title: Metabolic Control With the Bio-inspired Artificial Pancreas in Adults With Type 1 Diabetes: A 24-Hour Randomized Controlled Crossover Study.
abstract: BACKGROUND
  The Bio-inspired Artificial Pancreas (BiAP) is a closed-loop insulin delivery system based on a mathematical model of beta-cell physiology and implemented in a microchip within a low-powered handheld device. We aimed to evaluate the safety and efficacy of the BiAP over 24 hours, followed by a substudy assessing the safety of the algorithm without and with partial meal announcement. Changes in lactate and 3-hydroxybutyrate concentrations were investigated for the first time during closed-loop.
  
  
  METHODS
  This is a prospective randomized controlled open-label crossover study. Participants were randomly assigned to attend either a 24-hour closed-loop visit connected to the BiAP system or a 24-hour open-loop visit (standard insulin pump therapy). The primary outcome was percentage time spent in target range (3.9-10 mmol/l) measured by sensor glucose. Secondary outcomes included percentage time in hypoglycemia (<3.9 mmol/l) and hyperglycemia (>10 mmol/l). Participants were invited to attend for an additional visit to assess the BiAP without and with partial meal announcements.
  
  
  RESULTS
  A total of 12 adults with type 1 diabetes completed the study (58% female, mean [SD] age 45 [10] years, BMI 25 [4] kg/m(2), duration of diabetes 22 [12] years and HbA1c 7.4 [0.7]% [58 (8) mmol/mol]). The median (IQR) percentage time in target did not differ between closed-loop and open-loop (71% vs 66.9%, P = .9). Closed-loop reduced time spent in hypoglycemia from 17.9% to 3.0% (P < .01), but increased time was spent in hyperglycemia (10% vs 28.9%, P = .01). The percentage time in target was higher when all meals were announced during closed-loop compared to no or partial meal announcement (65.7% [53.6-80.5] vs 45.5% [38.2-68.3], P = .12).
  
  
  CONCLUSIONS
  The BiAP is safe and achieved equivalent time in target as measured by sensor glucose, with improvement in hypoglycemia, when compared to standard pump therapy.
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK m.reddy@imperial.ac.uk.
authors.forename: Monika
authors.initials: M
authors.lastname: Reddy
authors.affiliation: Centre for Bio-Inspired Technology, Department of Electrical and Electronic Engineering, Institute of Biomedical Engineering, Imperial College London, UK.
authors.forename: Pau
authors.initials: P
authors.lastname: Herrero
authors.affiliation: Centre for Bio-Inspired Technology, Department of Electrical and Electronic Engineering, Institute of Biomedical Engineering, Imperial College London, UK.
authors.forename: Mohamed El
authors.initials: ME
authors.lastname: Sharkawy
authors.affiliation: Centre for Bio-Inspired Technology, Department of Electrical and Electronic Engineering, Institute of Biomedical Engineering, Imperial College London, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Pesl
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: Narvada
authors.initials: N
authors.lastname: Jugnee
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: Darrell
authors.initials: D
authors.lastname: Pavitt
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: Ian F
authors.initials: IF
authors.lastname: Godsland
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: George
authors.initials: G
authors.lastname: Alberti
authors.affiliation: Centre for Bio-Inspired Technology, Department of Electrical and Electronic Engineering, Institute of Biomedical Engineering, Imperial College London, UK.
authors.forename: Christofer
authors.initials: C
authors.lastname: Toumazou
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: Desmond G
authors.initials: DG
authors.lastname: Johnston
authors.affiliation: Centre for Bio-Inspired Technology, Department of Electrical and Electronic Engineering, Institute of Biomedical Engineering, Imperial College London, UK.
authors.forename: Pantelis
authors.initials: P
authors.lastname: Georgiou
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK.
authors.forename: Nick S
authors.initials: NS
authors.lastname: Oliver
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019397:Pancreas, Artificial
chemical_list: D001786:Blood Glucose
keywords: Bio-inspired Artificial Pancreas; closed-loop insulin delivery; diabetes technology; type 1 diabetes