title: Clinical evaluation of a personalized artificial pancreas.
abstract: OBJECTIVE
  An artificial pancreas (AP) that automatically regulates blood glucose would greatly improve the lives of individuals with diabetes. Such a device would prevent hypo- and hyperglycemia along with associated long- and short-term complications as well as ease some of the day-to-day burden of frequent blood glucose measurements and insulin administration.
  
  
  METHODS
  We conducted a pilot clinical trial evaluating an individualized, fully automated AP using commercial devices. Two trials (n = 22, n(subjects) = 17) were conducted using a multiparametric formulation of model predictive control and an insulin-on-board algorithm such that the control algorithm, or "brain," can be embedded on a chip as part of a future mobile device. The protocol evaluated the control algorithm for three main challenges: 1) normalizing glycemia from various initial glucose levels, 2) maintaining euglycemia, and 3) overcoming an unannounced meal of 30 ± 5 g carbohydrates.
  
  
  RESULTS
  Initial glucose values ranged from 84-251 mg/dL. Blood glucose was kept in the near-normal range (80-180 mg/dL) for an average of 70% of the trial time. The low and high blood glucose indices were 0.34 and 5.1, respectively.
  
  
  CONCLUSIONS
  These encouraging short-term results reveal the ability of a control algorithm tailored to an individual's glucose characteristics to successfully regulate glycemia, even when faced with unannounced meals or initial hyperglycemia. To our knowledge, this represents the first truly fully automated multiparametric model predictive control algorithm with insulin-on-board that does not rely on user intervention to regulate blood glucose in individuals with type 1 diabetes.
authors.affiliation: Department of Chemical Engineering, University of California, Santa Barbara, California, USA.
authors.forename: Eyal
authors.initials: E
authors.lastname: Dassau
authors.forename: Howard
authors.initials: H
authors.lastname: Zisser
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Harvey
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Percival
authors.forename: Benyamin
authors.initials: B
authors.lastname: Grosman
authors.forename: Wendy
authors.initials: W
authors.lastname: Bevier
authors.forename: Eran
authors.initials: E
authors.lastname: Atlas
authors.forename: Shahar
authors.initials: S
authors.lastname: Miller
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.forename: Lois
authors.initials: L
authors.lastname: Jovanovic
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Doyle
mesh_terms: D000465:Algorithms; D001786:Blood Glucose; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D006801:Humans; D007332:Insulin Infusion Systems; D019397:Pancreas, Artificial
chemical_list: D001786:Blood Glucose