in hypoglycaemia were observed while mean glucose level was low and comparable in all interventions (P = NS).
  
  
  
  The dual-hormone artificial pancreas had the lowest risk of hypoglycaemia, but the differences were not statistically significant. Larger studies are needed.
authors.affiliation: Faculty of Medicine, Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.|Faculty of Medicine, Division of Endocrinology and Metabolism, McGill University, Montréal, Québec, Canada.
authors.forename: Ahmad
authors.identifier: 0000-0002-6700-0385
authors.initials: A
authors.lastname: Haidar
authors.affiliation: Institut de recherches cliniques de Montréal, Montréal, Québec, Canada.
authors.forename: Virginie
authors.initials: V
authors.lastname: Messier
authors.affiliation: Montreal Children's Hospital, McGill University Health Centre, Montréal, Québec, Canada.
authors.forename: Laurent
authors.initials: L
authors.lastname: Legault
authors.affiliation: The Research Center of the Université de Montréal Hospital Center, Montréal, Québec, Canada.|Département de Médecine Sociale et Préventive, School of Public Health, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Ladouceur
authors.affiliation: Institut de recherches cliniques de Montréal, Montréal, Québec, Canada.|The Research Center of the Université de Montréal Hospital Center, Montréal, Québec, Canada.|Faculty of Medicine, Nutrition Department, Université de Montréal, Montréal, Québec, Canada.|Montreal Diabetes Research Center, Montréal, Québec, Canada.
authors.forename: Rémi
authors.initials: R
authors.lastname: Rabasa-Lhoret
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D003131:Combined Modality Therapy / Q000009:adverse effects; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D005934:Glucagon / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007260:Infusion Pumps / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation; D019397:Pancreas, Artificial / Q000009:adverse effects; D010353:Patient Education as Topic; D011792:Quebec / Q000453:epidemiology; D012306:Risk
chemical_list: D001786:Blood Glucose; D005934:Glucagon; D006442:Glycated Hemoglobin; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: artificial pancreas, closed-loop insulin delivery, glucagon; hypoglycaemia; insulin therapy; randomised trial; type 1 diabetes