title: Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe.
abstract: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old children during a camp.
  
  
  
  A total of 30 children, 5- to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensor-augmented pump (SAP).
  
  
  
  Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P = 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P = 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001).
  
  
  
  This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.
authors.affiliation: Department of Information Engineering, University of Padua, Padua, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Del Favero
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Boscari
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Mirko
authors.initials: M
authors.lastname: Messori
authors.affiliation: Department of Pediatrics, University of Turin, Turin, Italy.
authors.forename: Ivana
authors.initials: I
authors.lastname: Rabbone
authors.affiliation: Pediatric Department and Diabetes Research Institute, Scientific Institute, Hospital San Raffaele, Milan, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bonfanti
authors.affiliation: Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Sabbion
authors.affiliation: Department of Pediatrics, Second University of Naples, Naples, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Iafusco
authors.affiliation: Unit of Endocrinology and Diabetes, Bambino Gesù Children's Hospital, Rome, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Schiaffini
authors.affiliation: Department of Information Engineering, University of Padua, Padua, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Visentin
authors.affiliation: Department of Information Engineering, University of Padua, Padua, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Calore
authors.affiliation: Department of Information Engineering, University of Padua, Padua, Italy.
authors.forename: Yenny Leal
authors.initials: YL
authors.lastname: Moncada
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Galasso
authors.affiliation: Department of Women's and Children's Health, University of Padua, Padua, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Galderisi
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Vallone
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Di Palma
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Losiouk
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
authors.forename: Giordano
authors.initials: G
authors.lastname: Lanzola
authors.affiliation: Department of Pediatrics, University of Turin, Turin, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Tinti
authors.affiliation: Pediatric Department and Diabetes Research Institute, Scientific Institute, Hospital San Raffaele, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rigamonti
authors.affiliation: Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Marigliano
authors.affiliation: Department of Pediatrics, Second University of Naples, Naples, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Zanfardino
authors.affiliation: Pediatric Diabetology Unit, Policlinico di Tor Vergata, University of Rome Tor Vergata, Rome, Italy.
authors.forename: Novella
authors.initials: N
authors.lastname: Rapini
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Avogaro
authors.affiliation: Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chernavvsky
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Lalo
authors.initials: L
authors.lastname: Magni
authors.affiliation: Department of Information Engineering, University of Padua, Padua, Italy cobelli@dei.unipd.it.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cobelli
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Bruttomesso
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D019397:Pancreas, Artificial
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin